Q: What are the key points to be aware of and why?

A:

• Every start-up, every innovator, and every opportunity is different. What is common to them all, however, is the need to be in touch with the COI Office and OCR, . We will look at your research portfolio, planned involvement, and then provide a roadmap of what to expect in terms of research management, activities management, timing for approvals, and recommendations to the senior administration. Let us help you stay organized!
• Help us help you! Let us also help you update your external interest disclosure with all the required information about your startup ahead of signing the incorporation documents you will need to sign eventually. Early disclosure means we can start you down the road to successful navigation of the requirements, approvals and management plans required. We work with the best and brightest in OCR, The Provost’s Office, OGC and Senior Faculty on the COI Committee to deliver exceptional service. Pick up the phone or send us an email, and we will help you start the process, navigate the disclosure form, and recommend next steps. In addition, we will route the information where it needs to go to avoid any delay caused by incomplete facts and missing requests.
• Always remember: We are your partners in this endeavor. Watching Yale inventions go from the laboratory to the marketplace is one of the greatest rewards of our work. We are rooting for our faculty, their startups and for the University as we navigate these issues together.

Q: What are common pitfalls, and how can they be avoided?

A:

• Late disclosure of your startup. The downstream effects of this misstep are many. If you wish to or need to sit on the Board of Directors of your startup to attract investment, the COI Committee needs to review that request in the light of your current research portfolio and University activities, and the COI Committee will then make a recommendation to the Provost’s Office, which will consider your request. This takes a short time, but timing is critical. Approval must be obtained before you may accept a seat on the Board of Directors. If you request a Board seat, make sure every part of your relationship with the startup is in the disclosure, i.e., IP to be licensed, the sponsor and award numbers, that the invention was discovered in your lab, the percentage of equity you plan to hold at signing, etc. All of this is relevant and necessary information.
• Leave of Absence and Sabbatical requests to run your startup. These two things are not the same and require much different considerations and approval processes. It is not enough for your Department Chair and Dean to sign off on these requests. It is a much more involved process that overlaps with COI and before you engage your Dean and Department Chair in these negotiations, please connect with the COI Office, OCR, and our colleagues in the Provost’s Office so we can guide and advise.
• Not thinking about research and commercialization simultaneously. Innovators typical do not see the direct and significant relationship between their ongoing research and the aims and commercial interests of their Startup. Our goal is identifying those direct and significant relationships where they exist, help manage them, and report as required to our Federal partners. We are typically agile at working these issues and our goal beyond our regulatory requirements is to add value to the faculty member, the University, and the startup investors.

Q: If I forget to disclose something, or do so incorrectly, what should I do?

A: Don’t panic. We’ve got you. Our staff and leadership are deeply attuned to the disclosure system and our obligations to faculty, administration, and our federal partners. Our goal is to deliver concierge level service. So, once you realize something has been forgotten, just call us and we will work with you immediately to rectify any issues and recommend any remediation required. We can jump into the system with you and guide you on what to include, how to navigate the disclosure and next steps. Our colleagues in OCR work closely with us so we can gather all the required IP information related to your startup and we can stage that information for your final review and approval. In the end, it is the innovator’s responsibility to accurately and timely disclose these relationships, but we are here to help at every turn.

Q: Who else outside of Yale benefits from the COI process i.e., the investment community?

A: Investors are primarily interested in financial return on their investment, so their interests don’t appear to be aligned with the COI Office’s mission of implementing and overseeing the regulations regarding conflict of interest. The goal of these regulations is to reassure our federal partners, the scientific community, and the public that your research is not biased by your financial interests and to protect research integrity at Yale. While our mission is to protect the research and implement and act on the regulations, the result adds value to the innovator, the institution, the startup and by extension, the investor. Simply put, by managing research related to the innovator’s startup we are protecting the University IP that has been licensed to the startup, the innovator’s publications, and public claims from accusations of bias, which protects the investors. Our approach protects the inventor/innovator, the University and the startup from reputational harm that could come when innovators fail to disclose financial interests properly and thoroughly. Other institutions have had to wrestle with the fallout of these types of disclosure failures and we will not let that happen here at Yale. In short, our (Yale’s) approach protects investors from undue risk.

Q: Can you share an example when the COI process “saved the day” so to speak?

A: As we discussed earlier, every case is unique, and all our work is confidential as you can imagine. An innovator’s external financial interests are highly confidential and must be handled with care, and as such I am not at liberty to discuss specifics. What I can tell you is that we have many faculty partners who, while initially skeptical about what this regulatory arm of the University could do to assist them, are grateful for our help. They see us as partners in their efforts to bring Yale inventions to the public for the greater good. This is how we approach our work, and therefore we show up every day. Yale is an amazing place, with brilliant faculty and administrators. When we all pull in the same direction, remarkable things happen. Almost every successful innovator who has formed a Yale startup has had help and guidance from the COI office and we are proud of our distinctive role in the process.