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Short Course

Course Information
Course Title: Introduction to Drug Discovery and Development Processes for Analytical Scientists
Categories: 1 - Life Sciences
2 - Management/Professional Development
3 - Clinical Analysis
4 - Pharmaceutical Sciences
5 - Quality/Regulatory/Compliance
6 - Validation
Instructor(s): Michael Dong Course Number: 3
Affiliation: Genentech
Course Date: 03/18/2013 - Monday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $480 ($680 after 2/18/13) Textbook Fee: $70

Course Description
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, challengesand trends), and discusses impacts from the human genome project and generic drugs. Course attendees will learn the current drug discovery approach, from basic research on disease pathophysiology, identification of drug targets, high-throughput screening, turning of hits to leads, to candidate nomination 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 associated regulations - GLP, GMP, GCP and ICH guidelines as well as the role of the chemist, particularly 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.

Target Audience
This course will benefit scientists currently working in the pharmaceutical industry, including biopharmaceutical and generic 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 highlyrecommended that you have some fundamental understanding of biology, chemistry or biochemistry.

Course Outline
Pharmaceutical industry: perspectives, challenges andtrends
• Historical and regulatory background; industry perspectives, challenges and trends.
• Overviewof 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
• 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.

4. Clinical Research, NDA and Regulations
• Role of the US FDA.
• Clinical trials: Phase I, II, III and IV, and NDA.
• Regulations: GLP, GMP, GCP and ICH guidelines.
• Concepts of quality systems, SOP, equipment qualification and method validation.

Course Instructor's Biography
Dr. Michael W. Dong is a Senior Scientist at Genentech, Small Molecule Drug Discovery, South San Francisco, CA. He is responsible for new technologies, automation, multiple late-stage research projects in Small Molecule Analytical Chemistry and QC, Small Molecule Pharmaceutical Sciences Department. He was formerly Research Director at Synomics Pharma, and Research Fellow/Group Leader at Purdue Pharma. He holds a Ph.D. in Analytical Chemistry from City University of New York Graduate Center, and a certificate in Biotechnology at U. California Santa Cruz. He has over ten years of experience in pharmaceutical development for early and late stage projects. He has conducted many training courses on HPLC, UHPLC, pharmaceutical analysis, method development, drug development and drug quality fundamentals and has over 80 publications in analytical chemistry including a best-seller in chromatography - Modern HPLC for Practicing Scientists, Wiley, 2006. He is an editorial advisory board member of LC.GC 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, 2013. ISBN 978-0-7020-4299-7.