Academic Innovations & Global Health Impacts

1. Academic Innovations & Global Health Impacts Usha R. Balakrishnan Founding President, CEO & Chairman of the Board CARTHA Iowa City, Iowa February 21, 2007 Presentation at University of Iowa College of Pharmacy Hazel Seaba’s New Course on Pharmaceutical Management in Underserved Populations

2. Presentation OutlinePersonalizing the Story from my Iowa Base • Part 1 • Managing technology transfer and alliance-building functions at the University of Iowa, 1990-2005 • Part 2 • Founding Technology Managers for Global Health, 2003 • Founding CARTHA, 2006 • Interactive Discussion

3. Part 1

4. Fostering Technology Transfer& Managing Alliances at the University-Industry-Community Interface 15-year career at The University of Iowa

5. Academic Innovations Technology Transfer Profession

6. Bayh-Dole Act of 1980 • Allowed US universities the right to retain title to inventions arising from federally-funded research, and patent/license these inventions • Spurred the birth of the modern “academic technology manager” • Association of University Technology Managers

7. Academic TT Roles • Receive invention disclosures from university researchers • Educate/advise researchers re IP policies & procedures • Evaluate disclosures for patentability and commercial potential • Engage patent lawyers to file, prosecute, maintain and enforce IP based on invention disclosures • Market inventions and negotiate license or other contractual agreements to formalize collaborations with industry partners to commercialize inventions • Monitor licensees for compliance with contractual terms • Disburse royalty proceeds to various stakeholders • Report periodically to research sponsors under various federal funding and other regulations, policies and guidelines.

8. Academic Patenting Functions • Patent searches, patentability opinions • Patent filings, prosecution strategy, interferences • Patent licenses, options, drafting/review of specific clauses • R&D agreements with IP clauses • Patent enforcement, license compliance, litigation • Inter-institutional agreements (for jointly owned patents) • Co-inventorship disputes • Negotiation of multi-party agreements

9. AUTM Membership Profile • 78% USA • 10% Canada • 12% Rest of the World Source: 2006 Presentation by John Fraser, President, Association of University Technology Managers (AUTM)

10. Growing volume of academic tech transfer • $40 billion in US R&D expenditures (FY’04); • 4,783 new licenses; • 27,322 current licenses; • 462 new spinout companies; • 4,543 new spinouts since 1980; • 50 FDA approved products based on academic inventions. Source: 2006 Presentation by John Fraser, AUTM President

11. Part 2

12. What began to bother me in 2002? • The figures relating to health disparities • The 10/90 gap: Only 10% of the world’s health research funding is allocated to 90% of the world’s health problems • Of 1300 new medical compounds in last 25 years – 11 were for tropical diseases of the poor (6 of those were for animals) • Significant other factors: lack of clean water, food, sanitation, health worker shortages, poor infrastructure • 1 child dies every 3 minutes from malaria in Africa • 2.2 m AIDS deaths in Africa; 26 m infected • 11m AIDS orphans in Africa ; 14m in the world

13. Disease Burdens Sources: UNAIDS, WHO

14. Who do you call? The need to connect with others: R&D players and prospective partners in global health fields

15. Collegial network set up in 2003 TMGH: A special interest group within the Association of University Technology Managers (AUTM) www.tmgh.orgwww.autm.net

16. TMGH: Founding Objectives • Creatively manage and license inventions for treatment of diseases that disproportionately affect the poor in developing countries • Ensure access to, and promote further development of technologies for the benefit of the poor in developing countries

17. My “global health” inspiration in 2002 MARIA FREIRE President & CEO Global TB Alliance New York

18. My angel investor in 2004 CHARLES A. GARDNER Associate Director Health Equity The RockefellerFoundation New York

19. TMGH Accomplishments, 2003-2006 • Initiated awareness-raising dialogs • Introduced sessions at key conferences • AUTM, Licensing Executive Society, Biotechnology Industry Organization, Global Health Council, other venues • Conducted global health tech transfer survey • Article published in AUTM Journal, December 2006 • Conceptualized professional exchange programs • Developed training programs, curricula, case studies • Produced and widely distributed booklets

20. TMGH-MIHR Booklet, 2005 • Produced in May 2005 • Originally intended for 100 • Distributed to >4,000 professionals • Gathered case studies to feature from NIH, MIT, UC-Berkeley, and a consortium of Southeast US universities

21. TMGH-MIHR Sequel Booklet, 2006 • Produced in August 2006 • Distribution to all AUTM members in October 2006 • “Sequel” booklet includes 4 case studies

22. Global Product Development Partnerships

23. Case Study 1 • Vanderbilt University & Aeras Global TB Vaccine Foundation • May 2006 • Exclusive license agreement for a TB vaccine • Aeras has exclusivity for the TB field • Vanderbilt retains rights in other fields

24. Case Study 2 • Institute for OneWorld Health, UC-Berkeley, Amyris Biotechnologies, Inc. • December 2004 • Improved production of artemisinin for malaria treatment • Artemisinin traditionally derived from wormwood plant • $42.6 million grant from the Gates Foundation

25. Case Study 3 • International AIDS Vaccine Initiative • Progress since the formation of the Neutralizing Antibody Consortium in July 2002 • Filling a critical gap in AIDS vaccine development • Initially included four founding institutions • Now an international group of 15 labs (academic, government and nonprofit research organizations)

26. Case Study 4 • Global TB Alliance & Bayer Healthcare • October 2005 • Global clinical development of Moxifloxacin • Working on reducing treatment time for TB • $104 million grant from the Gates Foundation

28. TMGH: Updated Objectives, 2006 • To enhance academic research translation and technology transfer practices, professional development, and networking in a way that advances global health causes. • To gather and feature case studies and inspiring “human interest” stories around the work of everyday professionals and everyday scientists engaged in research translation and technology transfer.

29. TMGH 4th annual meeting at AUTM 2007“Human Interest Stories” in Tech Transfer Linda Harrar Award-winning documentary producer Guest speaker at TMGH 2007 To be held in San Francisco, March 9 2006: Winner of the Emmy & Winner of Gates Award for Global Health Media Excellence

30. Interactive Discussion Transnational Concerns Extremely Complex Landscapes

31. Media Attention to Global Health

32. Topics for Interactive Discussion • TRIPS & Global Public Health • Compulsory Licensing, Generic Production, Litigation • IP, Innovation & Public Health • UK CIPR Commission, 2004 • WHO-CIPIH Commission Report, 2006 • Procurement: GAVI, UNICEF • Manufacturing Capacity, Regulatory, Clinical Trials: EDCTP • Financial Incentives-Adv. Purchase Commitments • Drugs: Access & Distribution Concerns: PEPFAR • WHO Globalization, Trade and Health Department, 2006

33. IP Licensing: Definitional Problems • Neglected diseases vs. diseases that disproportionately afflict poorer populations • Developed vs. Developing Countries • Market Segmentation within Low and Middle Income Nations • Global health: a vast and growing challenge • Include also chronic diseases (diabetes, cancer, heart disease, mental health disorders) • Metrics still being developed for evaluation & outcomes

34. Patent System is Not Perfect, Anywhere • Backlogs in patent offices, including in the US • “Trivial” inventions being patented • Increased litigation • Enforcement procedures and practices • “Pay-for-delay” patent term extension schemes between pharma & generics industry • Patent reform legislation pending

35. Even if IP issues were fully resolvedEven if drugs were made fully available… Lots of other concerns exist and are emerging (Laurie Garrett’s article in Foreign Affairs Journal)

36. Larger context for R&D, IP, drugs access in improving global health equity • Global health arena: complexity beyond medicines and drugs • Hunger, starvation…. • Crises: Natural disasters, pandemic flu threats…. • Lack of clean water, sanitation…. • Lack of healthcare personnel, uptake among users…. • Poor infrastructure, transportation systems…. • Corruption, delays, counterfeit products…. • Conflicts and large population displacements…. • Crumbling social structures, orphans…. • Pollution, environmental degradations….

37. Fostering Expanded Roles for Universitiesin Promoting Global Health Equity • Embrace a broader, more purposeful vision • Challenge to higher education leaders • Conduct cutting-edge R&D in “unmet needs” of our world • Involve scientists from a variety of disciplines • Engage in new global scientific collaborations, TT, capacity-building, policy making, training initiatives • Expand social networks and communication channels • Prepare students to be global thinkers, bridge builders, cultural translators, and future leaders in global health fields • Design career advising, internships: job descriptions needed!

38. With So Many Others Striving to Make a Difference in Local, Regional, National & Global SettingsTo Make Our World a Better Place

39. THANKS I welcome your comments! CARTHA.GLOBAL@gmail.com Phone: 319-248-9625 www.cartha.org