Leading in the Field of Regulatory Affairs

1. Leading in the Field of Regulatory Affairs Eric D. Kupferberg, PhD Senior Fellow 25 July 2013

2. Basic Definition of the Field • The essential steps and considerations necessary for a company to gain approval from a regulatory agency for the commercialization of biomedical product • The central focus is on the mechanisms and criteria enlisted to show safety and effectiveness of a product and its prescribed usage

3. Why Do We Need Regulatory Leaders? • Statutes are outdated and vague • Guidance documents are non-binding • FDA approvals, audits, and letters are geared toward particular products and companies • FDA regulations DO NOT define how to achieve compliance • Regulatory approval is a nuanced and negotiated act

4. Regulatory Stages for New Drugs

5. Respond to Shomen Chosa Q’s 3 Respond to 2nd Sen. Kyogi Q’s PMDA intro Meeting Preclin Shomen Chosa Clinical Shomen Chosa Reimb. Appl’n Reimb. Aproval FMA Audit & Approval Dossier PreCons Meeting Shomen Chosa Appl Shomen Chosa Approv. Re-submit STED Request 2nd Sen. Kyogi 2nd Senmon Kyogi Final Product Approval FMA Appl. Jichi chosa PMSS proposal 6 Request Senmon Kyogi 1st Senmon Kyogi Re-submit STED Y-Kai Meeting Submit MAH Submit STED 4 Sashi -kai 1 Product marketing Approval GMP Audit Sub’s GMP Audit approvals Bukai Meeting Respond to Senmon Kyogi Q’s 2 Respond to Bukai Q’s Respond to GMP Audit Questions 5 Respond to dossier technical questions Six critical sub-strategies of the Japan approval process

6. What Are the Basic RA Functions • Primary function = regulatory compliance • Day-to-day job is paper work • Must have knowledge of existing statutes and regulations • Must design careful documentation systems for all steps of approval • Biggest challenge = Regulatory filing and audit

7. What is the Intermediate RA Work? • Guide product through entire life-cycle, including clinical trials, approval, labeling, marketing, and post-market surveillance • Manage products “across” business units, including legal department, QA/QC, marketing, finance • Agility in working with teams and communicate

8. The Life Cycle of Biomedical Products

9. What is Advanced RA Work? • Proficiency in several technical areas, including science, medicine, policy analysis, economics • Ability to accommodate development of new product areas (e.g., nanotechnology, combination products, tissue engineering, genetic therapy) • Strong leadership skills, even without formal authority

10. What is Advanced RA Work? • Interpretation of international regulations and understanding of trade issues • Lobby governments for changes in regulations, laws, and health policies • Work with investors and executives • Ability to create sustainable competitive advantages for host organization

11. Crucial Role of “Regulatory Strategy” • Business strategy = deciding where you would like to take your company and the best ways to get there • Many core strategic decisions are really regulatory decisions • Ability to identify process gaps and create new processes • Difference between avoiding losses and maximizing cost-effectiveness of resources

12. Crucial Role of “Regulatory Strategy” www.priory-analysts.com/uploads/images/Business_system_chart_02.JPG

13. How to Break into the FieldWhere do RA leaders “come from”? • Chemistry • Engineering • Pharmacology • Quality • Toxicology • Writing • Clinical sciences • Management

14. Problem with Learning “On the Job” • Knowledge is limited to what the company currently “does” not what it might “want to do” or what it will “have to do” • Reproduce isolation of regulatory affairs • Under-prepared for mergers and acquisitions • Limited ability to advance the profession through research & publications

15. First Steps to Take • Develop skills and experience in one of the sciences that contribute to product development, manufacturing and marketing (most difficult part) • Learn the regulations that apply to the company’s products • Take courses that provide instruction in applying the regulations in industry • Join Regulatory Affairs Organizations

16. Northeastern University- MS in Regulatory Affairs for Drugs, Biologics & Medical Devices • Nearly all 44 courses are offered online and on-campus (Boston, Seattle, Charlotte) • Equal focus on medical devices and drugs • Broad curriculum on international topics • Unique emphasis on regulatory strategy, not just regulatory compliance

17. CURRICULUM 6 Core Courses 4 Specialized Elective Courses 1 Open Elective Course 11 Total Courses Curriculum – Core Courses 6 Core Foundation Courses • Introduction to Drug and Medical Device Regulation • Human Experimentation: Methodological Issues Fundamental to Clinical Trials • New Drug Development • Medical Device Development • Biologics Development • Food, Drug, and Medical Device Law *Note: Students may be required by the department to take RGA6280: Advanced Writing on International Biomedical Topics as a condition of their continued enrollment in the program

18. CURRICULUM 6 Core Courses 4 Specialized Elective Courses 1 Open Elective Course 11 Total Courses Curriculum – Elective Courses 4 Specialized Elective Courses Choose one course from each of the following areas • 1 Safety and Surveillance Course • 1 Business and Law Course • 1 Development and Strategy Course • 1 International Regulatory Affairs Course 1 Open Elective Course or co-op/internship • Students may choose 1 additional course from any elective course category or a co-op or internship • In order to participate in a co-op/internship all regulatory affairs students must complete the following courses: • RGA 6100 Introduction to Drug and Medical Device Regulations • BTC 6210 Human Experimentation

19. The Application Process Visit https://app.applyyourself.com/?id=NEU-CPS You will need to provide: • Original Personal Statement (500-1000 words) • Current resume • 2 recommendations • Undergraduate official transcript • Sent directly from your undergraduate institution to Northeastern • TOEFL/IELTS for non-native English speaking students • You do not need to submit GRE/GMAT scores • Send your questions to: cpsadmissions@neu.edu or call 877-668-7727 Already submit your application?Visit www.cps.neu.edu/admissions The next start date: September 9, 2013 Visit www.cps.neu.edu/admissions for additional information