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Biotherapeutic development is challenging due to evolving industry standards and increasing regulatory scrutiny. A roadmap for success is essential. Watch Veristat's on-demand webinar on Regulatory CMC Excellence in Biotherapeutics, including key considerations, challenges, and strategies:
- Deep Dive into Biotherapeutics: Understand the subtleties of biotherapeutics like never before.
- Mastery over Comparability: Learn the ropes of effectively demonstrating comparability during early to mid-phase development.
- Boost Your Analytical Acumen: Delve into analytical methods, grasp prevalent challenges, and adeptly craft winning strategies.
- Real-World Learning: Make you knowledge concrete with case studies and real-time insights from the field.
Whether you're an early-phase sponsor gearing up to transition from the benchtop to a manufacturing facility or are mid-phase and needing to make process or product tweaks, this webinar is tailored for you.
The on-demand webinar and slide presentation assets are just a click away. Gain a competitive edge in biotherapeutics today.
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.
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