Presenting a live 90-minute webinar with interactive Q&A Negotiating Collaborative Healthcare Research Agreements Structuring Joint Obligations, IP Rights, Confidentiality and Other Key Provisions THURSDAY, JULY 28, 2016 1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific Today’s faculty features: Eve M. Brunts, Partner, Ropes & Gray , Boston Susan M. Galli, Partner, Ropes & Gray , Boston Julie Rusczek, Esq., Health Sciences Law Group , Milwaukee The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10 .
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Research Collaborations: Intersection of Academia and Industry Strafford Webinars July 28, 2016 Eve Brunts Susan Galli Julie Rusczek Ropes & Gray Ropes & Gray Health Sciences Law Group 614.951.7911 617.951.7497 414.206.2102 eve.brunts@ropesgray.com susan.galli@ropesgray.com julie.rusczek@healthscienceslawgroup.com 57957354_3
Agenda • Scope and Background (Rusczek) • Structure and Governance (Rusczek) • Regulatory Considerations (Brunts) • Transactional Considerations (Galli) 57957354_3 5
Scope • “Research collaboration” can encompass a broad range of arrangements and activities involving academia ( including healthcare provider components ) and industry – Participants • All academia ( e . g ., consortium) • All industry ( e . g ., product co-development, extremely rare side effects) • Government and academia and/or industry ( e . g ., NIH Brain Initiative) • Non-profit foundations and academia and/or industry – Focus here is on research collaborations between academia and industry 57957354_3 6
Scope • Research – Pre-clinical research – Clinical research • Pre-commercialization and post-marketing – Data and biospecimen registries • Focus here covers full range of research activities 57957354_3 7
Scope • No generally recognized definition for “research collaboration” • Focus here on research arrangements in which academia and industry jointly contribute resources towards the conduct of research that: (1) is developed by both parties and (2) serves a common interest/mutually beneficial purpose 57957354_3 8
Agenda • Scope and Background (Rusczek) • Structure and Governance (Rusczek) • Regulatory Considerations (Brunts) • Transactional Considerations (Galli) 57957354_3 9
Trend toward Collaboration • 2003: NIH Roadmap in Science – Encouraged cross-disciplinary and multi-sector collaboration and non- traditional teams • 2004: FDA Critical Path Initiative – “The monumental effort involved in creating the scientific tools and processes necessary to support 21st-Century medical product regulation cannot be undertaken by any one entity alone. It requires the collaboration of all stakeholders — federal agencies, patient groups, academic researchers, industry, healthcare practitioners, and others.” • Increasing need for big data and specimens in research 57957354_3 10
Impetus for Collaboration - Industry • Industry facing declining R&D (e.g., July 12, 2016 news – Merck cutting 360 R&D jobs) • Productivity in drug development is falling over historical levels • Cost to bring new drug to market has been rising • Drug patents expiring 57957354_3 11
Impetus for Collaboration - Academia • NIH funding at an all time low • Applications to NIH for competing research project grants at an all time high for FY2015 – 52,190 • NIH funding struggles to keep up with inflation. • The success rate for competing FY 2015 RPG applications was 18.3% (compared to 18.1% in FY14). Remains far below the 30% approval levels 15 years ago • FY 2016, NIH budget increased by 5.9% • NIH’s capacity to fund research is still lower than it was before sequestration (prior to FY 2013). https://nexus.od.nih.gov/all/2016/03/14/fy2015-by-the-numbers/ http://faseb.org/Science-Policy-and-Advocacy/Federal-Funding-Data/NIH- Research-Funding-Trends.aspx 57957354_3 12
Industry-Academia Collaboration - Examples Yale – Gilead collaboration • Formed in 2011, extended for 3 more years in 2014 • Focused on developing novel targeted cancer therapies and determining the genetic basis and underlying molecular mechanisms for various cancers • Gilead provided $40M in research support and basic science infrastructure in first 4 years • Gilead has first option to license Yale inventions resulting from the collaboration • Research projects governed by joint steering committee http://news.yale.edu/2011/03/30/yale-and-gilead-sciences-announce- cancer-research-collaboration http://news.yale.edu/2014/10/23/yale-and-gilead-sciences-extend-cancer- research-collaboration 57957354_3 13
Industry-Academia Collaboration – Examples Bayer – UCSF collaboration • In 2011, entered into 10 year master R&D agreement • Goals include – Efficiency – provide framework for approval and funding of projects, cuts down on negotiation time for each project – Expedite the identification of potential therapeutic targets and development of drug discovery tools https://www.ucsf.edu/news/2011/02/8449/nurturing-delicate-balance-ucsfs- industry-partnerships 57957354_3 14
Industry-Academia Collaboration - Challenges • Competing goals – Industry – development/protection of intellectual property – Academia – freedom to publish results for public benefit • Conflict of interest concerns – Age of transparency/Sunshine Act – Non-exclusive relationship, researchers/institution free to work with others Address through research collaboration agreement 57957354_3 15
Collaboration Structure • Establish mutual goals – Benchmarks – Evaluate progress on periodic basis • Define scope of collaboration – Focus of research – Included/excluded topics or project types – Require industry and institution co-PIs for each project? • Set term and renewal options 57957354_3 16
Collaboration Governance • Typically governed by a steering committee – Membership – equal numbers from both sides? Provision for tiebreaker? – May be tasked with establishing more detailed policies and procedures for review, approval, funding, and monitoring of projects – Handling disputes – Regular meetings – Need for subcommittees? • Steering committee goals: efficiency, fairness, and fostering on-going collaboration 57957354_3 17
Infrastructure and Administration • Depends on scope of collaboration • Could include: – Space lease – Equipment lease – Establishing/maintaining biobank and/or databank (run by one of the parties or third party vendor) – Provision of research staff (e.g., industry scientist on-site at institution) 57957354_3 18
Budgeting and Funding • Agreement should establish cash and in-kind contributions from each party • Mechanism for determining funding for proposed projects over course of collaboration term • Critical for addressing potential conflict of interest concerns 57957354_3 19
Budgeting and Funding • Potential Anti-Kickback Statute concerns • AKS prohibits any person – from knowingly and willfully – offering, paying, soliciting, or receiving – any remuneration, directly or indirectly, – in return for • referring an individual to a person for the furnishing or arranging for the furnishing of an item or service for which payment may be made under a federal health care program, or • purchasing, leasing, ordering an item, good, or service for which payment may be made under a federal health care program. • Violators are subject to criminal and civil penalties and exclusion from federal health care programs. 57957354_3 20
Budgeting and Funding • Fair market value exchange – Take into account not only cash but in-kind contributions to work (e.g., use of space, equipment) – Often more complicated to determine in context of collaborative relationship • Ensure projects within defined scope of collaboration and help advance legitimate goals of partnership 57957354_3 21
Agenda • Scope (Rusczek) • Structure and Governance (Rusczek) • Regulatory Considerations (Brunts) • Transactional Considerations (Galli) 57957354_3 22
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