Industry’s Response to Concerns of Academic Medical Centers

1. Industry’s Response to Concerns of Academic Medical Centers Joseph S. Camardo, M.D. Senior Vice President CTSA Workshop June 22, 2009

2. A Twenty Year View of Clinical Research • Expansion from exclusive involvement of Academic Medical Centers (AMCs) to combined involvement of AMCs and private physician practices • Expansion from the U.S. to the rest of the world • A change from simple clinical research agreements to more complex contracts • Better methodology for clinical trials • An increase in the time and cost of clinical research • A variety of excellent clinical studies and some real advances in medicine

3. Expanded Complexity of Clinical Contracts • Clinical trials have expanded in scope and complexity resulting in more detailed and complex clinical contracts • More complex contracts require greater review time and a greater amount of resources dedicated to finalizing such contracts • Contracts often include multiple parties • Certain issues have become more heavily negotiated because of policy changes or current risk evaluation • Indemnification • Subject Injury • Insurance • Intellectual Property

4. Globalization and Standardization: A Process Change to Increase Efficiency • Global studies demand global standardization • Objective: global standards for contracting • Standardized study kick-off meeting process • Standardized global tools • Agenda • Kick-off meeting questions • Contracting plan • Creation of a global eRoom to house templates • Global access with Wyeth login

5. Academic Medical Centers and Industry Have Similar Concerns About Clinical Research • Access to decision makers • Changing policies and contract templates • Master agreements and previously negotiated agreements • Lack of understanding of academic mission • Priority given to sites that do not negotiate agreements • Complex process of contracting within industry

6. Academic Medical Centers and Industry Have Similar Concerns About Clinical Research • Access to decision makers • Sites work directly with individuals who have decision making authority over the contract and budget • For issues that fall outside of company policy, a committee of executives (VPs) meet weekly to make final decisions • Medical, legal and contract staff are always available to sites • Changing policies and contract templates • Very infrequent – this may differ from company to company • Templates and internal policies evolve on an on-going basis and changes are a result of outside influences • legal or regulatory change • greater oversight and scrutiny of industry • change in risk evaluation

7. Academic Medical Centers and Industry Have Similar Concerns About Clinical Research • Unwillingness to abide by master agreements or previously negotiated agreements • Case by case consideration depending on type and phase of study • May need more IP protection for Phase 2 versus Phase 4 • Risk evaluations depend on type of study, scope and procedures • AMCs often ask for study specific contract terms • Often require changes to master agreements • A policy change may require a change to the MSA • Lack of understanding of academic mission • Industry sponsored research different from academic research • Large scale clinical trials are time sensitive and goal directed • In general, each AMC is providing only a small part of the enrollment for any study, supported by the company funds

8. Academic Medical Centers and Industry Have Similar Concerns About Clinical Research • Priority attention given to sites that do not negotiate agreements • Smaller organizations (community hospitals, private practices, commercial research facilities) tend to negotiate less so contracts can be finalized and signed more rapidly • Study start-up and enrollment always under time pressures • AMCs have more layers of internal review • Less flexibility on contract negotiations: IP, budget • Often third party study sites involved • Master Agreements can address some issues, but there are no master budgets • Complex process of contracting within industry • Streamlined process and appropriate staff to handle legal and budget negotiations and administration of contracts • Contracting not frequently outsourced • Standard process followed across all therapy areas and most regions

9. How Can Academic Medical Centers Mission For Research Meet Industry Mission For Development? • When do we shift from R to D? • Is the AMC a Phase 2 not a Phase 3 site? • How can we improve protocol development? • Is there a new way to execute the industry sponsored study? • How can we make it easier and more efficient? • Can study start timelines be shortened? • Can costs be reduced? • Is a country-wide master agreement possible?

10. Industry’s Response to Concerns of Academic Medical Centers Joseph S. Camardo, M.D. Senior Vice President CTSA Workshop June 22, 2009