DURHAM, N.C.--(BUSINESS WIRE)--Nuventra Pharma Sciences is pleased to announce the addition of two former FDA reviewers, Brian Furmanski, Ph.D. and Gene Williams, Ph.D., to its growing team of experienced consultants. Both offer a wealth of clinical pharmacology knowledge and a fundamental understanding of how to effectively bring drugs to approval.
“Dr. Furmanski and Dr. Williams bring a new dimension to Nuventra’s team,” said Geoffrey Banks, Ph.D., Nuventra’s President and CEO, adding further, “Their extensive experience with the FDA brings value-added insights into the design and execution of clinical pharmacology programs. We are excited to welcome them to our team.”
Brian Furmanski, Ph.D.
Dr. Furmanski has over 8 years of drug development experience from an industry and regulatory standpoint. Prior to joining Nuventra, Dr. Furmanski was first an Investigator at GSK and then a Senior Clinical Pharmacology Reviewer at FDA, where he provided expert guidance on the design and interpretation of pharmacokinetic and pharmacodynamic findings across multiple therapeutic areas.
While at the FDA, Dr. Furmanski has reviewed and provided expert regulatory advice on numerous NDAs, sNDAs, sBLAs, 505b2s, and one BLA and biosimilar application. He has reviewed over 200 INDs spanning across all phases of development, along with briefing packages, product labeling, and post-marketing commitment and requirement studies.
Dr. Furmanski has been recognized for his work using model informed drug development tools for regulatory decision making, assessment of novel bioanalytical techniques and for his evaluation of the effects of immunogenicity on clinical efficacy and safety.
Gene Williams, Ph.D.
Dr. Williams has 24 years of experience in Clinical Pharmacology and 20 years of experience at the FDA, first as an FDA Primary Reviewer and subsequently as an FDA Team Leader. He specializes in the development of drugs for oncology, medical counter-measures for radiation, and medical imaging.
Dr. Williams has worked on over 400 different drugs as an FDA Primary Reviewer and on over 600 as an FDA Team Leader. Over 150 of these drugs were reviewed as NDAs/BLAs (NMEs and supplements).
He was a member of the FDA Working Groups that developed the boilerplate used by FDA Reviewers to complete NME NDA/BLA reviews and the draft FDA Guidance, “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs – General Considerations.”
About Nuventra
Nuventra is the pharmaceutical industry’s go-to resource for clinical pharmacology, pharmacokinetic, and pharmacometric consulting services. Nuventra gives pharmaceutical companies and CROs rare access to a hands-on team of industry-leading consultants experienced in complex studies and analyses. We embrace the notion that simplicity and clarity lead to good decisions by taking complex pharmacokinetic and pharmacometric principals and making them understandable and usable for common sense drug development. Read more at www.nuventra.com.
