Nuventra’s team of experienced consultants includes four former FDA Reviewers. Our former FDA reviewers will be available for complimentary 30-minute consultations during the virtual BIO Investor Forum. In this meeting, they can answer questions, offer advice on your regulatory strategy, interpret guidances, and offer their opinions on various clinical pharmacology issues.
Anita O’Connor, PhD spent 16 years at the FDA, including five years as a preclinical reviewer of vaccines, biologic drugs and blood products. She served as Cofounder and VP of Regulatory and Scientific Affairs for TregTherapeutics, a company focused on tolerance vaccines for autoimmune diseases.
Gene Williams, PhD has over 25 years of experience in clinical pharmacology, 20 of which occurred at the FDA, first as a FDA Primary Reviewer and subsequently as a FDA Team Leader. He has worked on more than 400 different drugs as an FDA Primary Reviewer and 600 as an FDA Team Leader. The majority of his time at the FDA was spent reviewing oncology applications.
Iftekhar Mahmood, PhD has more than 25 years of clinical pharmacology experience at the FDA. Dr. Mahmood worked in both the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). During this period, Dr. Mahmood worked on neurological products, therapeutic proteins, coagulation factors, and immunoglobulins.
Suliman Al-Fayoumi, MBA, PhD has over 20 years of experience in regulatory science and the pharmaceutical industry including experience in clinical pharmacology, biopharmaceutics, pharmacology, toxicology and translational sciences. In addition, Dr. Al-Fayoumi spent 8 years as a Senior Clinical Pharmacology and Biopharmaceutics Reviewer at FDA, 4.5 years at Novartis Pharma, and 8 years at two small biotech companies.