• Share
  • Email
  • Embed
  • Like
  • Save
  • Private Content
Pharmaceutical and Medical Device Development
 

Pharmaceutical and Medical Device Development

on

  • 3,138 views

 

Statistics

Views

Total Views
3,138
Views on SlideShare
3,133
Embed Views
5

Actions

Likes
1
Downloads
48
Comments
0

2 Embeds 5

http://www.slideshare.net 4
http://www.lmodules.com 1

Accessibility

Categories

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment
  • Targets are identified through a process called drug discovery
  • After drug discovery comes drug development
  • Similar due diligence is performed for pharmaceuticals

Pharmaceutical and Medical Device Development Pharmaceutical and Medical Device Development Presentation Transcript

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