Neglected Diseases: Policy Proposals for Universities

1. Neglected Diseases:Policy Proposals for Universities Basit Khan 30 Sept 2006

2. What is a neglected disease? • Primarily affect LMI countries • Gap in attention from global R&D • Shortage of safe, effective treatments Yamey, Brit. Med. J. 2002

3. Operational definition of neglected diseases • From the U.S. Orphan Drug Act • Any disease that either: • affects less than 200,000 persons in the United States OR • for which there is no reasonable expectation that the cost of developing and making available in the U.S. a treatment...can be recovered from sales of the treatment.

4. The landscape of R&D for neglected diseases • Push and pull incentives • Push: direct funding or facilitation of research and development (grants) • Public-private partnerships (PPPs) • Virtual R&D management • Pull: promise downstream rewards by organizing a market for eventual end products (patents) • Advanced Purchase Commitments

5. The landscape of R&D for neglected diseases Moran, PLoS Med, 2005

6. The landscape of R&D for neglected diseases Widdus, IPPPH, 2004

7. “This is an important milestone in the fight against Visceral Leishmaniasis, and it demonstrates the potential for public-private partnerships to develop new solutions to serious global health problems,” said Dr. Regina Rabinovich, Program Director of the Gates Foundation’s Infectious Diseases Program.

8. Case Study: Malaria • $323 million (2004) • 60% went to PPPs • 49%: NIAID and the Gates Foundation • Account for 80% of growth in funding (’93-’04) • 37%: Drugs • 24%: Vaccines • <1%: Diagnostics • “Were malaria research funded at the average rate for all medical conditions, it would receive more than $3 billion in annual R&D funding.” Malaria R&D Alliance

9. Where universities fit in • The preclinical gap • Source of scientific knowledge • Intellectual property transaction costs • Nontraditional partnerships • Progressive technology transfer metrics

10. UAEM policy proposals • Neglected diseases (ND) research partnering • ND research exemptions • ND research promotion

11. UAEM policy proposals:ND research partnering • Engage nontraditional partners • PPPs, nonprofits, and developing-world research institutions in ND drug development • Patent donation • Dual-market licensing • Straightforward exclusive/non-exclusive licensing • ‘Foundation’ funding for ND research projects

12. Is this contentious? • “According to several respondents, negotiations with academic institutions were often hard, reflecting rigidity and overvaluation.” • “2 cases of protracted negotiation in which the university demanded royalties for licenses covering developing-world markets.” • Universities are more difficult to deal with than pharmaceutical companies.

13. Case study: patent donation • UCSB: Ca2+-channel blockers for schistosomiasis treatment (to OneWorld) • University of Nebraska: royalty-free license to Medicines for Malaria Venture (MMV) for synthetic peroxides; allows MMV to take out subsequent patents on compounds

14. Case study: dual-market licensing • Azole compounds with anti-Chagas activity • Yale, U. Washington, and OneWorld Health • Universities reserve the right to partner with private companies for antifungal use in high-income countries

15. Case study: licensing to developing-world institutions Salicrup et al., IP Strategy Today 2005

16. Funding opportunities available • Real dollars are available for ND research • The Bill & Melinda Gates Foundation spends roughly $650M on global health each year, with a growing focus on R&D • In 2005, the foundation in partnership with the NIH awarded $450M in grants for basic science research – most went to universities • $20M to UC Irvine for new Dengue control methods • $20M to Imperial College London to treat latent TB • 9/14/06 – additional $68 million in funding for NDs www.gcgh.org

17. ‘Foundation’ funding • Upstream problem • UCSF-DNDi example: researcher unable to receive grant because of IP issues within the university • UAEM-UCSF helped to resolve the issue

18. UAEM policy proposals:ND research exemptions • Part of the EANDL • Open access to research innovations for neglected disease applications • If an innovation has not yet been out-licensed, universities should allow non-profit institutions to use that innovation for ND research as a matter of policy • For any innovations that a university out-licenses, the university should retain the right to non-exclusively open license use of its technology for ND research

19. UAEM policy proposals:ND research exemptions • In either case, the university should forego royalties on products sold in developing countries • What’s to keep companies from using the ND exemption and selling products in high-income countries? • Still actionable infringement • Cross-licenses required • PIPRA precedent

20. UAEM policy proposals:ND research promotion • Incentives to attract ND researchers and support for existing researchers • Example: UCB Center for Neglected Disease Research, Malaria Institute (JHU) • Compound libraries • Antihistamine Identified as Potential Antimalarial Drug (JHU - July 2, 2006) • Annual review practices (portfolio monitoring) • Marketing neglected disease capabilities

21. Case study: Berkeley • Socially Responsible Licensing Initiative • Several innovative licensing deals featuring royalty-free licenses, no-cost sublicenses, profit sharing, and inventor attribution. • Provides additional backing for technology licensing officers to draft licenses that pursue non-monetary goals in the future. • Increased foundation funding to Berkeley for research on neglected diseases that will be licensed under these principles

22. Research and evolution of proposals • Proposals are not static • Consultation with stakeholders and data-driven improvement • ND Policy Meeting • Research projects on non-traditional partnerships

23. The bottom line • Role of our activism: to amplify the voices of those who are directly affected by the access and research gaps • This changes the decision-making calculus of university administrators • Leads to policies that universities will eventually be proud of, but might resist mightily in the interim