1. Industry Sponsored Research Agreements Frank Sellke, MD Division of Cardiothoracic Surgery Brown Medical School Providence RI AATS Grant Course 2011

2. Industry Sponsored Research Agreements Disclosures: Steering Committee for Novonordisk DSMB: Cubist Pharmaceutical CSL Behering: Advisory Board Chairman, DSMB CT Surgery Network, National Institutes of Health National Institutes of Health (RO1 HL46716, RO1 HL 69024) to FWS Royalties from Elsevier Publishing

3. Why do Research for Industry?

5. Money is money, regardless of from where it comes NIH funding and $ from other sources is decreasing Industry often is aware of what is important clinically and in the market place. A direct link to patients. There is often a lot of funding available if you have something to offer, especially if you have a niche. The funded research often ties in with your clinical activity and interests. You can generally keep the left over money. You get to travel to very interesting places and speak with interesting and famous people.

6. Industry Sponsored Research A company wants to contract with you to do work. The company knows what they want to demonstrate. It is probably in an area in which you have an interest or some niche ability. Don’t be afraid to ask for enough money to cover all costs, and then some. When you negotiate, consider IDC to institution. Generally do not ask for salary support, especially in clinically related research.

7. Office of Technology Development: ISRA Safeguards researchers’ ability to publish the results of their research in accordance with academic custom Is limited in duration and tied to a specific research plan that is generated by the principal investigator and approved by OTD staff Negotiates who owns the results of the sponsored research and all associated intellectual property (IP), e.g., patents, copyrights and know-how

8. Office of Technology Development: ISRA Generally grants the company a time-limited option to negotiate licenses to the sponsored IP on usual and customary terms (i.e., in exchange for fair market value and with appropriate commercial diligence, including as regards global access to medical technologies) – no perpetual rights, ‘sweetheart’ deals or ability to suppress technology Offers no guaranteed results or other ‘deliverables’ – the research and any resulting IP are provided to the company on an ‘as is’ basis. Reserves the rights of researchers at the institution and elsewhere to use any sponsored IP for educational and not- for-profit research use.

9. Why Avoid Doing Research for Industry?

10. Why Not do Research for Industry? The money is considered tainted. It distracts from NIH funded and real basic science or clinical investigation. There is a temptation for you to give the Company what they want, or you are perceived as such. Promotion committees consider it less than NIH grants

11. How to get started Develop a technique or expertise in a certain area: Aortic surgery, Myocardial protection, Bleeding and transfusion therapy, Mitral valve repair, etc. Publish and give presentations at National Meetings. Speak up at National Meetings. Speak with companies: Ask if they would sponsor your research. If you are good, They will come.

12. Caution If you get paid for the research, often you cannot publish it. Consult your University or Hospital Guidelines Need to disclose relationships Keep things in perspective Make sure there is no limitation or restrictions on publication or presentation of results Don’t let industry control your academic career Don’t bias the results or give limited results to support what the Company wants to hear.

13. Questions?