Submitting your New Drug Application (NDA) to the US Food and Drug Administration (FDA) is the ultimate test of a drug program. Are you confident that you’ll have robust answers to the 40 different questions that the agency will ask about your clinical pharmacology data package at the time of a NDA submission? If the thought gives you “pre-test jitters,” you might want to invest in a clinical pharmacology gap analysis—a tool that can help you evaluate and address any potential gaps in your program before the FDA does.
The field of clinical pharmacology can help stakeholders address these challenges and improve decision-making at critical milestones, whether early in proof-of-concept phases (pre-clinical through 2a) or in the later stages where a more robust risk and efficacy profile is established (2b through 3). The tools, methods, and frameworks (eg, mechanistic or quantitative) of clinical pharmacology span distinct sub-specialties and can significantly impact these pre-clinical and clinical phases.
Attend this webinar to learn from Dr. Julie Bullock, Senior Director of Consulting Services at Certara, how gap analysis can help you ensure that your development program will contain all the elements needed to satisfy regulators and investors during all phases of drug development from IND to NDA. By attending this webinar, you will learn the following:
- What questions the agency will ask about your clinical pharmacology data package at the time of a NDA submission
- How gap analysis can help you develop a clinical pharmacology development strategy that covers all relevant domains
- What data to gather and when to gather it to enhance decision-making during development
- How a clear clinical pharmacology plan can assist in negotiations with regulators and investors during IND development
- What quantitative analyses (pharmacometrics and other model-informed drug development technologies) can be leveraged to diminish dedicated study needs and accelerate your path to drug approval
About Our Speaker
Dr. Bullock has over 10 years of drug development experience within the FDA. Dr. Bullock’s past appointments include Clinical Pharmacology Team Leader and Senior Clinical Pharmacology Reviewer (FDA). Her regulatory experience was focused in the therapeutic areas of hematology/oncology and coagulation. She has unique insight in pediatric development, PK/PD approaches for biosimilar products, oncology dose finding strategy, and streamlining development for breakthrough therapies and accelerated approval. Dr. Bullock has contributed to over 14 new molecular entity approvals during her 10 year FDA career.