RECAP OF CABS 2025 Clinical Development Workshop

Date: April 28, 2025 @ 9:00 am – April 28, 2026 @ 9:30 pm
Location: 1633 Old Bayshore Hwy #280, Burlingame, CA 94010

On April 26, 2025, the CABS Science and Technology Committee (STC) hosted the highly successful Clinical Development Workshop in Burlingame, CA, attracting over 80 attendees from the biotech and pharmaceutical community. This dynamic half-day event offered valuable insights into the clinical development, featuring industry experts from Genentech and ChemoCentryx/Amgen. Attendees engaged deeply with a comprehensive program covering study design, statistical considerations, clinical pharmacology, operational planning, and clinical trial protocol development, with enthusiastic participation throughout the day.

The workshop opened with a warm introduction to CABS by its President, Dr. Kay Tong, followed by an overview of the agenda and speaker introductions by Dr. Liping Meng (Principal Scientist II, Gilead), Co-Chair of the STC.

The first presentation featured Dr. Shichang Miao (Ex-VP, ChemoCentryx/Amgen), who delivered a comprehensive overview of clinical development fundamentals. Dr. Miao outlined the critical stages of drug development — from preclinical research to Phase 3 confirmatory studies, regulatory approval, and post-marketing surveillance. He also shared his personal 16-year journey leading the development of Tavneos, a small molecule drug, highlighting the many challenges and triumphs encountered before achieving FDA approval and the subsequent acquisition of ChemoCentryx by Amgen. His inspiring story deeply resonated with the audience, setting an encouraging tone for the day.

Following that, Dr. Sara Glickstein Bar-Zeev (Principal Clinical Scientist, Genentech) presented "Foundations in Clinical Science and Study Design." She emphasized that clinical development is inherently long, costly, and high-risk, requiring careful strategic planning aligned with the desired product label. Dr. Glickstein explained the crucial role of the Clinical Development Plan (CDP) in guiding teams through iterative, learning-focused studies towards pivotal trials, and discussed the importance of rigorous clinical trial protocols to ensure study integrity and regulatory compliance. She also highlighted how artificial intelligence and large databases are increasingly shaping modern clinical development.

Next, Dr. Chen Chen (Principal Statistical Scientist, Genentech) delivered an insightful presentation titled "Statistical Considerations in Clinical Trial Design and Analysis." Dr. Chen discussed the pivotal role of randomization in eliminating bias and ensuring statistical validity, as well as the strategic use of stratification to balance prognostic factors across treatment arms. He underscored the importance of careful endpoint selection, robust hypothesis testing, and proper sample size calculation. His discussion on the challenges posed by missing data, and the critical use of sensitivity analyses to ensure robustness, sparked lively and thoughtful audience engagement.

After a brief break, Dr. Shichang Miao returned to deliver his second talk, "Clinical Pharmacology Studies." He emphasized that clinical pharmacology is a cornerstone of drug development, linking pharmacology, pharmacokinetics, toxicology, and clinical safety to guide dosing strategies and support regulatory submissions. Dr. Miao detailed key clinical pharmacology studies — including Food Effect, Drug-Drug Interaction, Mass Balance, and QTc evaluations — and addressed the unique considerations required for biologics versus small molecules. Attendees found this session particularly rich in practical insights and real-world examples.

In the final talk, Dr. Sara Glickstein Bar-Zeev returned to present "Essential Elements of Clinical Trial Protocols." She outlined the critical components of a well-constructed protocol, including study rationale, objectives, design, safety and statistical methodologies, regulatory and ethical assurances, and data management policies. Dr. Glickstein emphasized that a poorly written protocol can result in added costs, delays, and challenges in data interpretation, and reinforced the fundamental importance of securing informed consent. Her detailed guidance provided attendees with a strong framework for effective protocol development.

The workshop concluded with an engaging panel discussion and Q&A session led by Dr. Alex Yang (Senior Scientist, Vir Biotechnology), Co-Chair of STC. Panelists addressed a wide range of timely topics, including adaptive clinical trial designs, global regulatory variations, statistical considerations, and the impact of the FDA’s recent move to phase out mandatory of animal studies. The audience responded enthusiastically, raising numerous thoughtful questions and contributing valuable perspectives on the evolving clinical development landscape.

The event concluded with loud applause and overwhelmingly positive feedback. The atmosphere remained vibrant as attendees enjoyed a networking lunch, fostering further discussions and new professional connections in a relaxed, collegial environment. Special thanks go to all the volunteers, whose dedication and hard work made this fully volunteer-supported event such a remarkable success. The 2025 CABS Clinical Development Workshop was a resounding success, leaving participants both inspired and better equipped to navigate the complex challenges of clinical development.