It seems like every week we hear of a new multi-million dollar sponsored research or collaboration agreement between a major corporation and a university. These massive undertakings – whether focused on pharma, computers, energy, agriculture, or medical devices – appear to be getting larger, more integrated, and more controversial as their sheer size and degree of industry involvement raise concerns regarding corporate influence over research activity.
These close partnerships are taking many forms with a wide variety of structures – industry-academic research teams, master IP agreements, open access arrangements, and entire specialty institutes focused on research arenas that dovetail with the sponsor’s business interests.
In the face of shrinking budgets many universities are seeking out these partnerships, and the benefits of big corporate research dollars can be significant – particularly in the current economic environment. But they don’t come without their own set of problems, challenges, and risks – legal, regulatory, and ethical — primarily revolving around the potential for conflicts of interest.
With recent revisions to NIH financial conflict of interest regulations and the adoption of “sunshine” payment provisions as part of health reform – along with the often untested structures being adopted in these far-reaching agreements — the stakes are getting higher, and the management of the myriad compliance challenges is becoming more complex. That’s why we’ve produced this critical and timely program:
Managing Conflicts of Interest in
Large-Scale Industry Partnerships
To help you navigate the pitfalls while ensuring vibrant and business-savvy collaborations, Technology Transfer Tactics’ Distance Learning Division has invited two top attorneys with a wealth of experience on this front. Please join Jennifer S. Geetter and Robert H. Underwood, PhD of McDermott Will & Emery, LLP, as they update you on important recent COI developments as well as provide practical strategies for tackling the broad spectrum of COI issues you will face and must address in today’s large-scale industry partnership initiatives.
Here’s what you’ll learn in this nuts-and-bolts session:
- Overview of research collaboration models and the business case for each
- Review of the latest developments regarding the sunshine provisions
- Best practices in COI policy and procedure development, monitoring and enforcement including:
- Defining individual, institutional, and imputed institutional interests
- Building conflict of interest management into partnership agreements
- Identifying and addressing regulatory considerations such as off-label promotion and fraud and abuse laws
- COI case studies — the good, the bad, and the really ugly
Your Expert Presenters:
Jennifer S. Geetter is a partner in the law firm of McDermott Will & Emery LLP and is based in the firm’s Washington, DC office. She focuses her practice on emerging biotechnology and safety issues, advising hospital, industry, insurance and provider clients on matters relating to research, drug and device development, off-label use, personalized medicine, formulary compliance, privacy and security, electronic health records and data strategy initiatives, patient safety, conflicts of interest, scientific review and research misconduct, internal hospital disciplinary proceedings, and emerging issues in secondary research concerning biological samples and data warehousing. Jennifer also assists health care clients in implementing research strategies, structuring research operational and compliance infrastructure, and in developing guidelines for the appropriate relationships between providers and industry.
Robert H. Underwood, PhD, is a partner in the law firm of McDermott Will & Emery LLP and is based in the firm’s Boston office. Bob has extensive experience creating and evaluating intellectual property protection in the areas of life sciences and chemistry including antibody-based and other protein therapeutics, nucleic acid and genetic technology, small molecule therapeutics, medicinal chemistry, drug discovery and development, organic chemistry, polymers, catalysts, and drug formulation and delivery. His practice focuses on patent portfolio development and management, patent prosecution, licensing, due diligence and related counseling. He also assists clients with product planning matters as they relate to intellectual property, patent life-cycle management and the acquisition and divestment of intellectual property assets.