The 2022 ACCP Trends in Drug Development Seminar addresses cutting-edge topics in preclinical and clinical drug development relevant to clinical pharmacologists primarily working in industry. The diverse Faculty Speakers are experts in their respective research area and will provide a current perspective on research and development, including applications relevant to the drug development process and other pertinent elements of clinical pharmacology. The topics are specifically tailored to current developments including dose determination from preclinical pharmacokinetic/ pharmacodynamic (PK/PD) studies, repurposing of drugs for new formulations or indications using 505(b)(2), novel & decentralized clinical study designs and novel partial opioid receptor agonists with improved safety profile.
Goals & Objectives
Meeting Date: September 24, 2022
Location: Bethesda N Marriott Hotel & Conf Ctr, Bethesda, MD
CE Credits: CE credits will not be offered for this Seminar.
Registration Cost: Please refer to the Trends in Drug Development pricing listed on the 2022 Annual Meeting Registration page.
8:00 – 9:30 AM ET | Early to Late-stage Development of Biologics: Clinical Pharmacology Challenges & Considerations, 1. Biological Products CMC for Clinical Pharmacologists
Faculty Speaker: Ankit Shah, PhD, Clinical Pharmacology Reviewer, Regulatory Toxicologist, US Food & Drug Administration
Faculty Speaker: Haoheng (Sandy) Yan, MD, PhD, Head of US Regulatory Affairs, Shanghai Henlius Biotech
Faculty Speaker: Lora Hamuro, MS, PhD, Director, Clinical Pharmacology & Pharmacometrics, Research & Early Development, Oncology, Bristol Myers Squibb Co
9:30 – 10:00 AM ET | Networking Break
10:00 – 11:30 AM ET | 505(b) (2) Development: “Resurrecting” Old Drugs for a New Purpose
Faculty Speaker: Patrick Marroum, PhD, Senior Director, Distinguished Research Fellow, Clinical Pharmacology & Pharmacometrics, AbbVie Inc
Faculty Speaker: Kofi Kumi, PhD, RPh, Sr. Reviewer, Clinical Pharmacology, Office of Clinical Pharmacology, US Food & Drug Administration
Faculty Speaker: Bharat Damle, PhD, Executive Director, Clinical Pharmacology, Global Product Development, Pfizer Inc
11:30 AM – 1:00 PM ET | Lunch Break
1:00 – 3:00 PM ET | Decentralizing Study Design & Novel Strategies
Faculty Speaker: Vikram Sinha, PhD, Vice President, Quantitative Clinical Pharmacology, Takeda Pharmaceuticals Intl Inc
Faculty Speaker: Jaap Mandema, PhD, Chief Innovation Officer, Certara
3:00 – 3:30 PM ET | Networking Break
3:30 – 5:00 PM ET | Opioid Receptor Partial Agonists as Novel Treatment Approaches & Formulations for Pain
Faculty Speaker: Christopher McCurdy, PhD, Professor & The Frank A. Duckworth Eminent Scholar Chair and Director of The UF Translational Drug Development Core, Univ of Florida
Faculty Speaker: Abhisheak Sharma, MPharm, PhD, Research Assistant Professor & Assistant Director, UF Translational Drug Development Core, Pharmaceutics, Univ of Florida Coll of Pharmacy