May 17 & 18; 10:00am – 2:30pm EDT
Dr. Michael Dong, MWD Consulting, Norwalk, CT
This introductory course provides a high-level overview of the entire drug development process for new therapeutics, focusing on the role of the analytical chemist in this complex, costly and multidisciplinary process. It introduces the pharmaceutical (biopharma) industry (perspectives, challenges, and trends) and discusses impacts from generic drugs and emerging new drug modalities. Course attendees will learn the current drug discovery approach, from basic research, identification of drug targets, turning hits to leads, and non-clinical and clinical development. The analytical chemist’s role 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 the drug discovery and development process of small molecule drugs.
WHO SHOULD ATTEND
This course will benefit scientists working in the pharmaceutical industry who want a better understanding of the entire drug discovery/development process and non-pharma scientists seeking more background of the industry’s challenges and opportunities. It is recommended that you have some fundamental understanding of biology, chemistry, or biochemistry.
- Pharmaceutical Industry: Perspectives, Challenges, and Trends
a. Historical and regulatory background; industry perspectives, challenges, and trends.
b. Overview of current processes and approaches; case studies.
- Drug Discovery Process: From Targets to Leads
a. Overall approaches: phenotypical, molecular, and genomic medicines.
b. Target: identification / validation and lead ID / optimization.
c. ADME, DMPK, toxicology, and animal models.
- Non-Clinical and Clinical Drug Development: From Candidate to IND and NDA
a. Characterization of lead molecules, API process scale-up, pre-formulation, analytical chemistry, stability, development of clinical trial materials (CTM).
b. Analytical procedures for assessing and controlling drug quality (physicochemical properties, purity, ID, stability), COA, release testing, quality control, and specifications.
c. GLP tox studies, IND filing, and case studies.
d. Clinical trials: Phase I, II, III and IV, and NDA.
ABOUT THE INSTRUCTOR:
Dr. Michael W. Dong is a principal in MWD Consulting, focusing on training and consulting services in HPLC/UHPLC, pharm analysis, and drug quality. He was formerly Senior Scientist 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 the City University of New York and a Biotechnology certificate at U. California. Santa Cruz. He has over 130 publications and a best-seller book in HPLC. He is an advisory board member of LCGC magazine, American Pharmaceutical Review, and Chinese American Chromatography Association.
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.