Speakers: Martina Sahre, FDA; Luna Musib, ArriVent Biopharma; Stephen Flach, Fortrea; Christine Bowman, Genentech; Mohamed Elmeliegy, Pfizer; Ying Ou, BeiGene; Chunze Li, Genentech; Sravanthi Cheeti, Genentech
Organizers: Jesse Yu, Joseph Chen, Chunze Li, Vikram Malhi, Department of Clinical Pharmacology, Genentech
Date: 2024-11-01
Time: 8:45-17:40 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: (2)Dr. Vince Clinical Research; Fortrea
Vendor show vendors registered to date: (4)Altasciences; George Clinical; Meadowhawk Biolabs; worldwide clinical trials
Registration: http://www.PBSS.org
Registration deadline:2024-10-31  (it will close sooner if the seating cap is reached)

About the Topic

Hepatic and renal functions are two important intrinsic factors for the clinical pharmacology assessment. Patients with reduced hepatic or renal function may have different pharmacokinetics profiles and require dose adjustment. This workshop aims to provide participants with an in-depth understanding of the strategies, design, conduct, and regulatory considerations of hepatic and renal impairment studies. Attendees will gain valuable insights into evidence generation and dose recommendations for patients with hepatic and renal impairments, ensuring efficacy and safety in these vulnerable populations.

Martina Sahre, PhD is a Policy Lead in the Office of Clinical Pharmacology (OCP), Food and Drug Administration (FDA). In her current role she contributes to regulatory policy development and regulatory research, mainly focused on intrinsic factors and related labeling considerations. Prior to this role, she was a Reviewer in the Cardiovascular and Renal Products team in OCP, conducting regulatory review of investigational new drug (IND), new drug (NDA), and Biologics License Applications (BLA).

Dr. Musib has over 24 years of experience in drug development.  She has worked on both early and late-stage programs.  She has an interest in Clinical development, biopharmaceutics, drug-drug interactions, and incorporation of modeling and simulation to help decision making. She received her PhD in pharmacokinetics from University of Minnesota, and then trained in clinical pharmacology as a fellow in the Department of Experimental and Clinical Pharmacology at the University of Minnesota.  She worked at Eli Lilly, Genentech, Gilead sciences and ArriVent BioPharma.  She is currently the VP of Pharmacology overseeing Clinical Pharmacology, Bioanalytical, DMPK and toxicology at ArriVent.

Stephen Flach, Md, PhD, is a board-certified internist who has worked in Clinical Pharmacology since 2005 as a Principal Investigator, Medical Monitor, and Consultant on a wide range of early phase drug development projects. He has helped design and execute numerous renal and hepatic impairment studies since 2017. He is an author on over 40 peer reviewed publications. He was an internal medicine resident on the Osler Medical Service at the Johns Hopkins Hospital and subsequently was a fellow in General Internal Medicine at the University of Pennsylvania. Prior to working at Fortrea, Dr. Flach was on the faculty at the University of Iowa College of Medicine.

Christine Bowman is a Principal Scientist in the Drug Metabolism and Pharmacokinetics Department at Genentech, Inc.  She is a DMPK project lead for discovery and development projects and her research interests include improving in vitro to in vivo extrapolation with new in vitro methods and PBPK modeling, with a specific focus on transporters.  Prior to joining Genentech, Christine received her PhD from the University of California, San Francisco under Dr. Leslie Benet.

Dr. Mohamed Elmeliegy holds a position as a Director, Oncology Clinical Pharmacology department at Pfizer. Prior to joining Pfizer, he held several positions in the Oncology Clinical Pharmacology Department in Novartis. Dr. Elmeliegy leads a team that provides clinical pharmacology and pharmacometrics input for different phases of development. He is an Affiliate Faculty in the University at Buffalo SUNY, Buffalo, New York and the University of California San Diego. He chaired the clinical pharmacology programming at AAPS Scientific Programming Committee for 2 years. He is the vice chair of the Life Cycle Management Community in ASCPT. He authored more than 100 peer-reviewed scientific publications, book chapters, conference presentations, and abstracts.

Ying Ou is an Executive Director, a group leader in Clinical Pharmacology at BeiGene BioPharma. Ying has over 20 years of drug development and regulatory experience with core expertise in clinical pharmacology, and PBPK modeling. Previously with Amgen, Onyx, Roche, and J&J, she contributed to approvals of 6 medicines including Brukinsa and Kyprolis.  She has published more than 40 manuscripts and book chapters.  Dr. Ou has been active serving in various roles for ASCPT, including Section Chair for Early Development and Drug Safety (EDSS) community. Ying received her PhD from University of Washington and postdoctoral fellowship in PBPK.  She also holds a Regulatory Affairs Certification (RAC). 

Chunze is an experienced leader with 20+ years of drug development experience. She is currently an Executive Director/ Distinguished Scientist and Head of Oncology Clinical Pharmacology at Genentech. She is passionate about strategic implementation of quantitative clinical pharmacology to accelerate the oncology drug development and improve portfolio decision-making. Prior to Genentech, Chunze worked as Associate Director at Pfizer and as Research Fellow at Merck to provide Clin Pharm and DMPK support in drug discovery and development of small molecules and therapeutic proteins across multiple diseases. Chunze obtained her PhD from UCSF and has published over 80 peer-reviewed papers. 

Sravanthi Cheeti is a Senior Principal Scientist in the Clinical Pharmacology group at Genentech. She has 16 years of clinical drug development experience and supported several oncology and neuroscience programs. In her role as a lead clinical pharmacologist, Sravanthi worked on development of clinical pharmacology strategies, including dose/regimen selection and clinical pharmacology assessments to inform clinical protocols and drug labels. Her areas of interest include special populations (organ impairment & pediatric), CYP & transporter DDI, and formulation bridging. She received BS in Pharmacy and MS in Pharmaceutical Sciences and has contributed to more than 25 papers in peer reviewed journals.