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Pharmaceutical and Medical Device Development

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Pharmaceutical and Medical Device Development

  1. 1. Pharmaceutical and Medical Device Development, and Public Safety<br />Andrew Helicher<br />HPA 520<br />October 7, 2009<br />
  2. 2. Pharmaceutical and Medical Device Development, and Public Safety<br /><ul><li>Pharmaceutical Development
  3. 3. Medical Device Development
  4. 4. Comparative Analysis
  5. 5. Pharmaceutical Development
  6. 6. Medical Device Development
  7. 7. Comparative Analysis</li></ul>2<br />
  8. 8. Pharmaceutical Definitions<br />http://medical-dictionary.thefreedictionary.com/Pharmaceuticals, 2007<br />http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm#ther_biological, 06/08/2009<br />3<br />
  9. 9. Target Identification<br />DNA (Genes)<br />RNA<br />Proteins<br />Target<br />Compound<br />4<br />(Ng, R., 2004, p. 16)<br />
  10. 10. Small Molecule Drug Discovery<br />Rational Approach<br />Irrational Approach<br />Understand 3D structure and amino acid sequence of receptor molecule<br />Use modeling software to design drug that will fit within binding site<br />Natural Product Collection<br />Extract Compounds for Screening<br />Screen compounds for ‘hits’<br />Modify/purify to enhance potency<br />Select compounds for development<br />Find Needles in Hay Stacks<br />Cut a Key based on a Lock Tumbler<br />vs<br />5<br />(Ng , Rick, 2004, p.16)<br />
  11. 11. Large Molecule Drug Discovery<br />6<br />(Ng , Rick, 2004, p.76)<br />
  12. 12. Drug Development<br />7<br />(Ng , Rick, 2004, p. 108)<br />
  13. 13. Clinical Trials<br />8<br />(Ng , Rick, 2004, p.144-147)<br />
  14. 14. Regulatory Overview<br /><ul><li>Investigational New Drug (IND)
  15. 15. FDA approval to start clinical trials
  16. 16. Good Clinical Practice
  17. 17. Protect human subjects, scientific validity, Independent Review Board
  18. 18. Good Manufacturing Practice
  19. 19. Defined process, quality control, trained operators, distribution, recall
  20. 20. FDA Pre-Marketing Approval
  21. 21. Post-Marketing Surveillance – FDA MedWatch</li></ul>9<br />http://www.fda.gov/downloads/regulatoryinformation/guidances/UCM129515.pdf, 1996<br />http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm<br />
  22. 22. Pharmaceutical and Medical Device Development, and Public Safety<br /><ul><li>Pharmaceutical Development
  23. 23. Medical Device Development
  24. 24. Comparative Analysis</li></ul>10<br />
  25. 25. Invention Process<br />Identify unmet needs<br />Physicians, Patients, Clinical Literature<br />Evaluate market potential<br />Research existing inventions and IP<br />Consider Regulatory and Reimbursement challenge<br />Consider company’s ability to commercialize product<br />11<br />(Pietzsch, J., Shluzas, L., Pate-Cornell, M., Yock, P., & Linehan, J., 2009, p. 6-8)<br />
  26. 26. Development Process<br />Maintain Design History File<br />Required by FDA Quality Systems Regulation<br />Create and refine prototype<br />Test prototype using computers, animals, and cadavers<br />Design manufacturing process<br />Good Manufacturing Process<br />12<br />(Pietzsch, J. et al., 2009, p. 9-10)<br />
  27. 27. Testing Process<br />Verify device complies with Quality System Regulation<br />Biocompatibility<br />Durability/Longevity<br />Sterilization<br />Validate device meets user requirements<br />Submit design and test data to the FDA for approval<br />13<br />(Pietzsch, J. et al., 2009, p. 10)<br />
  28. 28. Regulatory Overview<br /><ul><li>1976 Medical Device Amendment
  29. 29. Class 1-3 base on device risk (1 being low risk)
  30. 30. Class 3 – Investigational Device Exception (IDE)
  31. 31. Pre-Marketing Approval Application (PMAA)
  32. 32. 510(k) – “substantially equivalent” devices
  33. 33. Notify 90 days before launching product</li></ul>14<br />(Office of Technology Assessment, 1985, p. 8)<br />
  34. 34. Clinical Trials<br /><ul><li>Phases
  35. 35. Pilot: establish safety
  36. 36. Pivotal: establish safety and efficacy for patient populations
  37. 37. 1000 participants, 1-2 years, 30-50 sites
  38. 38. Institutional Review Board (IRB)
  39. 39. Contract Research Organizations</li></ul>15<br />(http://www.circ.ahajournals.org/cgi/content/full/109/25/3068, 2004)<br />
  40. 40. Pharmaceutical and Medical Device Development, and Public Safety<br /><ul><li>Pharmaceutical Development
  41. 41. Medical Device Development
  42. 42. Comparative Analysis</li></ul>16<br />
  43. 43. FDA Approvals (2008)<br />17<br />2<br />2<br />1<br />http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/default.htm<br />http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm<br />
  44. 44. FDA Drug Approvals (2002 - 2008)<br />18<br />50%<br />http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm<br />
  45. 45. Vioxx Case<br /><ul><li>1999: FDA approves Vioxx
  46. 46. 2000: NEJM accuses Merck of excluding heart attack data
  47. 47. 2000: Merck exposes heart attack / stroke data to FDA
  48. 48. 2002: FDA required Merck to include warning on label
  49. 49. 2004: Merck recalls Vioxx (27,000 heart attacks linked to Vioxx)
  50. 50. FDA leadership accused of blocking findings of FDA researcher</li></ul> Can the FDA both approve and recall drugs and devices?<br />19<br />http://www.usatoday.com/news/health/2004-10-12-vioxx-cover_x.htm, 10/12/2004<br />
  51. 51. Efforts to Increase Medical Device Safety<br /><ul><li>510(k) may be approving high risk products
  52. 52. GAO identified 24 products approved without close scrutiny through 510(k) process
  53. 53. Including hip replacement and heart implants
  54. 54. Institute of Medicine conducting a review of 510(k) process
  55. 55. Publish findings in March 2011</li></ul>20<br />http://www.physorg.com/news172947801.html, 9/3/2009<br />
  56. 56. Questions?<br />
  57. 57. References<br />Food 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.<br />
  58. 58. Judicial Findings<br /><ul><li>2008: Riegel vs. Medtronic
  59. 59. Cardiac catheter ruptured during surgery
  60. 60. 1976 Medical Device Amendment
  61. 61. FDA Pre-Marketing Approval gives Medtronic immunity in state courts
  62. 62. 2009: Levine vs. Wyeth
  63. 63. Musician lost hand after improperly injecting drug
  64. 64. Label warning inadequate
  65. 65. No state immunity (unlike Medical Devices)</li></ul>23<br />http://www.law.uh.edu/healthlaw/perspectives/2009/(BP)%20wyeth.pdf, 2009<br />

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