{"id":3249,"date":"2015-03-11T17:35:33","date_gmt":"2015-03-11T21:35:33","guid":{"rendered":"http:\/\/easinc.org\/wordpress\/?page_id=3249"},"modified":"2017-07-14T11:57:40","modified_gmt":"2017-07-14T15:57:40","slug":"3249-2","status":"publish","type":"page","link":"https:\/\/eas.org\/2024\/3249-2\/","title":{"rendered":"E17-29: Intro to Drug Discovery\/Development Process"},"content":{"rendered":"
\n

\u00a0<\/span><\/b>HALF-Day Course<\/span>
Wednesday, November 15; 8:30am – 12:30pm<\/strong><\/em>
\n<\/em><\/p>\n<\/div>\n

Dr. Michael W. Dong, MWD Consulting, Norwalk, CT<\/p>\n

COURSE DESCRIPTION<\/b> <\/b>
\n<\/b>This introductory half-day 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. \u00a0It introduces the pharmaceutical (biopharm) industry (perspectives, challenges and trends), and discusses impacts from generic drugs.\u00a0 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.\u00a0 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.\u00a0 The role of the analytical chemist, in\u00a0 supporting discovery, process scale-up, formulations, stability, DMPK, QC\/QA, and regulatory affairs functions, will be described.\u00a0 The focus of the course is on new drug discovery and development process of small molecule innovative drugs.<\/p>\n

WHO SHOULD ATTEND\u00a0
<\/b>This course will benefit scientists currently working in the biopharmaceutical industry who want to improve their understanding of the drug discovery \/development process (including pharma trends and perspectives, drug discovery, pre-clinical and clinical development). This course is also useful for non-pharma scientists and managers seeking a better technical understanding of the challenges and opportunities in the industry.\u00a0 A fundamental understanding of biology, chemistry or biochemistry is assumed.<\/p>\n

\n

TOPICS
\n<\/b>1. Pharmaceutical Industry: Perspectives, Challenges and Trends
\n*\u00a0Historical and regulatory background; industry perspectives, challenges and trends
\u00a0\u00a0\u00a0\u00a0 * Overview of current processes and approaches; case studies<\/p>\n

2. \u00a0Drug Discovery Process: From Targets to Leads
\n*\u00a0Overall approaches: phenotypical, molecular and genomic medicines
\u00a0 \u00a0 \u00a0* Target: identification \/ validation and lead ID \/ optimization\u00a0
\u00a0 \u00a0 \u00a0* ADME, DMPK, toxicology and animal models.<\/p>\n

3. Non-Clinical and Clinical Development: From Development Candidate to IND and NDA\u00a0
\u00a0 \u00a0 \u00a0*\u00a0Characterization of lead molecules, API process scale-up, pre-formulation, analytical chemistry, stability, development of clinical trial materials (CTM)
\u00a0 \u00a0 \u00a0* Analytical procedures for assessing and controlling drug quality (physicochemical properties, purity, ID, stability), COA, release testing, quality control, and specifications\u00a0
\u00a0 \u00a0 \u00a0* GLP tox studies, IND filing and case studies\u00a0
\u00a0 \u00a0 \u00a0* Clinical trials: Phase I, II, III and IV, and NDA<\/p>\n

ABOUT THE INSTRUCTOR
\n<\/b>Dr. Michael W. Dong<\/b> is\u00a0a principal consultant in MWD Consulting providing expert consulting and training services on HPLC\/UHPLC, pharmaceutical analysis and drug quality.\u00a0 He was formerly Senior Scientist in Analytical Chemistry and Quality Control at Genentech, Research Director at Synomics Pharma, Research Fellow at Purdue Pharma, and Senior Staff Scientist at Applied Biosystems \/ Perkin-Elmer.\u00a0 He holds a Ph.D. in Analytical Chemistry from the City University of New York, and a certificate in Biotechnology from U. C. Santa Cruz. He has 100+ publications including a bestselling book on chromatography (Modern HPLC for Practicing Scientists). He is an editorial advisory board member of LCGC magazine, American Pharmaceutical Review and Chinese American Chromatography Association as well as a career consultant for American Chemical Society.\u00a0 He is a columnist for LCGC North America since 2013.<\/p>\n

Recommended text:
<\/span><\/b>R. G. Hill and H.P. Rang (eds.), Drug Discovery and Development: Technology in Transition, \u00a02nd<\/sup> edition, Churchill Livingston, 2012. ISBN 978-0-7020-4299-7.<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

\u00a0HALF-Day Course Wednesday, November 15; 8:30am – 12:30pm Dr. Michael W. Dong, MWD Consulting, Norwalk, CT COURSE DESCRIPTION This introductory half-day course provides […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"open","template":"","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-3249","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/pages\/3249"}],"collection":[{"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/comments?post=3249"}],"version-history":[{"count":16,"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/pages\/3249\/revisions"}],"predecessor-version":[{"id":4745,"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/pages\/3249\/revisions\/4745"}],"wp:attachment":[{"href":"https:\/\/eas.org\/2024\/wp-json\/wp\/v2\/media?parent=3249"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}