E15-27: Drug Quality Fundamentals Part 1

Part 1: Introduction to Drug Discovery and Development Processes

Half-Day Course

Dr. Michael W. Dong, MWD Consulting, Foster City, CA

This introductory course provides a high-level overview of the entire drug development process for new therapeutics targeting human diseases, with a focus on the pivotal role of the analytical chemist in this complex, costly and multidisciplinary process.  It introduces the pharmaceutical (biopharm) industry (perspectives, challenges and trends), and discusses impacts from generic drugs.  Course attendees will learn the current drug discovery approach, from basic research on disease pathophysiology, identification of drug targets, turning of hits to leads and candidate for non-clinical and clinical development.  Regulatory filing procedures – Investigational New Drug (IND) prior to conducting human clinical trials and New Drug Application (NDA) allowing drug product commercialization will be discussed.  The role of the analytical chemist, in supporting discovery, process scale-up, formulations, stability, DMPK, QC/QA, and regulatory affairs functions, will be described.  The focus of the course is on new drug discovery and development process of small molecule innovative drugs.  This course can be combined with “Drug Development Part 2” as a one-day course (E15-26); a discount will be offered over separately registering for the two half-day courses.

This course will benefit scientists currently working in the biopharmaceutical industry who want to improve their understanding of the drug discovery and development process (including pharma trends and perspectives, drug discovery, pre-clinical and clinical development, and regulations). This course is also useful for non-pharma scientists, including instrumentation specialists, who are seeking a better technical understanding of the challenges and opportunities in the industry. It is highly recommended that you have some fundamental understanding of biology, chemistry or biochemistry.

1. Pharmaceutical Industry: Perspectives, Challenges and Trends
     * Historical and regulatory background; industry perspectives, challenges and trends
     * Overview of current processes and approaches; case studies
2.  Drug Discovery Process: From Targets to Leads
     * Overall approaches: phenotypical, molecular and genomic medicines 
     * Target: identification / validation and lead ID / optimization
     * ADME, DMPK, toxicology and animal models 
3.  Non-Clinical Drug Development: From Development Candidate to IND and NDA
     * Characterization of lead molecules, API process scale-up, pre-formulation, analytical chemistry, stability, development of clinical trial materials (CTM)
     * Analytical procedures for assessing and controlling drug quality (physicochemical properties, purity, ID, stability), COA, release testing, quality control, and specifications
     * GLP tox studies, IND filing and case studies
     * Clinical trials: Phase I, II, III and IV, and NDA

Dr. Michael W. Dong is a principal in MWD Consulting focusing on consulting and training services on HPLC/UHPLC, pharmaceutical analysis and drug quality.  He was formerly Senior Scientist in Analytical Chemistry and Quality Control of Small Molecule Pharm. Sci. at Genentech, Research Director at Synomics Pharma, Research Fellow at Purdue Pharma, and Senior Staff Scientist at Applied Biosystems / Perkin-Elmer.  He holds a Ph.D. in Analytical Chemistry from City University of New York, and a certificate in Biotechnology at U. California. Santa Cruz. He has 100+ publications and three books including a bestseller in HPLC (Modern HPLC for Practicing Scientists). He is an editorial advisory board member of LCGC magazine and American Pharmaceutical Review.

Recommended Text:
R. G. Hill and H.P. Rang (eds.), Drug Discovery and Development: Technology in Transition,  2nd edition, Churchill Livingston, 2012. ISBN 978-0-7020-4299-7.