Clinical pharmacology plans are not “one size fits all.” Selecting which studies are needed for approval is largely dictated by the nuances of the drug, disease and by the medical need for the drug. This is especially true for oncology, as the time from the first-in-human dose to approval is shorter for oncology relative to other indications and the medical need is substantial.
This webinar will cover the paths for successful oncology clinical pharmacology development programs, for both large and small molecule therapeutics. At the end of this webinar attendees should have a better appreciation of:
- The role that clinical pharmacology plays in oncology drug development
- Insights on when certain studies should be implemented early-on in development
- How to position a program based on therapeutic class
The webinar is free of charge. Register here.
Meet the Speakers
As former FDA Clinical Pharmacology Reviewers, Dr. Williams and Dr. Furmanski both bring direct Oncology drug development experience from a regulatory standpoint. Dr. Williams also specializes in the development of drugs for oncology, medical counter-measures for radiation, and medical imaging.
Gene Williams, PhD
Associate Vice President, Clinical Pharmacology
Dr. Williams has 24+ years of experience in Clinical Pharmacology, 20 of which occurred at the FDA, first as a FDA Primary Reviewer and then as a FDA Team Leader. Dr. Williams worked on over 400 different drugs as an FDA Primary Reviewer and 600 as an FDA Team Leader.
Brian Furmanski, PhD
Senior Director, Clinical Pharmacology & Pharmacokinetics
Dr. Furmanski has 10+ years of drug development experience, recently including 3 years as a reviewer in the Office of Clinical Pharmacology at FDA. He has reviewed and provided regulatory advice on 3 NDAs, 1 BLA, 6 sNDAs, 11 sBLAs, 2 505b2s, and 1 biosimilar application. He has also reviewed over 200 INDs spanning across all phases of development.