RESOURCES

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Jun 24, 2019

We believe that data-driven marketing shouldn’t be confusing. Every company should know what works for their campaigns in order to make more ROI-driven decisions. At Directive, we not only craft customized campaigns for your unique marketing ob...

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Jun 24, 2019

Today’s surge of big data coming from multiple sources is raising the stakes that pharmacovigilance has to win, making evidence synthesis a more and more robust approach in the field. In this scenario, many scholars believe that new computation...

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Jun 19, 2019

This paper, authored by Alireza Shabani, Founder & CEO of Qulab, describes the necessary computational architecture for pharmaceutical firms to accelerate R&D and drug discovery, especially utilizing special purpose silicon and quantum proces...

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Jun 19, 2019

USP Chapter 41 weighing requirements are mandatory in a Pharmaceutical Quality Control (QC) laboratory, where weighing is a fundamental step in almost every workflow. Typically, weighing of a sample or standard is the first step in the analytical pro...

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Jun 11, 2019

Vaccines have historically been a challenging corner of the industry, as they are highly-regulated and require a greater investment of time and money to develop than other biologics.

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Jun 11, 2019

The cost of employee substance abuse adds up quickly, and it is vital for your company to detect and deter drug and alcohol abuse among employees.

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Jun 11, 2019

Take the analysis from the Informa Pharma Intelligence R&D Annual Review 2019 further with the Pharma R&D Annual Review 2019 Supplement: New Active Substances Launched During 2018. This essential whitepaper uses critical data from Pharmaproje...

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Jun 11, 2019

Contract development and manufacturing organisations (CDMOs) in the pharmaceutical world are on the up. They benefit from an increasing number of companies that outsource parts of their production to external service providers.

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Jun 06, 2019

Sartorius Cubis® II is designed to follow US FDA data integrity principles that require data to be accurate, legible, contemporaneous, original and attributable.

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Jun 03, 2019

This white paper looks at the potential of x-ray inspection to solve a wide range of product safety and quality control issues typically found within food and pharmaceutical manufacturing. It explores how x-ray inspection can detect faulty products b...

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May 30, 2019

Pharmaceutical manufacturing is an industry laden with many challenges and risks due to the life-changing nature of its products—drugs that can affect millions of human lives. Manufacturers perform immensely complex research and testing daily, ...

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May 30, 2019

It is common to find Intermediate Bulk Containers (IBCs) being used for handling powders and granules in solid dosage manufacturing processes, from initial Dispensing through to Tablet Compression or Capsule Filling. The benefits of using IBCs for ef...

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May 29, 2019

The buzz may be around biologics, but the oral solid dose sector is still going strong

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May 28, 2019

Embracing and investing in new technologies is one way to get ahead, and adopting lean, efficient manufacturing procedures is another. At a fundamental level, achieving efficiency can start at the outset of a project by considering the very design of...

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May 27, 2019

The biopharma sector has seen incredible growth in recent decades, with growth the major long-term trend. Total annual revenue has increased from about $4.4 billion in 1990 to now about $275 billion, an increase of 6,250 percent, with biopharmaceutic...

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May 27, 2019

Pharmaceutical manufacturing is not immune to metal-object contamination, it is important to discuss ways to effectively incorporate metal detection into the production or packaging processes when practicable.

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May 22, 2019

Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties of drug products. The invitro disintegration and dissolution times of tab...

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May 13, 2019

Assume a generic drug company, let’s call them AB Generics, Inc., always targets the introduction of its generic drugs when the reference product comes off patent.

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May 01, 2019

The past year was marked by shifting business models, more stringent quality requirements, technological improvements and mounting political pressures to solve pharma-related policy issues. How has the industry responded?

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Apr 30, 2019

Demand forecasting plays a critical role in logistics and supply chain management. In the paper, state-of-art methods and key challenges in demand forecasting for the pharmaceutical industry are discussed. An integrated procedure for in-market produc...

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Apr 30, 2019

Sharp rises in opioid abuse and overdose rates in the United States over the past two decades have prompted much-needed review of prescription rates and ease of access to controlled substances.  Combatting these alarming trends requires assessin...

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Apr 29, 2019

For U.S. healthcare leaders, trusted data is more important than ever, as their organizations migrate from the fee-for-service model to value-based care. During this transition, healthcare organizations must weigh investments, risks, and trade-offs o...

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Apr 24, 2019

The vast majority of endotoxin tests for pharmaceuticals and medical devices, as well as their in-process intermediates and raw materials, are microplate-based. They require tedious reconstitution and dilution steps for preparation of Control Standar...

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Apr 22, 2019

Digital transformation does not stop at the pharmaceutical industry. But until Pharma 4.0 can become socially acceptable, it will first and foremost be necessary to define globally uniform standards. This is going to take time. Time which the industr...

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Apr 22, 2019

Efforts to ease patient burden with multi-API products and the increasing number of candidate products with low bioavailability are creating opportunities for contract manufacturing and development organizations (CDMOs) to create value with innovativ...

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Apr 16, 2019

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 pr...

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Apr 16, 2019

Over the past decade, the healthcare ecosystem has slowly moved toward the “triple aim”: better healthcare experiences, improved outcomes, and a slowing of the growth of overall healthcare costs. While many pharma companies have focused o...

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Apr 10, 2019

As pharmaceutical companies move increasingly toward changing production methods from batch to continuous processing, there is a need to re-evaluate the types and formulations of the excipients used. Within a continuous process, conventional monofunc...

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Apr 10, 2019

Rising drug spending and increased desire for expenditure controls are consistent themes across the US, Europe, and emerging markets. With governments and private healthcare systems under increasing pressure to fund high-cost, innovative therapies, w...

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Apr 10, 2019

To better predict the future of HIV pharmaceuticals, we must understand the past – that’s the premise behind Horizons in HIV Drug Development – What’s Past is Prologue, the free whitepaper from Citeline, part of the Informa Ph...

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Apr 09, 2019

The social, demographic and economic context in which the pharmaceutical industry (Pharma) operates is changing dramatically, as we noted in “Pharma 2020: The vision”.

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Apr 04, 2019

Lipids play a structural role in organisms, forming cells and organelles’ membranes. Due to their implication in widespread pathologies such as cancer or inflammation, they are gaining considerable interest within the scientific community.

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Apr 04, 2019

The social, demographic and economic context in which the pharmaceutical industry (Pharma) operates is changing dramatically, as we noted in “Pharma 2020: The vision”, the White Paper PricewaterhouseCoopers* published in June 2007 (see si...

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Apr 03, 2019

Herewith ACD/Labs presents their web-based software solution to the multiple challenges experienced in screening workflows; offering effective support for high-throughput catalyst screening.

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Apr 02, 2019

The FDA’s cGMPs for the 21st Century: A Risk-Based Approach Initiative In early 2002, the Food and Drug Administration (FDA) announced their Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach initiative. According to the FDA posit...

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Mar 27, 2019

A period of market exclusivity is critical for most novel pharmaceutical products and the duration of that exclusivity has a direct impact on the value of a pharmaceutical asset. There several forms of exclusivity that can apply to pharmaceutical pro...

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Mar 21, 2019

Following on from our review of trends in the current pharmaceutical R&D pipeline, published in March 2019 this supplement takes a look at the industry’s success stories of 2018 – the drugs which were launched on to the market for the...

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Mar 21, 2019

Affordable genome sequencing technologies promise to revolutionize the field of human genetics by enabling comprehensive studies that interrogate all classes of genome variation, genome-wide, across the entire allele frequency spectrum.

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Mar 20, 2019

Pharmaceutical companies aiming to develop innovative new therapies and treatments face many challenges. Without proper processes and systems in place, it is very difficult to replicate successful results, mitigate failures, reduce product variabilit...

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Mar 15, 2019

This whitepaper aims to provide pharmaceutical researchers with a better understanding of the uses and benefits of hybrid silica-based supports in HPLC separations of drug compounds. In a quick, absorbing read that includes commentary from a number o...

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Mar 14, 2019

How slow-motion trends are driving biopharma growth, the dangerous impact of unproven stem cell therapies and more. For over two decades, the biopharmaceutical manufacturing industry has created a body of industrial knowledge and institutional experi...

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Mar 12, 2019

The pathophysiology of neurological disease and injury is admittedly highly complex and temporally dynamic.  This poses a daunting challenge for the development and appropriate use of physiologically relevant models for investigative research.&n...

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Mar 11, 2019

Our understanding of tumor biology is constantly evolving and helps to shed new light on the behavior of many cancers as well as providing new pharmacological targets and treatment strategies. Over the past decade, there have been immense technologic...

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Mar 11, 2019

Drug development and production are challenging, however, high throughput characterization systems can greatly accelerate discovery programs. Using a proprietary discovery and development platform technology, Avitide enables its partners to rapidly a...

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Mar 09, 2019

In recent years, cancer immunotherapies, in particular, immune checkpoint blockade and combination therapies, have demonstrated remarkable success in treating multiple refractory cancers. One such therapeutic approach prevents T cell exhaustion by bl...

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Feb 27, 2019

Once deemed an “experts-only” approach to chemical synthesis, flow chemistry is a cost-efficient technique growing in popularity that can increase safety and flexibility and improve product quality. However, not all chemical profiles perf...

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Feb 26, 2019

The healthcare industry is facing major demographic changes that will dramatically impact which services are needed and how they are delivered.  As Millennials, Generation X, and Baby Boomers enter new life stages at the same time, there are sim...

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Feb 20, 2019

While there are many perspectives and publications on the “Hospital of the Future,” few, if any, provide a system perspective. Too often, when imagining the Health System of the Future, a hospital-centric model emerges. The challenge in t...

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Feb 20, 2019

When it comes to clinical supplies, the journey is every bit as important as the destination. And these days, the journey of clinical supplies to investigator sites is becoming costlier and more complex, much like the global trials for which the mate...

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Feb 20, 2019

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 mode...

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Feb 18, 2019

Recently, rapid advancements have been made in molecular testing technology for infectious diseases. This white paper briefly reviews those advances and discusses the choices laboratory managers face in light of them. We focus on flexible-content syn...

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Feb 18, 2019

The monitoring of biotechnological fermentation processes, used for the production of modern biopharmaceutical drugs, is becoming ever more relevant for the promotion of economic production, particularly within the manufacturing sector. Up until now,...

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Feb 15, 2019

Pharma R&D Annual Review 2019 is based on the stats and data from Pharmaprojects, part of Informa’s Citeline family of intelligence solutions. Authored for the 27th time by Ian Lloyd, Senior Director, Pharmaprojects, this whitepaper contain...

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Feb 13, 2019

Discover what strategies healthcare organizations are undertaking to address the top issues that face them: addressing cost pressures resulting from declining reimbursements and improving the patient experience. Learn about the steps necessary to add...

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Feb 12, 2019

Since the inception of electronic health record (EHR) systems, volumes of patient data have been collected, creating an atmosphere suitable for translating data into actionable intelligence. The growing field of artificial intelligence (AI) has creat...

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Feb 12, 2019

Adhesives are indispensable in the automotive, aeronautic, and medical industries, among others. Modern adhesives are complex, and their quality requires an assessment of initial components as well as the final product. Molecular spectroscopy approac...

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Feb 12, 2019

The incidences of pharmacy fraud involving pharmaceutical manufacturers’ co-pay card programs are on the rise. In this white paper, TrialCard discusses the steps it has taken to expand its Pharmacy Fraud Monitoring service, which identifies fra...

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Feb 11, 2019

Depending on your point of view, red blood cells, or erythrocytes, are throwaways and a nuisance, ruining a good blood specimen if the cells burst and contaminate the sample. On the other hand, erythrocytes have significant value in specific types of...

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Feb 04, 2019

Twenty years ago, there was a shift in pain management, and it became more common to prescribe opioids for chronic pain. Initially, physicians were misinformed that addiction to these medications was highly unlikely in a clinical setting, causin...

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Feb 04, 2019

This whitepaper explores how best in class anatomy, physiology and clinical content, images and customised solutions enable organizations to achieve strong competitive advantage, drive credibility, productivity and differentiation. We will share idea...

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Feb 01, 2019

Whilst commonly used air displacement pipettes are highly accurate for most liquid dispensing applications, the viscosity, volatility, surface tension and temperature of the solution can adversely affect their performance. In pharmaceutical formulati...

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Jan 31, 2019

Cellular heterogeneity plays a critical role in systems and pathologies, but many genomic analysis techniques derive their findings from multicellular samples, potentially burying key information from individual cells or rare subsets. Next-generation...

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Jan 28, 2019

A wide variety of polymer types are available to the DDCP developer,
and many are available on the market that meet the necessary
regulatory requirements. Careful consideration should be given to
the choice of vendor to ensure th...

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Jan 25, 2019

Artificial intelligence helps pharma companies find patients for clinical trials. While AI can be used to make sense of clinical trials data, another use of artificial intelligence in the pharmaceutical industry is to find the patients to take them.

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Jan 25, 2019

Finite Element Analysis (FEA) has been widely used to analyze the in vivo structural response of implantable medical devices and assess device performance, reliability and durability. In order to obtain a robust design, parameter variations and their...

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Jan 21, 2019

Patient satisfaction is currently treated as one proxy for the quality of care a patient receives. Admittedly subjective, satisfaction survey scores are nonetheless put to all kinds of concrete purposes, from reimbursement to performance pay. While s...

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Jan 18, 2019

ON DRUGS AND DRUG U. BY TAKING THE: 2019. National Drug. & Alcohol. IQ Challenge.

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Jan 17, 2019

Animal toxins present a major threat to human health worldwide, predominantly through snakebite envenomings, which are responsible for over 100,000 deaths each year. To date, the only available treatment against snakebite envenoming is plasma-derived...

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Jan 15, 2019

Crystallization of active pharmaceutical ingredients (API) and related pre- and early formulation development play critical roles in successful drug development and manufacturing. The associated challenges can create significant roadblocks in the pro...

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Jan 14, 2019

Drug company rebates and discounts have always been an opaque aspect of the US pharma industry. There is little transparency in how much drug companies pay in rebates and discounts. Indications are it is annually in the tens of billions of dollars fo...

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Jan 13, 2019

Orphan drugs (ODs) for rare diseases (RDs) present pharma companies with the opportunity to address a substantial unmet medical need, with approximately 7,000 RDs, and only about 5% having effective treatments. A large number of patients in the US ar...

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Jan 11, 2019

GABAA receptors represent a large and complex family of ion channels that consist of at least 16 subunits (α1-6, β1-3, γ1-3, δ, ε, π, θ) and have been shown to be vital for the normal functioning of the brain. ...

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Jan 10, 2019

15 minutes. That’s how long your doctor has to see you, assess your complaint, diagnose a solution and see you out the door hopefully on the pathway back to wellness. This isn’t much time when you consider the wealth of information that h...

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Jan 10, 2019

For decades medical devices have been standalone instruments that interacted only with the patient or medical provider. The advent of technological innovations including miniaturization, low power computation, and wireless technologies has created a ...

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Jan 08, 2019

In this white paper, it will be demonstrated that the use of three HILIC phases, which provide very different and complementary selectivity to one another, is both practical and effective for HILIC method development. These selectivity differences ca...

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Jan 07, 2019

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 are likely to halt the decline of the traditiona...

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Jan 05, 2019

In this paper, you will learn how far we have come in generating massive amounts of patient data, but how unprepared we are to make use of it. A digital twin promises an outcome-driven approach to handling the data deluge arising from the patient&rsq...

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Jan 04, 2019

The dates are confirmed, the syllabus completed and the course directors are ready to welcome you to the only MBA carefully developed for pharmaceutical leaders: the MBA Pharmaceutical Management.

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Jan 04, 2019

Large molecule discovery and development is a complex series of interwoven cycles that span many teams within a research and development organization. By making a commitment to informatics, Amgen pioneered the shift to large molecules and was on the ...

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Jan 04, 2019

Checkpoint inhibitors in bladder cancer, combination regimens in renal cell carcinoma (RCC) and novel anti-androgens in early prostate cancer treatment lines have demonstrated patient benefit, increasing survival times and addressing major areas of u...

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Jan 02, 2019

The quality and efficacy of drugs depends significantly on their proper packaging: Sterile products and moisture / oxygen sensitive drugs require excellent sealing throughout the shelf life of the product (up to a few years) in order to protect it fr...

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Jan 01, 2019

AIM’s Clinical Appropriateness Guidelines (hereinafter “AIM’s Clinical Appropriateness Guidelines” or the “Guidelines”) are designed to assist providers in making the most appropriate treatment decision for a speci...

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Dec 28, 2018

Intouch’s annual trends report highlights the healthcare and tech trends that will shape the year ahead. You can look back and see our predictions for 2018, 2017, and 2016. And if you do, you might think — wait! Some of these trends look ...

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Dec 27, 2018

Quantifying the direct and indirect value that a business unit delivers to its parent health system has traditionally been difficult. In this case study, we discuss the impact of pharmacy customer loyalty on the Fairview Health Services system, and w...

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Dec 26, 2018

Cloud computing represents an IT service model which helps in the delivery of computing services, both hardware and software, to customers, on demand, over a network, which utilizes the internet. Thus, users only incur operating expenses associated w...

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Dec 26, 2018

Monoclonal antibody (mAb) therapeutics have been widely used to treat various diseases, including cancer. Oftentimes, dimers and other high molecular weight aggregates are present in the mAb therapeutics, leading to reduced biological activity. Tradi...

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Dec 26, 2018

Scientific interest in rare disease drug discovery has been growing exponentially and the number of new therapies targeting rare and orphan diseases has doubled in the past 6 years. In this white paper, we have reviewed innovative approaches to devel...

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Dec 15, 2018

IT departments in large healthcare institutions face numerous challenges. They are expected to help implement new initiatives to improve patient care, oftentimes while having to support legacy applications that may have been cobbled together over man...

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Dec 14, 2018

Accenture commissioned a seven-country survey of 7,905 consumers aged 18+ to assess their attitudes toward healthcare technology, modernization and service innovation. The online survey included consumers across seven countries: Australia (1,031), En...

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Dec 12, 2018

The most essential requirement to enable the ability to move forward with confidence on a population health strategy is a solid foundation of data and information that is connected, complete, accurate, and available in real time. The rapid digitizati...

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Dec 12, 2018

Sterility testing of final drug products is a mandatory release test for pharmaceutical companies and is critical to ensure patient safety. However, traditional methods such as membrane filtration require a minimum incubation time of 14 days. This lo...

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Dec 11, 2018

Development and production of biopharmaceuticals are complex. Even minor impurities, orchanges in attributes such as glycosylation or charge heterogeneity, can have a profound impact on the safety and = ef cacy of the nal product. Traditionally, mul...

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Dec 11, 2018

According to a recent report from the Tufts Center for the Study of Drug Development, the total price tag for bringing a new drug to market can be up to $2.7 billion.1 While development costs are high, keeping costs low during commercial production w...

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Dec 10, 2018

The genome has given clinical researchers a powerful tool for understanding the biological foundations of many diseases, but it only tells part of the story. This ebook shows how different laboratories are employing mass spectrometry and other cuttin...

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Dec 05, 2018

Before placing a medical device on the European market, manufacturers need to produce technical documentation providing evidence of conformity with the relevant legislation. Technical documentation needs to be in compliance with the Medical Devices D...

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Dec 05, 2018

Whether decoding Data Matrix symbols, reading text with Optical Character Recognition (OCR), or performing product inspection with machine vision, Industrielle Sensorsysteme Wichmann (ISW) GmbH has been meeting demanding applications with high-perfor...

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Nov 30, 2018

The phosphatidylinositol 3-kinase (PI3K)/serine-threonine protein kinase Akt is a vital signaling cascade involved in cell survival, progression and thus causes various types of cancers. Various kinase inhibitors targeting PI3K/Akt have been extensiv...

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Nov 30, 2018

Gene therapy, the modification of genetic information in living cells to address a mutated gene, has the ability to dramatically change the way diseases are treated, or even cured. First conceptualized in the early 1970s, the seminal paper on the sub...

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Nov 29, 2018

Airflow visualization testing, conducted as part of a routine review program, can help assure that aseptic filling areas remain under a state of proper control. In fact, ISO standards recommend frequent airflow measurements. ISO standard 14644-2 requ...

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Nov 28, 2018

Biologics development and manufacturing is inherently complex and challenging. Compounding this is the added pressure to be first to market in a highly competitive healthcare landscape, where delays can put the success of a product and company at ris...

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Nov 28, 2018

The analysis of all incoming pharmaceutical raw materials is key part of 21CFR compliance.  It is therefore important to have a high-throughput method by which raw materials may be analyzed, while also preventing sample exposure. This applicatio...

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Nov 26, 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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Nov 25, 2018

Alzheimer’s disease (AD) is one of the most common multifactorial diseases, including a range of abnormal cellular/molecular processes occurring in different regions of the brain. This disease is considered to be a major contributor to dementia...

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Nov 22, 2018

The briefing note at hand has been prepared to annotate with further conceptual clarity the structure and organization of the Framework for Action, with the objective of specifying the following: its strategic vision according to the determinants of ...

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Nov 22, 2018

AI has the potential to provide huge benefits to the pharmaceutical industry, from improving R&D productivity through to more effective sales representative deployment and better supply chain management. Adoption of AI is lagging other sectors, w...

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Nov 21, 2018

The EU Medical Devices Regulation 2017/745 (MDR) has significantly increased the burden of compliance and potential legal liability exposure for economic operators, including EU authorized representatives (ARs) of manufacturers established outside of...

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Nov 19, 2018

The US health industry has often lagged other industries—think tech, retail, hospitality when it comes to modernizing. Once thought to operate outside the greater US economy, the industry with its byzantine payment system, complicated regulator...

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Nov 18, 2018

Lentiviruses are single-stranded RNA viruses and the second major subgroup of the retroviruses. Lentiviruses are powerful tools in molecular biology. They have long incubation periods and are capable of delivering relatively large loads of genetic in...

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Nov 17, 2018

Less than a hundred years ago diabetes was a death warrant. The discovery of insulin in The 1920s was a major breakthrough. Since then, thanks to the dedicated work of scientists, researchers, doctors, and nurses in this country and abroad, there hav...

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Nov 16, 2018

Drug discovery is undergoing a transformation powered by advances that provide more knowledge from biological assays, allow for screening orders of magnitude more molecules and enable smarter selection of compounds. We are on the cusp of having previ...

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Nov 15, 2018

Tablet hardness testing plays an important role in pharmaceutical product development and quality control. In the race to streamline tablet hardness analysis, Advantest combines speed, simplicity and increased the precision with innovative and non-de...

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Nov 14, 2018

Metabolomics is an emerging field of “omics” concerned with measuring and interpreting the metabolic state (i.e. metabolome) and is an essential technology for defining the key functional attributes of tumors or cancer cells.

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Nov 13, 2018

How advances in imaging technology and the use of artificial intelligence and analytics are improving the accuracy and cost of medical imaging for early cancer diagnosis, and increasing confidence in vital preventive screening programs.

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Nov 13, 2018

In this study, the Toxtyper is used for drug screening in drug consumption rooms which are seen as an important element to minimize drug-related health problems (e.g. infection risk) and promote contact of drug users with employees of drug help progr...

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Nov 12, 2018

Data protection regulations define how an individual’s personal information can be used by organizations, businesses, and government. These regulations also contain safeguards that seek to ensure healthcare data is not susceptible to attack, mi...

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Nov 12, 2018

Technology for People shows the way to an exciting future where healthcare technology is designed by humans, for humans, to create positive change that can transform healthcare organizations and society. Digital breakthroughs are enabling health...

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Nov 12, 2018

Immortality has long been treated as a work of fiction - a trait only possessed by mythological Gods and divine creatures. Is there an afterlife or life after death? Each religion or system of belief had its own way to deal with such questions. Certa...

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Nov 12, 2018

This white paper outlines the philosophy, methods, and deliverables for the PhUSE Computational Sciences Symposium Emerging Trends and Technology working group project “Clinical Trials Data as RDF.” The project was formed to investigate t...

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Nov 10, 2018

What matters most when building and sustaining a healthcare organization? What are the precise levers to pull to promote physician well being, financial success, and better outcomes at lower cost? To answer these questions, Athena health launched an ...

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Nov 10, 2018

Pharmaceuticals play a prominent role worldwide. This widespread presence is met with regulatory requirements at each phase of pharmaceutical development and manufacturing—from inspection of raw materials to quality control of final products. C...

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Nov 08, 2018

The landscape of clinical trials continues to evolve over time as scientific breakthroughs and technological innovations emerge, which continue to be tracked by assessing recently initiated trials through Trialtrove’s annual Clinical Trials Rou...

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Nov 08, 2018

On October 12, 2017, through Executive Order 13813, you directed the Administration, to the extent consistent with the law, to facilitate the development and operation of a health care system that provides high-quality care at affordable prices for t...

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Nov 07, 2018

Robust safety and tolerability data are essential in cancer therapeutic studies, and some trials are specifically designed with a key objective of demonstrating improved safety and tolerability. The development of a clinical trial framework and data ...

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Nov 06, 2018

Across the country, hearing health is becoming a hot topic of conversation and it’s grabbing the attention of the organizations that deliver health care benefits to millions of Americans. Driving this phenomenon are several wide-ranging factors...

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Nov 05, 2018

This white paper represents a key piece of research into the potential benefits of mobile working in healthcare and considers the obstacles that will have to be surmounted along the way. Given our research was conducted in the aftermath of last May&r...

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Nov 05, 2018

Depression affects approximately 1 in 6 Americans, with 10 – 30% of depression patients becoming treatment-resistant. Find out what the pipeline looks like for depression and what the emerging strategies in this area are in Depression: New Insi...

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Nov 02, 2018

Mobile value chain revenues in the US grew 10 percent per annum from 2009 to 2014, and profits rose by as much as 15 percent. The year 2015 is expected to see 3 percent growth in revenues and 6 percent growth in profits.

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Nov 02, 2018

The Center for Connected Health Policy’s (CCHP) Fall 2018 release of its report on “State Telehealth Laws and Reimbursement Policies” offers policymakers, health advocates, and other interested health care professionals a freshly re...

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Nov 02, 2018

As the pharmaceutical industry continues to look for new and innovative ways to treat disease, some companies are putting more focus on how to prevent them. Vaccine development, while a long and complex process, has the potential to save millions of ...

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Nov 02, 2018

A Nutanix enterprise cloud reduces the cost and complexity of IT infrastructure for healthcare while improving scaling, availability, and data protection. Conventional infrastructure is no longer able to address healthcare challenges, such as regulat...

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Oct 30, 2018

Raman spectroscopy has taken large strides in recent years as more Raman vendors have developed handheld Raman units capable of carrying out raw material identification or verification. Raman spectroscopy is used as a fingerprinting tool to capture t...

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Oct 30, 2018

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&D strategies implemented by drug innovators, and can be considered a c...

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Oct 25, 2018

The FDA has a number of regulatory routes through which a company can seek approval for a generic drug. The most notable is the Abbreviated New Drug Application (ANDA) route whereby a generic company develops an exact copy of the innovator product an...

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Oct 22, 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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Oct 19, 2018

Facing increasing margin pressures—and having already implemented many proven cost reduction and revenue-increasing measures—hospitals and health systems have to find new ways of reducing their costs without compromising quality or patien...

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Oct 19, 2018

Although previous regulation of prescription drug advertising has come from the U.S. Food and Drug Administration (FDA), this proposal comes from the Centers for Medicare & Medicaid Services (CMS).

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Oct 18, 2018

As Informa Pharma Intelligence has done for the past three years, this analysis examines the landscape of industry-sponsored clinical trials completed during 2017, of which there were a total of 3,534 Phase I through Phase III/IV. The nearly 700 tria...

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Oct 15, 2018

This white paper outlines the main benefits of using hard radiation for material analysis studies. X-ray powder diffractometers are generally equipped with X-ray sources using Cu anodes. For specific applications, however, switching to shorter wavele...

whitepaper

Oct 12, 2018

There are many different requirements with which in vitro diagnostic manufacturers must comply in order to place the product on the market. At the core of most of these requirements is a fundamental need to have a good quality management system (QMS)...

whitepaper

Oct 12, 2018

Make the most of BIO-Europe 2018 with essential partnering information from Informa Pharma Intelligence. Our insightful whitepaper, Pharma Partnering Trends Revealed: 2018 Edition, contains critical information on the landscape for biotech partnershi...

whitepaper

Oct 03, 2018

In the end, you need to be rewarding your sales reps with more than just money if you want to keep them motivated and if you want your sales compensation plan to deliver on its promises.

whitepaper

Oct 03, 2018

The first CRM launch truly changed the way sales were managed. We went from tracking customers on spreadsheets (and even in rolodexes) to tracking them and their attendant opportunities with software. It wasn’t long before reps started to feel ...

whitepaper

Oct 03, 2018

Let’s explore some of the current processes around pipeline management and forecasting and how they can be improved.

whitepaper

Oct 02, 2018

Chromatography resins used for the production of biopharmaceuticals need to be cleaned efficiently to ensure the safety and efficacy of the bioproduct. Impurities that are not removed can build up on the chromatography column and start to leach into ...

whitepaper

Sep 28, 2018

Countless studies and articles have confirmed that connected medical devices from implantable products like pacemakers to diagnostic devices such as CT scanners and more are indeed vulnerable to malicious exploitation. This paper offers both technica...

whitepaper

Sep 27, 2018

Even before the 1980s, the notion of attaching a cytotoxic agent to a tumorspecific antibody captured the collective imagination of the international drug development community. Were antibodydrug conjugates (ADCs) the magic bullets everyone was looki...

whitepaper

Sep 27, 2018

A thorough knowledge of an active pharmaceutical ingredient’s (API) solid state behavior is essential for reliable drug product manufacturing, patent protection, and formulation viability. This article discusses various aspects of the API in th...

whitepaper

Sep 26, 2018

High-throughput sequencing technologies have revolutionized the field of human genetics, allowing researchers to more easily investigate and understand biological processes and their impact. Using these technologies, researchers can analyze entire ge...

whitepaper

Sep 24, 2018

Experts have asserted that despite recent developments, pharmaceutical supply chains are still far from reaching their full technological potential. Blockchain holds significant promise to advance the digital strength of medicine supply.

whitepaper

Sep 21, 2018

In this white paper, we review a successful small molecule drug discovery project conducted by a team of scientists from Genentech and Charles River that spanned hit identification and lead optimization of a highly potent LRRK2 inhibitor.

whitepaper

Sep 21, 2018

While the outlook for medical device companies appears positive, unsustainable health care costs and new competitive forces threaten to alter the future industry landscape. If today’s manufacturers fail to stake their claim in the evolving valu...

whitepaper

Sep 19, 2018

CIO’s and IT professionals in healthcare organizations are tasked with achieving a balance between the demand for universal access to information and the need to ensure security. In particular, four critical challenges these organizations face ...

whitepaper

Sep 18, 2018

Has anyone asked you, "What is your laboratory capacity?" In the scientific world of planning laboratories, defining capacity is not so straightforward. This makes answering the question challenging unless you have a method in place. The re...

whitepaper

Sep 18, 2018

The era of precision medicine has arrived, and with it, a tidal wave of data from disparate sources, including electronic health records (EHRs), lab systems, pathology, and genomics. By integrating data from all available sources and analyzing it in ...

whitepaper

Sep 17, 2018

If you’ve ever bought a car, remodeled a room in your home, or shopping for a high-end TV, chances are the business you purchased from offered you a financing plan. The appeal of financing is simple: it helps people buy things they normally cou...

whitepaper

Sep 16, 2018

Anemia is a frequent complication of critical care, with up to 90% of ICU (Intensive Care Unit) patients being anemic by their third day in the ICU1. Anemia is associated with poor patient outcomes, especially amongst those patients with cardiovascul...

whitepaper

Sep 16, 2018

To promote sustainable development, the smart city implies a global vision that merges artificial intelligence, big data, decision making, information and communication technology (ICT), and the internet-of-things (IoT). The aging issue is an aspect ...

whitepaper

Sep 15, 2018

The publication of the stable text of the European Union (EU) Medical Devices Regulation (MDR), and the In Vitro Diagnostic Medical Devices Regulation (IVDR), in June 2016 documented political agreement between the three EU Institutions – the C...

whitepaper

Sep 15, 2018

The healthcare IT landscape continues to change. One minute you’re convinced the world is round and then a series of new technological advancements, entrants into the market, and mergers and acquisitions give it the appearance of being flat. Th...

whitepaper

Sep 10, 2018

With over 10 million new cases worldwide each year and approximately 1.7 million deaths, tuberculosis (TB) is one of the leading global threats to human health. While disease detection and control methods have yielded a steady decline in the number o...

whitepaper

Sep 09, 2018

When you experience the choreography of tens of thousands of face-to-face meetings at BIO-Europe®, you know for certain that partnering is still the deal in the biotech industry. From nearly 1,000 partnering booths, executives from across the ind...

whitepaper

Sep 06, 2018

When discussing the success of a drug therapy, a common topic amongst biopharmaceutical companies is data quality and data integrity; what the challenges are and what the key elements are to ensuring that the latest discovery is patentable, does not ...

whitepaper

Aug 28, 2018

Unlike well-defined chemical medicinal products and their generic counterparts, biologics and their biosimilar counterparts employ sophisticated bioprocessing technologies that utilize living systems for their manufacture. Because these complex heter...

whitepaper

Aug 27, 2018

Pervading every facet of daily life, the information superhighway that society has come to know and love – and occasionally loathe – has enabled a level of communication, collaboration, insight, and analysis that has rendered the current ...

whitepaper

Aug 24, 2018

Liquid chromatography is a technique of key importance for many areas of chemical analysis and one that has evolved with the progression of technology and instrumentation over time. Here we highlight some of the key similarities and differences betwe...

whitepaper

Aug 22, 2018

Fifty-one percent of national survey respondents say they’ve had a contact center strategy in place 3 – 5 years, and 48 percent call their strategy an enterprise transformation initiative. Can maximizing this resource take your hospital i...

whitepaper

Aug 21, 2018

Over the years, studies have been conducted to ascertain the cost of research and development (“R&D”) required to bring a new drug to market. Experts disagree on the exact amount, but the consensus is that the figure is in the hundred...

whitepaper

Aug 18, 2018

The healthcare industry has never been more focused on data its promise and its pitfalls as it is today. From slashing health care spending to detecting fraud or coordinating care across multiple providers improved the use of healthcare data has been...

whitepaper

Aug 15, 2018

The patient experience is the sum of all the interactions had with a healthcare organization. Therefore, the experience itself hasn't confined to the walls of a hospital or the examination rooms of an outpatient clinic the experience starts anywh...

whitepaper

Aug 12, 2018

Cloud computing is having a profound impact on healthcare. The healthcare cloud computing market is projected to almost triple between 2015 and 2020 to $9.48 billion.1 In the same time period, the Internet of Things (IoT) the number of devices connec...

whitepaper

Aug 10, 2018

Want to improve the reliability of your neuronal cell culture experiments by increasing the survival of the neurons? This white paper shows how the B-27 Plus Neuronal Culture System increases neuron survival and improves maturation and neural network...

whitepaper

Aug 08, 2018

The koala, the only extant species of the marsupial family Phascolarctidae, is classified as ‘vulnerable’ due to habitat loss and widespread disease. We sequenced the koala genome, producing a complete and contiguous marsupial reference g...

whitepaper

Aug 08, 2018

Transitional care encompasses a broad range of services and environments designed to promote the safe and timely passage of patients between levels of health care, across care settings, and among various providers. Care settings can include a range o...

whitepaper

Aug 08, 2018

DNAtix intends to create a future ecosystem for Genetics where consumers, researchers, laboratories, and clinics operate making Genetics more accessible, transparent and anonymous. DNAtix intends to offer cutting-edge Genetics and Blockchain services...

whitepaper

Aug 08, 2018

30 years ago, polymerase chain reaction (PCR) burst onto the scene and steadily became one of the most common procedures in the lab. Advanced technologies have made it possible to achieve more accurate copies in a fraction of the time, no matter whic...

whitepaper

Aug 03, 2018

The aim of this white paper is to demonstrate how GE Healthcare Life Sciences single-use products can be applied in the field of vaccine manufacturing. The white paper includes a brief discussion on modern vaccine processes, followed by a case study ...

whitepaper

Jul 30, 2018

Artificial Intelligence (AI) is seeing another spring and becoming a ubiquitous part of society. Researchers and engineers have made important steps towards solving practical problems in machine learning, particularly in such applications as vision, ...

whitepaper

Jul 24, 2018

The collection and analysis of data generated outside of restricted clinical trials are now critical to pharma companies. Data gathered in the routine delivery of healthcare can be mined to uncover insights into treatment efficacies and outcomes in t...

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 ...

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...

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 overlay...

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...

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...

whitepaper

Jul 14, 2018

The publication of the stable text of the European Union (EU) Medical Devices Regulation, and the In Vitro Diagnostic Medical Devices Regulation in June 2016 documents the political agreement between the three EU Institutions – the Commission, ...

whitepaper

Jul 12, 2018

Alzheimer’s Disease (AD) is the most common form of dementia and accounts for 60% to 80% of dementia cases. In this progressive disease, dementia symptoms gradually worsen over a number of years. Memory loss is mild during the early stages, but...

whitepaper

Jul 11, 2018

This whitepaper explains how you can find ways to optimize the holistic preclinical development process. When it comes to informatics and data management, each preclinical domain is characterized by specific requirements due to their diverse scientif...

whitepaper

Jul 07, 2018

Technological advancements occur with such frequency that it’s challenging to stay on top — or ahead — of the Next Big Thing, but successful businesses need to focus attention on advancements that make internal processes easier and ...

whitepaper

Jul 07, 2018

For the 14th year in a row, AHRQ is reporting on health care quality and disparities. The annual National Healthcare Quality and Disparities Report (QDR) is mandated by Congress to provide a comprehensive overview of the quality of health care receiv...

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...

whitepaper

Jul 05, 2018

As the cloud becomes more prevalent, healthcare leaders are finding themselves in a multi-cloud environment, moving beyond basic infrastructure on demand to strategic innovations such as running real-time data analytics for the management of chronic ...

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...

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...

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...

whitepaper

Jun 19, 2018

The incorporation of mortality data into healthcare data sets allows fraud prevention, accurate billing, and benefits distribution, and true outcome analysis (especially in fatal disease areas like oncology, where survival is a key endpoint). The net...

whitepaper

Jun 19, 2018

Accurate patient matching is becoming 10 times more challenging and 10 times more critical. Instantly and dramatically improve your EHR’s or EMPI’s patient matching without disrupting any of its core functionality. By injecting the power ...

whitepaper

Jun 18, 2018

For immuno-oncology research and the hunt for new immunotherapies, scientists are required to reliably quantify the functions and interactions of cancer cells and immune cells. Cell proliferation assays of tumor growth are a mainstay. Activation and ...

whitepaper

Jun 16, 2018

Employer medical cost trend has plateaued. While the predictability is a welcome change from the wild swings and peak double-digit trends in the 2000s, steady as she goes is not good enough. Medical costs continue to grow as a percent of total employ...

whitepaper

Jun 15, 2018

The views expressed by authors or editors do not necessarily represent the decisions or the stated policies of the European Observatory on Health Systems and Policies or any of its partners. The designations employed and the presentation of the mater...

whitepaper

Jun 15, 2018

The following situation is typical for many production plants: After a routine quality check, the production process is stopped or an already produced batch is suspended because the analysis results were not within the relevant critical values. But d...

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...

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...

whitepaper

Jun 06, 2018

The World Health Statistics series is WHO’s annual compilation of health statistics for its 194 Member States. The series is produced by the WHO Department of Information, Evidence, and Research, of the Health Metrics and Measurement Cluster, i...

whitepaper

Jun 06, 2018

Healthcare providers need to rethink their current patient payment collections strategy, thanks to two recent phenomena: high-deductible plans that are shifting a greater portion of the bill to the patient, and an increase in the number of patients s...

whitepaper

Jun 06, 2018

The aim of this White Paper is to identify inequalities in government policies towards opioids that contribute to the inadequate treatment of pain. It calls for their replacement with policies that will support doctors and patients in their efforts t...

whitepaper

Jun 06, 2018

The number of therapeutic antibodies entering the market continues to grow annually, with 2017 seeing ten approvals in either the European Union or the United States supported by a robust late-stage clinical pipeline that will likely yield even more ...

whitepaper

Jun 05, 2018

When choosing an EMR system, you need to consider what you will be charged for and when, in addition to how much. This highly visual guide offers a clear explanation of how various pricing models work, along with actual pricing for popular EMR and Pr...

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...

whitepaper

Jun 05, 2018

Millennials are quickly becoming the dominant health care consumers, both for themselves, their families and as caregivers. Having grown up in a technology-first environment, however, they are increasingly dissatisfied with the static nature of healt...

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...

whitepaper

May 22, 2018

According to a recent study conducted by AmericanEHR, nearly 40 percent of physicians would not recommend their EHR solution to another provider; only slightly fewer said they would not purchase the same software again. Conversely, a study conducted ...

whitepaper

May 19, 2018

This guide outlines some simple strategies and tips for improving communication with your patients. Research indicates that ‘soft skills’ have a direct bearing on patient perceptions of the value of care provided, the degree of trust plac...

whitepaper

May 17, 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...

whitepaper

May 16, 2018

With breakthroughs in molecular engineering and antibody humanization, monoclonal antibodies (Mab) are one of the fastest-growing classes of biopharmaceuticals for multiple clinical indications including cancer, cardiovascular disease, autoimmune dis...

whitepaper

May 16, 2018

The information set forth below may not be exhaustive and does not imply any elements of a contractual relationship. While we make every effort to ensure that any material in this whitepaper is accurate and up to date, such as products, services, tec...

whitepaper

May 15, 2018

By making use of external resources that assist in developing, implementing, and maintaining high-quality physician advisor programs, hospitals can improve their financial performance and ensure that patients receive the most appropriate care for the...

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...

whitepaper

May 15, 2018

Citeline’s Pharmaprojects’ Pharma R&D Annual Review 2018 is here! Tune into expert insights and score illuminating data on the trends that affected pharmaceutical R&D throughout 2017 and continue to shape the market today – ...

whitepaper

May 10, 2018

Truven Health Analytics™ offers a full suite of digital marketing and engagement services and support for healthcare organizations. These services range from email list management and execution; to multilayered, multimodal, lead nurturing campa...

whitepaper

May 09, 2018

The MDR is significantly more comprehensive and detailed compared to the MDD. While the MDD comprises 23 Articles and 12 annexes over 60 pages, the MDR has 123 articles and 17 annexes over 175 pages. This table presents a summary of the provisions of...

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...

whitepaper

May 05, 2018

Commonwealth Physicians (Commonwealth)* is a physician-owned multi-specialty, the multi-location practice that serves more than 500,000 patients and is comprised of 25 practices and nearly 100 primary care providers. For Commonwealth Physicians, the ...

whitepaper

May 05, 2018

Transitioning patients between outpatient, inpatient, post-acute and home settings can be a major challenge for hospitals. For organizations participating in value-based reimbursement models, it can also be costly. This case study examines how Holyok...

whitepaper

May 05, 2018

One of the best ways to maximize revenue under value-based care arrangements is for health plans and physicians to team up and work collaboratively on health care transformation. By building a strong and meaningful partnership, health plans and physi...

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...

whitepaper

May 02, 2018

The pharmaceutical industry is acutely aware that the future of health and care, particularly in the United States, are trending toward a digital revolution. The importance of successfully executing a digital health strategy, as well as creating new ...

whitepaper

May 01, 2018

Many healthcare organizations depend on the work of financial counselors to help patients understand both their insurance coverage and their financial obligations. These professionals help patients make smart choices by answering questions about the ...

whitepaper

Apr 30, 2018

Accurate benchmarking has never been more important to the biopharma industry than now, with increased scrutiny related to development costs at an all-time high. What benchmarks are you using? How does your development program compare to those of you...

whitepaper

Apr 30, 2018

Over the last decade, it is undeniable that China has emerged as a rising star in pharmaceutical R&D, with a rich pipeline of new drugs and robust clinical trial activities

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...

whitepaper

Apr 25, 2018

Automated image analysis systems that provide detailed morphological information are rapidly replacing manual microscopy as the most effective method of characterizing both particle shape and size. These sophisticated new instruments use the latest t...

whitepaper

Apr 24, 2018

The recent changes to the United States Pharmacopeia (USP) regarding requirements for elemental impurity testing has peaked interest into new ways to perform this testing. Combining these new requirements with the introduction of USP chapter <735&...

whitepaper

Apr 19, 2018

As plastics continue to enter the environment, understanding their global impact is vital to addressing microplastic pollution. Since its emergence as an environmental and potential human health threat, researchers have strived to develop tools for a...

whitepaper

Apr 06, 2018

With the prevalence of asthma and chronic obstructive pulmonary disease (COPD) growing worldwide, the availability of primary human cells from these respiratory diseases is critical to increasing research and knowledge about the disease at a cellular...

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...

whitepaper

Apr 05, 2018

Don't miss out on this comprehensive review of all the presentations from the conference, compiled by our analysts, with key points and expert insight, for you to download, for free. A full list of events and catalysts that were announced or upda...

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...

whitepaper

Mar 28, 2018

RNA sequencing (referred to as RNA-Seq with traditional sequencing technologies) has led to unprecedented advances in all fields of biology and medicine. It has been an invaluable tool for the study of human genetics and the pathology associated with...

whitepaper

Mar 22, 2018

Download this white paper, which looks at novel biologics in development for the treatment of uncontrolled, eosinophilic asthma and whether they can fulfill the promise of truly targeted therapies for one of the most prevalent respiratory diseases wo...

whitepaper

Mar 21, 2018

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...

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...

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...

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...

whitepaper

Mar 14, 2018

By partnering with Patheon, you have access to a remarkable range of dosage form technologies for oral solids. Take advantage of our expansive scientific resources and expertise to create a product that stands out in the marketplace. For more informa...

whitepaper

Mar 13, 2018

A major step towards personalized medicine was achieved in early 2014 when the first report of sequencing a human genome for $1,000 was announced—hailed by some as one of the greatest scientific and medical achievements of the last decade.

whitepaper

Mar 10, 2018

Top Country Involvement in Ongoing Oncology PGX Trials. Emerging Trend: Epigenetics. Unexpected Advantages and Potential Pitfalls of Using PGX Selection. Top Sponsors of Ongoing or Planned Oncology Trials. What's on the Horizon for Pharmacogeneti...

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...

whitepaper

Mar 07, 2018

Pharmaceutical companies face many challenges in Japan in terms of it's complex regulatory and pricing process. Regular price cuts also pose hurdles for the introduction of new innovative drugs. Despite these challenges, the world’s second ...

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,...

whitepaper

Feb 27, 2018

Maintaining specific levels of cleanliness in controlled environments is extremely difficult. It’s even more difficult when an assortment of cleaning tools are utilized. Standard operating procedures become unnecessarily complex and difficult t...

whitepaper

Feb 26, 2018

How can I trust my data? This is a common concern for many researchers using particle measurement instrumentation. Is the data affected in any way by the measurement technology, or alternatively by the user during sample preparation or by the analysi...

whitepaper

Feb 22, 2018

Screening is an essential method for analyzing a group of chemicals, molecules, and/or compounds for a particular function in a prescribed assay. Proper screening is important for the identification of meaningful associations between compounds and ta...

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...

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...

whitepaper

Feb 18, 2018

At first, users had to remember different passwords for each application, and provisioning and managing accounts was a cumbersome, manual IT task. In addition, compliance with the Health Insurance Portability and Accountability Act (HIPAA) in Heal&rs...

whitepaper

Feb 17, 2018

At Digital Health, we provide unparalleled insight into the world of NHS IT. It is little wonder that, in recent years, an increasing amount of our work has centered on the use of mobile technology in healthcare. As smartphones and tablets have ...

whitepaper

Feb 14, 2018

Patients are increasingly behaving like consumers in a healthcare setting. As a result, they expect enhanced services and experiences when engaging with providers and health systems. How can health systems engage patients in an integrated effort that...

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...

whitepaper

Feb 09, 2018

The mature mammalian central nervous system (CNS) is composed of three major differentiated cell types: neurons, astrocytes, and oligodendrocytes. Neurons transmit information through action potentials and neurotransmitters to other neurons, muscle c...

whitepaper

Feb 02, 2018

Healthcare providers face a variety of resource, compliance, security, cost, reimbursement, and integration challenges that have not only strained hospital IT departments but also have affected they way clinicians provide care

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...

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...

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 ...

whitepaper

Jan 08, 2018

Learn how predictive data analytics can drive new breakthroughs, accelerate big data solutions, and derive insights from publicly available data with this eBook from The Scientist and PerkinElmer, Inc. Thanks to technology, scientific research c...

whitepaper

Jan 07, 2018

Population health, value-based care, decreasing revenues, and increasing costs are just a few of the pivotal issues challenging healthcare IT leaders today. Among other requirements, these issues call for large amounts of data, real-time data access,...

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...

whitepaper

Dec 21, 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...

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...

whitepaper

Nov 22, 2017

The U.S. healthcare ecosystem has faced a myriad of changes in just the last decade, and pharmaceutical companies continue to face the effects of those changes. The players have become more diverse, and today’s target audience for pharmaceutica...

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...

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...

whitepaper

Oct 18, 2017

Since Haemophilus influenzae became the first organism to have its entire genome sequenced in 19951 , there are now thousands of completed genomes covering archaea, bacteria and eukarya. However, the term ‘completed genome’ (or sometimes ...

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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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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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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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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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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Oct 05, 2017

The aim of this hospital-based retrospective analysis is to estimate the prevalence of Lysosomal Storage Disease (LSDs) in the Eastern Province of Saudi Arabia between 1983 and 2016. A total number of 89 Saudi patients from 43 families were diagnosed...

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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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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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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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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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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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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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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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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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Jul 14, 2017

The presence of residual metal impurities during drug manufacturing has become a major issue in the pharmaceutical industry in recent years, prompting a wide amount of interest in solutions for their safe and efficient removal.

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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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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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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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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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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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Jun 19, 2017

Oracle’s Clinical One Platform will enable pharmaceutical companies to manage every trial function from randomizing patient participants and collecting and analyzing data to tracking budgets and ensuring trial safety from a single user interfac...

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Jun 17, 2017

From 2015 to 2019, global healthcare spending is expected to increase by 4.3% annually. Along with growth, the sector is going through the significant transformation of its operating models and supply chains. These include three key developments: Fir...

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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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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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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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Jun 01, 2017

Round-up of the 2015 debuts; Distribution of phases of unapproved drug trials per therapeutic area in 2015; Top 25 disease by trial count Top locations for unapproved drug trials starting in 2015; Average number of countries disclosed per trial acros...

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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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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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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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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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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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May 05, 2017

This IDC White Paper, sponsored by Pure Storage, discusses important healthcare IT storage needs for the growing provider market, focusing on how all-flash storage solutions can be used to provide faster access to patient data. Patient data includes ...

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Apr 04, 2017

Healthcare in the United States is and always has been a complex system. This complexity is ever increasing as value-based purchasing and population health management transform our hospital-centric industry into one focused on the continuum of care.`...

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Mar 23, 2017

Other than skin cancer, prostate cancer is the most common cancer in American men with about one in seven receiving a prostate cancer diagnosis during his lifetime.

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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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Feb 15, 2017

Thomas Edison once said, “The doctor of the future will give no medicine but will interest his patients in the care of the human frame, in diet, and in the cause and prevention of disease.” Since then, we have indeed moved in that directi...

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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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Feb 03, 2017

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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Jan 30, 2017

Prescription opioid misuse and opioid use disorder (OUD) are significant and growing public health problems in the United States (U.S.) that impact stakeholders across the healthcare sector, including private, employer-sponsored, and public health pl...

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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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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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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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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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Oct 06, 2016

Major Depressive Disorder is one of the most common psychiatric disorders in the US, with over 15 million people impacted and costing $100 billion annually, of which less than half achieve symptom remission with the first medication tried. The cost a...

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Feb 05, 2016

The following overview highlights the critical role adequate and effective intellectual property rights protections and fair and equitable market access play in enabling biopharmaceutical innovators in the United States to research, develop and deliv...

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Apr 06, 2012

The structure of how healthcare is delivered varies greatly between countries, depending on the financing arrangements and national primary healthcare concerns. However, the basic components and stakeholders are broadly similar, as are global concern...

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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 customize