Speakers: Peter Staehr, MD (Respira Therapeutics); Sara Glickstein Bar-Zeev, PhD (Genentech); Chen Chen, PhD (Genentech); Shichang Miao, PhD; Daniel Repplinger, MD (Genentech); Amanda Chanda, MA (ReCode Therapeutics); Amar Patel, MD (Scorpion Therapeutics); Lena Nasser (Genentech)
Organizers: Sara Glickstein, PhD (Genentech)
Date: 2025-03-07
Time: 8:45-17:00 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs/Out-of-Pocket: $45; Major Sponsorship: $3000; Vendor Show: $695, Happy Hour Sponsorship: $975; Lunch Sponsorship: $1250; On-site Registration: $500
Location: Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor:
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2025-03-06  (it will close sooner if the seating cap is reached)

About the Topic

Topics to be covered:

• Brief Introduction to Clinical Development (Peter Staehr, MD)
• Clinical Science (Sara Glickstein Bar-Zeev, PhD)
• Protocol Design (Sara Glickstein Bar-Zeev, PhD)
• Statistical Considerations in Clinical Trial Design and Analysis (Chen Chen, PhD)
• Clinical Pharmacology (Shichang Miao, PhD)
• Clinical Safety (Daniel Repplinger, MD)
• Clinical operations, clinical monitoring, CRO management, inspections (Amanda Chanda, MA)
• Oncology Clinical Development (Amar Patel, MD)
• Regulatory Overview & Strategy (Lena Nasser)

Dr. Peter Staehr, MD, is a medical doctor and executive with over 20 years in global clinical development across pharmaceutical, biotech, and medical device sectors. Trained as an internist and cardiologist at Johannes-Gutenberg University Mainz, Germany, with postdoctoral fellowship at Stanford, he has held leadership roles in early- and late-stage clinical development at J&J, Theravance, Gilead, and Abbott Vascular. He oversaw numerous IND drug development programs and was involved in the registration of Regadenoson and Abbott's Absorb™ bioresorbable stent. Currently, Dr. Staehr serves as Chief Medical Officer at Respira Therapeutics and chairs the San Francisco Bay Area PBSS chapter.

Dr. Sara Glickstein Bar-Zeev, Ph.D, is a Principal Clinical Scientist in gRED OMNI Early Clinical Development, Genentech, Inc in South San Francisco. Her area of focus includes first-in-human and proof-of-concept clinical trials in non-oncology indications. She received her PhD at Cornell University in Neurobiology. Before joining Genentech in 2017, she spent a decade in Medical Communications, focusing on publication strategy and medical writing, and previously held research faculty positions at Cornell and Columbia Universities. She has completed fellowships in ophthalmology and psychiatry and has published more than 30 research papers during her time as an academic scientist.

Ms. Amanda Chanda is a Clinical Operations consultant with over 18 years of combined experience as Sr Clinical Trial Manager, Clinical Research Associate and Study Coordinator. As a study coordinator, she worked on Genentech's rontalizumab indication for SLE. During her time as a CRA and Sr CTM/CTM, Amanda has worked on various indications including Pyruvate Kinase Deficiency, X-linked Retinitis Pigmentosa, Systemic Sclerosis, NASH, ALS and MPS7 which gained FDA and EMA approvals in 2018. She holds a B.A. and M.A. in International Relations from CU Boulder and SF State University respectively and is certified in Clinical Trial Management from UC Berkeley. 

Dr. Amar Patel, MD, currently serves as Vice President of Clinical Development at Scorpion Therapeutics leading precision oncology development programs focused on advancing next-generation, small molecule therapies for cancer. Previously at Bristol Myers Squibb, he oversaw early clinical development across various cancer development programs and therapeutic modalities. Dr. Patel holds a BA in Biochemical Sciences from Harvard University and received his MD from the Johns Hopkins School of Medicine followed by residency at UCLA and Hematology/Oncology fellowship at UCSF. He continues to serve as an Assistant Clinical Professor in the Division of Oncology. 

Dr. Chen Chen, PhD, is a Principal Statistical Scientist in Non-Oncology Data Science at Genentech, where he has been since 2018. He has made significant contributions to numerous clinical programs and due diligence projects across multiple therapeutic areas, including ophthalmology, neuroscience, and immunology. Chen effectively led data science teams through various stages of clinical development. He continues to publish and maintains an academic collaboration in statistics and ophthalmology with external researchers. Chen received his PhD in statistics from George Washington University and worked at Penn State University as a postdoctoral fellow before he joined Roche.

Dr. Daniel Repplinger, MD, is a Medical Safety Director in non-oncology Early Development Safety at Genentech.  He is board-certified in emergency medicine, medical toxicology, and addiction medicine after completing residency at UCSF and fellowship at NYU and the New York City Poison Control Center.  Prior to joining Genentech in 2021, he was an Assistant Professor of Emergency Medicine at UCSF and attending physician for the San Francisco Division of the California Poison Control System.

Ms. Lena Nasser is a Global Regulatory Leader at Genentech with over 13 years of experience in Regulatory Affairs. She has successfully led global programs, securing approvals for new indications in Oncology and Respiratory. With expertise spanning all phases of drug development, Lena has led health authority meetings, executed complex regulatory strategies, and conducted due diligence assessments for in-licensing assets. A dynamic leader, she empowers teams, builds strong alliances that drive program success, and is passionate about mentoring and developing regulatory talent. Lena is a native of San Francisco, and studied Biology at San Francisco State University.