Join us for a live panel discussion with drug development industry veterans. During this 45-minute session, we’ll discuss:
- How the industry may be impacted by social distancing and a global recession
- An overview of current guidances from the FDA
- Strategies for virtual drug development
- Real examples of how we’re seeing drug development programs adapt
Meet the Panelists
Mark A. Bush, PhD
Dr. Bush has over 20 years of experience in clinical pharmacology and pharmacokinetics with a particular focus in clinical pharmacology study design and interpretation. His therapeutic concentrations include endocrinology and metabolism in early phases of development. Dr. Bush has worked on over 100 PK and population PK analyses.
J. Fred Pritchard, PhD
Vice-President, Strategic Development, Celerion
Dr. Pritchard has over 35 years of experience in drug development with a focus on bringing new drug candidates into clinical testing through clinical proof-of-concept in patients. These include anti-inflammatories, anti-emetics, and cardiovascular agents as well as therapies to treat genetic metabolic diseases and neurodegenerative conditions. For the last 20 years he has led Celerion’s work with Asian companies advising them on global drug development strategies.
Betty Hussey, PharmD
Vice President, Clinical Pharmacology & Pharmacokinetics
Dr. Hussey has over 30 years of extensive leadership and experience in drug development, clinical development, clinical pharmacology, and pharmacokinetics across multiple therapeutic areas and all phases of development. Dr. Hussey’s primary therapeutic area experience includes dermatology, metabolic diseases, CNS, antivirals, anti-infectives with focus on early proof-of-concept.
Bill Wargin, PhD
Executive Vice President, Pharmacokinetics
Dr. Wargin has over 30 years of experience working in clinical pharmacology, pharmacokinetics, biopharmaceutics, and scientific writing. Dr. Wargin provides expertise in all aspects of pre-clinical and clinical pharmacokinetics including study design, clinical and toxicokinetic data analysis, report writing, IND and NDA PK section authorship.
Meet the Moderator
David Y. Mitchell, PhD
Dr. Mitchell has more than 28 years of leadership experience in clinical pharmacology and pharmacokinetics (PK). His focus is on strategic drug development, protocol design and planning, clinical and nonclinical data analysis/simulation/interpretation, and clinical pharmacology representation at regulatory meetings.