Career Opportunities for CMC Reviewer at FDA
Role of CMC in drug development at FDA, overview of FDA basics, FDA mission, and structures, product development for new drugs/biologics, and the significance of Chemistry, Manufacturing, and Control (CMC) in ensuring quality drug products for human usage.
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Presentation Transcript
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 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 . Adapted from http://www.callisonrtkl.com
FDA CDRH CDER CBER CTP OGROP ORA OPQ 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 DEVELOPMENTFOR NEW DRUG/BIOLOGICS Scale Up & process optimization Discovery Phase I/II/III Trials Lead Optimization NDA/BLA Preclinical studies Process Development Launch Commercial Operations and Sales Phase IV Trials IND IND: Investigational new drug BLA: Biologics license application (Adapted from T. Freedman 2008)
WHATIS CHEMISTRY, MANUFACTURINGAND 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 ISAMAJORPARTOF IND/BLA SUBMISSION (Adopted from ICH M4) CTD: Common Technical Document
TABLEOF CONTENTIN MODULE 3: QUALITY 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
TABLEOF CONTENTIN MODULE 3: QUALITY, CONTINUED P. Drug Product P.1 Description and Composition P.2. Pharmaceutical Development P.3 Manufacture P.4 Control of Excipient P.5 Control of Drug Product P.6 Reference Standards or Materials P.7 Container Closure System P.8 Stability A. Appendices R. Regional Information
MY TYPICAL DAYAT FDA Review Primary review on IND/BLAs Discuss review issues/concerns Review revisions Meetings (pIND/ IND/ BLA) Internal/ External Training Scientific Regulatory Extracurricular ativities Internal SOPs Workgroup (drug shortage, biosimilar, immunogenicity etc.) Guidance/ Policy (Adapted from shutterstock.com)
COMPENSATIONAND 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 (401K 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
PROSAND 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
OPPORTUNITIESAT 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
HOWTOAPPLYFOR FDA JOBS USAJOBS.GOV (Citizen only) FDA Website (https://www.fda.gov/AboutFDA/WorkingatFDA/ CareerDescriptions/) 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:
