There are not that many opportunities to consult agencies like FDA, EMA, Health Canada. Agency meetings (Pre IND, End of Phase 1, End of Phase 2, scientific advice, oral hearings and other meetings) take an enormous amount of planning and resources. It also takes time e.g. at least 60 days to receive the FDA responses starting from submitting the meeting request or 40/70 days to receive a written response from the SAWP. The panel will talk about how to plan for a request, the timing of the meeting, the data to provide, and most importantly, how to ask the type of questions to get the information needed to guide your CMC, Nonclinical, and Clinical development programs. After this discussion each attendee should have an understanding of the types of questions that are appropriate to ask at each stage of development and also when to ask the “forward looking” questions that guide future planning. Getting a “yes” answer from health authorities is good, but sometimes getting the “no” is equally important.
Clara Li – VP Regulatory and Strategic Development
Frank Wierckx – Exec Director Regulatory Affairs, Europe
Clara Li has over twenty-nine (29) years’ experience in regulatory affairs with expertise in the US, European, Canadian, and Asia Pacific regions (Phases I-IV). She plays a strategic regulatory leadership role in the development of well characterized biologics; small molecules, cell, tissue, and gene therapy, microbiome, vaccines and combination products. Clara is a lead strategist with quick understanding and assessment of how to develop innovative regulatory paths leading to clinical programs and marketing approval. She is an expert in integrating and leading multi-disciplinary project teams to meet aggressive timelines. Her therapeutic area of expertise includes oncology, inflammation, immunology, cardiovascular, renal, endocrine, neurology, ophthalmology, infectious diseases, and dermatology. Clara has planned and successfully executed FDA and EU health authority negotiations, submissions, approvals of clinical trial (IND, CTA) and marketing submissions (NDA, 505(b)2 NDA, BLA, MAA), and life cycle management of dossiers as well as made successful submissions and approvals of Orphan, Fast Track, Breakthrough, QIDP, Pediatric Plans (PIP/PSP) and PRIME.
Frank Wierckx leads the EU RSD group and has 27 years of experience in all phases of development (1-4) in EU with EMA and European National agencies (BfArM, MHRA, ANSM, PEI, Swissmedic). Spanning a broad range of therapeutic areas: cardiovascular, anti-infectives, gastro-intestinal, and women’s health, Frank has a thorough and deep understanding of innovative pathways for clinical development and regulatory approval. With an emphasis on Orphan Drug, pediatric investigational plans, scientific advice, PRIME designation, conditional and/or accelerated approval, Frank advises on all aspects of the regulatory needs of product development and strategy in Europe.