Pharma R&D Today

Ideas and Insight supporting all stages of Drug Discovery & Development

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Jeffrey Paul, PhD

Jeffrey Paul, PhD

Principal at JPharm Consulting

Connect with Jeffrey Paul, PhD on LinkedIn

About the author: Dr. Paul is a clinical pharmacology consultant to the pharmaceutical industry, focusing his practice on early clinical development of drugs for CNS and pain. Dr. Paul has spent nearly 30 years in pharmaceutical R&D, including Discovery, and Phase 1 through 4 clinical development phases. He has global clinical and regulatory experience, especially in Europe and Japan. He has worked at Berlex, Pfizer (formally Wyeth), and Astellas at the Executive Director/Assistant VP level. Dr. Paul has an adjunct faculty appointment at Drexel Medical College (Philadelphia) where he teaches in the graduate Drug Discovery and Development program and Neuropharmacology courses; and is active in Drexel’s Clinical Research for Health Professionals Program and Clinical & Translational Research Institute. Dr. Paul is also active in promoting translation medicine as a member of the Executive Committee of Translation, Clinical Pharmacology Division of American Society for Pharmacology & Experimental Therapeutics (ASPET).

Posts by Jeffrey Paul, PhD

Women and minorities in clinical trials

Posted on September 16th, 2016 in Pharma R&D

You are a female and/or a minority and concerned if you will respond to your medication. So you read the product label, asking yourself, “Do I see myself described as a patient in the drug testing trials?” (more…)

The Many Shapes and Colors of Biomarkers

Posted on August 12th, 2016 in Pharma R&D

The future is biomarkers. This is an often-cited phrase you will have heard at drug development symposia and printed in articles. The line reminds me of the film, The Graduate, where Mr. McGuire tells young Benjamin that there is a “great future in in plastics.”  Biomarkers are the plastics for personalized medicine, (more…)

Qualification, Validation, and Fit-for-Purpose Biomarkers

Posted on July 22nd, 2016 in Pharma R&D

As drug developers we rely greatly on biomarkers for providing information to our drug development programs and supporting submission to regulators.  (more…)

Reducing the Risk of Late-Phase Failures

Posted on July 5th, 2016 in Pharma R&D

Late-stage failures are common. The likelihood of a phase transition from Phase 2 to 3 is about 30%, and moving from Phase 3 to submission is only about 60% likely. The majority of late-stage failures are due to a lack of demonstrated efficacy (56%), followed by safety issues (28%)[1]. (more…)

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