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Does the Drug Shortage White Paper Fall Short?

FDA Law Blog: Biosimilars

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.

Drugs 59
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Evolution of Clinical Operations Drives FSP Staffing Models to the Forefront

PPD

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.

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Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

Conversations in Drug Development Trends

Are there differential financial incentives to encourage sponsors to initiate early phase clinical research under a CTA, and how do those incentives compare to incentives that exist to initiate the same research under an IND? For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

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Patient-Centric Strategies for Successful Oncology Trials

PPD

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. Researchers often employ cell therapy studies for oncology indications, and the U.S.

Trials 64
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Informed Design of Bioanalytical PCR Assay Testing Parameters

PPD

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Emerging areas of pharmaceutical research not only bring novel opportunities but also new regulatory guidance.

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Keeping tabs on Covid-19: Starpharma creates slow release remdesivir nanoparticl…

The Pharma Data

Covid-19 command center aims to accelerate clinical research by individual sponsors to combat disease. The Covid-19 command center was created to provide sponsors of clinical trials pursuing in-house Covid-19 research with an AI-powered data analytics platform. Saama Technologies, Inc. ,

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Top 10 Drug Discovery Trends at the Top 20 Pharma

PerkinElmer

Dr. Eckelt conducted 23 hour-long, 1:1 interviews over five months in 2020 to gather market insights on how the top 20 Pharma are increasing productivity, efficiency, and speed of drug discovery in the short and long-term. A PerkinElmer White Paper offers a detailed look at the findings. Small molecules are making a comeback.