Analytical Method Strategies for Drug Development Seminar
Regis Technologies invites you for a seminar on "Analytical Method Strategies for Drug Development" delivered by Paul Wrezel, PhD. Read the abstract below for more details. A light breakfast will be served.
Join us for coffee and chemistry on Wednesday, June 3rd, 8-9:30AM.
Coffee served at 8:00am; presentation begins at 8:30am; Q&A at 9:30am.
Analytical Method Strategies for Drug Development
Paul Wrezel, PhD
Director of Analytical Method Development, Regis Technologies
Analytical Development is the series of method development and validation tasks required to bring a drug candidate into animal safety studies, through clinical trials, and ultimately, commercial sales. The required tasks get more stringent as the program moves toward commercial. The challenge is in knowing these requirements for each stage of the candidate drug evolution, for instance, what is necessary to support a Phase-1 IND or a generic ANDA. Regulatory agencies like the FDA and EMEA, compendial sources such as the US and European pharmacopeias, and harmonization efforts like ICH provide guidances at steps along the path. Analytical Development is divided into two key areas, namely Active Pharmaceutical Ingredients and drug products, the former to be the focus for this presentation. Strategies for method development and validation will be discussed, with the information reflecting industry best practices, and based on numerous projects from a CMO perspective.
Dr. Paul Wrezel has worked in the pharmaceutical industry for over 20 years. He received his undergraduate degree in chemistry from Loyola University of Chicago and his Ph.D. in biochemistry from Northwestern University. Prior to joining Regis, Paul had worked for both Searle/Pharmacia and Kraft General Foods. Paul has a diverse background with deep experience in biochemistry, microbiology, food science, and analytical chemistry. Within the pharmaceutical industry, he has developed dosage form methods, managed a toxicology pre-formulation group, and served as a multi-functional project team leader for drug candidates in clinical development.
Paul has worked for Regis as the Director of Analytical Method Development since 2003. He is responsible for leading the Regis Analytical Team with oversight on method development, validation, stability, quality control, and pharma services. While with Regis, Paul has formed the method development/validation department. Paul’s group has published in peer-reviewed journals such as LCGC North America.