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Pharmaceutical Challenges Aided by a Laboratory Powder X-ray Diffraction (PXRD) System PHARMACEUTICAL CHALLENGES AIDED BY A LABORATORY POWDER X-RAY DIFFRACTION (PXRD) SYSTEM

whitepaper

Aug 11, 2018

This white paper explores a number of ways that today’s modern, laboratory-based  PXRD instrumentation and advanced software can greatly assist pharmaceutical scientists in their quest to develop high quality, stable products and accelerat...

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Moving Away from Spreadsheets: How to Know When It’s Time MOVING AWAY FROM SPREADSHEETS: HOW TO KNOW WHEN IT’S TIME

whitepaper

Jul 23, 2018

The spreadsheet conundrum... Joe Smith, sales director for Great Start-Up Number 5 Billion and Thirty-One, puts on a blindfold and reaches out blindly for something, ANYTHING, to help him organize his team’s deals and commissions. He’s ho...

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Why Enterprise CPQ Implementations Fail WHY ENTERPRISE CPQ IMPLEMENTATIONS FAIL

whitepaper

Jul 23, 2018

You’ve reached a certain point in the evolution of your company and you know it’s time to invest in a CPQ system. But buyer beware: There’s a certain misconception around CPQ systems as being plug-in devices or turnkey-ready overlays of your existing...

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The Three “S’s” of a Great Incentive Compensation Management System THE THREE “S’S” OF A GREAT INCENTIVE COMPENSATION MANAGEMENT SYSTEM

whitepaper

Jul 23, 2018

It all ties together. You want your sales reps to behave a certain way and close a certain amount of deals in specific verticals that match your company’s 3- and/or 5-year vision, but the systems you currently have in place to drive this behavi...

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Incentive Compensation Management: Build Versus Buy INCENTIVE COMPENSATION MANAGEMENT: BUILD VERSUS BUY

whitepaper

Jul 23, 2018

Custom ICM solutions are built for you, not auditors, so they typically don’t offer visibility into actions performed over time. Auditors may lack confidence in your homegrown system, especially if they find errors or omissions. In fact, audit ...

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Detection of immune checkpoint markers in peripheral blood mononuclear cell lysates with AlphaLISA DETECTION OF IMMUNE CHECKPOINT MARKERS IN PERIPHERAL BLOOD MONONUCLEAR CELL LYSATES WITH ALPHALISA

whitepaper

Jul 17, 2018

Quickly and easily quantitate immune checkpoint markers using a fraction of the sample volume required by traditional ELISA. In this technical note, we show how AlphaLISA can be used to detect and quantify additional immune checkpoint molecules withi...

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Tufts CSDD-Veeva eClinical Study CRO Report TUFTS CSDD-VEEVA ECLINICAL STUDY CRO REPORT

whitepaper

Jul 06, 2018

See results from the Tufts eClinical Landscape Study – CRO Report on current data management practices, goals, and challenges for contract research organizations (CROs). Findings include. Anticipated growth and variety of data sources used by C...

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Ideas to Make Health Care Affordable Again IDEAS TO MAKE HEALTH CARE AFFORDABLE AGAIN

whitepaper

Jun 29, 2018

More Americans are concerned about health care costs (85%) that are concerned about other common worries like retirement (73%), housing (66%), and child care (49%).1 While Republicans, Democrats, and independents are divided over many healthcare issu...

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Accelerating the Journey from Research to Clinic ACCELERATING THE JOURNEY FROM RESEARCH TO CLINIC

whitepaper

Jun 26, 2018

Bridging the gap from discovery to verification and validation requires high-performing instruments and software as well as competency in mass spec-based biomarker discovery and method development for biomarker verification. The Thermo Scientific&tra...

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Regulatory Considerations for Incorporating PCID into SODF Drugs REGULATORY CONSIDERATIONS FOR INCORPORATING PCID INTO SODF DRUGS

whitepaper

Jun 23, 2018

Unauthorized diversion and falsification of drug products create safety risks in the supply chain, creating life-threatening risk for patients and reducing revenue, profitability and brand equity for drug owners. To reduce the proliferation of c...

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The Impact of the Clinical Educator THE IMPACT OF THE CLINICAL EDUCATOR

whitepaper

Jun 12, 2018

From passive consumer to active participant, the role of the patient is changing as dramatically as the healthcare system itself. The fee-for-service, volume-based care of the past is giving way to a value-based care system focusing on quality and ou...

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Six Principles for Getting Pharmaceutical Development Right from the Start SIX PRINCIPLES FOR GETTING PHARMACEUTICAL DEVELOPMENT RIGHT FROM THE START

whitepaper

Jun 10, 2018

Pharmaceutical or biotechnology companies looking to outsource their API production are planning for success by looking at the entire development cycle. The growing desire to select one API partner to work with throughout the drug development process...

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THE FUTURE OF THE PHARMACEUTICAL INDUSTRY THE FUTURE OF THE PHARMACEUTICAL INDUSTRY

whitepaper

Jun 05, 2018

Ever participated in one of those benchmarking exercises? You know what I mean. When a (usually) fresh-faced consultant asks lots of questions and fills in a spreadsheet comparing what you do with your competitors. Well, beware. Trying to copy and fo...

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HOW TO EXTEND IDENTITY SECURITY TO YOUR API’S HOW TO EXTEND IDENTITY SECURITY TO YOUR API’S

whitepaper

May 25, 2018

The number of users and devices requesting access to applications is growing exponentially, and enterprises are scrambling to adapt their authentication and authorization infrastructure to deal with this fast growth. REST APIs are a critical new appl...

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Manufacturing Of Sterile Aqueous Suspensions: A Primer MANUFACTURING OF STERILE AQUEOUS SUSPENSIONS: A PRIMER

whitepaper

May 15, 2018

Manufacturing of sterile aqueous suspensions requires the thorough understanding of the factors that influence their physical and chemical stability. Particle morphology of the active pharmaceutical ingredient (API) plays a key factor in drug product...

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Avoid Clinical Trial Enrollment Pitfalls AVOID CLINICAL TRIAL ENROLLMENT PITFALLS

whitepaper

May 06, 2018

Selecting the right site is the single most crucial decision
you’ll make about your next clinical trial. And perhaps the
single most important consideration in selecting a site is
whether it can make its enrollment. Many do...

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EPIC FAIL: FIVE PROVEN WAYS TO BOTCH YOUR SUPPLIER RELATIONSHIP MANAGEMENT PROGRAM EPIC FAIL: FIVE PROVEN WAYS TO BOTCH YOUR SUPPLIER RELATIONSHIP MANAGEMENT PROGRAM

whitepaper

May 04, 2018

Supplier Relationship Management (SRM) is not a new concept, but it has been growing in importance. The theory is that SRM helps enterprises drive value in both recessionary periods – like that of the last few years – by enabling cost red...

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Digital Pathology in Accelerating Drug Development DIGITAL PATHOLOGY IN ACCELERATING DRUG DEVELOPMENT

whitepaper

Apr 25, 2018

Tissue pathology is at the core of various aspects of the pharmaceutic pipeline. Digital pathology is a technology that converts glass microscope slides with tissue samples into whole slide digital images, which can be used to identify, quantify, and...

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ALIGNING STAKEHOLDERS IN A NEW HEALTHCARE ECOSYSTEM ALIGNING STAKEHOLDERS IN A NEW HEALTHCARE ECOSYSTEM

whitepaper

Apr 05, 2018

Preventable chronic diseases such as diabetes, cardiovascular disease, and cancers are responsible for over 40 of the 56 million annual deaths worldwide (7 out of every 10 deaths). Our medical communities spend vast resources battling complications o...

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Discriminating insulin analogs with liquid chromatography-mass spectrometry DISCRIMINATING INSULIN ANALOGS WITH LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY

whitepaper

Apr 04, 2018

There is currently a half-dozen different insulin analogues on the market. These differ from each other and from natural insulin by just a few amino acids but exhibit markedly different pharmacokinetic and pharmacodynamic properties. Liquid chromatog...

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The Benefits of Aqueous Critical Cleaning THE BENEFITS OF AQUEOUS CRITICAL CLEANING

whitepaper

Mar 20, 2018

Aqueous cleaners are typically formulated to ensure maximal cleaning performance by using key ingredients such as surface active agents (surfactants) excellent wetting agents that allow the cleaning solution to penetrate into crevices while getting u...

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AN ANALYSIS OF DRUG THERAPY TAPERING GUIDELINES AN ANALYSIS OF DRUG THERAPY TAPERING GUIDELINES

whitepaper

Mar 16, 2018

Chronic pain, the kind of pain a person wakes up with every morning and goes to sleep with every night, has a standard of care that is often incomplete and sometimes inaccurate. Chronic pain treatment often revolves around drug therapy and managing s...

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Analysis Using Counter-rotating Twin Screw Extruder ANALYSIS USING COUNTER-ROTATING TWIN SCREW EXTRUDER

whitepaper

Mar 14, 2018

While the co-rotating, intermeshing TSE is more commonly used in pharmaceutical R&D and production, the counter-rotating, intermeshing TSE is a viable tool to successfully process these formulations. Energy input must be strategically balanced to...

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High capacity containment check screening HIGH CAPACITY CONTAINMENT CHECK SCREENING

whitepaper

Mar 10, 2018

This paper will discuss the aspects of bioburden reduction in a manufacturing area or cleanroom during operational shutdown or for routine maintenance scheduling. Relevant regulatory requirements are overviewed, along with the factors constituting as...

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A Recent History of Antibiotics and Where We May Be Going A RECENT HISTORY OF ANTIBIOTICS AND WHERE WE MAY BE GOING

whitepaper

Mar 01, 2018

About Clinical Research Management, Inc. Clinical Research Management (ClinicalRM) is not only involved in the testing of new antibiotics in Phase I, II, III studies, monitoring protocol development, site selection, and assistance with FDA approvals,...

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4 Pillars Pharma Distributors Can Stand On 4 PILLARS PHARMA DISTRIBUTORS CAN STAND ON

whitepaper

Feb 21, 2018

Despite a recent global economic downturn, the world pharmaceutical market is currently estimated to be valued at around $300 billion and rising, according to the World Health Organization (WHO). In a recent post, the WHO states that more than a thir...

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Using Technology to Revolutionize the Health Care Industry USING TECHNOLOGY TO REVOLUTIONIZE THE HEALTH CARE INDUSTRY

whitepaper

Feb 18, 2018

What if we could focus interventions on the exact group that can be most impacted? Target those that can benefit most from a particular series of actions? Identify transient patients so they could be intensely targeted before they move on? Effectivel...

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TRACK & TRACE IN THE PHARMACEUTICAL INDUSTRY TRACK & TRACE IN THE PHARMACEUTICAL INDUSTRY

whitepaper

Feb 13, 2018

The pharmaceutical industry is not short of challenges patent cliffs, regulatory scrutiny, and R&D productivity, as well as a complex supply chain. Pharmaceutical products see several changes of hands from the manufacturers to distributors to dis...

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Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs CHOOSING THE BEST STERILE DOSAGE FORM FOR YOUR PHASE I CLINICAL SUPPLY NEEDS

whitepaper

Jan 20, 2018

There are many parenteral dosage forms from which the pharmaceutical scientist can choose to develop their drug product. For primary pack choices, there are traditional vials, ampoules, cartridges, pre-filled syringes and complex containers such as t...

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Pharma R&D Annual Review 2017 PHARMA R&D ANNUAL REVIEW 2017

whitepaper

Jan 12, 2018

Welcome to Pharmaprojects’ 2017 review of trends in pharmaceutical R&D. For around a quarter of a century now, I’ve been taking an annual look at the evolution of pharma R&D, and in this article, I’ll look at how the land li...

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Population Health Management: Optimizing Pharmacy’s Capacity for Value-Based Patient Care POPULATION HEALTH MANAGEMENT: OPTIMIZING PHARMACY’S CAPACITY FOR VALUE-BASED PATIENT CARE

whitepaper

Jan 10, 2018

This whitepaper addresses value-based health care as a driver of Population Health Management (PHM), the integral role of pharmacy-based Population Health Management, and strategies for optimizing patient care capacity to improve health outcomes and ...

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Medical Research Law & Policy Report MEDICAL RESEARCH LAW & POLICY REPORT

whitepaper

Jan 03, 2018

Will the 21st Century Cures Act further its aim to boost drug and device development in 2018? That's one of the questions the life sciences industry and attorneys are asking for the new year. The law provides extra money for research and developm...

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Reforming Biopharmaceutical Pricing at Home and Abroad REFORMING BIOPHARMACEUTICAL PRICING AT HOME AND ABROAD

whitepaper

Nov 23, 2017

The affordability of healthcare and biopharmaceutical drugs is a top concern for Americans. It is often asserted that promoting innovation and affordable drugs are conflicting goals. New innovations, however, often provide improved health that was no...

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Application note: Verification of pharmaceutical raw materials using the Spectrum Two N FT-NIR Spectrometer APPLICATION NOTE: VERIFICATION OF PHARMACEUTICAL RAW MATERIALS USING THE SPECTRUM TWO N FT-NIR SPECTROMETER

whitepaper

Nov 01, 2017

Near-infrared (NIR) spectroscopy is an important technique for materials checking at various stages of the manufacturing process but is particularly useful at the raw materials inspection stage. Raw materials come in a variety of physical forms inclu...

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A Better Prescription for Reducing Medication Errors and
Maximizing the Value of Clinical Decision Support A BETTER PRESCRIPTION FOR REDUCING MEDICATION ERRORS AND MAXIMIZING THE VALUE OF CLINICAL DECISION SUPPORT

whitepaper

Oct 30, 2017

Medication errors remain an unnecessary public health menace. While industry awareness of the problem has existed for some time, efforts to reduce the incidence and impact of medication errors have not yet yielded much success. Consequently, the sign...

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Accelerating precision medicine ACCELERATING PRECISION MEDICINE

whitepaper

Oct 17, 2017

The fully realized vision of precision medicine includes the capability to rapidly diagnose, sequence and develop a personalized treatment plan based on combined analysis of genotype, phenotype, environmental, clinical and behavioral data. Precision ...

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The Scientific Path To Cycle Development THE SCIENTIFIC PATH TO CYCLE DEVELOPMENT

whitepaper

Oct 17, 2017

Management of medication delivery through lyophilization - freeze-drying - is a crucial enabling process technology for many important parenteral drugs. Close to 50% of biopharmaceuticals, including enzymes, proteins and monoclonal antibodies, must b...

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The National Pharmaceutical Strategy 2016 2018 THE NATIONAL PHARMACEUTICAL STRATEGY 2016 2018

whitepaper

Oct 16, 2017

The Government and the Swedish Association of Local Authorities and Regions, together with a broad set of pharmaceutical actors, have agreed to continue to build on and enhance the work that has been in progress for several years under the National P...

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Liposome Technology LIPOSOME TECHNOLOGY

whitepaper

Oct 09, 2017

Polymun offers the development of liposomal formulations for all kinds of pharmaceutically active ingredients and vaccine antigens. A broad spectrum of analytical methods has been established for this purpose. Polymun produces GMP material including ...

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De-Risking Antibiotic Drug Development with PK-PD DE-RISKING ANTIBIOTIC DRUG DEVELOPMENT WITH PK-PD

whitepaper

Oct 05, 2017

Pharmacometrics, which includes the science of pharmacokinetics-pharmacodynamics (PK-PD), is one of the most commonly misunderstood, misused, and under-appreciated resources available to drug developers. In the past PK-PD was an afterthought, but tod...

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Access controls for medical devices ACCESS CONTROLS FOR MEDICAL DEVICES

whitepaper

Sep 27, 2017

Healthcare information technology has quickly become one of a clinician’s most powerful instruments. The implementation of technology to automate the collection and documentation of patient information, such as vital signs, continues to expand ...

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The BlockRx pharma Ecosystem THE BLOCKRX PHARMA ECOSYSTEM

whitepaper

Sep 21, 2017

BlockRx is a series of initiatives presented by iSolve, a privately owned Blockchain solution provider for the Life Sciences Industry. The mission of BlockRx is to interconnect systems that do not readily communicate, establish data provenance that s...

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4 Factors Critical to the Financial Success of an Emerging Pharmaceutical Company 4 FACTORS CRITICAL TO THE FINANCIAL SUCCESS OF AN EMERGING PHARMACEUTICAL COMPANY

whitepaper

Sep 20, 2017

Fascinating developments within the biopharmaceutical sector have been grabbing industry headlines for years now. The field is exciting and developing rapidly. However, the reality is that small, synthetic molecules remain critically important to bot...

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Life Sciences Manufacturing and Quality: The New Path to Performance LIFE SCIENCES MANUFACTURING AND QUALITY: THE NEW PATH TO PERFORMANCE

whitepaper

Sep 11, 2017

Life Sciences companies are attempting to improve compliance and manufacturing efficiency while they drive to grow revenue and margins. However, current market conditions are creating substantial headwinds to attaining these targets. S

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Regulatory compliance in pharma – software requirements and solutions REGULATORY COMPLIANCE IN PHARMA – SOFTWARE REQUIREMENTS AND SOLUTIONS

whitepaper

Sep 01, 2017

The Drug Supply Chain Security Act (DSCSA) has been on the mind of pharmaceutical manufacturers since it was enacted in 2013, and the latest requirements are rapidly approaching. Beginning in November 2017, manufacturers will be expected to mark thei...

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Value-Based Contracting for Oncology Drugs VALUE-BASED CONTRACTING FOR ONCOLOGY DRUGS

whitepaper

Aug 29, 2017

A revolution is occurring in cancer treatment, based on new insights into the biology of cancer, and resulting in dozens of new drugs on the market or in the development pipeline. Many of these new drugs are “targeted” therapies that are ...

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Agile Process Development In Biopharmaceuticals AGILE PROCESS DEVELOPMENT IN BIOPHARMACEUTICALS

whitepaper

Aug 23, 2017

The development of novel therapeutic products involves a complex network of internal departments and external partners. Different groups across Process Development organizations typically use a variety of approaches to capture, manage, analyze and re...

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BREAST CANCER DRUGS FUNDING AND TRIALS BREAST CANCER DRUGS FUNDING AND TRIALS

whitepaper

Aug 01, 2017

This white paper arises out of the Pink Ribbon drugs funding & trials conference, held at the faculty of pharmaceutical medicine on 23 March 2017 (full programme provided on page 13-15). The general theme to emerge from the conference is that the...

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Big Data Lipidomics for Lipid Biomarker Identification and Drug Discovery BIG DATA LIPIDOMICS FOR LIPID BIOMARKER IDENTIFICATION AND DRUG DISCOVERY

whitepaper

Jul 04, 2017

At Lipotype our expertise are lipids, lipid metabolism, lipid chemistry and lipidomics. Therefore, statistical analysis is always done with this knowledge as a basis. We treat lipids not as isolated entities but as a metabolic network with substructu...

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Sponsor CRO Pharmacovigilance Alliances White Paper SPONSOR CRO PHARMACOVIGILANCE ALLIANCES WHITE PAPER

whitepaper

Jun 21, 2017

Outsourcing pharmacovigilance activities is a standard business practice in a continuously expanding market segment. In the past, outsourced safety services were limited due to concerns about confidentiality, data security, and liability in cases of ...

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Silicones for pharmaceutical applications analytical capabilities at Solvias SILICONES FOR PHARMACEUTICAL APPLICATIONS ANALYTICAL CAPABILITIES AT SOLVIAS

whitepaper

Jun 21, 2017

Silicones are used in pharmaceutical applications as part of formulations, as well as during manufacturing and in packaging. The term ‘silicones’ encompasses a large number of compounds based on polydialkylsiloxanes. The most common are t...

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Pharmacy at a glance PHARMACY AT A GLANCE

whitepaper

Jun 20, 2017

For the 2017 survey,the maximum sample size- the number of countries and territories with at least one FIP member organisation or candidate member organisation at the time of the survey.

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The Pharmaceutical Blockchain of Value Digital Token Launch THE PHARMACEUTICAL BLOCKCHAIN OF VALUE DIGITAL TOKEN LAUNCH

whitepaper

Jun 20, 2017

Drug manufacturers currently do not have an effective way to securely, transparently, and rapidly track the provenance of drugs or to access the data required to combat counterfeit drug sales. (1) As a result, they are unable to decrease the time and...

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Pharmaceutical Innovation Index 2017 PHARMACEUTICAL INNOVATION INDEX 2017

whitepaper

Jun 14, 2017

The most eye-catching change in innovation for 2016 from the previous year was the fall in the number of new agents approved by the FDA, 22 for 2016 versus 41 and 45 in 2014 and 2015 respectively. Five agents being licensed at the end of 2015, plus t...

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Whitepaper: Raman Hyperspectral Imaging – An essential tool in the pharmaceutical field WHITEPAPER: RAMAN HYPERSPECTRAL IMAGING – AN ESSENTIAL TOOL IN THE PHARMACEUTICAL FIELD

whitepaper

Jun 12, 2017

In the pharmaceutical environment, and especially in the research and development field, the quality of the medicine is a critical step as it is facing challenges with increased? demand from the regulatory affairs to improve the quality of a pharmace...

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ANALYSIS OF EXTRACTABLES AND LEACHABLES ANALYSIS OF EXTRACTABLES AND LEACHABLES

whitepaper

Jun 08, 2017

Manufacturers of pharmaceuticals, drug delivery systems, and biomedical devices have come under growing pressure to perform sensitive and accurate analytical studies to detect, identify, and quantify extractable and leachable compounds (E&Ls). E&...

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US Pharma’s Business Model: Why It Is Broken, and How It Can Be Fixed US PHARMA’S BUSINESS MODEL: WHY IT IS BROKEN, AND HOW IT CAN BE FIXED

whitepaper

May 22, 2017

Price gouging in the US pharmaceutical drug industry goes back more than three decades. In 1985 US Representative Henry Waxman, chair of the House Subcommittee on Health and the Environment, accused the pharmaceutical industry of “gouging the A...

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Applications in Pharmaceutical Manufacturing APPLICATIONS IN PHARMACEUTICAL MANUFACTURING

whitepaper

May 18, 2017

The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefi ts in terms of effectiveness, minimal surface residue, and easier cleaning validation. Virtually any pharmaceutical manufacturing equipment — from tablet presses...

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Solving Complex Pharmaceuticals Dosing Tasks SOLVING COMPLEX PHARMACEUTICALS DOSING TASKS

whitepaper

May 18, 2017

In the field of dosing and filling in the pharmaceutical industry, one usually thinks of waterlike, non-viscous products such as solutions used for injecting. For the most part, these can be filled with a high degree of process reliability using hose...

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Cancer medicines shortages in Europe Policy recommendations to prevent and manage shortages CANCER MEDICINES SHORTAGES IN EUROPE POLICY RECOMMENDATIONS TO PREVENT AND MANAGE SHORTAGES

whitepaper

May 17, 2017

Access to medicines for cancer patients is crucial for providing high quality care. However, cancer medicines shortages are a problem affecting countries across Europe. These shortages occur when the supply of medicines, identified as essential by th...

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White paper - Cancer medicines shortages in Europe WHITE PAPER - CANCER MEDICINES SHORTAGES IN EUROPE

whitepaper

May 17, 2017

Access to medicines for cancer patients is crucial for providing high quality care. However, cancer medicines shortages are a problem affecting countries across Europe. These shortages occur when the supply of medicines, identified as essential by th...

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Pharmacy’s global transformation is pharma’s opportunity PHARMACY’S GLOBAL TRANSFORMATION IS PHARMA’S OPPORTUNITY

whitepaper

Mar 15, 2017

Pharmacy’s role is expanding from supply chain to primary care, from intermediary and retailer to expert advisor in health and wellness. From the developing nations of India and China to more-developed markets like the UK, this evolution is acc...

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Chemistry for Better Health CHEMISTRY FOR BETTER HEALTH

whitepaper

Feb 11, 2017

The annual Chemical Sciences and Society Summit (CS3) brings together the best minds in chemical science research from around the world and challenges them to propose innovative solutions for society’s most pressing needs in the areas of health...

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Pharma & Biotech 2017 – Review of Outsourced Manufacturing PHARMA & BIOTECH 2017 – REVIEW OF OUTSOURCED MANUFACTURING

whitepaper

Jan 26, 2017

This report is an update on the pharmaceutical outsourced manufacturing sector with the last Results’ report published in 2013. By 2015, the global Pharmaceutical market reached $1.11 trillion and is expected to continue growing at approx. 5.5% per a...

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The Use of EDX Fluorescence Spectrometry for Pharmaceutical Elemental Impurity Analysis Based on USP<735> THE USE OF EDX FLUORESCENCE SPECTROMETRY FOR PHARMACEUTICAL ELEMENTAL IMPURITY ANALYSIS BASED ON USP<735>

whitepaper

Jan 06, 2017

New guidelines governing the analysis of elemental impurities in pharmaceuticals are being implemented.Toxic heavy metals and residual metal catalysts may exist in the raw materials of Active Pharmaceutical Ingredients (APIs) or be added during the m...

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The Use of EDX Fluorescence Spectrometry for Pharmaceutical Elemental Impurity Analysis Based on USP THE USE OF EDX FLUORESCENCE SPECTROMETRY FOR PHARMACEUTICAL ELEMENTAL IMPURITY ANALYSIS BASED ON USP

whitepaper

Dec 27, 2016

New guidelines governing the analysis of elemental impurities in pharmaceuticals are being implemented. Toxic heavy metals and residual metal catalysts may exist in the raw materials of Active Pharmaceutical Ingredients (APIs) or be added during the ...

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COLD CHAIN, HOT TOPIC: The Challenge and Opportunity of Distributing Temperature-Sensitive Biopharmaceuticals and Cell Therapies COLD CHAIN, HOT TOPIC: THE CHALLENGE AND OPPORTUNITY OF DISTRIBUTING TEMPERATURE-SENSITIVE BIOPHARMACEUTICALS AND CELL THERAPIES

whitepaper

Dec 20, 2016

Pharmaceutical industry interest in biopharmaceuticals, cell therapies and, more recently, biosimilars has increased significantly1,2. In addition to targeting and treating disease more effectively than small molecule medicines, such products have th...

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Strategies for Developing Mobile Medical Apps for Patient-interactive Medical Devices STRATEGIES FOR DEVELOPING MOBILE MEDICAL APPS FOR PATIENT-INTERACTIVE MEDICAL DEVICES

whitepaper

Oct 03, 2016

To manage chronic medical conditions, real-time monitoring of disease-specific physiologic metrics is becoming an important part of standard of care, and smartphone technology is making it possible. Existing smartphone interfacing devices now record ...

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Pharmaceutical Regulation and Off-Label Uses PHARMACEUTICAL REGULATION AND OFF-LABEL USES

whitepaper

Sep 19, 2016

This White Paper reviews the empirical evidence on pharmaceutical regulation and private investments from the health economics and health policy literature. First, off-label use is defined and the rationale for government regulation is reviewed. The ...

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For Regulatory Retention Compliance In Life Science Industries And Clinical Trial Research FOR REGULATORY RETENTION COMPLIANCE IN LIFE SCIENCE INDUSTRIES AND CLINICAL TRIAL RESEARCH

whitepaper

Sep 14, 2016

“Digital born data” is found everywhere in regulated Good Practice environments for laboratory (GLP), clinical (GCP), and manufacturing (GMP) purposes, e.g., (GXP). Paper documents are also scanned into digital format (PDF) for storage an...

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Generic and Brand Name Drugs: Understanding the Basics GENERIC AND BRAND NAME DRUGS: UNDERSTANDING THE BASICS

whitepaper

Aug 03, 2016

A brand name drug is a medicine that’s discovered, developed and marketed by a pharmaceutical company. Once a new drug is discovered, the company files for a patent to protect against other companies making copies and selling the drug. At this ...

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No Patient Left Behind – Connecting Rare Disease Patients to Orphan Drug Manufacturers NO PATIENT LEFT BEHIND – CONNECTING RARE DISEASE PATIENTS TO ORPHAN DRUG MANUFACTURERS

whitepaper

Jul 28, 2016

If you have ever worked with Orphan Drugs, you know finding appropriate patients is a major commercial challenge. Pharmaceutical sponsors of Orphan Drugs often lack the infrastructure and capabilities necessary to identify physicians who diagnose, tr...

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Targeting innovation in antibiotic drug discovery and development TARGETING INNOVATION IN ANTIBIOTIC DRUG DISCOVERY AND DEVELOPMENT

whitepaper

Jul 20, 2016

the designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the european observatory on Health Systems and Policies concerning the legal status of any country...

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2nd pharmacovigilance 2016 2ND PHARMACOVIGILANCE 2016

whitepaper

Jul 12, 2016

RecunnectLtd takes the pleasure to invite professionals involved in pharmacovigilance, risk assessment and management, clinical research, data analysis and related fields for a two day conference on Pharmacovigilance to enable them to gain a vantage ...

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Pharmaceutical Drug Analysis PHARMACEUTICAL DRUG ANALYSIS

whitepaper

Jun 27, 2016

Modern Pharmaceutical Drug Analysis essentially involves as a necessary integral component even greater horizons than the actual prevalent critical analysis of not only the active pharmaceutical substances but also the secondary pharmaceutical produc...

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Connecting the Dots in Specialty Pharmacy Data CONNECTING THE DOTS IN SPECIALTY PHARMACY DATA

whitepaper

Jun 22, 2016

The rapidly expanding specialty pharmacy market has created unique challenges for pharmaceutical manufacturers looking to obtain dispensing, adherence, and switching data for specialty drugs. Access to timely, anonymized, longitudinal patient data fo...

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Pharma Companies’ Sales Reporting Eff orts Oft en Fall Short PHARMA COMPANIES’ SALES REPORTING EFF ORTS OFT EN FALL SHORT

whitepaper

Jun 22, 2016

Since the time of blockbuster drugs and mirrored sales teams a decade ago, pharmaceutical reps’ access to physicians continues to decline each year. Studies indicate that between 36.5% - 44% of physicians are now being designated as “no a...

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Quality manufacturing A blockbuster opportunity for pharmaceuticals QUALITY MANUFACTURING A BLOCKBUSTER OPPORTUNITY FOR PHARMACEUTICALS

whitepaper

Jun 22, 2016

Pharmaceutical manufacturing is shedding its “poor cousin” image and gaining in importance relative to R&D and marketing. Decades of regulatory and industry standard practice in manufacturing are being reworked to help push operating ...

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From ideals to execution: the reality of patient-centricity in 2016 and what’s next for pharma FROM IDEALS TO EXECUTION: THE REALITY OF PATIENT-CENTRICITY IN 2016 AND WHAT’S NEXT FOR PHARMA

whitepaper

Jun 21, 2016

Since eyeforpharma, Barcelona 2015, we have heard industry, vendors, specialists, advocacy groups and patients talking about patient-centricity: what is it? What does it mean for the industry and the wider healthcare environment? What does it mean fo...

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2030 Outlook on sustainability in the biopharma industry 2030 OUTLOOK ON SUSTAINABILITY IN THE BIOPHARMA INDUSTRY

whitepaper

Jun 16, 2016

Sustainalytics is an independent ESG and corporate governance research, ratings and analysis firm supporting investors around the world with the development and implementation of responsible investment strategies. With 14 offices globally, Sustainaly...

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NTA: Applications in drug delivery Part 5 of NTA 1000 publications review NTA: APPLICATIONS IN DRUG DELIVERY PART 5 OF NTA 1000 PUBLICATIONS REVIEW

whitepaper

Apr 13, 2016

Nanoparticle Tracking Analysis represents a rapid and information-rich multi-parameter nanoparticle characterization technique allowing the user to obtain number frequency particle size distributions of polydisperse nanoparticulate systems. It has re...

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NTA: Applications in drug delivery NTA: APPLICATIONS IN DRUG DELIVERY

whitepaper

Apr 08, 2016

It is well established that the use of nanotechnology in medicine and more specifically drug delivery is spreading rapidly. Driven by the diminishing rate of discovery of new biologically active compounds that can be exploited therapeutically to trea...

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Size Exclusion Chromatography / Gel Permeation Chromatography SIZE EXCLUSION CHROMATOGRAPHY / GEL PERMEATION CHROMATOGRAPHY

whitepaper

Dec 14, 2015

The bulk physical properties such as strength and toughness of materials such as synthetic and natural polymers, or the activity and efficacy of proteins and biopharmaceuticals are strongly dependent on their molecular properties.

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Generic Drug Pricing: Understanding the Impact GENERIC DRUG PRICING: UNDERSTANDING THE IMPACT

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Nov 13, 2015

The evolution of the generic drug market in recent decades has introduced many benefits to the healthcare industry lower pharmaceutical costs and greater consumer access to needed medicines. By offering the bioequivalent product of a brand name drug ...

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Medicinal Cannabis in Australia: Science, Regulation & Industry MEDICINAL CANNABIS IN AUSTRALIA: SCIENCE, REGULATION & INDUSTRY

whitepaper

Jul 22, 2015

This report sets out the key challenges, risks and opportunities associated with establishing a national medicinal cannabis scheme in Australia. The report is comprised of several sections, each intended to serve as a reference for future policy disc...

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Marketing the future Which path will you take? MARKETING THE FUTURE WHICH PATH WILL YOU TAKE?

whitepaper

Jul 22, 2015

Published in June 2007 this paper highlights a number of issues that will have a major bearing on the industry over the next 11 years. The publication outlines the changes we believe will best help pharmaceutical companies realise the potential the f...

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Development and implementation of a pharma-collaborative large historical control database DEVELOPMENT AND IMPLEMENTATION OF A PHARMA-COLLABORATIVE LARGE HISTORICAL CONTROL DATABASE

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Jul 15, 2015

Clinical development modernization efforts have become essential as clinical trials have experienced increased expectations, costs and design complexity. The utilization of historical clinical data can enhance drug research and development by refinin...

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Challenging business models Which path will you take? CHALLENGING BUSINESS MODELS WHICH PATH WILL YOU TAKE?

whitepaper

Jun 24, 2015

The pharmaceutical marketplace is undergoing huge changes, as we indicated in “Pharma 2020: The vision”, the White Paper PricewaterhouseCoopers published in June 2007.1 These changes will have a major bearing on the kind of business model...

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Near-infrared spectroscopy in compliance with pharma regulations NEAR-INFRARED SPECTROSCOPY IN COMPLIANCE WITH PHARMA REGULATIONS

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Jun 23, 2015

The pharmaceutical industry is unique with its extensive regulations. Decisions concerning quality assurance are usually made on the basis of regulatory requirements and guidelines. Quality control takes a central role in the pharmaceutical industry....

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A Tufts Center for the Study of Drug Development White Paper A TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT WHITE PAPER

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May 05, 2015

Biopharmaceutical drug development has been experiencing one of its most productive periods in recent history. During the past decade, the total number of new chemical and biologic entities in the R&D pipeline has been rising 6% each year and now...

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The firepower of the EU pharmaceutical lobby and implications for public health THE FIREPOWER OF THE EU PHARMACEUTICAL LOBBY AND IMPLICATIONS FOR PUBLIC HEALTH

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Mar 11, 2015

This report exposes the excessive lobbying influence of the pharmaceutical industry on EU decision-making. Big pharma enjoys semi-systematic privileged access to decision-making in Brussels, facilitated by its vast lobby expenditure, complex web of a...

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Where are Pharmaceutical Anti-counterfeiting Technologies Headed? WHERE ARE PHARMACEUTICAL ANTI-COUNTERFEITING TECHNOLOGIES HEADED?

whitepaper

Jan 03, 2015

Interpol estimates the annual turnover from pharmaceutical crime as USD 75 billion worldwide.1 In the US alone, the number of IPR-related seizures in the pharmaceutical and personal care industries amounted to USD 72,939,399, or 6% of the market shar...

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Good manufacturing practice guideline for pharmaceutical products GOOD MANUFACTURING PRACTICE GUIDELINE FOR PHARMACEUTICAL PRODUCTS

whitepaper

Oct 29, 2014

This guideline is intended to help manufacturers implementing modern quality systems and risk management approaches to meet the requirements of quality products to ensure their intended purpose and to protect the public health. The requirement in thi...

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Prescription Drug Management in Workers’ Compensation PRESCRIPTION DRUG MANAGEMENT IN WORKERS’ COMPENSATION

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Oct 29, 2014

Prescription drugs have become a key factor in workers’ compensation. Accounting for one of every six medical dollars, pharmacy’s impact on disability duration, return to work and claim settlement outweighs the benefit’s dollar expe...

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2017 Pharma by numbers 2017 PHARMA BY NUMBERS

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Jun 17, 2014

Annual spending by the pharmaceutical industry is 5.5 times greater than the defence and aerospace industries 5 of the 11 leading global R&D firms were research-based pharmaceutical companies In 2014, pharmaceutical industry gross value added was...

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A White Paper of the American Society of Addiction Medicine A WHITE PAPER OF THE AMERICAN SOCIETY OF ADDICTION MEDICINE

whitepaper

Oct 26, 2013

This White Paper explains the science and current practice of drug testing in various contexts and outlines the ways in which drug testing can be used more effectively in medical practice. We focus on ways that physicians, other health care providers...

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The Global Pharmacovigilance Landscape Considerations Beyond the US and the EU THE GLOBAL PHARMACOVIGILANCE LANDSCAPE CONSIDERATIONS BEYOND THE US AND THE EU

whitepaper

Jul 17, 2013

The World Health Organization describes pharmacovigilance as the process of detecting, assessing, understanding, and preventing adverse events associated with medicinal products, with the aim of enhancing patient care and safety.1 While the goal of p...

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Crafting an End-to-End Pharma GRC Strategy CRAFTING AN END-TO-END PHARMA GRC STRATEGY

whitepaper

Jun 19, 2013

Understanding the most appropriate regulatory compliance solution extends beyond pure technological functionalities; it requires intimate understanding of policies and procedures required to achieve meaningful compliance with regulations, worldwide. ...

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The 340b drug discount program THE 340B DRUG DISCOUNT PROGRAM

whitepaper

Oct 30, 2012

Congress created the 340B program in 1992 to help uninsured indigent patients gain better access to prescription medicines. To achieve that goal, Congress created a program that requires pharmaceutical manufacturers to provide discounts on outpatient...

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AI-Enabled Phenotypic Screens Reveal Clinically Relevant Drugs AI-ENABLED PHENOTYPIC SCREENS REVEAL CLINICALLY RELEVANT DRUGS

whitepaper

Jun 20, 2012

Rare genetic disease research is an important area of unmet medical need. There are thousands of untreated rare diseases caused by tens of thousands of individual genetic defects, and each presents with unique clinical manifestations. To meet the cha...

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Laser coding still the technology of choice for the Pharma industry LASER CODING STILL THE TECHNOLOGY OF CHOICE FOR THE PHARMA INDUSTRY

whitepaper

Jan 17, 2012

A milestone in terms of the introduction of new regulations in the campaign to combat counterfeiting in the pharmaceutical industry. However, even before this date, global manufacturers had already started to introduce new coding measures to increase...

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Quantitative and Systems Pharmacology in the Post-genomic Era: New Approaches to Discovering Drugs and Understanding Therapeutic Mechanisms QUANTITATIVE AND SYSTEMS PHARMACOLOGY IN THE POST-GENOMIC ERA: NEW APPROACHES TO DISCOVERING DRUGS AND UNDERSTANDING THERAPEUTIC MECHANISMS

whitepaper

Nov 02, 2011

This white paper arises from two workshops held at the NIH to review the state of the art in systems biology and pharmacology. Workshop participants included leaders in the two fields working in academia, industry and government (including the FDA). ...

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Pharmacy benefit management: Pros and cons of various approaches PHARMACY BENEFIT MANAGEMENT: PROS AND CONS OF VARIOUS APPROACHES

whitepaper

Dec 16, 2004

Pharmacy benefit managers (PBMs) historically have used practices such as broad pharmacy networks and pricing models that rely on several revenue sources. Recently, new approaches have placed substantial emphasis on transparency, suggesting that conc...

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Risk Management Programs for the Pharmaceutical Industry RISK MANAGEMENT PROGRAMS FOR THE PHARMACEUTICAL INDUSTRY

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Oct 27, 2004

“The FDA oversees the quality of drug products using a two-pronged approach involving review of information submitted in applications as well as inspection of manufacturing facilities for conformance to requirements for current Good Manufacturi...

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Mobile integrated healthcare: the patient-centered approach to population health MOBILE INTEGRATED HEALTHCARE: THE PATIENT-CENTERED APPROACH TO POPULATION HEALTH

whitepaper

This White Paper is an informational document. Readers should note that this document does not represent an endorsement by any entity. All page headers and custom graphics are service marks, trademarks and/or trade dress of Envision Healthcare, Inc.,...

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Journal of pharmaceutical and biomedical analysis JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

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This journal is an international medium directed towards the needs of academic, clinical, government and industrial analysis by publishing original research reports and critical reviews on pharmaceutical and biomedical analysis. It covers the interdi...

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Pharma experts identify the true cost of product loss PHARMA EXPERTS IDENTIFY THE TRUE COST OF PRODUCT LOSS

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These events act as a reminder of how far we have come as an Association but they also remind us of why TAPA is so important and the increasing level of risk facing global supply chains. As we know, there is no finishing line in the fight against org...

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Achieving Operational Excellence in Pharma & Biotech ACHIEVING OPERATIONAL EXCELLENCE IN PHARMA & BIOTECH

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With the pharmaceutical industry currently going through major transformation, improving productivity and reducing costs by implementing Operational Excellence is increasingly important for business success. Pharma and biotech companies can benefit s...

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Drug Price Forecast Executive Summary July 2017 DRUG PRICE FORECAST EXECUTIVE SUMMARY JULY 2017

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This Vizient "Drug Price Forecast" is our best estimate of the change in the cost of pharmaceuticals that Vizient Pharmacy Program participant organizations will purchase between Jan. 1, 2018, and Dec. 31, 2018. The forecast is focused on p...

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Digital Health in Pharma: Exploring the Potential Impact DIGITAL HEALTH IN PHARMA: EXPLORING THE POTENTIAL IMPACT

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Industry experts discuss how digital health is poised to disrupt the pharmaceutical industry and revolutionize the clinical trial process and medication adherence. Digital health – the use of wearables, sensors and applications to remotely coll...

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How Pharma Can Fully Digitize Interactions with Healthcare Professional HOW PHARMA CAN FULLY DIGITIZE INTERACTIONS WITH HEALTHCARE PROFESSIONAL

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Since the advent of the commercial Internet, digital technologies have empowered consumers worldwide, leading them to play an active and demanding role with the companies with which they do business. The rules of engagement have changed: By using the...

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Pharmaceutical Innovation Index 2018 PHARMACEUTICAL INNOVATION INDEX 2018

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The PII ranks companies by their ability to bring products from Phase I/II to market and commercialize them successfully, and utilizes a range of clinical, regulatory and commercial metrics to do this, ranging from the corporate level down to individ...

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Product Serialisation to Advance Pharmaceutical Authentication and Patient Safety PRODUCT SERIALISATION TO ADVANCE PHARMACEUTICAL AUTHENTICATION AND PATIENT SAFETY

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The pharmaceutical industry faces complex issues in ensuring patient safety. It must test and provide safety and efficacy profiles on its prescription drugs during clinical trials and throughout the product lifecycle. It must adhere to strict quality...

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70th World Congress of Pharmacy and Pharmaceutical Sciences 70TH WORLD CONGRESS OF PHARMACY AND PHARMACEUTICAL SCIENCES

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What parallels can we draw between portugal’s 500-year history of maritime explorations and global pharmacy,healthcare and the international pharmaceutical federation .

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Seizing the potential of commercial outsourcing in the pharmaceutical sector SEIZING THE POTENTIAL OF COMMERCIAL OUTSOURCING IN THE PHARMACEUTICAL SECTOR

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The power and potential of outsourcing has long been recognized as a core enabler of business growth. Yet while the pharmaceutical industry has been making strides in this area, there is still some way to go to realize the full potential; only in the...

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Clinical research white paper CLINICAL RESEARCH WHITE PAPER

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The evolution from scientific hypothesis to approved and marketed medicine is a lengthy and arduous process that typically spans many years of research and development. to understand clinical research and data flows.

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Facility Shutdown sanitisation regimes – How deep must you clean? FACILITY SHUTDOWN SANITISATION REGIMES – HOW DEEP MUST YOU CLEAN?

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Although there are differences in approach across the various regulatory guidelines, the general message is that aseptic processing is key, necessitating floors, walls, and ceilings to be readily cleanable with smooth and rigid surfaces. A system is ...

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Cleaning of Medical Device by supercritical CO 2 CLEANING OF MEDICAL DEVICE BY SUPERCRITICAL CO 2

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Supercritical CO2 has the characteristics of both a liquid and a gas. Like a gas, it diffuses rapidly, has low viscosity, near zero surface tension, and thus, penetrates easily into deep trenches and porosities allowing more effective cleaning. Like ...

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A Scowcroft Institute of International Affairs A SCOWCROFT INSTITUTE OF INTERNATIONAL AFFAIRS

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The threat posed by pandemics grows alongside increased globalization and technological innovation. Distant cultures can now be connected in a day’s time, and international trade links global health and economic prosperity. In this report, the ...

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Pharmaceutical policy in China PHARMACEUTICAL POLICY IN CHINA

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Pharmaceuticals make a significant contribution to the health and well-being of a population and government policy regarding pharmaceuticals exerts a significant effect on the state of the pharmaceutical market. Governments generally have several obj...

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A Case for Small Cap Investing: Biotech A CASE FOR SMALL CAP INVESTING: BIOTECH

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In this paper, we sought to lay out the rationale for investing in small cap biotech. There are two key drivers of stock performance of small cap biotech: clinical data and acquisitions. As clinical data must be analyzed on a case-by-case basis, we h...

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Uniform and Scalable EB Formation for Drug Discovery and Regenerative Medicine Applications UNIFORM AND SCALABLE EB FORMATION FOR DRUG DISCOVERY AND REGENERATIVE MEDICINE APPLICATIONS

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The developmental versatility of pluripotent stem cells (PSCs) offers a powerful approach for directing cell fate, and these cells are a promising source of progenitors and terminally differentiated somatic cells for cell replacement therapy and drug...

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Precision Material Creates New Applications and Markets PRECISION MATERIAL CREATES NEW APPLICATIONS AND MARKETS

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Another common porous silica material, developed in the late 1990’s at the University of California at Santa Barbara, is SBA-15. Similar to MCM-41, it is relatively low cost to produce and has controllable pore diameters. But relative to MCM-41...

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Understanding the Regulations and How LabVantage Successfully Helps Customers Comply With These Requirements UNDERSTANDING THE REGULATIONS AND HOW LABVANTAGE SUCCESSFULLY HELPS CUSTOMERS COMPLY WITH THESE REQUIREMENTS

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Pharmaceutical, medical device, food & beverage and other companies in regulated markets are required to comply with government regulations, standards and guidelines that are designed to ensure the safety and quality of the products manufactured,...

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Accelerating Drug Discovery and Development Using Genomics ACCELERATING DRUG DISCOVERY AND DEVELOPMENT USING GENOMICS

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The Multiple Myeloma Research Foundation (MMRF) has the principal goal of accelerating development of next-generation drugs for treating multiple myeloma. By making targeted investments in key research areas such as genomics and epigenetics, the MMRF...

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A New Pharmaceutical Commons: Transforming Drug Discovery A NEW PHARMACEUTICAL COMMONS: TRANSFORMING DRUG DISCOVERY

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The Oxford Martin School at the University of Oxford is a worldleading centre of pioneering research that addresses global challenges. We invest in research that cuts across disciplines to tackle a wide range of issues such as climate change, disease...

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Porous Silica Creates New Applications and Markets POROUS SILICA CREATES NEW APPLICATIONS AND MARKETS

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Pharmaceutical and nutraceutical companies have identified product identification (PI) as a major focus to identify and deter counterfeiting and product diversion. This is done through track and trace technologies. To date, the majority of the PI has...

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Pharmaceutical Cleaning Validation PHARMACEUTICAL CLEANING VALIDATION

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Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and the cost reduced if the cleaner supplier can provide support — ultimately allowing pharmaceuticals to get t...

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Harnessing innovative technologies HARNESSING INNOVATIVE TECHNOLOGIES

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Introduction: The rise of the super-bug in today’s world, the biodiversity of vital ecosystems is threatened by factors, such as overpopulation, deforestation, mass migrations, war, famine, depletion of natural resources and animal-human intera...

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TUBERCULOSIS Diagnostics Technology Landscape TUBERCULOSIS DIAGNOSTICS TECHNOLOGY LANDSCAPE

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The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area ...

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Examination of non-sterile products tests for specified microorganisms EXAMINATION OF NON-STERILE PRODUCTS TESTS FOR SPECIFIED MICROORGANISMS

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For certain product types, there is a requirement for testing to determine the absence of certain microorganisms. These specified microorganisms include pathogens and are known as indicator microorganisms. This is due to the fact that they may indica...

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Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing RAMAN SPECTROSCOPY AS A PROCESS ANALYTICAL TECHNOLOGY FOR PHARMACEUTICAL MANUFACTURING AND BIOPROCESSING

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Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing. In this review,...

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Particle characterisation of pharmaceutical powder mixtures PARTICLE CHARACTERISATION OF PHARMACEUTICAL POWDER MIXTURES

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One of the most important performance factors of a pharmaceutical product is the bioavailability, i.e. the release of the active compound in a human body. In a solid dosage product (e.g. tablets, powders or capsules), this is directly related to the ...

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Raman monitoring of active coating composition RAMAN MONITORING OF ACTIVE COATING COMPOSITION

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Pharmaceutical tablets are coated for a variety of reasons, such as to enhance the appearance, taste, chemical stability, or swallowability of the tablet or to create a particular release profile for the active pharmaceutical ingredient (API). Recent...

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2018 Pharma Quality Outlook 2018 PHARMA QUALITY OUTLOOK

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In this report, Sparta Systems, a quality management system (QMS) software provider, examines the results of a Pharmaceutical Technology survey of 160 respondents. The survey was designed to explore the evolving function of pharmaceutical quality man...

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Cleaning Validation for Pharmaceutical Manufacturing CLEANING VALIDATION FOR PHARMACEUTICAL MANUFACTURING

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Cleaning validation is a requirement in industries such as pharmaceutical manufacturing that adhere to current Good Manufacturing Practice (cGMP) and Quality Systems Regulations (QSR). It is specifi c to the cleaning method and cleaner employed. Simp...

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Fully Automated Structure Verification of Organic Compounds by Combining High Resolution Accurate MS with NMR Data Analysis FULLY AUTOMATED STRUCTURE VERIFICATION OF ORGANIC COMPOUNDS BY COMBINING HIGH RESOLUTION ACCURATE MS WITH NMR DATA ANALYSIS

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The calibrant region is determined automatically. The mass calibration function and its ideal polynomial degree are selected automatically using an information criterion to avoid over-fi tting. No manual recalibration is necessary. Novel isotope patt...

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Biochemical Assay Development Using Novel MALDI High-Throughput Screening System BIOCHEMICAL ASSAY DEVELOPMENT USING NOVEL MALDI HIGH-THROUGHPUT SCREENING SYSTEM

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Assay development was done in 384 well format using acetylcholinesterase (AChE) from electric eel and equine butyrylcholinesterase (BChE) as target enzymes. The reactions were started by adding 25 µM substrate solution and quenched by adding 1%...

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Raman monitoring of active coating composition RAMAN MONITORING OF ACTIVE COATING COMPOSITION

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Recently a technique called active coating has become more common in the pharmaceutical processing industry. In active coating, the API is included in the tablet’s coating in order to create a multi-step release profile for a single API or to s...

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Raman-based nutrient control in bioprocessing optimizes viable cell density and protein glycation RAMAN-BASED NUTRIENT CONTROL IN BIOPROCESSING OPTIMIZES VIABLE CELL DENSITY AND PROTEIN GLYCATION

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Production of protein therapeutics by mammalian cells is the most widely used bioprocess because of its ability to properly produce and fold a recombinant protein. 60-70% of biopharmaceuticals are produced by this bioprocess. Bioreactor parameters af...

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A basic guide to particle characterization A BASIC GUIDE TO PARTICLE CHARACTERIZATION

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The aim of this guide is to provide you with a basic grounding in the main particle characterization techniques currently in use within industry and academia. It assumes no prior knowledge of particle characterization theory or instrumentation and sh...

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Pharmaceutical Industry Outlook 2016 PHARMACEUTICAL INDUSTRY OUTLOOK 2016

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Tougher competition and margin pressures create more challenges for the pharma industry in 2016. As more physicians are graduating med school to work directly for a health system instead of opening their own practice, sales force is struggling to ada...

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UK Chemical and Pharmaceutical Industry Facts and Figures UK CHEMICAL AND PHARMACEUTICAL INDUSTRY FACTS AND FIGURES

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In our 2015 facts and figures publication we show how today’s UK chemical and pharmaceutical industry continues to be a vital part of this country’s economy. When the final 2014 figures are published, we expect them to show growth of arou...

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Chemical and Pharmaceutical Industry on the Rise CHEMICAL AND PHARMACEUTICAL INDUSTRY ON THE RISE

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The chemical industry is one of the most demanding branches in terms of capital investment, and in view of its complicated production processes and technologies, it requires a highly skilled workforce and considerable investment in research and devel...

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U.S. Government Zika Vaccine Strategy U.S. GOVERNMENT ZIKA VACCINE STRATEGY

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To address the Zika virus public health threat, the Departments of Health and Human Services and Defense2F 1 are coordinating efforts to help accelerate the development of Zika virus vaccines. Given the need for a vaccine to prevent disease caused by...

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Quality of 3M Canada Drug Products QUALITY OF 3M CANADA DRUG PRODUCTS

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Recent reports of intrinsic contamination of drug products, including skin antiseptics in the United States have focused attention on the importance of strict adherence to established good manufacturing processes and the application of quality assura...

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TRACK AND TRACE FOR PHARMACEUTICAL SERIALIZATION: THE WAY FORWARD TRACK AND TRACE FOR PHARMACEUTICAL SERIALIZATION: THE WAY FORWARD

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The pharmaceuticals industry has struggled to ensure the integrity of its products as they are transferred between the different stops on the value chain from contract manufacturers to wholesalers to dispensers and finally to the patient. This is par...

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Pharmaceutical Line Extensions in the United States PHARMACEUTICAL LINE EXTENSIONS IN THE UNITED STATES

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Innovative pharmaceutical companies engage in sophisticated strategies to moderate the loss of revenue they will face when generic competitors enter the market. Known in the industry as product lifecycle management, these strategies often rely on the...

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AN ANALYSIS OF DRUG THERAPY TAPERING GUIDELINES AN ANALYSIS OF DRUG THERAPY TAPERING GUIDELINES

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Chronic pain, the kind of pain a person wakes up with every morning and goes to sleep with every night, has a standard of care that is often incomplete and sometimes inaccurate. Chronic pain treatment often revolves around drug therapy and managing s...

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Managing The Costs Of Specialty Drugs MANAGING THE COSTS OF SPECIALTY DRUGS

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While the term “specialty drugs” has no standard definition, these pharmaceuticals are universally associated with high costs and complex conditions. Unique and highly targeted, such drugs can provide significant improvement or even a cur...

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THE FLOW OF MONEY THROUGH THE PHARMACEUTICAL DISTRIBUTION SYSTEM THE FLOW OF MONEY THROUGH THE PHARMACEUTICAL DISTRIBUTION SYSTEM

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Prescription drugs sold in retail pharmacies accounted for almost $325 billion or 10% of total healthcare costs in 2015, up 9% from 2014. Such dramatic growth has prompted calls for government intervention to regulate drug prices or otherwise control...

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Pharma outlook 2030: From evolution to revolution PHARMA OUTLOOK 2030: FROM EVOLUTION TO REVOLUTION

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The pharmaceutical sector is at a crossroads. In a heavily disrupted marketplace, characterized by shifting payer attitudes and patient empowerment, neither incremental adjustments nor steady evolution is likely to halt the decline of the traditional...

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Prescription Drug Abuse and Prevention PRESCRIPTION DRUG ABUSE AND PREVENTION

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America is in the midst of a prescription opioid epidemic. It is estimated that in 2016, 11.8 million Americans, or 4.4 percent of the population, age 12 years and older were nonmedical users of opioids – defined as prescription pain relievers ...

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Prescription Drug Abuse PRESCRIPTION DRUG ABUSE

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Deaths from drug overdose have been rising steadily over the past two decades and have become the leading cause of injury death in the United States. Every day in the United States, 114 people die as a result of drug overdose, and another 6,748 are t...

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CENTRAL & EASTERN EUROPE INVESTMENT OPPORTUNITIES IN PHARMACEUTICALS: RISK/REWARD ANALYSIS CENTRAL & EASTERN EUROPE INVESTMENT OPPORTUNITIES IN PHARMACEUTICALS: RISK/REWARD ANALYSIS

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Central & Eastern European markets are not considered amongst the most attractive globally for companies looking to launch innovative pharmaceuticals. The Czech Republic, which ranks first in Central & Eastern Europe, is ranked 22nd globally,...

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MEA INVESTMENT OPPORTUNITIES IN PHARMACEUTICALS: RISK/REWARD ANALYSIS MEA INVESTMENT OPPORTUNITIES IN PHARMACEUTICALS: RISK/REWARD ANALYSIS

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The Middle East & North Africa average in our Innovative Pharmaceuticals Risk/Reward Index (RRI) slightly underperforms the global average. The region is highly diverse, with a number of large Gulf States including Saudi Arabia, the UAE, and Kuwa...

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The Challenges of Connecting Globally in the Pharmaceutical Industry THE CHALLENGES OF CONNECTING GLOBALLY IN THE PHARMACEUTICAL INDUSTRY

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The pharmaceutical industry is globalizing. Conducting global clinical trials to get a broader and more diverse participant base and expanding into less-saturated developing markets are two significant drivers of globalization. However, this expansio...

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Discussion Paper on Pharmaceutical Disposal to Sewer Systems DISCUSSION PAPER ON PHARMACEUTICAL DISPOSAL TO SEWER SYSTEMS

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This white paper has been prepared to initiate a regional dialogue regarding pharmaceutical disposal to the sewer system. It provides an overview of research on pharmaceuticals in the environment and potential actions for consideration during that re...

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THE MUST-HAVE COLLABORATIONS FOR SUCCESSFUL
DRUG DEVELOPMENT THE MUST-HAVE COLLABORATIONS FOR SUCCESSFUL DRUG DEVELOPMENT

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Collaborations among academic and government researchers, pharmaceutical and biotechnology companies, regulatory agencies, and patients and their families are crucial to research and development of therapeutics for rare diseases. Industry, academic a...

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The Rebirth Of The Pharmaceutical Sales Force THE REBIRTH OF THE PHARMACEUTICAL SALES FORCE

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At Accenture, we believe the healthcare industry’s focus on delivering improved patient outcomes, along with advances in digital technologies, create an environment in which sales reps will be more valuable than ever. With new skills and digita...

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Is Your In-House Strategy Ready For The Uncertainties Of Biologic Drug Development? IS YOUR IN-HOUSE STRATEGY READY FOR THE UNCERTAINTIES OF BIOLOGIC DRUG DEVELOPMENT?

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The pharmaceutical industry’s past reliance on blockbuster drugs has evolved to include a focus on developing drugs that treat the unmet needs of smaller patient populations. These niche drugs most often come in the form of biologics, which are...

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The Leadership Challenge in the Pharmaceutical Sector What Critical Capabilities are Missing in Leadership Talent and How Can They be Developed? THE LEADERSHIP CHALLENGE IN THE PHARMACEUTICAL SECTOR WHAT CRITICAL CAPABILITIES ARE MISSING IN LEADERSHIP TALENT AND HOW CAN THEY BE DEVELOPED?

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Pharmaceutical companies face complex issues that grow more challenging by the day. Healthcare reform and changes in technology, government policy, and consumer expectations are revolutionizing relationships with key stakeholders and impacting operat...

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Outsourcing in the Pharma Industry – Experience, Expertise and Enthusiasm OUTSOURCING IN THE PHARMA INDUSTRY – EXPERIENCE, EXPERTISE AND ENTHUSIASM

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2012 will be regarded by many commentators as one of the most challenging years in the pharmaceutical industry’s history, due in no small part to numerous products facing patent expirations and increased global competition. It is now considered...

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2015 profile biopharmaceutical Research Industry 2015 PROFILE BIOPHARMACEUTICAL RESEARCH INDUSTRY

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Biopharmaceutical companies make the medicines that save and improve patients’ lives every day. Patients often rely on medicines to keep their symptoms at bay and allow them to continue to work and live healthy, productive lives. Others rely on...

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Pharmaceutical marketing: ethical and responsible conduct PHARMACEUTICAL MARKETING: ETHICAL AND RESPONSIBLE CONDUCT

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At EY, we have conducted a survey among healthcare professionals (HCPs) and pharmaceutical companies to understand their perspective of the Medical Council of India’s (MCI) guidelines and the Department of Pharmaceuticals’ (DoP) marketing...

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Pharma Market Access Success: Shifting the Dialogue from Price to Value Through Strategic Communications PHARMA MARKET ACCESS SUCCESS: SHIFTING THE DIALOGUE FROM PRICE TO VALUE THROUGH STRATEGIC COMMUNICATIONS

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As healthcare costs continue to rise, the decision to cover a new drug and provide access to patients who need it lies increasingly in the hands of payers, not physicians. To achieve uptake of its new product, a pharmaceutical company must reorient i...

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How Digital is Shaping the Future of Pharmaceutical Marketing HOW DIGITAL IS SHAPING THE FUTURE OF PHARMACEUTICAL MARKETING

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Technology has prompted drastic changes in the marketing world over the past decade, and pharmaceutical marketing has not been excluded from this evolution. Faced with shifting consumer and physician media preferences and shrinking budgets - what is ...

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How Medical Device Manufacturers Can Improve Quality by Applying the Principles of Process Analytical Technologies (PAT) HOW MEDICAL DEVICE MANUFACTURERS CAN IMPROVE QUALITY BY APPLYING THE PRINCIPLES OF PROCESS ANALYTICAL TECHNOLOGIES (PAT)

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This white paper reviews how the Process Analytical Technologies (PAT) originally developed by the FDA for the pharmaceutical industry can also improve quality and efficiency in medical device manufacturing. The underlying principle of the PAT approa...

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Medical Device Home Use Initiative MEDICAL DEVICE HOME USE INITIATIVE

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Assuring the safety and safe use of medical devices in the home is becoming an increasingly important public health issue. The aging of the U.S. population and shifts toward shorter hospital stays continue to make home healthcare more common. With th...

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WHY MEDICAL DEVICE MANUFACTURERS MUST LEAD ON CYBERSECURITY IN AN INCREASINGLY CONNECTED HEALTHCARE SYSTEM WHY MEDICAL DEVICE MANUFACTURERS MUST LEAD ON CYBERSECURITY IN AN INCREASINGLY CONNECTED HEALTHCARE SYSTEM

whitepaper

Harbisson is one of many patients reaping the benefits of increased connectivity in the healthcare industry. Connected medical device—such as pacemakers and insulin pumps that communicate with other networks and devices over the Internet—...

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Product Serialization to Advance Pharmaceutical Authentication and Patient Safety PRODUCT SERIALIZATION TO ADVANCE PHARMACEUTICAL AUTHENTICATION AND PATIENT SAFETY

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In today’s global pharmaceutical distribution environment, the risks to undermine product safety are significant. Counterfeiting and product diversion are major problems and growing. In 2007 the World Health Organization estimated that drug cou...

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IBM Solution for Pharmaceutical Track & Trace IBM SOLUTION FOR PHARMACEUTICAL TRACK & TRACE

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At its core, the pharmaceutical industry is about improving the quality of people’s lives. But today’s life-saving drugs are often small, high-value items which are easily stolen or diverted. Nearly impossible to authenticate by the end u...

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Solutions to Global Pharmaceutical Supply Chain Challenges SOLUTIONS TO GLOBAL PHARMACEUTICAL SUPPLY CHAIN CHALLENGES

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The global pharmaceutical sector is embarking on a transformational journey in which the supply chain will play an increasingly strategic role. There will be a need for greater agility and improved speed to market – while ensuring compliance wi...

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Learning From Failure: Leveraging Modeling and Simulation for Pediatric Drug Development Success LEARNING FROM FAILURE: LEVERAGING MODELING AND SIMULATION FOR PEDIATRIC DRUG DEVELOPMENT SUCCESS

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Historically, clinical trials have not examined most pediatric medications.This is due to the ethical and practical challenges of conducting pediatric drug trials. Children are 40% of the world’s population. Yet, regulatory agencies have approv...

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The Benefits of Modeling and Simulation in Drug Development THE BENEFITS OF MODELING AND SIMULATION IN DRUG DEVELOPMENT

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M&S has the ability to influence every phase of the drug development process, including the commercial decisions around the benefits of even bringing a specific drug to market. One of the most important elements of biosimulation is that it allows...

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Physiologically-based Modeling Supports Drug Development Decisions, Regulatory Interactions and Drug Labeling PHYSIOLOGICALLY-BASED MODELING SUPPORTS DRUG DEVELOPMENT DECISIONS, REGULATORY INTERACTIONS AND DRUG LABELING

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Today’s powerful and actively evolving computational tools enable sponsors and regulators to understand potential drug characteristics and subject responses earlier in development, with greater certainty. Model-based approaches support timely, ...

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Drug Development and Label Optimization Using Proven Biosimulation Methodology DRUG DEVELOPMENT AND LABEL OPTIMIZATION USING PROVEN BIOSIMULATION METHODOLOGY

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The Food and Drug Administration (FDA) or other regulatory body-approved drug label is the official description of a drug product and includes what the drug is used for, who should take it, side effects, instructions for use, and safety information f...

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Introducing Population Pharmacokinetic Analysis Into Your Early Drug Development Efforts INTRODUCING POPULATION PHARMACOKINETIC ANALYSIS INTO YOUR EARLY DRUG DEVELOPMENT EFFORTS

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Population pharmacokinetic (PopPK) analysis has become a key tool for clinical pharmacology experts when working with data from human subjects. In the recent past, new drug registrations utilized pharmacokinetic (PK) information from healthy voluntee...

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Model-based Drug Development for Generic Products MODEL-BASED DRUG DEVELOPMENT FOR GENERIC PRODUCTS

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As a generic drug manufacturer, the goal of your product development program is to demonstrate bioequivalence of your product to the branded product. Often a straightforward trial and error process based on the experience of the formulation team has ...

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Best Practices in Drug Development Modeling and Simulation BEST PRACTICES IN DRUG DEVELOPMENT MODELING AND SIMULATION

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The use of modeling and simulation (M&S) in drug development has evolved from being a research nicety to a regulatory necessity. Today, modeling and simulation are leveraged to some extent, across most development programs to understand and optim...

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Drug Asset Evaluation: Increasing “Probability of Success” of a Deal DRUG ASSET EVALUATION: INCREASING “PROBABILITY OF SUCCESS” OF A DEAL

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The current model of drug development has become economically unsustainable. According to Tufts Center for the Study of Drug Development (CSDD), the cost of bringing a new drug to market now tops $2.6 billion and can take up to 15 years, with less th...

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Applying Model Reduction to Lessen the Complexity of Quantitative Systems Pharmacology Models APPLYING MODEL REDUCTION TO LESSEN THE COMPLEXITY OF QUANTITATIVE SYSTEMS PHARMACOLOGY MODELS

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One of the greatest challenges in drug development is the high attrition rate obtained in Phase 2 clinical trials, resulting in significantly elevated R&D costs and time. In fact, approximately 80% of new drugs that move into Phase 2—the ph...

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Pharmacy: A Prescription for Improving the Healthcare System PHARMACY: A PRESCRIPTION FOR IMPROVING THE HEALTHCARE SYSTEM

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The information contained in this document is the proprietary and exclusive property of the National Council for Prescription Drug Programs, Inc. (NCPDP) except as otherwise indicated. No part of this document, in whole or in part, may be reproduced,...

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Use of the NCPDP Manufacturer Rebate Standard to Support Payment Processes between Medicaid and Supplemental Programs and Pharmaceutical Companies USE OF THE NCPDP MANUFACTURER REBATE STANDARD TO SUPPORT PAYMENT PROCESSES BETWEEN MEDICAID AND SUPPLEMENTAL PROGRAMS AND PHARMACEUTICAL COMPANIES

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Provide a high-level description of the issues experienced with current data management practices involving the Medicaid Drug Rebate Program and the functions related to drug rebate invoicing, billing quantity/pricing discrepancies, and the reconcili...

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NCPDP Recommendations for Improving Prescription Drug Monitoring Programs NCPDP RECOMMENDATIONS FOR IMPROVING PRESCRIPTION DRUG MONITORING PROGRAMS

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This document is Copyright 2015 by the National Council for Prescription Drug Programs (NCPDP). It may be freely redistributed in its entirety provided that this copyright notice is not removed. It may not be sold for profit or used in commercial doc...

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Production processes in the pharmaceutical industry PRODUCTION PROCESSES IN THE PHARMACEUTICAL INDUSTRY

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A great source of worry in industrialized societies is disease or health problems caused by taking medicines that are in poor condition or are subject to a health alert. Society expects that manufacturers, distributors, and employees should be in con...

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Measuring Pharmaceutical Quality through Manufacturing Metrics and Risk-Based Assessment MEASURING PHARMACEUTICAL QUALITY THROUGH MANUFACTURING METRICS AND RISK-BASED ASSESSMENT

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Quality assurance and control play an essential role in the pharmaceutical manufacturing process, by ensuring that patients are provided with medications that are safe, effective, and produced at a high level of quality.

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FDA Pharmaceutical Quality Oversight One Voice FDA PHARMACEUTICAL QUALITY OVERSIGHT ONE VOICE

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The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA’s efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OP...

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Your partner for oral drug delivery services YOUR PARTNER FOR ORAL DRUG DELIVERY SERVICES

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To meet your requirements even better, we have created a specific range of drug delivery technologies, EUDRATEC. For both EUDRAGIT and EUDRATEC we offer tailor-made development services for commercially viable formulations. We develop and manufa...

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We make drugs smarter WE MAKE DRUGS SMARTER

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Using our 40 years of experience, our state of the art facilities and our IP protected technologies, we leverage existing capabilities to create value for our pharmaceutical partners by providing a complete portfolio of integrated drug delivery servi...

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Pharmaceutical Serialization: An Implementation Guide PHARMACEUTICAL SERIALIZATION: AN IMPLEMENTATION GUIDE

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Global pharmaceutical companies lose an estimated $75 billion annually to counterfeit, gray market and stolen product. Impending regulations aimed at protecting public health, intellectual property and national security will require pharmaceutical, m...

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Pharmaceutical Serialization Track & Trace PHARMACEUTICAL SERIALIZATION TRACK & TRACE

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Pharmaceutical Companies have to contend with challenges stemming from supply chain security lapses (Resulting in theft, diversion, and product RE calls), Counterfeiting stringent regulation.

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Value-based pricing in pharmaceuticals VALUE-BASED PRICING IN PHARMACEUTICALS

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Value-based pricing (VBP) of pharma products has exciting potential to help improve patient outcomes – at an affordable cost. The concept of VBP has been around for some time, but healthcare stakeholders are still grappling with what it means f...

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Fundamentals of Spray-Dried Dispersion Technology FUNDAMENTALS OF SPRAY-DRIED DISPERSION TECHNOLOGY

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A common problem statement in the pharmaceutical industry is low oral bioavailability of drug candidates with poor aqueous solubility. The literature suggests that a significant majority of new drug candidates are in the Biopharmaceutics Classificati...

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Drug efficacy evaluation in bone metastasis models - Why and How DRUG EFFICACY EVALUATION IN BONE METASTASIS MODELS - WHY AND HOW

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Metastatic and primary tumors are known to respond differently to chemotherapy. Therefore, when establishing drug efficacy it is important not to rely only on experiments in primary tumor models but to also study the test compound in metastasis model...

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Embracing China’s brave new pharmaceutical world EMBRACING CHINA’S BRAVE NEW PHARMACEUTICAL WORLD

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Sales of pharmaceuticals in China are already the third highest in the world, and China is likely to become the world’s second-largest drug market within the next year. Multinational pharmaceutical corporations cannot afford to underperform in ...

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Pharmaceutical Waste Management PHARMACEUTICAL WASTE MANAGEMENT

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Every day, healthcare organizations dispense a broad spectrum of medications. An essential yet often overlooked aspect of this drug delivery process is what to do with any unused medications.

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AI-Enabled Phenotypic Screens Reveal Clinically Relevant Drugs AI-ENABLED PHENOTYPIC SCREENS REVEAL CLINICALLY RELEVANT DRUGS

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Rare genetic disease research is an important area of unmet medical need. There are thousands of untreated rare diseases caused by tens of thousands of individual genetic defects, and each presents with unique clinical manifestations.

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Specialty Drug Spending SPECIALTY DRUG SPENDING

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The IMS Institute for Healthcare Informatics reported that spending on specialty pharmaceuticals almost doubled from 2010 to 2015, and spending on this subset of drugs was responsible for 70% of overall drug spending growth during this timeframe.

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Drug Discovery: An Innovative Approach to Application Integration using SOA & Ontology DRUG DISCOVERY: AN INNOVATIVE APPROACH TO APPLICATION INTEGRATION USING SOA & ONTOLOGY

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Service Oriented Architecture (SOA) has radically changed the application integration landscape. However, the need for intelligent service discovery based on invocation context and service capability is still a challenge. Ontology-based techniques ar...

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Pharmaceutical Freeze Drying Technology PHARMACEUTICAL FREEZE DRYING TECHNOLOGY

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Although it is one of the oldest techniques in the pharmaceutical industry for the preservation of unstable materials, there still is an increased demand for lyophilized products and equipment. To accommodate such a growth, the freeze-drying process ...

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Tamper-proof Pharmaceutical Packaging TAMPER-PROOF PHARMACEUTICAL PACKAGING

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There is hardly another product that reaches consumers or patients for which packaging requirements are as varied as for pharmaceutical products. The »Poisons Prevention Packaging Act« (PPPA) enacted in the United States back in 1970 addr...

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How Machine Vision Cameras Help Medicine HOW MACHINE VISION CAMERAS HELP MEDICINE

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Cameras have been playing an increasingly important role in medicine for many years now. Regardless of whether you‘re looking at medical devices, laboratory automation or the operating room, in almost every field there is a multitude of everyda...

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Drug Branding Through the Eyes of the Consumer DRUG BRANDING THROUGH THE EYES OF THE CONSUMER

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Pharmaceutical drug naming and branding can seem like a complicated mystery to most consumers. Because of extensive research and regulations, medication names are getting less and less intuitive but marketed more than ever. It wasn’t too long a...

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The Changing Landscape of Branding Pharmaceutical Assets: A Focus on Oncology THE CHANGING LANDSCAPE OF BRANDING PHARMACEUTICAL ASSETS: A FOCUS ON ONCOLOGY

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Branding means a lot of different things to a lot of different people, but in its simplest form, a name is the face of a brand. Just as people have names. Something we’re recognized by and called—so do pharmaceutical brands

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Public procurement of medicinal products PUBLIC PROCUREMENT OF MEDICINAL PRODUCTS

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The purpose of this white paper is to provide an overview of the applicability of public procurement legislation in the healthcare sector, and more specifically the challenges it sets to the pharmaceutical industry.

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Challenges to Traditional Pharma Incentive Compensation Plan Design for Today’s Rapidly Changing Pharmaceutical Environment CHALLENGES TO TRADITIONAL PHARMA INCENTIVE COMPENSATION PLAN DESIGN FOR TODAY’S RAPIDLY CHANGING PHARMACEUTICAL ENVIRONMENT

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GlaxoSmithKline (GSK) executives made industry news in 2011 by announcing that their sales reps would no longer have their at-risk compensation based on prescription (Rx) volume generated by physicians.1 The traditional proportion of base-salary to a...

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for Laser Marking in Pharmaceutical Applications FOR LASER MARKING IN PHARMACEUTICAL APPLICATIONS

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The Drug Quality and Security Act, a United States bill passed in 2013, calls for manufacturers to make prescription drugs traceable on a per-unit basis. Manufacturers will need to mark each package with a serial number or machine-readable code in or...

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Vitamins for pharmaceutical applications VITAMINS FOR PHARMACEUTICAL APPLICATIONS

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Micronutrients play a critical role in overall nutrition and health. This is highlighted by the plethora of continuous research published in high profile scientific journals focused on the benefits of vitamins and minerals. However, evidence shows th...

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Process reinvention for better IT service delivery in the pharmaceutical industry PROCESS REINVENTION FOR BETTER IT SERVICE DELIVERY IN THE PHARMACEUTICAL INDUSTRY

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Soaring drug development costs, patent expiration, and reduction in the number of blockbuster drugs are driving pharma companies to look at IT-enabled productivity.

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The Future of Pharma: Challenges and Opportunities of Research and Development, Safety, Regulatory and Compliance Functions THE FUTURE OF PHARMA: CHALLENGES AND OPPORTUNITIES OF RESEARCH AND DEVELOPMENT, SAFETY, REGULATORY AND COMPLIANCE FUNCTIONS

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As organizations implement a patient-centric model, they will discover that there is an urgent need to innovate and find effective healthcare solutions. While the Research and Development (R&D) function is becoming complex in terms of portfolio a...

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Estimated Annual Pharmaceutical Revenue Loss Due to Medication Non-Adherence ESTIMATED ANNUAL PHARMACEUTICAL REVENUE LOSS DUE TO MEDICATION NON-ADHERENCE

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In our 2012 report, we assessed the magnitude of the medication adherence problem in chronic conditions and gauged its impact on pharmaceutical revenues. Our findings showed estimated revenue losses of $188 billion in the US and $564 billion globally...

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BREAST CANCER DRUGS FUNDING AND TRIALS BREAST CANCER DRUGS FUNDING AND TRIALS

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Pink Ribbon is a growing international network for breast cancer prevention and cure, seeking to help eliminate all breast cancer-related deaths. In the UK, its current focus includes an annual conference called the Breast Cancer Forum, held in assoc...

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Vaccine Safety VACCINE SAFETY

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This white paper provides an introduction to vaccine safety science and policy in the United States. Section “I” discusses how Congress granted pharmaceutical companies immunity from liability for vaccine injuries and transferred all resp...

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Procurement’s Impact on Pharma in 2016 PROCUREMENT’S IMPACT ON PHARMA IN 2016

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Within the highly regulated pharmaceutical industry, pipeline activity is fueled by M&A and drug development. This process is drawn out by lengthy phases of research and discovery as well as risky clinical trials. For pharma companies (and by ext...

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Manufacturing Injectables in the Multiplex MANUFACTURING INJECTABLES IN THE MULTIPLEX

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Today, pharmaceutical companies need to produce a higher number of therapeutics for smaller patient populations. But as the FDA points out, companies have not invested in manufacturing infrastructure and practices to meet these challenges. The goal o...

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The New Partnership Paradigm: What Patient Advocates Seek From Pharmaceutical Partners THE NEW PARTNERSHIP PARADIGM: WHAT PATIENT ADVOCATES SEEK FROM PHARMACEUTICAL PARTNERS

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Dramatic changes in U.S. healthcare over the last few years have forced a rethinking of the partnerships pharmaceutical companies to form with groups representing patients and families. inVentiv Health Public Relations Group interviewed dozens of pat...

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Beyond Immune Checkpoint Inhibitors to a New Era of Personalized Medicine: Planning and Conducting Trials of the Latest Immunotherapies BEYOND IMMUNE CHECKPOINT INHIBITORS TO A NEW ERA OF PERSONALIZED MEDICINE: PLANNING AND CONDUCTING TRIALS OF THE LATEST IMMUNOTHERAPIES

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Immunotherapies are being touted both in scientific literature and the general media as the most promising advances in cancer treatment in decades. Indeed, newly approved drugs are improving survival dramatically for patients with many difficult-to-t...

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Application Note: Drug product identification using Handheld Raman APPLICATION NOTE: DRUG PRODUCT IDENTIFICATION USING HANDHELD RAMAN

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Handheld Raman is an attractive ID method because it provides a portable measurement that can distinguish different concentrations of active pharmaceutical ingredients (API) in drug product (DP) doses and placebos with little or no sample preparation...

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Exploring the Importance of Rater Reliability in Drug Development for Alzheimer’s Disease EXPLORING THE IMPORTANCE OF RATER RELIABILITY IN DRUG DEVELOPMENT FOR ALZHEIMER’S DISEASE

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Patients with Alzheimer’s disease suffer from progressively worsening memory impairment, thought processes, and behaviors. Alzheimer’s disease symptoms manifest primarily in short-term memory loss: patients forget names, dates, or events;...

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Investigational Drugs Outside of Clinical Trials: Understanding Expanded Access and Right-to-Try INVESTIGATIONAL DRUGS OUTSIDE OF CLINICAL TRIALS: UNDERSTANDING EXPANDED ACCESS AND RIGHT-TO-TRY

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The Food and Drug Administration (FDA) has a system, known as expanded access, to provide investigational drugs outside of clinical trials. Critics of this program have said that it is cumbersome and discourages many patients and physicians from appl...

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Personalized Medicine in Oncology and the Implication for Clinical Development PERSONALIZED MEDICINE IN ONCOLOGY AND THE IMPLICATION FOR CLINICAL DEVELOPMENT

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The notable success of imatinib for the treatment of chronic myeloid leukemia and trastuzumab for the management of HER2-positive breast cancer patients has generated great enthusiasm for the delivery of more effective and safer treatment to patients...

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In Their Lifetime: Outlook for Rare Disease and Orphan Drug Research IN THEIR LIFETIME: OUTLOOK FOR RARE DISEASE AND ORPHAN DRUG RESEARCH

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Collectively rare diseases comprise a large segment of the global population. Developing effective treatments to combat these diseases demand heavy resources from biopharmaceutical companies - both monetary and scientific. Even though these diseases ...

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Track-And-Trace Solutions for the Pharmaceutical Supply Chain TRACK-AND-TRACE SOLUTIONS FOR THE PHARMACEUTICAL SUPPLY CHAIN

whitepaper

Industry concern about counterfeiting, diversion, mishandling, mislabeling, and unintended or mistaken administration of prescription drugs is mounting at an unprecedented pace. Stakeholders at all junctures of the pharmaceutical supply chain from po...

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Mixing Technologies in the Pharmaceutical and Medical Industries MIXING TECHNOLOGIES IN THE PHARMACEUTICAL AND MEDICAL INDUSTRIES

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Process equipment used in the healthcare industry follow rigid specifications for accuracy, consistency and cleanliness.These regulations ensure that end products are safe, pure, and effective. In particular, mixing equipment employed in the producti...

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Ten Tips for Single Use Pharmaceutical Tubing Selection TEN TIPS FOR SINGLE USE PHARMACEUTICAL TUBING SELECTION

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Tubing used in pharmaceutical and biotech applications has particular requirements. Among them are the ability to withstand sterilization processes, the delivery of favorable test results regarding extractable substances, and the absence of animal de...

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Creating Value with Integrated Coupon & Co-Pay Card and Patient Support Service Programs CREATING VALUE WITH INTEGRATED COUPON & CO-PAY CARD AND PATIENT SUPPORT SERVICE PROGRAMS

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From a patient perspective, hub services can often be a lifeline to managing complicated, chronic conditions. Creating a solution that supports patients who rely on “middle-ground” specialty medications is a necessity for an area that is becoming a l...

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Applications in Pharmaceutical Manufacturing APPLICATIONS IN PHARMACEUTICAL MANUFACTURING

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The use of aqueous cleaning in pharmaceutical manufacturing can provide numerous benefits in terms of effectiveness, minimal surface residue, and easier cleaning validation. Virtually any pharmaceutical manufacturing equipment, from tablet presses to...

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Innovative High Containment Pharmaceutical Sieving System from Russell Finex INNOVATIVE HIGH CONTAINMENT PHARMACEUTICAL SIEVING SYSTEM FROM RUSSELL FINEX

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With a reputation as one of the original pioneers of containment technology, Powder Systems Limited (PSL) hold a wealth of experience designing and engineering advanced containment processes, supplying customized process equipment to the pharmaceutic...

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Paperless manufacturing in the pharmaceutical industry PAPERLESS MANUFACTURING IN THE PHARMACEUTICAL INDUSTRY

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With growing cost pressures and new regulations, manufacturers and quality managers in the pharmaceutical industry are always looking for ways to improve their processes and procedures. A new electronic batch record solution enables complete paperles...

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Addressing Serialisation Challenges to Achieve Business Benefits and Best Practice Deployment in the Pharmaceutical Sector ADDRESSING SERIALISATION CHALLENGES TO ACHIEVE BUSINESS BENEFITS AND BEST PRACTICE DEPLOYMENT IN THE PHARMACEUTICAL SECTOR

whitepaper

This white paper sets out a roadmap for the successful implementation of a serialization programme applicable to pharmaceutical companies of any size and complexity. It is based on practical experience of implementing serialization for some of the wo...

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Pharmaceutical Consultant on Adaptive Clinical Trial Design in 2016 PHARMACEUTICAL CONSULTANT ON ADAPTIVE CLINICAL TRIAL DESIGN IN 2016

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Clinical trial consulting and pharmaceutical consulting professionals will benefit by becoming current on adaptive trial design. Gaining in popularity since the early 1990s,1 adaptive trials are those which observe patient outcomes after review of in...

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PLM for Pharmaceutical Industry PLM FOR PHARMACEUTICAL INDUSTRY

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The Pharmaceutical industry holds an undeniably important place in the Life Sciences sector world-wide as it is solely responsible for designing and manufacturing lifesaving drugs and medications. The revenue from this industry alone has almost touch...

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Convergence of Health and Pharma CONVERGENCE OF HEALTH AND PHARMA

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Traditionally, the healthcare and pharmaceutical industries have followed a conventional supplier-consumer relationship. However, both industries face the same core challenge to deliver better health outcomes at lower cost. This paper discusses chall...

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Pharmaceutical Hard Capsule Dissolution Equivalence PHARMACEUTICAL HARD CAPSULE DISSOLUTION EQUIVALENCE

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Empty hard capsules are widely used as a dosage delivery system in the pharmaceutical industry. Gelatin or Hypromellose (HPMC) are used as the shell raw material in the majority of pharmaceutical applications for various reasons including their uniqu...

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Medical Devices & In Vitro Diagnostic Medical Devices Reform MEDICAL DEVICES & IN VITRO DIAGNOSTIC MEDICAL DEVICES REFORM

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The European regulators therefore considered that a change was needed. Following recent scandals such as the Poly Implant Prothese ("PIP”) scandali, certain initiatives were having already been taken under the current regime (a) to minimise the risk ...

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Regulatory Compliance: Weighing in Pharma Manufacturing REGULATORY COMPLIANCE: WEIGHING IN PHARMA MANUFACTURING

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The Pharma IQ survey depicts the trend of increasingly stringent regulations in the pharmaceutical industry. However, regulations usually only provide broad guidance (e.g. measuring devices must be calibrated) and leave it to the manufacturer to defi...

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Labeling Best Practice in a Challenging Manufacturing Landscape - A survival guide for pharmaceutical companies LABELING BEST PRACTICE IN A CHALLENGING MANUFACTURING LANDSCAPE - A SURVIVAL GUIDE FOR PHARMACEUTICAL COMPANIES

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The number of challenges for the global pharmaceutical industry is perhaps higher than ever before. Competitive pressures, new stipulations from governments and regulators, products coming off patent and market pricing pressures have combined: pharma...

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Drug Attrition in Check: Shifting Information Input to Where It Matters DRUG ATTRITION IN CHECK: SHIFTING INFORMATION INPUT TO WHERE IT MATTERS

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Expenditures in pharmaceutical R&D are higher than ever, and attrition rates have reached 80-90%. The few compounds that make it to market have to carry the cost of the inefficient development process, but hope lies in improving the data that flows i...

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Precision Medicine: The New R&D Paradigm PRECISION MEDICINE: THE NEW R&D PARADIGM

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The drug that can be considered the first precision medicine entered the market in 1998, at a time when the concept was referred to as personalized medicine. Herceptin (trastuzumab) was first used for the treatment of a subgroup of breast cancer pati...

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Creating New Value for Biopharma CREATING NEW VALUE FOR BIOPHARMA

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In this paper we envisage future opportunities for value creation by the global biopharma industry. We set these opportunities in the context of an evolving healthcare ecosystem which continually creates new business opportunities and challenges for ...

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Leverage Your Quality Management Software Across Laboratory and Clinical Trial Drug Development LEVERAGE YOUR QUALITY MANAGEMENT SOFTWARE ACROSS LABORATORY AND CLINICAL TRIAL DRUG DEVELOPMENT

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Clinical trial drug development requires manufacturers to have the capability to identify, track and manage events in order to stay compliant with protocols and regulatory bodies. A consistent need for quality management is created by the drug develo...

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Future Trends In Pharmaceutical and Biotech Distribution FUTURE TRENDS IN PHARMACEUTICAL AND BIOTECH DISTRIBUTION

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This research study was oriented primarily around the Pharmaceutical and Biotech distribution sector. We focused on the analysis of the current situation and the likely changes in this industry in the next 3 to 5 years. At the outset of the study, we...

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The Hidden Challenges of Pharmaceutical Serialization by Domino Printing Sciences THE HIDDEN CHALLENGES OF PHARMACEUTICAL SERIALIZATION BY DOMINO PRINTING SCIENCES

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In the almost 40 years since counterfeiting of pharmaceutical products was recognised as a problem by the World Health Organization (WHO), the industry has waged a constant battle against increasingly sophisticated and organised counterfeiters, with ...

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Market access for medical devices: Challenges and potential Solutions MARKET ACCESS FOR MEDICAL DEVICES: CHALLENGES AND POTENTIAL SOLUTIONS

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According to the World Health Organization (WHO) definition, a medical device is “an article, instrument, apparatus, or machine that is used in the prevention, diagnosis, or treatment of illness or disease, or for detecting, measuring, restoring, cor...

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Modern Drug Commercialization MODERN DRUG COMMERCIALIZATION

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In today's pharmaceutical market, it often takes more than a decade and an estimated $2.6 billion to bring a new drug to market. The long development lead time result in approximately 7 to 10 year of patent protection before generic competition launc...

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Improving the Quality of Generic Drugs IMPROVING THE QUALITY OF GENERIC DRUGS

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This white paper addresses key policy issues, best practices, and key challenges around the pharmaceutical value chain that has an impact on quality of pharmaceuticals available to patients. This white paper also discusses the key stakeholders involv...

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Medical Information Role in the Pharmaceutical Industry MEDICAL INFORMATION ROLE IN THE PHARMACEUTICAL INDUSTRY

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Medical information (MI) teams at pharmaceutical and medical device companies primarily respond to inquiries about the company’s products. Inquiries can originate from healthcare providers, patients, scientists or anyone interested in information abo...

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EVOLVING CLOSED LOOP MARKETING FOR PHARMA: THERE’S MORE THAN ONE LOOP TO CLOSE EVOLVING CLOSED LOOP MARKETING FOR PHARMA: THERE’S MORE THAN ONE LOOP TO CLOSE

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The increasingly busy schedule of physicians and healthcare providers has led the pharmaceutical industry as a whole to adopt a Closed Loop Marketing (CLM) strategy. However, many pharma companies struggle with implementing and maintaining an effecti...

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Challenges of Analytical Method Transfer in the Pharmaceutical Industry CHALLENGES OF ANALYTICAL METHOD TRANSFER IN THE PHARMACEUTICAL INDUSTRY

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The development and validation of suitable analytical methods is a critical part of the overall drug-development life-cycle. For the majority of products, particularly those that are clinically successful, the transfer of the analytical method betwee...

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Outsourcing in the Pharma Industry Experience, Expertise and Enthusiasm OUTSOURCING IN THE PHARMA INDUSTRY EXPERIENCE, EXPERTISE AND ENTHUSIASM

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2012 will be regarded by many commentators as one of the most challenging years in the pharmaceutical industry’s history, due in no small part to numerous products facing patent expirations and increased global competition. It is now considered a sou...

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Pharmaceutical Manufacturing PHARMACEUTICAL MANUFACTURING

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The manufacture of ethical pharmaceutical products is a critically important process in the provision of healthcare. The process is both technical and carefully regulated, and staff ed by highly trained professionals, and thus the business enjoys hig...

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CROs and other outsourced pharmaceutical support services CROS AND OTHER OUTSOURCED PHARMACEUTICAL SUPPORT SERVICES

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I n recent years, biopharmaceutical companies large and small have become increasingly reliant on the contract research organisation (CRO) sector and other clinical services specialists to provide research services across the breadth of their R&D...

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Stability Testing of Biopharmaceuticals. STABILITY TESTING OF BIOPHARMACEUTICALS.

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Stability testing of a drug substance or a finished product is a vital part of the data package submitted in support of new drug applications or marketing authorisations. The principle ethos of stability testing is to provide evidence to a regulatory...

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Realising the potential of stratified medicine REALISING THE POTENTIAL OF STRATIFIED MEDICINE

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Although patient treatment has always been personalised by clinicians based upon individual circumstance and medical history, advances in our understanding of the molecular basis of diseases are redefining how diseases are classified and present a po...

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THE DEVELOPMENT OF A DIGITAL PLANT MATURITY MODEL TO AID TRANSFORMATION IN BIOPHARMACEUTICAL MANUFACTURING THE DEVELOPMENT OF A DIGITAL PLANT MATURITY MODEL TO AID TRANSFORMATION IN BIOPHARMACEUTICAL MANUFACTURING

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Surely, we cannot consider a manufacturing plant in isolation but need to see it in its context of a seamless, endto-end value chain from suppliers, through an internal and external manufacturing ecosystem, and all the way to the patient. This is not...

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Boost field IQ to increase pharmaceutical sales BOOST FIELD IQ TO INCREASE PHARMACEUTICAL SALES

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The more sales reps know about the physicians in their territory, the better their leverage in gaining access to them, which is why one top 10 pharmaceutical company decided to focus on enhancing field intelligence. They turned to LexisNexis Health C...

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Regulatory compliance in pharma: Software requirements and solutions REGULATORY COMPLIANCE IN PHARMA: SOFTWARE REQUIREMENTS AND SOLUTIONS

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Records and signatures in regulated environments can be either created on paper or electronically. In the past, the use of paper has been favored over electronic records and signatures. Advantages of electronic records compared to paper-based records...

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Finding and Executing Pharma Licensing Opportunities FINDING AND EXECUTING PHARMA LICENSING OPPORTUNITIES

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It is not surprising that mostly small to medium sized companies seek the help of specialist consultancies to find commercial partners or find in-licensing opportunities. Large pharma is in the attractive position that they get thousands of unsolicit...

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The Challenges of Connecting Globally in the Pharmaceutical Industry THE CHALLENGES OF CONNECTING GLOBALLY IN THE PHARMACEUTICAL INDUSTRY

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The pharmaceutical industry is globalizing. Conducting global clinical trials to get a broader and more diverse participant base and expanding into less-saturated developing markets are two significant drivers to globalization. However, this expansio...

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The New Reality: Maximizing Value in Rare Disease Launches THE NEW REALITY: MAXIMIZING VALUE IN RARE DISEASE LAUNCHES

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A modern Integrated Pharmaceutical Development Platform will include builtin requesting capabilities, which provide laboratory managers with early insight into the workload coming their way so they can make more informed scheduling decisions. This re...

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Biopharmaceuticals In Perspective BIOPHARMACEUTICALS IN PERSPECTIVE

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This chart pack provides facts and figures about prescription medicines and their role in the health care system. Topics include medicines’ impact on health and quality of life, the drug discovery and development process, health care spending and cos...

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The Internet of Things: The New Rx for Pharmaceuticals Manufacturing & Supply Chains THE INTERNET OF THINGS: THE NEW RX FOR PHARMACEUTICALS MANUFACTURING & SUPPLY CHAINS

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Product quality, regulatory compliance and operational efficiencies top the long list of business priorities for pharmaceuticals executives, who lead the charge in improving manufacturing and supply chain performance. Investments in areas such as sho...

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Patient centricity: How does Boehringer Ingelheim UK measure up? PATIENT CENTRICITY: HOW DOES BOEHRINGER INGELHEIM UK MEASURE UP?

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In 2015 Boehringer Ingelheim UK set out on a pioneering journey with two clear aims in mind. One was to define what it means for a pharmaceutical company to be patient centric and, the second, to generate a broad set of internal and external measures...

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Anti-Microbial Resistance and the search for New Antibiotics ANTI-MICROBIAL RESISTANCE AND THE SEARCH FOR NEW ANTIBIOTICS

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The ‘antibiotic crisis’ is rarely out of the news these days, with headlines issuing dire warnings that the rise in resistance to anti-microbial drugs could result in a return to the medical dark ages. In order to tackle this problem, various initiat...

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Stars in Our Eyes Ophthalmology Drugs Report STARS IN OUR EYES OPHTHALMOLOGY DRUGS REPORT

whitepaper

The ophthalmology drug segment continues to shine brightly with a number of deals announced in November such as Genentech’s partnering with Novartis to split ex-US rights to Ophthotech’s eye drug, which could be worth more than $1 billion. Allergan, ...

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Pharma Collaboration – The Solution to Common Pharma Problems PHARMA COLLABORATION – THE SOLUTION TO COMMON PHARMA PROBLEMS

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To start our series on the fruitful benefits of collaboration in the Pharma industry, we chose to discuss a well-familiar, in-house, long-existing, dichotomous relationship between brands and sales, and how a reconciliation between them, based on a s...

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The Affordable Care Act and the Pharmaceutical Industry: Trends and Perspectives THE AFFORDABLE CARE ACT AND THE PHARMACEUTICAL INDUSTRY: TRENDS AND PERSPECTIVES

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One major goal of the ACA is to provide better patient outcomes at lower costs. This is where Accountable Care Organizations (ACOs) come into play. ACOs are one of the ACA’s voluntary initiatives to reduce medical costs by rewarding groups of HCPs an...

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Moving to Specialty Pharma: How to Succeed MOVING TO SPECIALTY PHARMA: HOW TO SUCCEED

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The Pharma industry is increasing its focus on developing Specialty drugs. It is expected to grow by 67% in 2015 alone, while the overall Specialty drug spending is expected to more than quadruple by 2020, accounting for about $402 billion a year in ...

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Streamlining Pharma Drug Development STREAMLINING PHARMA DRUG DEVELOPMENT

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The costs of drug development continue to rise. Dramatically. According to a 2015 report by Deloitte, costs have increased by a third in just the last five years. If that weren’t trouble enough, sales during the same time frame have tumbled 50%. Incr...

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Providing an Unparalleled Range of Contract Pharmaceutical Development and Manufacturing Services Globally for Over 40 Years PROVIDING AN UNPARALLELED RANGE OF CONTRACT PHARMACEUTICAL DEVELOPMENT AND MANUFACTURING SERVICES GLOBALLY FOR OVER 40 YEARS

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Only we can combine the expertise from our range of specialized services to provide you with the right solutions to help you develop and commercialize your products. We will work with you in the most appropriate manner for your situation; either on a...

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Big Data Breathes Life into Next-Gen Pharma R&D BIG DATA BREATHES LIFE INTO NEXT-GEN PHARMA R&D

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The process of drug development is lengthy and complex combined with several processes, applications and approvals. Unquantified and unstructured data is produced from multiple systems in various forms. However, recent advances in storage, network an...

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Pharmaceutical packaging serialization PHARMACEUTICAL PACKAGING SERIALIZATION

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Packaging standards are growing in complexity as manufacturers serve an increasingly global customer base, and serialization requirements continue to be deployed across a number of countries. Life sciences packaging needs have driven innovation in th...

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Process PLM: The Future of Pharmaceutical Manufacturing PROCESS PLM: THE FUTURE OF PHARMACEUTICAL MANUFACTURING

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It’s been over a dozen years since The Wall Street Journal famously observed that pharmaceutical manufacturing techniques lagged “far behind those of potato-chip and laundry-soap makers.”1 The same publication made a similarly stark observation just ...

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Prescription Drug User Fee Act (PDUFA): Adding Resources and Improving Performance in FDA Review of New Drug Applications PRESCRIPTION DRUG USER FEE ACT (PDUFA): ADDING RESOURCES AND IMPROVING PERFORMANCE IN FDA REVIEW OF NEW DRUG APPLICATIONS

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The Prescription Drug User Fee Act (PDUFA) program is the cornerstone of modern FDA drug review. User fees currently fund about half of new drug review costs. By providing needed funds, PDUFA ended slow and unpredictable review and approval of new dr...

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Oncology Drug Development and Value-Based Medicine ONCOLOGY DRUG DEVELOPMENT AND VALUE-BASED MEDICINE

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Cancer drugs constitute the second biggest category of drugs sold in the U.S. Worldwide, sales of cancer drugs are forecast to grow steadily, driven by the aging population and by opportunities for earlier therapeutic intervention using more effectiv...

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How to Reduce Costs of Specialty Pharmaceutical Shipments and Increase Patient Satisfaction HOW TO REDUCE COSTS OF SPECIALTY PHARMACEUTICAL SHIPMENTS AND INCREASE PATIENT SATISFACTION

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The specialty pharmacy industry could reduce costs by $27.5 million annually (product and call center staff costs only) if visual temperature indicators were used as decision-making tools to determine if medicine should be used or returned when patie...

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Pharmaceutical serialization track and trace an easy guide to country-wise mandates PHARMACEUTICAL SERIALIZATION TRACK AND TRACE AN EASY GUIDE TO COUNTRY-WISE MANDATES

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Pharmaceutical companies have to contend with challenges stemming from supply chain security lapses, counterfeiting and stringent regulations. This guide, complied by the Legal and Research team at Infosys.

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A NEW PARADIGM FOR MANUFACTURING INJECTABLE MEDICINES A NEW PARADIGM FOR MANUFACTURING INJECTABLE MEDICINES

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The drug they were making was a predecessor of today’s therapies. It was complex, high-value and hard to manufacture. Seeing that pharmaceutical companies’ drug discovery platforms were swelling the ranks of clinical product candidates, they could se...

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Human Error in Pharmaceutical Manufacturing HUMAN ERROR IN PHARMACEUTICAL MANUFACTURING

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Human Error frequently occurs in pharmaceutical manufacturing, even when the organisation considers that they have done everything to prevent its occurrence. Documentation appears accurate, personnel are fully trained and equipment operates as design...

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The Issues and Regulation of Pharmaceutical Waste Management THE ISSUES AND REGULATION OF PHARMACEUTICAL WASTE MANAGEMENT

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The EPA’s recent focus on pharmaceutical waste management has been influenced by increasing evidence of pharmaceuticals in drinking water. An Associated Press series on pharmaceutical waste in May 2009, reported that EPA has found traces of pharmaceu...

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Feasibility of shipping clinical trial drugs directly to patients’ homes FEASIBILITY OF SHIPPING CLINICAL TRIAL DRUGS DIRECTLY TO PATIENTS’ HOMES

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Conducti ng clinical trials for rare, debilitate ng diseases can be particularly challenging, owing to the smaller patient population with limited mobility and greater caregiving requirements. Direct-to-patient shipping of clinical trial drugs, while...

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The changing biopharma risk equation THE CHANGING BIOPHARMA RISK EQUATION

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As pharma companies expand, they are looking more and more to biologics for their next potential blockbusters. However, this class of product ranging from well-established large molecule drugs to truly novel therapies poses major challenges because o...

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Developing and Manufacturing Life-Saving Biopharmaceutical Products DEVELOPING AND MANUFACTURING LIFE-SAVING BIOPHARMACEUTICAL PRODUCTS

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Porton Biopharma Limited (PBL) is a UK-based company experienced in developing, manufacturing and bringing life-saving biopharmaceutical therapeutics and vaccines to market. The company is expert at taking concepts from the research laboratory, progr...

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The Challenges, Solutions, and Strategies Driving Pharmaceutical Supply Chain Innovation THE CHALLENGES, SOLUTIONS, AND STRATEGIES DRIVING PHARMACEUTICAL SUPPLY CHAIN INNOVATION

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In recent years, pharmaceutical and biotechnology companies have come to understand that supply chains ultimately impact the delivery of healthcare, and supply chains can and should serve as value centers for their company and the end-user. While the...

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Pharma PHARMA'S SHIFTING PARADIGM IN INDIAN BECOMING MULTI- CHANNEL MARKET

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To date / the Indian pharma market has been dominated by the trade/retail segment which has contributed up to 85% of the market value. This is unlike most mature markets globally which usually operate in a multi-channeled business model involving not...

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The importance of COPQ for the pharmaceutical industry THE IMPORTANCE OF COPQ FOR THE PHARMACEUTICAL INDUSTRY

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As any senior executive within an organisation knows, the reduction of waste and, more importantly, the cost associated with that waste can have a major effect on any business. Whilst some waste is unavoidable, an executive can begin to implement pri...

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Perfect climate for pharmaceutical manufacture PERFECT CLIMATE FOR PHARMACEUTICAL MANUFACTURE

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Pharmadule, the world leader in modular manufacturing facilities for the pharmaceutical industry, has in recent years been working with Munters to supply humidity controlled facilities for Eli Lilly Indianapolis, Baxter Bloomington USA and Eli Lilly ...

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Silicones for pharmaceutical applications –analytical capabilities at Solvias SILICONES FOR PHARMACEUTICAL APPLICATIONS –ANALYTICAL CAPABILITIES AT SOLVIAS

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Silicones are used in pharmaceutical applications as part of formulations, as well as during manufacturing and in packaging. The term ‘silicones’ encompasses a large number of compounds based on polydialkylsiloxanes. The most common are trimethylsily...

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Nasal Drug Delivery With A Focus On Chronic Rhino-Sinusitis NASAL DRUG DELIVERY WITH A FOCUS ON CHRONIC RHINO-SINUSITIS

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Aptar Pharma recently hosted a scientific roundtable on “Nasal drug delivery with a focus on chronic rhino‑sinusitis”. This international scientific forum was held in Paris, France on November 13th 2012. The roundtable was organized to explore and ex...

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SCHOTT FIOLAX - Special Glass Tubing for Pharmaceutical Packaging SCHOTT FIOLAX - SPECIAL GLASS TUBING FOR PHARMACEUTICAL PACKAGING

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Glass has many advantages over other packaging materials used for pharmaceutical primary packaging. It has only a few components, ensuring reliable information on the chemical resistance and protection of the medicines. In this manner, reliable recom...

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Origin Hybrid Pharmaceutical Packaging (HP3) Brochure ORIGIN HYBRID PHARMACEUTICAL PACKAGING (HP3) BROCHURE

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Origin’s ethos is everything we do, we innovate. Whether that is a new child resistant closure for a major pharmaceutical company, to a new, state of the art Enterprise Resource Planning System to further improve the customer’s experience with Origin...

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Addressing the Challenges of Pharmaceutical Content ADDRESSING THE CHALLENGES OF PHARMACEUTICAL CONTENT

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As demographics change, and more and more new pharmaceutical and medical devices come to market, content plays an increasingly important role in regulatory requirements, and physician and patient knowledge and support. Yet content is still created an...

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How to Choose the Right CMO for Your Pharmaceutical
Product HOW TO CHOOSE THE RIGHT CMO FOR YOUR PHARMACEUTICAL PRODUCT

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The development of a new drug is a complex venture associated with in-depth analysis and difficult decisions prior to commercialization of the product. A lot of drug sponsors find themselves lacking experience, equipment, or both in development of th...

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Turkish Pharmaceutical Market TURKISH PHARMACEUTICAL MARKET

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Ranked as the 16th largest pharmaceutical market in the world and the seventh biggest in Europe in 2011 in terms of sales, Turkey's domestic market offers many opportunities. According to data from the Association of Research-Based Pharmaceutical Com...

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Eyeforpharma market access and pricing excellence conference review 2015 EYEFORPHARMA MARKET ACCESS AND PRICING EXCELLENCE CONFERENCE REVIEW 2015

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A solution to the current funding crisis for budget-busting breakthrough treatments has been proposed by Soeren Mattke, senior scientist at the RAND Corporation think tank, involving payers and governments borrowing from pharma. However, multiple obs...

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What does the road to 2020 look like for Pharma with digital? WHAT DOES THE ROAD TO 2020 LOOK LIKE FOR PHARMA WITH DIGITAL?

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Featuring the views and experiences of industry experts from inside and outside of pharma & healthcare, this series of four white papers from PharmiWeb Solutions looks at how pharma can make the right decisions about the technologies, devices and ski...

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Is pharma brand marketing dead? IS PHARMA BRAND MARKETING DEAD?

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That is the provocative question I have been posing to pharmaceutical marketers, industry leaders and stakeholders over the last few months. This supplement brings together a series of articles, insights and discussions Kantar Health has produced in ...

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Process Refractometry Everything from Physical Basics to Innovative Solutions for The Food And Pharmaceutical Industries PROCESS REFRACTOMETRY EVERYTHING FROM PHYSICAL BASICS TO INNOVATIVE SOLUTIONS FOR THE FOOD AND PHARMACEUTICAL INDUSTRIES

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Process measuring instruments are essential tools for monitoring and controlling critical process parameters. Risk analysis identifies critical process parameters which must be monitored and controlled during the production process in order to achiev...

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Recognising The Needs Of The Pharmaceutical Industry RECOGNISING THE NEEDS OF THE PHARMACEUTICAL INDUSTRY

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Catalysis is an essential part of many pharmaceutical processes. With increasing innovation in catalytic chemistry coupled with ever increasing regulatory requirements for residual levels of metal catalysts, particularly Platinum and Palladium, the r...

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Quality manufacturing A blockbuster opportunity for pharmaceuticals QUALITY MANUFACTURING A BLOCKBUSTER OPPORTUNITY FOR PHARMACEUTICALS

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The pharmaceutical industry is transforming the mass production of drugs. More complex compounds, impatient regulators and increasedmarket pressures leave little doubt that manufacturing will no longer be viewed as a standalone activity, but will joi...

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Seizing the potential of commercial outsourcing in the pharmaceutical sector SEIZING THE POTENTIAL OF COMMERCIAL OUTSOURCING IN THE PHARMACEUTICAL SECTOR

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The power and potential of outsourcing has long been recognized as a core enabler of business growth. Yet while the pharmaceutical industry has been making strides in this area, there is still some way to go to realize the full potential; only in the...

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Econometric Analysis Of Biopharmaceutical Transfer Pricing ECONOMETRIC ANALYSIS OF BIOPHARMACEUTICAL TRANSFER PRICING

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Interestingly, the above quote by Benjamin Franklin epitomizes in many respects the significant daily challenges faced by biopharmaceutical companies – to lengthen and improve the quality of life, while always facing the mortality of patients against...

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Is It Time To Adjust The Pharma PDE Sales Force Optimization Model? IS IT TIME TO ADJUST THE PHARMA PDE SALES FORCE OPTIMIZATION MODEL?

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The rise of performance-based managed care contracts is requiring pharma companies to demonstrate drug value in producing health outcomes and/or health economic benefits.1 While performance-based contracts are currently still relatively rare, even wi...

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The Strategic Importance of Biomarkers to the Pharmaceutical Industry THE STRATEGIC IMPORTANCE OF BIOMARKERS TO THE PHARMACEUTICAL INDUSTRY

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In the last few years, pharmaceutical companies have become increasingly interested in biomarkers and their incorporation into company drug development programmes and use as companion tests for targeted therapeutics. Identifying patients that will be...

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Stars in Our Eyes Ophthalmology Drugs Report STARS IN OUR EYES OPHTHALMOLOGY DRUGS REPORT

whitepaper

The ophthalmology drug segment continues to shine brightly with a number of deals announced in November such as Genentech’s partnering with Novartis to split ex-US rights to Ophthotech’s eye drug, which could be worth more than $1 billion. Allergan, ...

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The Reasons for And Solutions to Chronic Drug Shortages in The United States THE REASONS FOR AND SOLUTIONS TO CHRONIC DRUG SHORTAGES IN THE UNITED STATES

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One of the more vexing and troubling public health policy issue that has plagued the US pharma industry, yet receiving less deserving public news coverage than other industry stories, has been the existence of chronic drug shortages since the turn of...

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Bioassay Survey 2006–2007 Cell-Based Bioassays in the Biopharmaceutical Industry BIOASSAY SURVEY 2006–2007 CELL-BASED BIOASSAYS IN THE BIOPHARMACEUTICAL INDUSTRY

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Bioassays are required for a variety of purposes in the development and production of biopharmaceuticals including drug candidate selection, product releases, product stability assessment, and comparability to support proposed process changes. Howeve...

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Formulation customization: Applying Diffucaps Customized Release Technology to reduce dosing frequency and encourage patient adherence FORMULATION CUSTOMIZATION: APPLYING DIFFUCAPS CUSTOMIZED RELEASE TECHNOLOGY TO REDUCE DOSING FREQUENCY AND ENCOURAGE PATIENT ADHERENCE

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The pharmaceutical industry is driven to develop oral drug formulations that deliver significant patient benefits. Drug delivery technology can be leveraged to reduce dosing frequency, and therefore, help encourage patient adherence to prescribed the...

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Overcoming dosage administration challenges with a patient-centric solution OVERCOMING DOSAGE ADMINISTRATION CHALLENGES WITH A PATIENT-CENTRIC SOLUTION

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Innovative medication formulation encourages adherence for patients with cystic fibrosis for pharmaceutical manufacturers and healthcare providers, patient nonadherence to medication is a significant concern. In the United States alone, research has ...

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PHARMACOMETRICS: A COMPETITIVE ADVANTAGE IN IMPROVING R&D FOR COMPANIES OF ALL SIZES PHARMACOMETRICS: A COMPETITIVE ADVANTAGE IN IMPROVING R&D FOR COMPANIES OF ALL SIZES

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Pharmacometrics the use of modeling and simulation to support drug development and assessment decisions has been in use for more than two decades. Today, however, the urgent need for improved R&D productivity within the pharmaceutical sector has high...

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Delivering on the Potential of Biosimilar Medicines DELIVERING ON THE POTENTIAL OF BIOSIMILAR MEDICINES

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Realizing this potential is neither easy nor assured. The lack of uniformity across EU nations that have had access to biosimilar medicines for almost a decade suggests the underlying elements of achieving the full potential from biosimilar medicines...

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The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing THE REAL COST OF POOR DATA INTEGRITY IN PHARMACEUTICAL MANUFACTURING

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With the rapid growth of the generics market, economic and regulatory pressure on pharmaceutical manufacturers is increasing. In this environment, time to market has become even more critical to shareholder value creation and sustainable profitabilit...

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Pharmaceutical Marketing PHARMACEUTICAL MARKETING

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it’s been almost 15 years since U.S. direct-to-consumer advertising regulations were loosened. And in those years, the consumer pharmaceutical marketing industry has gone from about $700 million in ad spending to a peak of $5.4 billion in 2006. Spend...

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Mastering Change in Inhalation Drug Delivery MASTERING CHANGE IN INHALATION DRUG DELIVERY

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The first evidence of humans smoking Atropa Belladonna as a cough remedy can be dated back over 4,000 years. Fortunately, technology and expertise in inhalation drug delivery have improved significantly since then, offering better predictability, eff...

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Value Added Medicines VALUE ADDED MEDICINES

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The current pool of existing molecules potentially re-positioned, re-formulated or combined with new technological platforms and services might offer therapeutic alternatives and opportunities for patients and health care systems. Even if this concep...

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ORPHAN DRUG & RARE DISEASE DEVELOPMENT: Understanding the U.S. and European Regulatory Landscape ORPHAN DRUG & RARE DISEASE DEVELOPMENT: UNDERSTANDING THE U.S. AND EUROPEAN REGULATORY LANDSCAPE

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Approximately $14 million are provided per year to sponsor companies through the orphan drug grant program, which is applicable to drugs, biologics, medical devices or even medical foods. While this amount may seem small for traditional drugs, it has...

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Continued Development of Approved Biological Drugs CONTINUED DEVELOPMENT OF APPROVED BIOLOGICAL DRUGS

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As the U.S Congress considers creating a process that allow the FDA to approve follow -on biologics (FOBs) also referred to as biosimilars on the basis of an abbreviated application by follow on manufacturers there has been heightened interest in und...

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The Journal of Human Pharmacology and Drug Therapy THE JOURNAL OF HUMAN PHARMACOLOGY AND DRUG THERAPY

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This White Paper examines the pharmacy profession’s future. It discusses pharmacy’s changing philosophy of practice, factors influencing the evolution of professional roles and responsibilities, preparation for future roles, future leadership and man...

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Improving Productivity in Pharmaceutical Research and Development: The Role of Clinical Pharmacology IMPROVING PRODUCTIVITY IN PHARMACEUTICAL RESEARCH AND DEVELOPMENT: THE ROLE OF CLINICAL PHARMACOLOGY

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The high failure rate of investigational compounds during drug development, especially in late stages of the clinical development process, is widely seen as a key contributor to the large amount of time and resources necessary to develop new drugs. R...

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Pressure Mounts for Patient Access to Investigational Drugs PRESSURE MOUNTS FOR PATIENT ACCESS TO INVESTIGATIONAL DRUGS

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Regulations allowing compassionate use of investigational drugs have been in effect since 1987, when public anger about the slow pace of approvals for HIV/AIDS drugs resulted in rules allowing greater access to drugs in development. Last year, the FD...

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Rewarding Results: Moving Forward on Value-Based Contracting for Biopharmaceuticals REWARDING RESULTS: MOVING FORWARD ON VALUE-BASED CONTRACTING FOR BIOPHARMACEUTICALS

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The shift in US health care, from payment based on volume to payment based on value, has sparked interest among payers and pharmaceutical companies in new pricing and contracting arrangements for prescription drugs. The objective of these new arrange...

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Selecting a Dosage Form for Drug Delivery to the Lungs SELECTING A DOSAGE FORM FOR DRUG DELIVERY TO THE LUNGS

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Salt form screening (if applicable) is an important early step in inhalation dosage form selection. Approximately 50% of active pharmaceutical ingredients (APIs) in approved products are salt forms,1 and that proportion is slightly higher (approx. 60...

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Pharmaceutical Development for ADCs: Not as Simple as ABC PHARMACEUTICAL DEVELOPMENT FOR ADCS: NOT AS SIMPLE AS ABC

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Formulation, process, and analytical development for antibody-drug conjugates, or ADCs, is complex. While the development of an aqueous solution formulation may be preferred over a lyophilized product, it is useful to initially pursue a dual path and...

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Drug Nanocarriers DRUG NANOCARRIERS

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The role that nanoparticles play in the rapidly developing field of ‘NanoMedicine’ has been discussed previously in Chapter 5. In this Chapter, we review the specificmechanisms by which such nanoparticles are designed and formulated and in which NTA ...

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Abuse-Deterrent Studies for Controlled Drugs - A Changing Landscape ABUSE-DETERRENT STUDIES FOR CONTROLLED DRUGS - A CHANGING LANDSCAPE

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Prescription drug abuse is the Nation's fastest-growing drug problem and has been classified as an epidemic by the Centers for Disease Control and Prevention.1 Abuse in this case can be defined as intentional misuse of prescription pharmaceuticals to...

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An Opioid Abuse-Deterrent Roadmap for the Pharmaceutical Industry AN OPIOID ABUSE-DETERRENT ROADMAP FOR THE PHARMACEUTICAL INDUSTRY

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Since 1999, the quantity of prescription opioids sold in the United States has nearly quadrupled, resulting in an average of 650,000 opioid prescriptions dispensed daily. Deaths from prescription opioids—drugs like oxycodone, hydrocodone, and methado...

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Extractables and Leachables Testing in the Pharmaceutical Industry EXTRACTABLES AND LEACHABLES TESTING IN THE PHARMACEUTICAL INDUSTRY

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Leachables are organic or inorganic compounds that migrate into the drug product formulation from the container closure system as result of direct contact with the formulation. They are typically low‐molecular weight volatile compounds that migrate t...

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Guide to Pharmaceutical Serialization 2017 GUIDE TO PHARMACEUTICAL SERIALIZATION 2017

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The entire pharmaceutical supply chain, including drug manufacturers, wholesale drug distributors, repackagers, and many dispensers (primarily pharmacies), have been called upon to act within their respective portion of the supply chain. An initiativ...

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Elemental Impurity Analysis in Pharmaceuticals and Implementation of ICH Q3D ELEMENTAL IMPURITY ANALYSIS IN PHARMACEUTICALS AND IMPLEMENTATION OF ICH Q3D

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Elemental impurities have been a hot topic since 2009 when the International Conference of Harmonisation (ICH) commenced work on a new standard to provide a global policy to limit these impurities in drug products and ingredients. Their guidance docu...

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A Cure for Pharmaceutical Supply Chain Complexity A CURE FOR PHARMACEUTICAL SUPPLY CHAIN COMPLEXITY

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The pharmaceutical industry lags in the sophistication and performance of its supply chains when they are compared with best-in-class companies in other industries. This is due to the complexity that has come with new drugs, more complex production t...

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DSCSA IMPLEMENTATION FOR PHARMACEUTICAL 3PL PROVIDERS DSCSA IMPLEMENTATION FOR PHARMACEUTICAL 3PL PROVIDERS

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With the stroke of a pen in 2013, the pharmaceutical industry mobilized in order to comply with sweeping changes enacted by the Drug Quality and Safety Act. The law includes the Drug Supply Chain Security Act (“DSCSA”), written to increase patient sa...

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Pharmaceutical Waste Management PHARMACEUTICAL WASTE MANAGEMENT

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The EPA’s recent focus on pharmaceutical waste management has been influenced by increasing evidence of pharmaceuticals in drinking water. An Associated Press series on pharmaceutical waste in May 2009, reported that EPA has found traces of pha...

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How to Boost Profits with Single-Use Powder Transfer in Biopharmaceuticals Manufacturing HOW TO BOOST PROFITS WITH SINGLE-USE POWDER TRANSFER IN BIOPHARMACEUTICALS MANUFACTURING

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Many biopharmaceutical manufacturers are Implementing single-use containment and transfer of media and buffer materials to prevent feedstock contamination and to promote worker safety. Choosing the proper containment system can have a significant imp...

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Solutions for the future of biomanufacturing SOLUTIONS FOR THE FUTURE OF BIOMANUFACTURING

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The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless-steel infrastructure to flexible, multi-product facilities using single-use technology. Though single-use is being widely adopted, there still exis...

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Almac: Crystallisation of Pharmaceutical Compounds ALMAC: CRYSTALLISATION OF PHARMACEUTICAL COMPOUNDS

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The Almac Group provides development and manufacturing services for Active Pharmaceutical Ingredients (APIs) to pharmaceutical industries worldwide. Over the past 40 years, we have made numerous discoveries that have become powerful intellectual prop...

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Marketing to Digital Docs: Innovative Ways to Reach Healthcare Providers in the New Media Age MARKETING TO DIGITAL DOCS: INNOVATIVE WAYS TO REACH HEALTHCARE PROVIDERS IN THE NEW MEDIA AGE

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Reaching doctors today with traditional marketing materials is more challenging than ever. For pharma reps, the days of in-person sales calls and free lunch seminars are gone. Today’s digital-savvy doctors are time-crunched and mobile, and they want ...

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Migration safe pharmaceutical labels improve patient safety MIGRATION SAFE PHARMACEUTICAL LABELS IMPROVE PATIENT SAFETY

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Labels play an invaluable role on pharmaceutical packages. Pharmaceutical companies should only use labels that meet low-leachability and extraction requirements. Labels that are not migration safe, e.g. create leachable chemical compounds, may fail ...

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Addressing the needs of drug discovery with the MicroCal PEAQ-ITC instruments ADDRESSING THE NEEDS OF DRUG DISCOVERY WITH THE MICROCAL PEAQ-ITC INSTRUMENTS

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Measurements and characterization of binding interactions between proteins and low-molecular weight ligands are fundamental for drug discovery. Among the most recognized challenges in characterizing binding interactions are (1) the need to accurately...

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Pharmacokinetic Modeling Supports the Approval of a Rare Liver Disease Treatment PHARMACOKINETIC MODELING SUPPORTS THE APPROVAL OF A RARE LIVER DISEASE TREATMENT

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Primary biliary cholangitis (PBC) is a chronic, rare disease characterized by cholestasis—the impaired flow of bile from the liver.1 The resulting increased bile acid concentrations cause cellular injury. Untreated PBC can lead to liver failure and d...

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2016 State of Drug Development: From Molecule to Market 2016 STATE OF DRUG DEVELOPMENT: FROM MOLECULE TO MARKET

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Drug development is an area of high risk, but it also has potential to be of high reward. Developers can create therapeutics that have an enormously positive impact on outcomes for patients, reduce the burden on healthcare and create return on invest...

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High Potency Drugs – from Molecule to Market HIGH POTENCY DRUGS – FROM MOLECULE TO MARKET

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PCI Pharma Services has invested in state-of-the-art containment equipment and created a ‘Potent Passport’ philosophy to identify the specific handling requirements for any Highly Potent Active Pharmaceutical Ingredients (HPAPI) project. Backed by 30...

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The Pharmaceutical Innovation Platform THE PHARMACEUTICAL INNOVATION PLATFORM

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Global progress in addressing people’s health needs over the past century has been nothing short of spectacular. Many factors have contributed to this improvement, but one has been particularly critical: advances in medical technologies from the priv...

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Indication-specific Pricing of Pharmaceuticals in the United States Health Care System INDICATION-SPECIFIC PRICING OF PHARMACEUTICALS IN THE UNITED STATES HEALTH CARE SYSTEM

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ISP involves setting different prices for different indications or for distinct patient subpopulations eligible for treatment with a medication. The relative clinical benefit of a drug can vary widely between different indications or between differen...

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Innovation In Heart Failure Drug Development - Is There Enough INNOVATION IN HEART FAILURE DRUG DEVELOPMENT - IS THERE ENOUGH

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Within Citeline’s Pharmaprojects database, there are currently 85 compounds in development (preclinical through preregistration) by industry for heart failure. Bayer and Servier lead all companies in overall drug development with six and five compoun...

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Epigenetic Drugs in Oncology: Current Clinical Landscape and Emerging Trends EPIGENETIC DRUGS IN ONCOLOGY: CURRENT CLINICAL LANDSCAPE AND EMERGING TRENDS

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Epigenetics is the study of heritable, reversible forms of gene regulation that are not dependent on the DNA sequence. This regulation includes DNA methylation and histone methylation, acetylation, ubiquitination, and phosphorylation. 1 While epigene...

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Maximizing Pharmaceutical Processes with Vacuum Technology MAXIMIZING PHARMACEUTICAL PROCESSES WITH VACUUM TECHNOLOGY

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Pharmaceutical manufacturers are implementing vacuum conveying technologies to deliver drugs to consumers faster, safer and more economically. Vacuum technology provides safer transfer of dry bulk materials and allows pharmaceutical processors to mee...

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Thermal Analysis with Pharmaceutical Applications THERMAL ANALYSIS WITH PHARMACEUTICAL APPLICATIONS

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Thermal analysis techniques are used to characterize the properties of crystalline solids and identify polymorphs. These techniques can also be used to study the effects of lyophilization on a test material. Differential scanning calorimetry (DSC) an...

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Advanced Biopharmaceutical Manufacturing: An Evolution Underway ADVANCED BIOPHARMACEUTICAL MANUFACTURING: AN EVOLUTION UNDERWAY

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The past decade has seen a significant shift in the nature of the products being manufactured and sold by the innovative biopharmaceutical (biopharma) industry. The global biopharmaceutical portfolio of today reflects increased therapeutic competitio...

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Pharmaceutical Product Serialization Regulations and Strategies for Compliance PHARMACEUTICAL PRODUCT SERIALIZATION REGULATIONS AND STRATEGIES FOR COMPLIANCE

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The Drug Supply Chain Security Act – DSCSA (Title II, Drug Quality and Security Act, 2013) has been signed into law, with full implementation phased in over the next 10 years. The next milestone for manufacturers, November 27, 2017, is the date b...

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A Dose of Shared Services: Why Big Pharma is Turning South A DOSE OF SHARED SERVICES: WHY BIG PHARMA IS TURNING SOUTH

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With blockbuster drugs coming off patent, rising research and development costs and profit margins growing ever slimmer, biotechnology and pharmaceutical companies are feeling the pressure to find every business advantage they can. One of the sym...

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SOLVING THE KNOWLEDGE MANAGEMENT PUZZLE IN BIOPHARMA SOLVING THE KNOWLEDGE MANAGEMENT PUZZLE IN BIOPHARMA

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In the ever-quickening quest for knowledge, a diversity of biopharma professionals are driven by a multiplicity of agendas spanning research to regulation. From the seeking of medical breakthroughs to the preparation of FDA submissions; from clinical...

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Getting serious about serialization: A comprehensive look at the
legislation shaping U.S. pharmaceutical supply chains GETTING SERIOUS ABOUT SERIALIZATION: A COMPREHENSIVE LOOK AT THE LEGISLATION SHAPING U.S. PHARMACEUTICAL SUPPLY CHAINS

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On Nov. 27, 2013 President Obama signed the Drug Quality and Security Act into law, effectively setting the framework of what would become a nationwide initiative toward wide-scale pharmaceutical serialization. The Drug Supply Chain Security Act is o...

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Controlling temperature in pharmaceutical
supply chains CONTROLLING TEMPERATURE IN PHARMACEUTICAL SUPPLY CHAINS

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This is especially important for sensitive pharmaceuticals, which can be fundamentally compromised when exposed to incorrect temperatures. The effects of this decomposition can vary from lack of therapeutic effect to toxicity and even death.

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Risk Assessment for Single-Use Pharmaceutical Manufacturing Systems RISK ASSESSMENT FOR SINGLE-USE PHARMACEUTICAL MANUFACTURING SYSTEMS

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In order to help ensure patient safety, biopharmaceutical companies must identify possible risks and mitigate exposure to those risks. Risk assessment programs are conducted to support this critical objective by identifying materials and consumables...

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Contract Manufacturing of Biopharmaceuticals CONTRACT MANUFACTURING OF BIOPHARMACEUTICALS

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Biovian is a one-stop-shop in GMP contract manufacturing of biopharmaceuticals covering services from early development to finished vial. Biovian’s 2700 m2 facilities are EMA and FDA certified for GMP production of investigational and commercial m...

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Innovating For better  Health INNOVATING FOR BETTER HEALTH

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Our Innovating for Improvement programme aims to improve health care delivery and/or the way people manage their own health care through the redesign of processes, practices and services. We support clinical teams to develop their innovative ideas an...

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Control Systems Engineering in Continuous Pharmaceutical Manufacturing CONTROL SYSTEMS ENGINEERING IN CONTINUOUS PHARMACEUTICAL MANUFACTURING

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This white paper provides a perspective of the challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing. The main motivation for writing this paper is to facilitate the development and ...

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Nasal Drug Delivery Devices and Pain Management Systems NASAL DRUG DELIVERY DEVICES AND PAIN MANAGEMENT SYSTEMS

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the nasally administered systemic drugs market has an increasing generics sector, is placing greater emphasis on patient compliance and convenience, and is benefitting from an increasingly ageing population.In contrast, severe pressure on health care...

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Flexible Drug Containers for Parenteral Drugs FLEXIBLE DRUG CONTAINERS FOR PARENTERAL DRUGS

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Valuable time of healthcare personnel, as well as high cost for time spent in hospitals, is outweighing the actual cost of drugs by far, thus increasing the total cost of treatment dramatically. Two thirds of injectable drugs are infused via infusion...

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The EU5 Market Access Landspace for Oncology Drugs THE EU5 MARKET ACCESS LANDSPACE FOR ONCOLOGY DRUGS

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Global sales of oncology medicines were widely reported to have exceeded $100 billion for the first time in 2014, with the U.S. and European markets generating the majority of sales. This trajectory is expected to continue: Decision Resources Gro...

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CONVERGENCE DRIVERS IN THE BIOPHARMACEUTICAL AND MEDICAL DEVICE INDUSTRIES CONVERGENCE DRIVERS IN THE BIOPHARMACEUTICAL AND MEDICAL DEVICE INDUSTRIES

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Over the last decade the life sciences sector has evolved substantially from its traditionally siloed industries, namely (bio)pharmaceuticals (”Biopharma”) and medical devices (“Med Tech”), towards a market that is increasingly converging to enable t...

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Key Drivers of Change in the Global Pharmaceutical Manufacturing Industry KEY DRIVERS OF CHANGE IN THE GLOBAL PHARMACEUTICAL MANUFACTURING INDUSTRY

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Policy-driven changes in healthcare spending and the growing significance of generic competition are acting in tandem to force pharmaceutical companies to adopt more costeffective manufacturing strategies resulting in an upsurge in the level of M&A a...

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Pharma is attracted to antibody deals in Oncology PHARMA IS ATTRACTED TO ANTIBODY DEALS IN ONCOLOGY

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Antibody therapeutics clearly offer clinical benefi ts over cheaper, older and mainly generic cytotoxic drugs. However, due to their high development and manufacturing costs and the cost to payers, they tend to get used as later-stage treatments ...

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Bringing a new drug to life Regulatory Sciences BRINGING A NEW DRUG TO LIFE REGULATORY SCIENCES

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For patients with severe neuropsychiatric conditions, the right drug was available—but there was a problem. The drug was in hard-tablet form, which often caused an issue with patient adherence. Patients would “cheek the pill,” instead of actually swa...

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CRISPR Delivery Challenges and Applications within Pharma CRISPR DELIVERY CHALLENGES AND APPLICATIONS WITHIN PHARMA

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CRISPR is now one of the most affordable forms of gene editing causing a boom in R&D over the last few years. However, the technique does have its limitations which include maintaining end to end control on geneti manipulation, avoiding off targets ...

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Understanding the links between drug delivery route and in vitro test methods UNDERSTANDING THE LINKS BETWEEN DRUG DELIVERY ROUTE AND IN VITRO TEST METHODS

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In vitro tests are widely used, from R&D through to QC, to improve the efficacy of drug delivery and confirm product consistency. Ensuring a drug reaches its intended site of action in vivo, in anappropriate state, is a crucial first step towards mee...

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Accelerating development of enabled formulations for poorly soluble drugs ACCELERATING DEVELOPMENT OF ENABLED FORMULATIONS FOR POORLY SOLUBLE DRUGS

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Efficacy issues due to inadequate gastrointestinal (GI) absorption caused by insufficient aqueous solubility are encountered in up to 70% of new drugs in development. 1 Typically, in vitro analysis and preclinical studies are used to predict the beh...

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Defining Drug Response for Stratified Medicine DEFINING DRUG RESPONSE FOR STRATIFIED MEDICINE

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The premise for stratified medicine is that drug efficacy, drug safety, or both, vary between groups of patients, and biomarkers can be used to facilitate more targeted prescribing, with the aim of improving the benefit:risk ratio of treatment. Howev...

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Split protein biosensor assays in molecular pharmacological studies SPLIT PROTEIN BIOSENSOR ASSAYS IN MOLECULAR PHARMACOLOGICAL STUDIES

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Cellular signalling is commonly mediated through dynamic protein– protein interactions (PPIs). When pivotal PPIs are deregulated, cellular signalling can be altered; itis therefore attractive to monitor regulated PPIs to understand their role in heal...

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Product Lifecycle Management for the Pharmaceutical Industry PRODUCT LIFECYCLE MANAGEMENT FOR THE PHARMACEUTICAL INDUSTRY

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In recent years the pharmaceutical industry has faced declining R&D productivity, a rapidly changing healthcare landscape and fierce competition from generics resulting in lower growth and profit margins. Historically, drug development focused on cli...

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Follow-on drugs: Circumventing the customary patent cliffs in Big Pharma FOLLOW-ON DRUGS: CIRCUMVENTING THE CUSTOMARY PATENT CLIFFS IN BIG PHARMA

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Follow-on drugs, also referred to as ‘next-generation drugs’, are ‘an established practice’ among drug innovators. They are one of the most effective R&Dstrategies implemented by drug innovators, and can beconsidered a cannibalization or switching s...

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Cleaning Validation for Pharmaceutical Manufacturing CLEANING VALIDATION FOR PHARMACEUTICAL MANUFACTURING

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Cleaning validation is a necessary and time-consuming part of manufacturing pharmaceuticals. The validation process can be expedited and the cost reduced if the cleaner supplier can provide support — ultimately allowing pharmaceuticals to get to mark...

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Big Pharma Deal Making – The Beginning of a New Dawn? BIG PHARMA DEAL MAKING – THE BEGINNING OF A NEW DAWN?

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It’s useful to review deal trends periodically to gain insight in how behaviours are changing from the perspective of numbers and value of deals as well as how emphasis shifts from one therapeutic area to another. The majority of small and mid-size d...

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Bugs as Drugs, Microbiome Dealmaking Poised to Take Off BUGS AS DRUGS, MICROBIOME DEALMAKING POISED TO TAKE OFF

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Probiotics, prebiotics, medical food and supplements have been commercially available as OTC products for some time. These products claim to support human health by restoring the balance of the gut microfl ora in favour of ‘benefi cial’ bacteria, mo...

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Chemical Characterization of Pharmaceutical Samples by Confocal Raman Microscopy and Correlative Techniques CHEMICAL CHARACTERIZATION OF PHARMACEUTICAL SAMPLES BY CONFOCAL RAMAN MICROSCOPY AND CORRELATIVE TECHNIQUES

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Development, production and quality control in the pharmaceutical industry requires efficient and reliable control mechanisms to ensure the safety and therapeutic effect of the final products. These products can vary widely in composition and applica...

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Guide to Pharmaceutical Labelling Excellence GUIDE TO PHARMACEUTICAL LABELLING EXCELLENCE

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The future of every pharmaceutical company is dependent on its efforts to find new ways to increase revenue, reduce costs, and reduce the risk of catastrophic product recalls. Labeling, artwork management, and packaging are not usually considered pa...

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IC – The all-rounder in pharmaceutical analysis IC – THE ALL-ROUNDER IN PHARMACEUTICAL ANALYSIS

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High standards have to be met by the pharmaceutical industry when it comes to drug quality and safety. These standards are documented in pharmacopoeias as officially recognised pharmaceutical rules, and published as legal tools of customer protection...

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Simple steps to speed encapsulated drug development SIMPLE STEPS TO SPEED ENCAPSULATED DRUG DEVELOPMENT

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In the pharmaceutical industry, speed to market is essential for gaining a competitive position. New encapsulation technologies now make it possible to streamline research and development activities, improve product development, and jump-start time t...

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The Integrated Pharmaceutical Development Platform THE INTEGRATED PHARMACEUTICAL DEVELOPMENT PLATFORM

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Despite breaking global sales records in 2015, biopharmaceutical companies are witnessing a slowing in growth and are under increasing pressure from payers and competitors to reduce costs1 Compounding this, a recent study has found that the average c...

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Characterization of biopharmaceutical stability with Differential Scanning Calorimetry CHARACTERIZATION OF BIOPHARMACEUTICAL STABILITY WITH DIFFERENTIAL SCANNING CALORIMETRY

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Protein stability is critical to the success or failure of the development of a biopharmaceutical. Protein stability is an important parameter during production, manufacturing, formulation, long term storage, delivery to patient, and efficacy. Highly...

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