Annual Biotech Symposium| Biotechnology-Derived Therapeutics Perspectives on Nonclinical Development


Sunday, September 10, 2017 (Optional Workshop)

Where Does My Protein Go and Why Does It Matter? The Role of PK/PD in Biotherapeutics

Understanding the disposition of biotherapeutics is critical to assessing their pharmacologic and toxicologic behaviour, and can have substantial implications for drug development. In this full day workshop, we will cover the key concepts of biotherapeutic disposition, including absorption, distribution, and elimination; and the importance of appropriate bioanalysis. The application and relevance of these concepts will be exemplified using case studies showing how PKPD can inform decisions such as target selection, molecule selection, and translation from nonclinical studies to humans. 

The selection of the first-in-human (FIH) dose, dose regimen, and dose range relies heavily on the use of PKPD concepts and modelling. Strategies and approaches for FIH dose determination will be presented, including the concepts of MABEL and PAD. Toxicokinetic (TK) evaluation is a fundamental element in the FIH dose determination, and is critical supporting information for toxicology studies. During the workshop, the basic principles of TK will be discussed, as will key considerations for integrating PD and toxicologic outcomes, and managing the impact of immunogenicity on exposure. Other topics to be covered include principles and considerations associated with therapeutic index estimates, and incorporating variability and uncertainty into PKPD and decision making.


8:00-9:00 a.m.
Registration and Breakfast

9:00-9:15 a.m.
Welcome and Opening Remarks
Jay Tibbitts, PhD, Senior Director of Nonclinical PK/PD, UCB Biopharma

9:15-10:00 a.m.
Introduction to ADME for Biologics
Susan Crowell, PhD, Scientist, Genentech

10:00-10:15 a.m.

10:15-11:00 a.m.
Impact of PKPD in the Early Development of Biologics
Doug Leipold, PhD, Principal Scientific Researcher, Genentech

11:00 a.m.-11:45 a.m.
Introduction to Toxicokinetics
Sarah Woolsey, PhD, Research Scientist, Charles River

11:45 a.m.-12:45 p.m.

12:45-1:30 p.m.
Therapeutic Index: Determination, Considerations and Interpretations
Candace Graff, PhD, Associate Director, AbbVie

1:30-2:15 p.m. 
Methods and Important Considerations for Dose Setting for FIH Studies
Mark Penney, PhD, Associate Director Mechanistic PK/PD, UCB Biopharma

2:15-2:45 p.m. 

2:45-3:30 p.m.
KAI-4169: A PK/PD Case Study
Andy Vick, PhD, VP, Safety Assessment, Charles River

3:30-4:15 p.m.
Trastuzumab Emtansine: PK/PD and ADME for an Antibody Drug Conjugate
Jay Tibbitts, PhD, Senior Director of Nonclinical PK/PD, UCB Biopharma

4:15-4:30 p.m. 
Closing Remarks 


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