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Clinical Drug Development & Investigations
Symposia

Symposium 2: HIV Pre-exposure Prophylaxis: Evolving Clinical Practice & Product Development Guided by Clinical Pharmacology

Sunday, September 10, 2023
10:00 AM - 11:30 AM PT
Location:Grand Ballroom I-K
CE: 1.5

    Co-Chair & Faculty(s)

  • Robert Bies, PharmD, PhD

    Professor, Pharmaceutical Sciences
    Univ of Buffalo

  • Craig Hendrix, MD, DABCP

    Professor of Medicine (Clinical Pharmacology)
    Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology

    • Faculty(s)

  • CM

    Charu Mullick, MD

    Medical Officer, Ctr for Drug Evaluation & Research
    US Food & Drug Administration

  • Ethel Weld, MD, PhD

    Assistant Professor, Medicine (Clinical Pharmacology)
    Johns Hopkins Univ School of Medicine

The target audience for this Symposium includes clinicians, both MD and PharmD, who may provide primary care in institutional settings where prevention is a part of routine healthcare. In addition, all professions, MD, PharmD and PhD, engaged in drug development will benefit from the discussion of innovations in early product development in a complex anatomic space, modeling & simulation and innovative efficacy trial designs.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:
  • Describe the rationale for pre-exposure prophylaxis (PrEP) and evidence for its preventive efficacy sufficient to prescribe PrEP as one part of the standard of preventive care in routine clinical practice;
  • Describe novel applications of clinical pharmacology to advance drug development for PrEP;
  • Evaluate new emerging evidence from novel clinical trial designs to enable continuous updating of new PrEP evidence in the future.

Presentations:

  • Clinical State-of-the-Art HIV Pre-exposure Prophylaxis (PrEP): Proven Options Available Now & On the Horizon

    Faculty: Ethel Weld, MD, PhD – Johns Hopkins Univ School of Medicine

  • Clinical Pharmacology Innovations: Novel Methods to Inform Early Drug Development

    Co-Chair & Faculty: Craig W. Hendrix, MD, DABCP – Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology

  • Modeling & Simulation to Guide Optimized PrEP Implementation in Diverse Patient Populations

    Co-Chair & Faculty: Robert Bies, PharmD, PhD – Univ of Buffalo

  • Pivotal Clinical PrEP Trial Innovations: Considering Counterfactual Study Design & Innovative Control Groups

    Faculty: Charu Mullick, MD – US Food & Drug Administration

  • Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation