1. CAREER OPPROTUNTIES FOR CMC reviewer AT fda
Kevin Li
04/22/2017
Thanks CBA and the workshop organizer for giving me the opportunity to share my experience here. I’d here today to provide an introduction about working as a CMC reviewer at FDA from my prospective. Hopefully this will be useful for your personal career development.
(CMC: Chemistry, Manufacturing and Control)

2. 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.

3. Overview FDA Basics The role of CMC in Drug Development
Life of a CMC Reviewer
Career opportunities at FDA

4. 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

5. Office of Biotechnology Products
FDA
CDER
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
CBER
CTP
OGROP
ORA
CDRH
Office of Pharmaceutical Quality (OPQ) is the main CMC office under CDER.

6. product Development for New Drug/Biologics
Discovery
Scale Up & process optimization
Phase I/II/III Trials
Lead Optimization
NDA/BLA
Process Development
Preclinical studies
Launch
Now you may be wondering what exactly is CMC and how does it fit into the drug development process? In order to answer this question, I want to give a brief illustration about the drug development process so that you can see where CMC is a role?
Commercial Operations and Sales
Phase IV Trials
IND
IND: Investigational new drug
BLA: Biologics license application
(Adapted from T. Freedman 2008)

7. 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.

8. CMC is a major part of IND/BLA Submission
If u submit to EU, you have certain requirement. If you submit to USA, you have other requirements.
Module 2 is an over all summary of the data provided.
Module 3 is the main body of the submission.
(Adopted from ICH M4)
CTD: Common Technical Document

9. Table of Content in 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
Ds is the active ingredient in the finished product. What is the DS? How is made? What are the properties? How is it controlled, stored, and how stable it. The goal is to ensure consistent production of drug substance of the same quality under CGMP

10. Table of Content in 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
DP is the finished product that get delivered to the end user. Goal is to ensure consistent production of drug substance of the same quality under CGMP

11. My Typical Day at 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)
You are literally sitting in front of the computer with multiple monitors most of the time.
based on feedback from secondary and tertiary reviews
Scientific trainings includes seminars, conferences. Regulatory includes reviewer’s training, best practice, new guidance documents, new systems.

12. 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 (401K equivalent))
Work at home options
Contrary to common belief, the pension at federal government is not generous at all. The best benefit is the health care insurance coverage that you can use after retiring from federal workforce.

13. Career Path Technical Management Alternative Path
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
One of the greatest benefit for working for federal government is that you are working for the biggest employer in the country

14. Pros and Cons Pros: Cons:
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
Keep up with the latest technology that can be applied in biopharmaceutical area. You will never get bored. And you don’t really worry that the experiments wouldn’t work.
Not allowed to trade any biotech related stocks and funds for you and your spouse. Neither you, your family members or your friends can financially benefit from your position at the Agency.

15. opportunities at FDA Internship Fellowship Staff Fellow
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
In general, FDA hiring is unpredictable, and is highly dependent on the funding sources and the political climates. The hiring process is long and cumbersome (could take 6 months to one year). One of the best way is to get into the door first and wait for the opportunities to present themselves. At OLDP, quite a few of my coworkers started as a ORISE fellow and converted to staff fellow when opportunities come. At OBP, most of the new CMC reviewers that I know are coming from this fellowshop.

16. How to apply for FDA jobs
USAJOBS.GOV (Citizen only)
FDA Website ( CareerDescriptions/)
Professional Societies and Conferences
Employee Referral
Employee referral can be very effective.

17. Resources (Personal Favorites)
Career Opportunities for Scientists
General job hunting books:
I have struggled before with my first job hunting. I understand the frustration, the uncertainness, and the sense of helplessness after spending 6-8 years of your life to get a degree that can’t land you’re a job. Those resources helped me to better prepare for my job application so when the opportunity actually comes, I am able to grab it and be at what I am at currently.
The truth is Getting a Ph.D is like getting a license to hunt, it is not a guarantee to bring food to the table.
Job hunting itself is a full time job.
“If somebody offers you an amazing opportunity but you are not sure you can do it, say yes – then learn how to do it later!” by Richard Branson
How can the organization benefit from hiring and developing you over other qualified candidates?

18. Questions and Comments