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Acrp Presentation Jan 2009

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Acrp Presentation Jan 2009

  1. 1. Bridging the Gap and Building Partnerships Between Academia and Industry Industry Perspective
  2. 2. Academic Allure <ul><li>Why Industry works with Academic Institutions: </li></ul><ul><li>Premier scientific and clinical knowledge </li></ul><ul><li>Access to specialized patient populations </li></ul><ul><ul><li>CTCL, organ transplant </li></ul></ul><ul><li>Scientific -> Clinical evaluation of early compounds </li></ul><ul><li>Clinical feasibility assessment during protocol development </li></ul><ul><ul><li>Clinical purpose vs regulatory purpose – frequently not the same </li></ul></ul><ul><li>Credibility through association with reputable institutions and key opinion leaders </li></ul><ul><li>Reputation for authoring publications </li></ul>
  3. 3. Industry Dowry <ul><li>What Industry brings to the relationship: </li></ul><ul><li>70% of clinical research funding comes from Industry </li></ul><ul><ul><li>2008 Global clinical research business = $50B </li></ul></ul><ul><li>Cultivate access to new medicines/treatments/diagnostics </li></ul><ul><li>Clinical trial design and data analysis </li></ul><ul><ul><li>Rigorous data collection </li></ul></ul><ul><li>Regulatory Authority knowledge </li></ul><ul><ul><li>Develops regulatory strategies </li></ul></ul><ul><ul><li>Understands regulations and requirements </li></ul></ul><ul><li>Regulatory capabilities </li></ul><ul><ul><li>Submission preparation </li></ul></ul>
  4. 4. Industry Business Model <ul><li>Even before the current financial crisis, industry has been focused on building efficiencies </li></ul><ul><li>Reduced sales and marketing costs </li></ul><ul><li>Moving trials overseas </li></ul><ul><li>General & Administrative costs – cut to the bone </li></ul><ul><li>Last frontier for cutting costs….. </li></ul><ul><ul><li>Research and Development </li></ul></ul>
  5. 5. Even the Government… <ul><li>“ The clinical research enterprise needs to evolve. It needs to be much more streamlined and efficient.” – Janet Woodcock, FDA Deputy Commissioner, 2008 </li></ul><ul><li>Clinical Trials Transformation Initiative </li></ul>
  6. 6. Challenges for Biotech/Pharma <ul><li>Competition for and access to academic institutions and investigators </li></ul><ul><li>Forced to operate within and accommodate academic confines </li></ul><ul><ul><li>Inflexible and inconsistent systems within and between institutions </li></ul></ul><ul><ul><li>Difficulty integrating processes or equipment to meet study requirements (e.g., software) </li></ul></ul><ul><li>Beholden to shareholders </li></ul><ul><ul><li>Balance high quality with cost-effectiveness </li></ul></ul><ul><ul><li>Time to market </li></ul></ul><ul><ul><li>Pressure to get products on the market - Revenue </li></ul></ul>
  7. 7. Challenges for Industry <ul><li>How the relationship generally begins - Time to Study Start </li></ul><ul><ul><li>Institutional Bureaucracy </li></ul></ul><ul><ul><ul><li>Does the investigator know how to navigate the system? </li></ul></ul></ul><ul><ul><ul><li>Scientific review boards </li></ul></ul></ul><ul><ul><ul><li>Align institutional bureaucracy with industry bureaucracy (hurry up and wait) </li></ul></ul></ul><ul><ul><li>Contract Issues </li></ul></ul><ul><ul><ul><li>Individual contract negotiations, whose contract do you use? </li></ul></ul></ul><ul><ul><ul><li>Significant delays in legal review </li></ul></ul></ul><ul><ul><ul><li>Intellectual property (data ownership) and publication rights </li></ul></ul></ul><ul><ul><ul><li>Payment schedules and milestone establishment </li></ul></ul></ul><ul><ul><li>Budget delays and expense </li></ul></ul><ul><ul><ul><li>Navigating multiple departments to collect budget data </li></ul></ul></ul><ul><ul><ul><li>Higher cost for procedures </li></ul></ul></ul><ul><ul><ul><li>Institutional overhead </li></ul></ul></ul><ul><ul><li>Local IRB </li></ul></ul><ul><ul><ul><li>Application gridlock </li></ul></ul></ul><ul><ul><ul><li>Delays in time to obtain IRB approval (summers, holidays) </li></ul></ul></ul><ul><ul><li>All of this work required if there is one subject enrolled or 100 subjects enrolled </li></ul></ul>
  8. 8. Some room for improvement <ul><li>Industry can bridge the gaps: </li></ul><ul><li>Establish Master Service Agreements with partner institutions and be consistent in their use </li></ul><ul><li>Set realistic project duration dates to accommodate study start up time </li></ul><ul><li>Budget – understanding academic funding needs </li></ul><ul><ul><li>Study start up fees and payment process </li></ul></ul><ul><li>Customized training, give sites tools (checklists) to make their jobs easier, not always a one size fits all mentality </li></ul><ul><li>Develop relationships with key stakeholders / departments within the institution (beyond the investigator) </li></ul><ul><ul><li>Contracts and accounting </li></ul></ul><ul><ul><li>Find a champion at the site </li></ul></ul>
  9. 9. Heather Snyder, PhD Executive Director Ext. 304 Catherine Martin, MD Principal Investigator Department of Psychiatry UKY College of Medicine 3470 Blazer Parkway Lexington, KY 40536 (P): 859-257-9341 (F): 859 -257-3898 [email_address] John Ranseen, PhD Co-Investigator [email_address] Greg Guenther Assistant to Dr. Martin (P): 859-257-9362 [email_address] Bryan D. Beck, MS, LPCC Research Assistant (C): 859-967-4048 (P): 859-323-5824 (F): 859-257-3898 [email_address] Stephen C. Sitzlar, RPh, PharmD Manager, Investigation Drug Service Department of Pharmacy UKY College of Medicine (P): 859-323-2894 (F): 859-323-4765 [email_address] John Hajner Sponsored Projects Administration Kinkaid Hall, Room 114 Lexington, KY 40506-0057 (P): 859-257-4526 [email_address] Sharon Walsh, PhD Consultant Dept. of Behavioral Science University of Kentucky (P): 859-257-6485 [email_address] Laura D’Alonzo Clinical Trial Support Specialist Ext. 324 Alan Smith Statistical Consultant (C): 908-723-0474 (P): 908-879-6168 [email_address] Thomas Laughren, MD Nicholette Hemmingway FDA, CDER Division of Psychiatry Products IND # 100,962 (P): 301-796-9838 Mark Walters Grants Management Specialist Margaret Grabb Program Official NIMH Grant #1R43MH081553-01 Mark Kleven, PhD PI on NIMH Grant Ext. 316 Paul A. Nuzzo Center for Human Behavioral Science Robert Straus Building 515 Oldham Court, Suite 110 Lexington, KY 40502 (P): 859-323-0002 (F): 859-257-5232 [email_address] Yaupon ACI UKY FDA/NIMH
  10. 10. Compromises What can Industry do? What would Industry like to see? <ul><li>Eliminate as many protocol challenges as possible </li></ul><ul><li>Set reasonable timelines </li></ul><ul><li>Develop better personal relationships with key stakeholders at the site </li></ul><ul><li>Elicit continuous feedback from the sites and make accommodations where possible </li></ul><ul><li>Pay invoices on time </li></ul><ul><li>Communicate </li></ul><ul><li>Easier navigation through the institution </li></ul><ul><li>Stronger commitments to timelines </li></ul><ul><li>Refunds for low to no enrollment </li></ul>
  11. 11. References <ul><li>Global Clinical Trial Business Report and Analysis 2008-2018 </li></ul><ul><li>Mello et al, “Academic Medical Centers’ Standards for Clinical Trial Agreements with Industry” NEJM, May 26, 2005 </li></ul><ul><li>Yamada “Academia-industry collaboration: A dynamic partnership on behalf of patients”, presentation to Assoc. of Amer. Phys. 2005 </li></ul>