Event Schedule
Host: Dara Wambach, RAPS SF
Kok Seong Lim, BPharm, PhD, RAC, is the Founder and Principal of Eight Crest Strategies. He brings more than 20 years of experience in biologics research and development, with leadership roles at Metagenomi, Aura Biosciences, Editas Medicine, and Thermo Fisher Scientific. Throughout his career, he has advanced more than 15 gene therapy, cell therapy, and gene-editing programs spanning AAV, mRNA and guide RNA, lipid nanoparticles, Cas enzymes, and oligonucleotides.
His experience includes building GMP manufacturing and analytical infrastructure, developing phase-appropriate control strategies, and contributing CMC content to regulatory submissions and health authority interactions in the U.S. and Europe. He serves on the USP Biologics—Cell and Gene Therapy Expert Committee, contributes to ISO/TC 276, and serves as Chair of the RAPS San Francisco Bay Area Chapter. He holds a PhD in Biochemistry from the National University of Singapore and a BSc in Pharmacy from the University of Strathclyde.
Maurizio Franzini is a Regulatory CMC professional with multi-year experience supporting synthetic molecules across a broad range of therapeutic indications. He is a strategic planner and contributors to eCTD quality sections in marketing applications, INDs/IMPDs and related amendments, post-approval changes, and annual reports, covering oral and subcutaneous dosage forms as single agents and fixed-dose combinations across multiple regions. Maurizio contributes to strategy and content in response to agency requests for information and letters of non-acceptance and supports phase-appropriate manufacturing control strategies that safeguard patient safety while meeting regulatory expectations. He’s currently the proud people manager of a fantastic RA CMC team, focusing on their individual development and empowerment. Earlier in his career, Maurizio spent over a decade as a synthetic organic and medicinal chemist in drug discovery, from lead validation to development candidates. His work is reflected in a record of publications and patents
Dara Wambach, MA, is Executive Director of Regulatory Affairs at Mirum Pharmaceuticals and a regulatory and R&D leader with more than 20 years of experience advancing therapies from early development through commercialization. Her experience includes regulatory leadership roles across small and mid-sized Bay Area biotechnology companies, including more than a decade at Gilead where she led the U.S. regulatory submission and FDA review for the first HIV pre-exposure prophylaxis (PrEP) indication for Truvada.
Dara has contributed to pediatric development programs in HIV, sickle cell disease, and narcolepsy, as well as programs addressing pulmonary and liver diseases. At Janssen Global Public Health R&D, she developed and led Johnson & Johnson’s two-year R&D Fellowship Program with the Institute of Tropical Medicine Antwerp for scientist-physicians from Africa. She is also a member of the RAPS San Francisco Bay Area Chapter Leadership Team and serves as Chair of the Sponsorship Committee.
