Understanding how an organism affects a drug is a critical knowledge point that carries throughout the development and marketing lifetime of a drug. Thus, the first in human or typically Phase 1 studies include an in- depth evaluation of a drug’s pharmacokinetics in addition to safety and tolerability. In fact, as the product moves through mid and later stages of clinical development where the main focus turns to drug efficacy, there continues to be a series of pharmacokinetic studies that examine additional variables such as food and drug interactions and how these variables affect pharmacokinetic parameters. The importance of having a clinical development plan that includes a comprehensive pharmacokinetic evaluation plan is essential. The importance of executing the details of pharmacokinetic sample collection and analysis is equally essential.

A panel of CATO SMS experts will review key pharmacokinetic issues encountered during product development and the expectations of the FDA in registration submissions. Their presentation will step through the various considerations for both drugs and biologics during early and late stage development. When pharmacokinetic sample collection timing is important the logistics of how Phase 1 units manage the collection of samples for pharmacokinetics, safety labs, electrocardiograms, biomarkers, and vital signs simultaneously will be addressed.

Key Learning Objectives

  • Introduction to pharmacokinetic parameters and analyses
  • When pharmacokinetics is involved during drug development
  • When the timing of sample collection is important
  • What considerations are involved in Pharmacokinetic modeling
  • The importance of early planning and study design
  • How a Phase 1 unit addresses the logistics of study conduct
  • Managing quality control in a Phase 1 unit

Speakers:

Dr. Jo Cato
Vice President, Pharmokinetics Development, Consulting Business Unit , CATO SMSAs an accomplished drug development scientist with expertise in pharmacokinetics, Dr. Jo Cato has nearly 30 years of experience in both small and large pharma companies and in the CRO industry. He has over 45 publications, abstracts, and patents, and is experienced in pharmacokinetic study design, data analysis, and report authoring. He has supported hundreds of development projects including pre-IND through marketing submission stage. Dr cato has analyzed data from and authored reports for over 100 clinical studies. He has also produced numerous compartmental modeling and simulations reports.
Dr. Melanie Fein
Medical Director, High Point Clinical Trials CenterDr. Melanie Fein is a certified Physician Investigator, board certified in Family Medicine. She has 16 years of clinical trial experience (involving both small and large molecules) and has been involved in over 350 early phase trials across multiple therapeutic areas in both healthy Participants and Patient populations. Her expertise lies in the conduct of clinical trials, setup, implementation and supervision of operational and clinical systems and process improvement for clinical study centers. She has experience in implementation of safety programs in high-risk studies and oversight systems to mitigate the potential for AEs, including hypersensitivity reactions. Dr. Fein has collaborated extensively with Sponsors, medical writers, and study management teams from review of protocol feasibility through conduct and study reporting. Dr. Fein has medical licenses in both North Carolina and Florida.

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