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Pharmaceutical Regulatory Affairs: Discovery to Approval R. Sam Niedbala, Ph.D. (SAN204@Lehigh.edu) Lecture 1

Pharmaceutical Regulatory Affairs: Discovery to Approval R. Sam Niedbala, Ph.D. (SAN204@Lehigh.edu) Lecture 1. Course Overview What is Regulatory Affairs? Primer on Drug, Biologics, Device Law and How do I find Answers?. Lecture 1. Course Overview.

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Pharmaceutical Regulatory Affairs: Discovery to Approval R. Sam Niedbala, Ph.D. (SAN204@Lehigh.edu) Lecture 1

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  1. Pharmaceutical Regulatory Affairs: Discovery to Approval R. Sam Niedbala, Ph.D. (SAN204@Lehigh.edu) Lecture 1

  2. Course Overview What is Regulatory Affairs? Primer on Drug, Biologics, Device Law and How do I find Answers? Lecture 1

  3. Course Overview Course Goal: Present concise information on each step for the development of pharmaceuticals and biologics. Breath of discussions will include topics from Concept to Market Introduction. Overview of Lectures: The initial lectures will be given by Dr Sam Niedbala who will also act as the coordinator for the overall course, subsequent topics will be provided by guest lecturers with specialized training and expertise in respective areas. Guest lecturers may use course recommended text books as well as personal experience to create presentations. Exams/Projects: Exams will be given to students during lecture 10 and in the final class. Weight for exams plus student projects are equal. Student Project Goal: Demonstrate the ability to navigate text and FDA available information to research and recommend solutions to proposed problems. Students will prepare a written summary and brief power point slide presentation.

  4. Course/Topic Sequence (Lectures 1-10) • Lectures 1-8 • FDA History • FDA functions • CDER Training • NDA Components • FDA Operations • Lecture 9 • Economics of Drug Development • Lecture 10-Exam 1

  5. Course/Topic Sequence (Lectures 11-28) • Lectures 11-12 • NDA Strategies • Lectures 13-17 • Biologics & Drug Discovery • Lectures 18 • Preclinical/Clinical Considerations • Lecture 19-22 • Facilities & Manufacturing Considerations • Lecture 23-24 • Packaging Considerations • Lectures 25-27 • Student Presentation • Lecture 28-Final Exam

  6. What is Regulatory Affairs? Lecture 1

  7. Definition Field of practice that monitors, implements and ensures compliance with existing laws and regulations regarding drugs, cosmetics & medical devices for both humans and animals.

  8. Simplified Process • Congress passes a new law • One or more agencies implement the law by enacting regulations

  9. Brief History of Drug Laws & Regulations • USP existed in 1820 as standard for strength and purity • 1848, first US drug law-the Drug Importation Act • Prior to 1902, US Government took a “hands-off” approach • 1902, the Virus, Serum and Toxins Act (Biologics Control Act)

  10. Brief History of Drug Laws & Regulations (cont.) • Dr. Harvey W Wiley establishes Hygienic Table—uses poison squad • 1906, US First Food & Drug Law- Pure Food and Drug Act • 1911, Shirley Amendment prohibits misbranding of therapeutic claims • 1937, Massingill Co kills 107 people with adulterated Sulphanilamide Elixer

  11. Brief History of Drug Laws & Regulations (cont.) • 1938, Comprehensive Food Drug & Cosmetic Act (FDCA)—becomes the foundation for today’s FDA • 1950’s, birth defects lead to discovery of thalidomide as cause • 1962, Kefauver-Harris Act closes loop-holes in Law. • 1966, Congress charges NSF & NRC to examine and sort effectiveness of 3,400 drug products

  12. Brief History of Drug Laws & Regulations (cont.) • 1972, FDA examines 300,000 OTC products and creates 80 categories. Took 20 years! • 1970’s, many laws & regulations implemented to control substances • 1980’s, biologics are introduced • 1983, Orphan Drug Act passed • 1984, Generic drug scandal helps create Price Competition and Restoration Act (Waxman-Hatch Act)

  13. Brief History of Drug Laws & Regulations (cont.) • 1992, Prescription Drug User Fee Act • 1997, FDA Modernization Act extends PDUFA

  14. Primer on Drug, Biologics, Device Law and How do I find Answers? Lecture 1

  15. Sources of Information • Existing Regulations • Meetings and FDA Presentations • www.FDA.gov • Competitive Analysis • Historical Precedence

  16. Specific Examples • CFR • RegSource.com • www.fda.gov/opacom/laws/lawtoc.htm • Limited use of books

  17. Student Projects • Student Project Goal: Demonstrate the ability to navigate text and FDA available information to research and recommend solutions to proposed problems. Students will prepare a written summary and brief power point slide presentation.

  18. Project Expectations • Written Summary: Not to exceed 5 typed pages along with no more than 10 charts, graphs, pictures. • Summary should be written to support executive decision. • Specific recommendations along with supporting data is key. • Sources: Historical precedence, FDA policy or regulations, competitive products • Include: Technical Approach, Timelines, budgets, manpower requirements

  19. Project Choices-1 • Our company is considering expansion into the area of suncare OTC products. Our R&D/Patent portfolio includes several sunscreen chemicals available in commercial products sold in Europe. Marketing has recommended that a new sunscreen chemical would create a distinct advantage in the market. What regulatory path would be required to achieve Corporates’ goal? Would you recommending pursuing this project?

  20. Project Choices-2 • Our company is considering the commercialization of a combination product containing Compound X which is approved for treating mouth sores imbedded into a device that slowly delivers the approved formulation into the oral cavity. The product would treat a non-pathogenic form of the Herpes Virus. The delivery device is also approved for a similar use in the mouth. The delivery device was previously cleared as a class II medical device. What are the regulatory requirements in order to commercialize this combination product? What possible paths can the company take to quickly obtain approval.

  21. Project Choices-3 • Our company has developed a drug to treat Anthrax exposure. It may also be useful for treatment of other infections, specifically following early exposures to the HIV virus. What regulatory path would you suggest to management? What would be the timeline and requirements to obtain approval for either indication?

  22. Project Choices-4 • The importation of pharmaceuticals may cause harm to all companies in the US pursuing research and development of NME’s. Quantify for management the potential effects of these imports. Include in your briefing the FDA’s roles and responsibilities. Site specific Laws and regulations that will be critical in this debate. Finally, state whether the importation of pharmaceuticals will negatively influence R&D investments in the United States.

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