A pharma outsourcing mission

August 18, 2021 | 524 views

In a way, getting through the initial stages of a complex pharmaceutical project that is being outsourced to a contract development and manufacturing organization is like getting a rocket off the ground. Many drug developers express frustration with the time it often takes during the initial stages of working with a CDMO — from the time they first reach out to a CDMO for help until they receive a proposal. Some have described it as months of silence from when they send a request for proposal (RFP) until they have a proposal in hand.

The initial stages of a relationship between drug sponsor and CDMO often do not get the attention it deserves, and valuable time is lost, delaying projects and delaying delivery of therapeutics to patients. The quick scheduling of the ACT meeting with the right attendees can deliver immediate answers to key questions needed by the drug sponsor for effective planning and can help propel projects to a successful launch.

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Raleigh Radiology

Raleigh Radiology is Wake County's most experienced radiology practice. Our team of 35 board certified radiologists are truly dedicated individuals. Their combined knowledge and broad sub-specialized expertise is unparalleled making us the most experienced in the triangle. Raleigh Radiology has six free-standing outpatient imaging facilities throughout Wake and Johnston counties. Our radiologists provide professional services for all WakeMed Health & Hospital facilities.

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PHARMA TECH

Tips for Managing Chronic Pain Beyond Prescription Painkillers

Article | July 19, 2022

Painkillers like Oxycontin, Percocet, and Vicodin, have been prescribed by primary physicians, surgeons, dentists, and other healthcare providers to patients suffering from varying levels of pain. Though these medications have proven to be an effective source of pain relief, they have also proven to be highly addictive. In fact, it has even been reported that there are more cases of a drug overdose and deaths from prescription painkillers than heroin or cocaine. While there are a number of factors that play into this opioid epidemic, educating doctors and patients on alternative solutions to managing chronic pain is a great place to start combatting this nationwide crisis.

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PHARMA TECH

What are the advantages of PCD Pharma Company?

Article | July 20, 2022

PCD Pharma stands for propaganda distribution. A PCD company gives brand name and support to its franchises. They also provide distribution rights and monopoly rights within a particular region. If a person wants to establish their business, it is a must for them to know the pros and cons of the business to make a sound decision. Needless to mention that PCD company has a lot to contribute in the medical filed. Worldwide in a medical field, A PCD Pharma Company is playing an essential and crucial role in the rapid growth. The pharma industry is progressing t a fast pace. The company uses the latest technologies for each brand which ensures the safety of products and accepts the responsibility of human health & life by providing better outcomes. To have a drug license number and company registration, the cost to establish the company is quite cost-effective that is15000-20000rs. So this gives people a brilliant opportunity to have their unit without digging a big hole in their bank balance. Indian produces exquisite quality products, which make pharma companies a considerable success.

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PHARMA TECH

WALGREEN’S IN HOT WATER OVER PHONY PHARMACIST

Article | August 9, 2022

The drugstore chain agreed to pay $7.5 million in fines after an unlicensed pharmacist at several San Francisco Bay locations illegally filled more than 700,000 prescriptions over a ten-year period. According to California prosecutors, Kim Thien Le stole license numbers from other pharmacists to fill prescriptions for Fentanyl, morphine, and other painkillers. Le pleaded guilty to multiple felony impersonation counts. Walgreen’s agreed to the settlement to avoid being charged with consumer fraud in Alameda and Santa Anna Counties. Prosecutors alleged that Walgreen’s failed to verify Le’s license and did not conduct a thorough background check. The company insisted it has taken remedial measures.

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How Can Medical Cannabis Help to Manage Pain Conditions? – The Cannabis Exchange

Article | February 11, 2020

Pain management is one of the most common reasons for the use of medical cannabis products. However, despite many jurisdictions – including Canada, Germany, and the Netherlands – now allowing the prescription of medical cannabis for this purpose, there remains little ‘high-quality’ evidence to support, or oppose its efficacy. Madden et al. (2018) set out to review the evidence available in order to determine the efficacy of medical cannabis when employed in the management of various forms of musculoskeletal pain. The researchers analysed various studies that assessed the use of cannabinoids in the treatment of arthritis pain; back pain; postoperative pain; and trauma-related pain. It is estimated that up to 30% of the population may suffer from a non-cancer-related pain condition. As such a high percentage of people suffer from these conditions, the development of simple and safe therapies is an essential area of research. This is particularly important as the therapeutic options for people with chronic pain are increasingly limited.

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Spotlight

Raleigh Radiology

Raleigh Radiology is Wake County's most experienced radiology practice. Our team of 35 board certified radiologists are truly dedicated individuals. Their combined knowledge and broad sub-specialized expertise is unparalleled making us the most experienced in the triangle. Raleigh Radiology has six free-standing outpatient imaging facilities throughout Wake and Johnston counties. Our radiologists provide professional services for all WakeMed Health & Hospital facilities.

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PHARMACY MARKET

REALM IDx Launches REALM Pharma Services to Improve Drug Development and Research

Businesswire | June 02, 2023

REALM IDx announced the launch of REALM Pharma Services, an end-to-end discovery, translational research, and clinical trial service for biotechnology and pharmaceutical partners. Through a strategic integration, REALM Pharma Services brings together the research arms of subsidiaries, Ambry Genetics and Invicro, to offer cutting-edge genomics, traditional and molecular pathology, and advanced imaging and spatial biology. Combined with machine learning and artificial intelligence (AI) from REALM’s informatics organization, the company believes this end-to-end service can help reveal new insights and develop multi-dimensional models for drug discovery and validation. “We are excited to offer a comprehensive multiomic and multimodal program that has been tailored to support the needs of our biopharma partners,” said Aaron Elliott, PhD, CEO of REALM IDx. “We believe the integrated approach offered through REALM Pharma Services is a transformative shift in research and will bring new, data-driven insights to precision medicine.” Use of advanced omics, including single-cell omics, is increasingly being incorporated by biopharma into discovery and research efforts, particularly in the field of cancer. This approach can support improved understanding of biological complexity in immuno-oncology and a system-wide path to drug efficacy. However, a significant challenge has been the lack of a consolidated infrastructure to not only support analytical testing and data collection, but also computational analysis of unique data sets to find novel associations for translational insights. “In supporting our biopharma partners, we see ourselves as a powerful connecting force,” said Jonathan Usuaka, PhD, Chief Strategy and Informatics Officer for REALM IDx. “Along with world-class genomics, pathology, spatial imaging and analysis services, we support real-world data and advanced analytics to inform drug development at every stage.” The company will introduce REALM Pharma Services while exhibiting at the upcoming American Society of Clinical Oncology annual conference in Chicago, June 3 – 5. While at the conference, the company will also share details of a new comprehensive genomic profiling test (CGP) for cancer developed in collaboration with its partners in Japan and set to launch this summer. Additional information about REALM Pharma Services may be found on REALM’s website. About REALM IDx REALM IDx, Inc. is a health care company pioneering in the field of Integrated Diagnostics (IDx), an advanced field of clinical science that brings together laboratory medicine, radiology, pathology and sophisticated artificial intelligence to derive actionable insights to predict, diagnose and treat disease. Powered by proprietary software platforms, industry-leading genomics technology from Ambry Genetics Corporation and radiology and pathology services from Invicro, LLC, the company is equipped to collect, analyze and report on multi-modal precision diagnostic data sets.

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PHARMA TECH

Leading Pharmaceutical Company in Brazil Chooses ValGenesis iRisk to Redefine and Automate Risk-Based Validation Processes

prnewswire | May 30, 2023

ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems announced that a leading pharmaceutical company in Brazil selected ValGenesis iRisk to redefine and automate the company's risk-based validation processes. ValGenesis iRisk is the world's most advanced risk management platform, used by top pharmaceutical companies across the world. With corporate origins in Japan, the company draws upon a rich legacy of innovation and a pipeline of robust therapeutics that are enhancing the lives of millions of people across the globe. Working to keep pace with ever-changing business and regulatory landscapes, the company chose ValGenesis iRisk because it enhances business performance and business process excellence across end-to-end product and process lifecycles. On this compliant platform, experts can analyze, visualize, query, and compare risk over different products, processes, production sites, and more, sharing a continuous flow of risk communications between relevant stakeholders to get products to market more quickly and safely. "Brazil is the largest pharmaceutical market in Latin America, and we are happy that more companies are turning to ValGenesis for risk-based validation solutions that enforce a structured and consistent approach to risk, " says Steve Reynolds, Chief Revenue Officer at ValGenesis. "ValGenesis iRisk is able to deliver on these stringent requirements simply, efficiently, and very cost-effectively." ABOUT VALGENESIS ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.

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PHARMACY MARKET

Exscientia Highlights "The Future of AI-enabled Drug Discovery" at SLAS Europe

Businesswire | May 23, 2023

Exscientia plc announced two abstracts for oral and poster presentation, as well as the closing keynote to be delivered at the Society for Laboratory Automation and Screening (SLAS) Europe Conference and Exhibition being held May 22-26, 2023, in Brussels, Belgium. These presentations highlight Exscientia’s recent advancements in technology, including the development of computer-aided biology (CAB) approaches, encompassing design of experiments (DoE) and automation for biochemical assay optimisation. The SLAS Conference is Europe’s premiere venue for industry, government and academic researchers, developers and providers of laboratory automation technology innovation. “At Exscientia, our mission is to encode and automate drug discovery. We believe that within this decade the design of all new drug candidates will be augmented with AI. I am delighted to showcase at SLAS Europe how our recent technology advances enable and drive our projects,” said Dr Garry Pairaudeau, Chief Technology Officer at Exscientia. Integrating laboratory automation of synthesis and screening with its AI-driven computational design platform is the logical next step for the company. “This will facilitate the next transformation in speed and productivity, as we aim to bring better medicines to patients faster. We’re looking forward to opening our purpose-built automation studio in Oxfordshire, U.K., later in 2023.” The company’s presentation at SLAS will demonstrate how far along Exscientia is in automating the drug discovery processes. “We believe automation has the potential to radically improve the timely creation of high-quality drug candidates, so that future patients may benefit from innovative science faster,” Pairaudeau stated. Closing Keynote Presentation Title: The future of AI-enabled drug discovery Room/Location: Plenary Theater Date/Time: Thursday, May 25 / 16:30 – 17:30 PM CET This presentation will highlight Exscientia’s distinct approach to molecular design, using an end-to-end patient centric, AI-enabled platform, which has led the way in the precision design of AI-generated molecules resulting in the first AI-designed compounds to enter clinical trials. To reach Exscientia's goal of fully encoding and automating drug discovery, the company is assembling an automated physical laboratory alongside its suite of sophisticated computational design tools, methods and scalable engineering platform. This presentation will highlight Exscientia's current progress in the automation field and the critical steps needed in the implementation of automated, digital laboratories. Abstracts Accepted for Presentation Oral Presentation Title: Computer-aided biology: DoE solutions Track: Frontiers in Technology Room/Location: 231 Date/Time: Thursday, May 25 / 15:30 – 16:00 PM CET Exscientia is building an automated ecosystem of chemistry, biology and compound management, including developing a pipeline of fully automated biochemical assays from assay development onwards. This presentation highlights how CAB has been leveraged to achieve this pipeline, combining DoE (a statistical methodology) with automation to rapidly determine optimum conditions to run assays efficiently through analysis of multi-factorial experimental results. Utilising CAB also allows Exscientia to increase capacity and efficiency across FTEs, time and reagents required to run assays, increase assay robustness and investigate areas of biology not normally studied. Poster Title: Improving assay optimisation and pharmacological sensitivity of a nuclease by employing a computer-aided biology approach Session/Track: Session A; Frontiers in Technology Abstract Number: 1034-A Date/Time: Wednesday, May 24 / 13:30 – 14:30 PM Exscientia researchers demonstrated the practical use of CAB to simultaneously improve an assay’s performance and reduce the reagent requirement, cost and labour for assay development. This presentation highlights the application of CAB to optimise the buffer of a nuclease assay, resulting in a 15-fold enhanced assay signal in low salt buffer conditions, alongside over a three-fold decrease in protein requirement​ and reduced assay development cycle times. The low salt requirement is a previously unforeseen result from CAB use which would have not been predicted from the literature. This highlights the potential for technology to improve assay performance in ways a human alone would not have been able to predict. About Exscientia Exscientia is an AI-driven precision medicine company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to progress AI-designed small molecules into the clinical setting. Our internal pipeline is focused on leveraging our precision medicine platform in oncology, while our partnered pipeline broadens our approach to other therapeutic areas. By pioneering a new approach to medicine creation, we believe the best ideas of science can rapidly become the best medicines for patients.

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PHARMACY MARKET

REALM IDx Launches REALM Pharma Services to Improve Drug Development and Research

Businesswire | June 02, 2023

REALM IDx announced the launch of REALM Pharma Services, an end-to-end discovery, translational research, and clinical trial service for biotechnology and pharmaceutical partners. Through a strategic integration, REALM Pharma Services brings together the research arms of subsidiaries, Ambry Genetics and Invicro, to offer cutting-edge genomics, traditional and molecular pathology, and advanced imaging and spatial biology. Combined with machine learning and artificial intelligence (AI) from REALM’s informatics organization, the company believes this end-to-end service can help reveal new insights and develop multi-dimensional models for drug discovery and validation. “We are excited to offer a comprehensive multiomic and multimodal program that has been tailored to support the needs of our biopharma partners,” said Aaron Elliott, PhD, CEO of REALM IDx. “We believe the integrated approach offered through REALM Pharma Services is a transformative shift in research and will bring new, data-driven insights to precision medicine.” Use of advanced omics, including single-cell omics, is increasingly being incorporated by biopharma into discovery and research efforts, particularly in the field of cancer. This approach can support improved understanding of biological complexity in immuno-oncology and a system-wide path to drug efficacy. However, a significant challenge has been the lack of a consolidated infrastructure to not only support analytical testing and data collection, but also computational analysis of unique data sets to find novel associations for translational insights. “In supporting our biopharma partners, we see ourselves as a powerful connecting force,” said Jonathan Usuaka, PhD, Chief Strategy and Informatics Officer for REALM IDx. “Along with world-class genomics, pathology, spatial imaging and analysis services, we support real-world data and advanced analytics to inform drug development at every stage.” The company will introduce REALM Pharma Services while exhibiting at the upcoming American Society of Clinical Oncology annual conference in Chicago, June 3 – 5. While at the conference, the company will also share details of a new comprehensive genomic profiling test (CGP) for cancer developed in collaboration with its partners in Japan and set to launch this summer. Additional information about REALM Pharma Services may be found on REALM’s website. About REALM IDx REALM IDx, Inc. is a health care company pioneering in the field of Integrated Diagnostics (IDx), an advanced field of clinical science that brings together laboratory medicine, radiology, pathology and sophisticated artificial intelligence to derive actionable insights to predict, diagnose and treat disease. Powered by proprietary software platforms, industry-leading genomics technology from Ambry Genetics Corporation and radiology and pathology services from Invicro, LLC, the company is equipped to collect, analyze and report on multi-modal precision diagnostic data sets.

Read More

PHARMA TECH

Leading Pharmaceutical Company in Brazil Chooses ValGenesis iRisk to Redefine and Automate Risk-Based Validation Processes

prnewswire | May 30, 2023

ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems announced that a leading pharmaceutical company in Brazil selected ValGenesis iRisk to redefine and automate the company's risk-based validation processes. ValGenesis iRisk is the world's most advanced risk management platform, used by top pharmaceutical companies across the world. With corporate origins in Japan, the company draws upon a rich legacy of innovation and a pipeline of robust therapeutics that are enhancing the lives of millions of people across the globe. Working to keep pace with ever-changing business and regulatory landscapes, the company chose ValGenesis iRisk because it enhances business performance and business process excellence across end-to-end product and process lifecycles. On this compliant platform, experts can analyze, visualize, query, and compare risk over different products, processes, production sites, and more, sharing a continuous flow of risk communications between relevant stakeholders to get products to market more quickly and safely. "Brazil is the largest pharmaceutical market in Latin America, and we are happy that more companies are turning to ValGenesis for risk-based validation solutions that enforce a structured and consistent approach to risk, " says Steve Reynolds, Chief Revenue Officer at ValGenesis. "ValGenesis iRisk is able to deliver on these stringent requirements simply, efficiently, and very cost-effectively." ABOUT VALGENESIS ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.

Read More

PHARMACY MARKET

Exscientia Highlights "The Future of AI-enabled Drug Discovery" at SLAS Europe

Businesswire | May 23, 2023

Exscientia plc announced two abstracts for oral and poster presentation, as well as the closing keynote to be delivered at the Society for Laboratory Automation and Screening (SLAS) Europe Conference and Exhibition being held May 22-26, 2023, in Brussels, Belgium. These presentations highlight Exscientia’s recent advancements in technology, including the development of computer-aided biology (CAB) approaches, encompassing design of experiments (DoE) and automation for biochemical assay optimisation. The SLAS Conference is Europe’s premiere venue for industry, government and academic researchers, developers and providers of laboratory automation technology innovation. “At Exscientia, our mission is to encode and automate drug discovery. We believe that within this decade the design of all new drug candidates will be augmented with AI. I am delighted to showcase at SLAS Europe how our recent technology advances enable and drive our projects,” said Dr Garry Pairaudeau, Chief Technology Officer at Exscientia. Integrating laboratory automation of synthesis and screening with its AI-driven computational design platform is the logical next step for the company. “This will facilitate the next transformation in speed and productivity, as we aim to bring better medicines to patients faster. We’re looking forward to opening our purpose-built automation studio in Oxfordshire, U.K., later in 2023.” The company’s presentation at SLAS will demonstrate how far along Exscientia is in automating the drug discovery processes. “We believe automation has the potential to radically improve the timely creation of high-quality drug candidates, so that future patients may benefit from innovative science faster,” Pairaudeau stated. Closing Keynote Presentation Title: The future of AI-enabled drug discovery Room/Location: Plenary Theater Date/Time: Thursday, May 25 / 16:30 – 17:30 PM CET This presentation will highlight Exscientia’s distinct approach to molecular design, using an end-to-end patient centric, AI-enabled platform, which has led the way in the precision design of AI-generated molecules resulting in the first AI-designed compounds to enter clinical trials. To reach Exscientia's goal of fully encoding and automating drug discovery, the company is assembling an automated physical laboratory alongside its suite of sophisticated computational design tools, methods and scalable engineering platform. This presentation will highlight Exscientia's current progress in the automation field and the critical steps needed in the implementation of automated, digital laboratories. Abstracts Accepted for Presentation Oral Presentation Title: Computer-aided biology: DoE solutions Track: Frontiers in Technology Room/Location: 231 Date/Time: Thursday, May 25 / 15:30 – 16:00 PM CET Exscientia is building an automated ecosystem of chemistry, biology and compound management, including developing a pipeline of fully automated biochemical assays from assay development onwards. This presentation highlights how CAB has been leveraged to achieve this pipeline, combining DoE (a statistical methodology) with automation to rapidly determine optimum conditions to run assays efficiently through analysis of multi-factorial experimental results. Utilising CAB also allows Exscientia to increase capacity and efficiency across FTEs, time and reagents required to run assays, increase assay robustness and investigate areas of biology not normally studied. Poster Title: Improving assay optimisation and pharmacological sensitivity of a nuclease by employing a computer-aided biology approach Session/Track: Session A; Frontiers in Technology Abstract Number: 1034-A Date/Time: Wednesday, May 24 / 13:30 – 14:30 PM Exscientia researchers demonstrated the practical use of CAB to simultaneously improve an assay’s performance and reduce the reagent requirement, cost and labour for assay development. This presentation highlights the application of CAB to optimise the buffer of a nuclease assay, resulting in a 15-fold enhanced assay signal in low salt buffer conditions, alongside over a three-fold decrease in protein requirement​ and reduced assay development cycle times. The low salt requirement is a previously unforeseen result from CAB use which would have not been predicted from the literature. This highlights the potential for technology to improve assay performance in ways a human alone would not have been able to predict. About Exscientia Exscientia is an AI-driven precision medicine company committed to discovering, designing and developing the best possible drugs in the fastest and most effective manner. Exscientia developed the first-ever functional precision oncology platform to successfully guide treatment selection and improve patient outcomes in a prospective interventional clinical study, as well as to progress AI-designed small molecules into the clinical setting. Our internal pipeline is focused on leveraging our precision medicine platform in oncology, while our partnered pipeline broadens our approach to other therapeutic areas. By pioneering a new approach to medicine creation, we believe the best ideas of science can rapidly become the best medicines for patients.

Read More

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