Investigator Initiated Protocol: From Idea to Funding. SRA International Annual Meeting October 2016

Transcription

1 Investigator Initiated Protocol: From Idea to Funding SRA International Annual Meeting October

2 WELCOME Marlena Kern, DNP, RN Director, Clinical Research Programs Center for Genomics and Human Genetics Feinstein Institute for Medical Research Northwell Health Diane M Marbury, CRA Director, Pre Award Grants Management Office Northwell Health

3 Learning Objectives Participants will be able to identify potential ways of engaging industry sponsors for funding investigator initiated research projects. Participants will be able to identify the necessary clauses in research agreements for collaborations. Participants will be able to effectively identify how to communicate what unmet needs they can provide for the sponsor and begin to negotiate terms and conditions which best fit their research.

4 What are Investigator Initiated Agreements? Research funded as a result of an investigator, on his/her own, submitting a research application. Also known as unsolicited research. Protocol authored by a Investigator who can collaborate with industry employees to develop preclinical programs Depending on the type of research, industry may provide flexible funding to support preclinical and early clinical development activities. If approved, funding will be accessible in installments related to achievement of specific program milestones.

5 SPONSOR A sponsor is an organization or business that provides funds for a project or activity carried out by another entity. The sponsor provides: Financial support Assistance with protocol development The sponsor can be an individual, company, academic institution, private organization or government agency.

6 What are the advantages of Investigator Initiated Industry Sponsored Research Collaborations? You have an innovation or idea to improve science or data You have an idea for a new use or indication of a current medication or treatment You have the infrastructure available to plan and complete the project but need funding when you can partner with industry or a company, you can fund innovative projects

7 Benefits of Industry Sponsored Agreements Associated prestige of being aligned with an Industry leader Access to specialized materials, equipment, methods, etc. The right Sponsor will complement your Institution s existing capabilities, activities and resources.

8 Forming Effective Partnerships with Industry Clearly define the investigator s role and the sponsor s role in the research project. This should be clearly delineated in the contract. Ensure the investigator understands his/her responsibility. Ensure that the Investigator does not work outside the scope of his/her responsibility.

9 Points to Consider Do the Institutional policies and the corporate policies of the Sponsor align? Is there freedom to publish? The Federal mandates that your Institution may be bound to as a result of other ongoing research projects and funding. Is working with the Sponsor a conflict in any way? The Investigator has responsibility and accountability for his/her research.

10 What Types of Research Can Get Funded? Industry Sponsors fund may types of research, the focus this presentation is on observational studies, such as epidemiology studies and certain outcomes research studies where the primary focus is the scientific understanding of disease. Other types of research projects also funded this way include: independent laboratory based or translational research on disease states. These may include novel diagnostic screening tools or surveys that the sponsor may have no direct commercial interest

11 Design Your Project The Investigator and the Sponsor should have mutual goals: Generating quality research High quality data Publication Innovation Look for companies or entities that match your expertise You can provide valuable data and advance scientific knowledge finding an entity who has a tie to a specific disease state or under-studies patient population

12 What s An Acceptable Project Period? The investigator needs to take ownership and devote sufficient time to the plan and make sure he/she really wants to do the research it can be a long process. What Types of Projects are Feasible? The investigator should partner with research support services within their Institution such as the Grants Management Office, IRB, Biostatistics to ensure that the project can be accomplished.

13 Budget Assure that the budget represents the real costs of performing the project. Personnel Training Laboratory work/procedures Supplies Monitoring

14 How Do You Manage Risk? Manage risk by designing a solid work plan, following the plan, completing the plan and reporting on the results! Communicate any problems promptly to stakeholders. Follow your Institution s policy for oversight of Sponsored Projects.

15 What Are The Pitfalls? Protocol Oversight Not having an appropriate sample size or not being able to recruit the promised sample size Not having clear endpoints Not having clear plan for study conduct and validity of data Protocol Monitoring Not having appropriate staff to conduct and monitor Not having appropriate staff for data oversight

16 Intellectual Property Consideration must be given to your Institution's requirements regarding ownership of patents and inventions. Publication rights must not be restricted. How will you deal with Joint IP? Set game plan for how IP ownership is dealt with Sponsor IP, Institution IP, and Joint IP

17 Successful Negotiation of Agreements Negotiation of agreements need to be a collaborative process between the Grants Office, Investigator and Sponsor. Determine what issues are truly negotiable. Acknowledge that each agreement or arrangement may be different template contracts may not suffice. Keep the end goal in mind. Know when it s time to walk away. Every negotiation may not result in a successful contract.

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19 Questions?

20 Marlena Kern, DNP, RN Diane M Marbury, CRA mkern@northwell.edu dmarbury@northwell.edu (516) (516)