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Sponsored Webcast: Planning for a Successful Initial IND and Moving Beyond: Regulatory CMC Considerations for Biotherapeutics and Cell and Gene Therapies
Tuesday, 19 Sep 2023 | 11:00 AM Eastern Time (US & Canada)
For biotherapeutics, including cell and gene therapies, strategic product development and CMC regulatory planning start early on at the pre-IND stage and apply to the entire development lifecycle. For early-phase sponsors looking to successfully move from benchtop to a manufacturing facility or mid-phase programs implementing process, product, and facility changes, the planning of manufacturing, comparability, and analytical programs is crucial to reducing regulatory risk. In this webinar, Veristat Regulatory CMC experts discuss key challenges, strategies, and considerations to ensure the effective development of an analytical program to demonstrate comparability.
Learning Objectives
- Focus on biotherapeutics, including cell and gene therapies
- Demonstrating comparability in early to mid-phase development
- Analytical methods, including common challenges, strategies, and considerations
- Case studies and real-world insights
Meet the Speakers
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Kevin Hennegan
Director of US Regulatory Affairs, Veristat
Kevin Hennegan has provided strategic clinical and regulatory guidance to the pharmaceutical, biotech, and medical device industry for over 15 years. He has led and participated in the preparation of many successful FDA filings, including Investigational New Drug Applications (INDs), New Drug Applications (NDAs), Biologics License Applications (BLAs), Breakthrough Therapy Designations, Orphan Drug Designations, and Fast Track Applications. His experience covers a wide array of therapeutic indications (oncology, neurology, rheumatology, infectious disease, etc.) and product classes (therapeutic proteins, small molecule drugs, cell therapies, gene therapies, vaccines, and more). He is an advocate for patient-focused drug development and excels in engaging the FDA and other regulatory authorities as development partners.
Kevin earned a bachelor’s degree in microbiology from Colorado State University and a master’s degree in Molecular, Cellular, and Developmental Biology from the University of Colorado at Boulder.
Sarah Roemer, Ph.D.
Principal Regulatory CMC Strategist, Veristat
Sarah specializes in CMC regulatory strategy and CMC program development (early-phase through late-phase projects) for small molecule, botanical, and biological products. Sarah has 7 years' experience in translating global health authority CMC requirements into practical applications which ensures the success of pharmaceutical manufacturing and associated regulatory submissions. Sarah provides advice to teams on regulatory agency interactions and the preparation of CMC content spanning pre-INDs, FDA meeting requests and packages, INDs, IMPDs, CMC amendments, Scientific Advice, NDAs/BLAs, and post-approval changes.
Sarah has a bachelor's degree in biology from the University of New Mexico and a Ph.D. in Molecular Biology, specializing in Structure Biology, from the University of Colorado.
Lisa Erickson
Principal Regulatory CMC Strategist, Veristat
Lisa Erickson has over 30 years of experience in the biopharmaceutical CMC area and has spent the last 20 years specializing in Regulatory CMC strategies and submissions. She has supported numerous biological product therapeutics from Pre-IND, IND through BLA/MAA, and Post-Approval. She has also provided CMC support for CTAs and IMPDs globally. Lisa has led teams through many successful FDA interactions throughout development including support of FDA Pre-Approval inspections.
Lisa earned a Bachelor of Science in Physiology from the University of California, Davis.
Learn More
- View our Expedited Pathways Infographic
- Learn more about our Regulatory Consulting Expertise
- Download our IND Infographic