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2024 ACCP Trends in Drug Development Seminar

Saturday, September 7, 2024
8:00 AM – 5:00 PM ET
Location:Grand Ballroom G
CE: 5.5

Target Audience:

The 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.



Description:

This 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.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:
  • 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;
  • Explain ways in which cutting-edge clinical pharmacology science contributes to improved patient-related outcomes.

Presentations:

  • Welcome & Introductions

    Co-Chair & Faculty: Jomy George, PharmD – US Food & Drug Administration

  • Opioid Crisis in the US: A Complex Problem Requires an Innovative Approach

    Faculty: Dorothy Chang, MD – US Food & Drug Administration

    Faculty: Zachary Dezman, MD – US Food & Drug Administration

    Faculty: Zhihua Li, PhD – US Food & Drug Administration

    Faculty: Elana Rosenthal, MD (she/her/hers) – Univ of Maryland School of Medicine

  • Leveraging mRNA Technology for Vaccines & Therapeutics: Let’s Expand the Clinical Pharmacology Paradigm

    Faculty: Vivaswath Ayyar, PhD – Janssen Research & Development LLC

    Faculty: Bhargava Kandala, MS, PhD – Merck & Co Inc

    Faculty: Nitin Mehrotra, PhD – AInylam Pharmaceuticals Inc

  • Introductions

    Co-Chair & Faculty: Stefanie Drescher, PhD – Pfizer Inc

  • A Quest for Aging Well: Addressing Drug Development & Safety in the US Older Adult Population

    Faculty: Haden Bunn, MS, PharmD – Pumas AI

    Faculty: David J. Greenblatt, MD – Tufts Univ School of Medicine

    Faculty: Patricia Slattum, PharmD, PhD – Virginia Commonwealth Univ

  • Applications of Artificial Intelligence & Machine Learning in Clinical Pharmacology

    Faculty: Amit Roy, PhD – Pumas AI

    Faculty: Maxwell Sherman, PhD – Serinus Biosciences

    Faculty: Weifeng Tang, PhD – AstraZeneca plc

  • Discussion, Questions & Answers, Learner Feedback & Evaluations