Improve future success by understanding DMPK compound properties in early development
What makes a good drug? What would make a patient select one drug over another? Certainly things like once-a-day dosing versus having to take the drug three or four times a day. The route of administration is important. Most patients prefer an oral drug as opposed to one that must be injected. There should be minimal side effects or adverse events and no drug-drug interactions. There must be sufficient mechanisms to ultimately clear the drug from the body. And, of course, it must work.
Evidence has shown that optimizing the drug metabolism and pharmacokinetic (DMPK) profile of molecules early in its development greatly reduces the odds of clinical failure due to human pharmacokinetics. Covance has assembled a package of tests – a series of specific in vitro and in vivo experiments – to evaluate absorption, distribution, metabolism and excretion (ADME) properties of compounds prior to clinical development. The packaging and interpretation of these tests together, performed in concert, enables a more thorough analysis of key characteristics, more informed decisions regarding compound candidates, and helps to ensure that your DMPK test provides maximum value in the pre-development phase.
The following topics will be covered in this webinar:
• Enhanced analysis and interpretation of results enabling the creation of a better roadmap for drug development studies.
• Reduced risk of development failure due to DMPK issues, increasing the value of development candidates.
• Required information supporting regulatory submissions.
Presented by
Donald L McKenzie, PhD,
Director of Drug Metabolism
Don has been with Covance since August 2009 and is the Director of Drug Metabolism. In this role he is the business unit and scientific leader working to develop partnerships with clients to enable the further advancement of compounds through the various discovery and development stage gates. Don received his B.S. in Biochemistry from Michigan State University and his Ph.D. in Medicinal Chemistry from the University of Michigan under the guidance of Kevin Rice.
Following his degree work, Don joined Pfizer Global Research & Development, Ann Arbor Laboratories in 2000 as a Scientist in the department of Pharmacokinetics, Dynamics & Metabolism (PDM). His initial role was part of the structural elucidation team and he advanced through the organization to eventually lead the Mechanistic Metabolism group. Additionally, Don was part of a number of development teams including the Schizophrenia/Biopolar Research Clinical Management Team, a global multidisciplinary team accountable for developing and executing the strategy for the Pfizer schizophrenia/biopolar late discovery and early development portfolio.
In 2007, Don moved to Schering-Plough to manage the Discovery Metabolite Identification group in Kenilworth, NJ. In leading this group, he focused on applying metabolite identification to understand the role of biotransformation and its relationship to broader metabolic issues in order to better fit structural elucidation results into the larger DMPK package.
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Key Learning Objectives
- What key scientific and regulatory attributes should be understood from a DMPK perspective
- Why understanding the DMPK properties of a molecule early in development leads to future success
- Developing future strategy based on early learnings
Audience
- ADME Scientist
- DMPK Interest Group
- ADME Interest Group
- Drug Metabolism & Pharmacokinetics
- CEO/President/Vice President
- Director/Associate Director/Department Head
- Discovery/Development Team Representative