Docstoc

Diversity _amp; Inclusion Symposium - University of Pennsylvania

Document Sample
Diversity _amp; Inclusion Symposium - University of Pennsylvania Powered By Docstoc
					             Diversity & Inclusion Symposium




                                       Diversity at the
                                       Academia/Industry Interface


                                       T. J. Fadem
                                       Office For Corporate Alliances
                                       10/06/06




UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE                           1
       Diversity at the Academia/Industry
                     Interface


                                       What is the interface?
                                       How do we work together at
                                       the interface?
                                       What are the diversity
                                       challenges at this interface?




UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE                   2
                           PENN Medicine



                            Unique structure defines the Penn
                            Academic Interface




UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE              3
                              A Unified Structure
                                             Trustees of the
                                      UNIVERSITY OF PENNSYLVANIA




                                           PENN MEDICINE




     University of Pennsylvania
                                                                  University of Pennsylvania
        School of Medicine
                                                                       Health System


Academic Activities


          CPUP            HUP            PAH         PPMC   CCA   Wis Hospice    CHOP & VA



         UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE                                    4
         Interface: Office for Corporate Alliances



                                     PENN MEDICINE




University of Pennsylvania
                                                     University of Pennsylvania
   School of Medicine
                                                          Health System


      Research Activities



            OCA

   UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE                             5
PENN Medicine Industry Interface
•    Traditional interfaces still exist
       - Sponsored research, consulting, fellowships
       - Licensing, philanthropy etc.
•    Office for Corporate Alliances – established as a
     singularly focused industry interface in 2003
       - Strategic oversight of all Industry research
       - Review/engaged in (some way) in all corporate
         relationships
       - Clinical Trials are ~42% of our corporate research
•    Innovative strategic approach


    UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE         6
PENN & Industry Interests are Aligned
          at the Interface

•   Enhanced early phase clinical optimization and
      decision process in humans - study design and
      conduct

•   Potential new drug target identification in defined
      clinical areas

•   Efficacy and outcomes analysis in populations




UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE             7
                       What are the diversity challenges
                       seen at this interface?




UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE          8
     Challenges Observed at the Interface


• Can we take the time to focus the clinical trial fire hose on
  diversity?
• Are we looking for diversity in the trials?
• Volunteering vs. Study Budgeting – Should we consider a
  new model for budgeting clinical trials?
• Adherence – Is it time to expand study protocols to
  incorporate compliance along with studies in diverse
  populations?



   UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE                  9
     Challenges Observed at the Interface
The “fire hose” of clinical trials:
• 3800 – 4500 product trials ongoing in the US
• System output:
   ~25 drugs a year
   ~700 devices
• New clinical trial protocols reviewed every day by some of
  our 1800 faculty
• Penn works with >200 companies
• Penn share of this market is ~350 trials


   UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE           10
     Challenges Observed at the Interface
Targeting diversity in clinical trials in a sample of Penn data:
• Last 800 industry-sponsored clinical trials (3 – 5 years)
• Study titles cover the spectrum of:
   - Clinical Specialties
   - Phases I – IV
   - Are of all types (double blinded, dose-ranging, drug
     interaction, case-studies…)
• <5% include a “diversity population target” in the title
• All 800 protocols were not reviewed for this talk, some of
  them may have targeted these populations, but titles reflect
  primary objectives
   UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE                   11
     Challenges Observed at the Interface
Volunteering vs. study budgeting:
• Per patient budgets are common
• This systems opts for ‘volunteers of convenience’
   - Enrollment is key to completing the study
   - Completing the study is key to publishing for academia
   - Speed is the driver for industry, drives enrollment
• Estimates are between 5% and 20% of eligible patients
  become volunteers depending on condition and diverse
  subpopulations volunteer at an even lower rates
• Is this an optimum method for addressing diversity in trails?

   UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE              12
     Challenges Observed at the Interface
Patient compliance with prescribed medication:
• New medication, better therapy for patients is a common
  goal for academia and industry
• Studies indicate:
   - Up to 50% of patients may not even fill their prescriptions
     the first time
   - Another 25% - 50% may not refill
• The reasons may vary by group of patients, and it may be
  better business and better medicine to find out as early as
  possible how to address this problem.
• Is it time to consider addressing compliance as part of
  clinical trials?
   UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE              13
                   Academia/Industry Interface

   •   Shared Goals of improved patient care
   •   Academic interests and business
       interest are aligned in clinical research
   •   View across all trials enables
       challenges to be seen more readily




UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE      14
                             PENN Medicine




                                                Medical School, Ninth Street
                                                          Campus,
                                                      c. 1830s-1840s

UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE                                  15

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:9
posted:4/6/2013
language:English
pages:15