Non Profit and Industry Collaboration: JDRF Perspective Richard Insel JDRF Chief Scientific Officer rinsel@jdrf.org Practical Ways to Achieve Targets in Diabetic Care Keystone, CO July 20, 2013 1
Financial Disclosure I have no relevant financial relationships with any commercial interests to disclose. I have not accepted the speaker s honorarium for this meeting. 2
JDRF Mission: Cure, Treat, and Prevent T1D Cure Treat Prevent Cure T1D by removing the disease from the lives of our loved ones Implant encapsulated islets Regenerate beta cells + Prevent their autoimmune destruction Better ways to Treat T1D so people can live healthier lives more conveniently Improve metabolic control: Devices: Artificial Pancreas Systems; Drugs: Repurposing from T2D; Smart Insulins Complications: Prevent, Reverse Prevent T1D from occurring & stopping it early Primary prevention: Vaccines Secondary prevention: Combinations
JDRF Focusing Across the R&D Pathway Discovery Lab Research ($$) Animal Testing ($$$$) Clinical Studies ($$$$$$$$) Market - Broad Availability Key Translational Points Demonstrate lab findings have effect in animals Proof of concept in humans; safe & effective Prove value; educate clinicians; reimbursement Improving Lives. Curing T1D. Proactively accelerate the discovery, development, and delivery of drugs and devices to cure, better treat, and prevent type 1 diabetes and its complications. 4
Partnerships are Critical to JDRF s Mission
JDRF: Research linked to Advocacy ADVOCACY RESEARCH ADVOCACY RESEARCH ADVOCACY RESEARCH Discovery Research Clinical Development Regulatory Delivery to Patients
JDRF: FDA Activities FDA NIH JDRF Workshops and Seminars Artificial Pancreas: Obstacles and Opportunities on the Road to Artificial Pancreas: Closing the Loop: December 2005 Towards An Artificial Pancreas: July 2008 Innovation Towards an Artificial Pancreas: April 2013 How Good Does a Beta Cell Have to Be: November 2009 Seminars: Alternative beta cell source, encapsulation, etc. Artificial Pancreas placed on Critical Path list in 2006 Algorithms can be extensively tested on in silico patients prior to clinical study; eliminates animal testing Regulatory clarity on artificial pancreas systems 7
JDRF: Reimbursement Activities JDRF multicenter phase IV clinical trial of effectiveness of Continuous Glucose Monitors in Type 1 Diabetes Change in reimbursement policy (United Healthcare, Aetna, Cigna, Wellpoint, Kaiser Permanente) 8
Development of New Therapeutics is Slow, Expensive, and Failure Prone: Role for Biomedical Research Foundations to De Risk Process 9
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Increasing Biomedical Research Foundation Partnering with Industry Cystic Fibrosis Foundation Announces Investment to Speed Development of Additional Drugs to Treat the Most Common CF Mutation April 7, 2011 (up to $75 million over five years) Cystic Fibrosis Foundation Therapeutics Announces $58 Million CF Drug Discovery Agreement with Pfizer November 19, 2012 The Stanley Family Foundation co-leads a $21 million venture round for Heptares Therapeutics to advance GPCRbased drugs into the clinic for Alzheimer s and schizophrenia June 27, 2013
Goals of JDRF Industry Partnering Advance and accelerate translation of research, product development, and clinical proof of concept Gap addressing Catalyzing commitment and pace of R&D Partnerships not grants 12
JDRF Industry Partnerships Project/product specific; Not equity investment Contract, not a grant; Milestone driven payments Financial and non financial (strategic); Minimum matching $ from partner; In kind from partner Funding of projects in either academia, biotech, or pharma High level of accountability, reporting (monthlyquarterly) Interruption clause Capped royalty stream based on multiple of funding 13
Types of JDRF Industry Partnering JDRF + Pharma co funding projects in academia and early stage biotech companies JDRF funding (+ partner matching funding) specific projects with pharma and biotech companies No seeding or company formation to date (future goal)
JDRF Pharma Joint Funding Collaborations JDRF & Pharma co funding to support innovative, high risk projects Pharma $ JDRF $ Scientific & Grants Management 15
JDRF Industry Discovery & Development Partnerships (IDDP) JDRF co funds specific project in company
JDRF Strategic Industry Partnerships (Non Financial)
JDRF Industry Partnering FY05 13 Partnered with 42 companies to support 56 collaborative projects 25 currently active industry partnerships $130M commitment of a total of $1.17B JDRF research funding commitments during that period (11% of total) Some projects co funded with other non profit disease foundations (e.g., Helmsley Charitable Trust, MS Foundation, etc.)
JDRF Industry Partnerships Cure & Prevent Therapies Pipeline
JDRF Industry Partnerships Treat Therapies Pipeline
Increasing Non Profit Academia Industry Partnering Academia Non- Profit Academia Non- Profit Industry Industry
JDRF Pharma Joint Funding of Precompetitive Consortium JDRF & Pharma co funds to support tool development (biomarkers, imaging), or target/pathways discovery Pharma $ JDRF $
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