View On Demand

Drug clearance: how do we optimize this pharmacokinetic parameter and predict for human?

This webinar will describe the importance of clearance in the design of new drugs and provide an overview on mechanisms and measurements for metabolic, biliary and renal clearance mechanisms. Methods of extrapolating preclinical data to humans will be presented. 

Click here to view on demand. 

Agenda: 

1. Role of clearance in pharmacokinetics and drug design
2. Overview of clearance mechanisms and optimization strategies
   • Defining major clearance mechanisms for optimization in drug discovery, including ECCS
   • Metabolic clearance
     • In vitro and in vivo systems, rates, P450 & non-P450 enzymes and phenotyping
   • Biliary and renal clearance
     • In vivo determinations, role of in vitro data
3. Quantitative prediction of human clearance 
   • Scaling Techniques
   • Intrinsic clearance assay calibration to improve metabolic clearance predictions
   • In vitro-in vivo correlations and extrapolations
   • Case Studies

Click here to view on demand. 

Moderated by: Barry Jones, Ph.D. - Senior Research Fellow, Metabolism at Pharmaron

Speakers:

Dr. Dennis Smith - Visiting Professor,  University of Capetown

Dr Dennis Smith gained his Ph.D from the University of Manchester. He was employed by Fisons Pharma and then Pfizer, where he retired as a vice-president. During this period he directly helped in the Discovery and Development of eight marketed NCEs. For the last nine years he has taken on a number of roles. Academic appointments include Honorary Professor at the University of Capetown, where he is closely involved with H3D, the leading academic drug discovery unit in Africa. He is a member or chair of a number of Expert Panels working within organisations such as Cancer Research UK as well as serving on Scientific Advisory Boards for a number of Research Institutions.  His research interests and publications span all aspects of Drug Discovery and Development particularly where drug metabolism knowledge can impact on the design of more efficacious and safer drugs. He has co-authored over 200 publications. Books that he has co-authored and edited include “Pharmacokinetics and Metabolism in Drug Design”, “Metabolism, Pharmacokinetics and Toxicity of Functional Groups, “Reactive Drug Metabolites”, “Attrition in the Pharmaceutical Industry” and “Metabolite Safety in Drug Development”. He was elected as the first Fellow of the Drug Metabolism Discussion Group in 2015. Science referred to him in 2017 in a review of biomedical scientists.

Simon Taylor - Vice President, DMPK at Pharmaron 

Simon Taylor is Vice President of DMPK and is based in Hoddesdon, UK.  He is responsible for DMPK/ADME and PKPD strategy for Pharmaron’s integrated drug discovery projects from early discovery through to IND submission. Prior to Pharmaron, Simon worked at GSK for 20 years leading DMPK and Quantitative Pharmacology teams and projects from the Hit Identification stage through to Phase 2.  He has worked across respiratory, inflammation, oncology and cardiovascular therapy areas with drugs of varying routes of administration.  Simon is a committee member of the DMDG and has tutored on the DMDG ‘PK in discovery’ course since 2010.

Simon has a BSc in Pharmacology from the University of Leeds and an MSc in Model Based Drug Development from the University of Manchester.  He has co-authored over 30 scientific publications in the literature.