CAREER OPPROTUNTIES FOR CMC REVIEWER AT FDA Kevin

CAREER OPPROTUNTIES FOR CMC REVIEWER AT FDA Kevin Li 04/22/2017 (CMC: Chemistry, Manufacturing and Control)

DISCLAIMER The views expressed in this presentation are expressly those of the speaker and must NOT be taken to provide official policy or guidance on behalf of the FDA.

OVERVIEW FDA Basics The role of CMC in Drug Development Life of a CMC Reviewer Career opportunities at FDA

FDA BASICS Headquartered at White Oak, MD ~15, 000 full time employee （Adapted from http: //www. callisonrtkl. com） Regulate 25% of all consumer spending in US Mission � “…assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. ” � “…speed innovations that make medicines more effective, safer, and more affordable…” � “…regulating the manufacturing, marketing and distribution of tobacco products…” � ”…plays a significant role in the Nation’s counterterrorism capability…”.

FDA CDER CBER CTP OGROP OPQ CDRH ORA Office of Biotechnology Products Office of Lifecycle Drug Products Office of New Drug Products Office of Testing and Research Office of Policy for Pharmaceutical Quality Office of Surveillance Office of Program & Regulatory Operations Office of Process and Facilities

PRODUCT DEVELOPMENT FOR NEW DRUG/BIOLOGICS Discovery Lead Optimization Process Development Preclinical studies IND: Investigational new drug BLA: Biologics license application Scale Up & process optimization Phase I/II/III Trials NDA/BLA Launch Commercial Operations and Sales Phase IV Trials (Adapted from T. Freedman 2008)

WHAT IS CHEMISTRY, MANUFACTURING AND CONTROL (CMC)? All activities involved in the design, manufacturing, formulation, storage and control of the drug/biologics that ensures consistently delivering quality product for human usage. Serves as a bridge between early research and clinical studies/ commercial operations.

CMC IS A MAJOR PART OFIND/BLA SUBMISSION (Adopted from ICH M 4) CTD: Common Technical Document

TABLE OF CONTENT IN MODULE 3: QUALITY q S. Drug Substance S. 1 General Information S. 2 Manufacture S. 3 Characterization S. 4 Control of Drug Substance S. 5 Reference Standards or Materials S. 6 Container Closure System S. 7 Stability

TABLE OF CONTENT IN MODULE 3: QUALITY, CONTINUED q P. Drug Product q P. 1 Description and Composition q P. 2. Pharmaceutical Development q P. 3 Manufacture q P. 4 Control of Excipient q P. 5 Control of Drug Product q P. 6 Reference Standards or Materials q P. 7 Container Closure System q P. 8 Stability q A. Appendices q R. Regional Information

MY TYPICAL DAY AT FDA Review � Primary review on IND/BLAs � Discuss review issues/concerns � Review revisions Meetings (p. IND/ BLA) � Internal/ External Training � Scientific � Regulatory (Adapted from shutterstock. com) Extracurricular ativities Internal SOPs � Workgroup (drug shortage, biosimilar, immunogenicity etc. ) � Guidance/ Policy �

COMPENSATION AND BENEFITS Salary is generally lower than industry, bonuses are few/rare (Recruiting challenges) Benefits � Health care insurance (OK for employee, great for retiree) � Retirement (Pension and TSP (401 K equivalent)) � Work at home options

CAREER PATH Technical � Reviewer (GS-13), Senior Reviewer (GS-14), Expert Reviewer (GS-15) Management � Reviewer, team lead (GS-14), branch chief (GS-14 or GS-15), division director, office director Alternative Path � Project management � Consumer safety officer (inspector) � Policy analyst � Other federal agencies Going back to academia, industry

PROS AND CONS Pros: � Emotionally rewarding: making recommendation that has direct impacts on patients all over the world � Intellectually rewarding � Great training opportunities to understand how drug approval process � Stable, great work/life balance Cons: � Lower pay � Timeline driven, can be stressful sometime � Limited promotion potential � Strong ethics regulation

OPPORTUNITIES AT FDA Internship Fellowship � ORISE � Commissioner's fellowship � FDA-NCI Inter-Agency Oncology Task Force Joint Fellowship � Other fellowships Staff Fellow General Schedule (U. S. Citizen only) Senior Executive Service

HOW TO APPLY FOR FDA JOBS USAJOBS. GOV (Citizen only) FDA Website (https: //www. fda. gov/About. FDA/Workingat. FDA/Car eer. Descriptions/) Professional Societies and Conferences Employee Referral

RESOURCES (PERSONAL FAVORITES) Career Opportunities for Scientists http: //scforum. sciencecareers. org/ www. mitbbs. com/pharmaceutical General job hunting books:

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