Pharmaceutical and Medical Device Development

1. Pharmaceutical and Medical Device Development, and Public SafetyAndrew HelicherHPA 520October 7, 2009

2. Pharmaceutical and Medical Device Development, and Public SafetyPharmaceutical Development

3. Medical Device Development

4. Comparative Analysis

5. Pharmaceutical Development

7. Comparative Analysis2

8. Pharmaceutical Definitionshttp://medical-dictionary.thefreedictionary.com/Pharmaceuticals, 2007http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm#ther_biological, 06/08/20093

9. Target IdentificationDNA (Genes)RNAProteinsTargetCompound4(Ng, R., 2004, p. 16)

10. Small Molecule Drug DiscoveryRational ApproachIrrational ApproachUnderstand 3D structure and amino acid sequence of receptor moleculeUse modeling software to design drug that will fit within binding siteNatural Product CollectionExtract Compounds for ScreeningScreen compounds for ‘hits’Modify/purify to enhance potencySelect compounds for developmentFind Needles in Hay StacksCut a Key based on a Lock Tumblervs5(Ng , Rick, 2004, p.16)

11. Large Molecule Drug Discovery6(Ng , Rick, 2004, p.76)

12. Drug Development7(Ng , Rick, 2004, p. 108)

13. Clinical Trials8(Ng , Rick, 2004, p.144-147)

14. Regulatory OverviewInvestigational New Drug (IND)

15. FDA approval to start clinical trials

16. Good Clinical Practice

17. Protect human subjects, scientific validity, Independent Review Board

18. Good Manufacturing Practice

19. Defined process, quality control, trained operators, distribution, recall

20. FDA Pre-Marketing Approval

21. Post-Marketing Surveillance – FDA MedWatch9http://www.fda.gov/downloads/regulatoryinformation/guidances/UCM129515.pdf, 1996http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm

25. Invention ProcessIdentify unmet needsPhysicians, Patients, Clinical LiteratureEvaluate market potentialResearch existing inventions and IPConsider Regulatory and Reimbursement challengeConsider company’s ability to commercialize product11(Pietzsch, J., Shluzas, L., Pate-Cornell, M., Yock, P., & Linehan, J., 2009, p. 6-8)

26. Development ProcessMaintain Design History FileRequired by FDA Quality Systems RegulationCreate and refine prototypeTest prototype using computers, animals, and cadaversDesign manufacturing processGood Manufacturing Process12(Pietzsch, J. et al., 2009, p. 9-10)

27. Testing ProcessVerify device complies with Quality System RegulationBiocompatibilityDurability/LongevitySterilizationValidate device meets user requirementsSubmit design and test data to the FDA for approval13(Pietzsch, J. et al., 2009, p. 10)

28. Regulatory Overview1976 Medical Device Amendment

29. Class 1-3 base on device risk (1 being low risk)

30. Class 3 – Investigational Device Exception (IDE)

31. Pre-Marketing Approval Application (PMAA)

32. 510(k) – “substantially equivalent” devices

33. Notify 90 days before launching product14(Office of Technology Assessment, 1985, p. 8)

34. Clinical TrialsPhases

35. Pilot: establish safety

36. Pivotal: establish safety and efficacy for patient populations

37. 1000 participants, 1-2 years, 30-50 sites

38. Institutional Review Board (IRB)

39. Contract Research Organizations15(http://www.circ.ahajournals.org/cgi/content/full/109/25/3068, 2004)

43. FDA Approvals (2008)17221http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/default.htmhttp://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm

44. FDA Drug Approvals (2002 - 2008)1850%http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm

45. Vioxx Case1999: FDA approves Vioxx

46. 2000: NEJM accuses Merck of excluding heart attack data

47. 2000: Merck exposes heart attack / stroke data to FDA

48. 2002: FDA required Merck to include warning on label

49. 2004: Merck recalls Vioxx (27,000 heart attacks linked to Vioxx)

50. FDA leadership accused of blocking findings of FDA researcher Can the FDA both approve and recall drugs and devices?19http://www.usatoday.com/news/health/2004-10-12-vioxx-cover_x.htm, 10/12/2004

51. Efforts to Increase Medical Device Safety510(k) may be approving high risk products

52. GAO identified 24 products approved without close scrutiny through 510(k) process

53. Including hip replacement and heart implants

54. Institute of Medicine conducting a review of 510(k) process

55. Publish findings in March 201120http://www.physorg.com/news172947801.html, 9/3/2009

56. Questions?

57. ReferencesFood and Drug Administration (FDA) definition of Biologic (2009, Jun. 18). Retrieved from http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm#ther_biological.FDA. Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations (2009, Apr. 30) Retrieved from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm. FDA. Drug and Biologic Approval Reports (2009, Jul. 15). Retrieved from http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalRe ports/default.htmFDA. Device Approvals and Clearances (2009, Jun. 18) Retrieved from http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm FDA. Guidance for Industry: E6 Good Clinical Practice (2006, Apr.) Retrieved from http://www.fda.gov/downloads/regulatoryinformation/guidances/UCM129515.pdf. Medical Dictionary definition of Pharmaceutical. Retrieved from http://medical- dictionary.thefreedictionary.com/Pharmaceuticals, 2007. Ng, Rick (2009) Drugs: From Discovery to Approval. Hoboken, New Jersey: John Wiley & Sons, Inc. Office of Technology Assessment (1985) Federal Policies and the Medical Devices Industry. Oxford: Pergamon Press. Patsner, Bruce. (2009, Mar.) Wyeth v. Levine: The Supreme Court Gets It Right . Health Perspectives. Retrieved from: http://www.law.uh.edu/healthlaw/perspectives/2009/(BP)%20wyeth.pdf, 2009Perrone, Matthew. (2009, Sept. 23) FDA medical device approvals get external review. The Associated Press. Retrieved from: http://www.physorg.com/news172947801.html, 9/3/2009.Pietzsch, J., Shluzas, L., Pate-Cornell, M., Yock, P., & Linehan, J., (2009, Jun.) Stage-Gate Process for the Development of Medical Devices. Journal of Medical Devices. Volume 3. , No. 021004.Rubin, Rita. (2004, Oct. 12) How did the Vioxx Debacle Happen? USA Today. Retrieved from: http://www.usatoday.com/news/health/2004-10-12-vioxx-cover_x.htm.

58. Judicial Findings2008: Riegel vs. Medtronic

59. Cardiac catheter ruptured during surgery

60. 1976 Medical Device Amendment

61. FDA Pre-Marketing Approval gives Medtronic immunity in state courts

62. 2009: Levine vs. Wyeth

63. Musician lost hand after improperly injecting drug

64. Label warning inadequate

65. No state immunity (unlike Medical Devices)23http://www.law.uh.edu/healthlaw/perspectives/2009/(BP)%20wyeth.pdf, 2009

Pharmaceutical and Medical Device Development

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