2024 ACCP Trends in Drug Development Seminar
Saturday, September 7th | 8:00 AM – 5:00 PM | CE: 5.5 |
Location: Grand Ballroom GCo-chairsStefanie Drescher, PhD, Manager, Clinical Pharmacology, Pfizer IncJomy George, PharmD, Senior Pharmacokineticist, US Food & Drug AdministrationMember Benefits that enhance your professional growth. Join today!
Target AudienceThe 2024 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 developments, including applications relevant to the drug development process and other pertinent elements of clinical pharmacology.
Seminar DescriptionThis Seminar is split into four sessions, providing a current perspective on research and development, including applications relevant to the drug development process and other pertinent elements of clinical pharmacology. The first session seeks to provide an overview of the US regulatory strategy of making the first naloxone product available as over the counter; the use of a pharmacokinetic/pharmacodynamic (PK/PD) translational model and framework for evaluating the effectiveness of different opioid antagonists and dosing strategies and to discuss the community impact and opportunities for outcomes research. The second session will discuss the role of clinical pharmacology in driving model-informed decision making in the development of mRNA-based vaccines and therapies as well as broadening the clinical landscape of therapeutic areas being investigated using this novel platform. The third session seeks to have a robust discussion around drug evaluation and safety considerations with aging; focusing on specific drug classes where age may be a clinically relevant variable, opportunities to evaluate drug safety and efficacy in clinical phases of drug development, model-informed precision dosing and the current US regulatory framework. The final session seeks to explore the role of artificial intelligence (AI) in drug development. Speakers will look at AI applications in post-marketing studies including clinical trials and real-world evidence studies. The session will also discuss real world applications of AI in clinical pharmacy practice in the modern world.
Educational Objectives
- Identify innovations in drug development & regulatory science that are relevant to advancing patient care;
- Define novel drug development approaches and their utilization in clinical pharmacology to advance targeted pharmacotherapy;
- Explore ways in which cutting-edge clinical pharmacology science contributes to improved patient-related outcomes.
8:00 – 9:30 AMOpioid Crisis in the US: A Complex Problem Requires an Innovative Approach
Dorothy Chang, MD, Senior Physician, DNPD-I, ONPD, IND, CDER, US Food & Drug Administration
Zachary Dezman, MD, Medical Officer, DAAP, ON, OND, CDER, OC, US Food & Drug Administration
Zhihua Li, PhD, Pharmacokineticist, DARS, OCP, OTS, CDER, US Food & Drug Administration
Elana Rosenthal, MD, Associate Professor, Infectious Diseases & Internal Medicine, Univ of Maryland School of Medicine9:30 – 10:00 AMNetworking Break10:00 – 11:30 AMLeveraging mRNA Technology for Vaccines & Therapeutics: Let's Expand the Clinical Pharmacology Paradigm
Vivaswath Ayyar, PhD, Associate Scientific Director, Clinical Pharmacology & Pharmacometrics (US), Johnson & Johnson Innovative Medicines
Bhargava Kandala, PhD, Director, Quantitative Pharmacology & Pharmacometrics, Merck & Co Inc
Nitin Mehrotra, PhD, Senior Director & Head of Pharmacometrics, Alnylam Pharmaceuticals Inc11:30 AM – 1:00 PMLunch Break1:00 – 2:30 PMA Quest for Aging Well: Addressing Drug Development & Safety in the US Older Adult PopulationHaden Bunn, MS, PharmD, Director, Precision Therapeutics, PumasAI
David J. Greenblatt, MD, Professor, Tufts Univ School of Medicine
Patricia Slattum, PharmD, PhD, Professor, Virginia Ctr on Aging, Pharmacotherapy & Outcomes Science, Virginia Commonwealth Univ2:30 – 3:00 PMNetworking Break3:00 – 5:00 PMApplications of Artificial Intelligence & Machine Learning in Clinical PharmacologyAmit Roy, PhD, Head, PumasAI
Maxwell Sherman, PhD, Co-founder & Chief Technology Officer, Serinus Biosciences
Weifeng Tang, MD, PhD, Executive Director, Clinical Pharmacology & Pharmacometrics, AstraZeneca plc
