1. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Strategies for Managing Innovation for Neglected Health Needs: Some experiences from India Dr K. Satyanarayana Sr Deputy Director-General & Chief, Intellectual Property Rights Unit Indian Council of Medical Research New Delhi 110029 India Kanikaram_s@yahoo.com

2. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Scope of my talk  Why partnerships?  What were the objectives?  Strategies  Lessons learnt  Way ahead

3. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Long term goals  Strengthen existing capacities in neglected disease R&D in India  Set up and strengthen capability for conduct of clinical trials as per GCP norms – Regulatory/Ethics  Secure the market for, and thus the use of, new medicines  Encourage industry to be more engaged in neglected diseases and to find innovative ways to share their enormous resources, expertise etc. with public sector  Seek participation of donor agencies

4. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Constraints  No existing template or model provisions  Understand the complex dynamics that shape successful technology partnering for public health outcomes  Concerns of the industry  Right mix of ownership, access and exclusivity (IP) needed to achieve project goals  Convince the Govt about the strategy

5. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Short term objective  In cooperation with pharmaceutical companies, provide access to affordable, HIV vaccine for India and other developing countries  Collaborate with the private sector to secure and access new vaccine technologies  Participate in the development of one or more projects for developing safe and effective AIDS vaccine(s) suitable for India.

6. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Develop and evaluate candidate HIV vaccines appropriate for use in India, and neighboring countries

7. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Specific Objectives  To develop and evaluate a muligenic recombinant MVA based clade C vaccine, initially in phase I clinical trials  Conduct clinical trials for safety, immunogenecity and efficacy profile of the vaccine in HIV seronegetive high risk volunteers  Establish partnerships to design, develop and evaluate candidate AIDS vaccines appropriate for use in India  Assist in conduct of Phases - II and III  Technology transfer, including transfer of manufacturing technology for production by an Indian manufacturer(s)  Put the vaccine in the public health system

8. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Strengths of partners  The ICMR has the technical know-how, infrastructure and capability for vaccine development, and conduct clinical trials.  IAVI has experience in AIDS vaccine development and evaluation, and willing to help.  Indian manufacturing units have GMP facilities for producing world class vaccine.  Development of safe and effective vaccine for HIV/AIDS is the priority by Govt. of India.

9. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Role of Partners in HIV Vaccine Development HIV/AIDS Vaccine IAVI Min Health & F W ICMR Design, develop and evaluate candidate vaccines appropriate for India Capacity building, advocacy, training for vaccine trials Transfer of technology for manufacture of vaccine in India Facilitate permissions and permits Harmonization of goals Selection of Indian manufacturer Select appropriate HIV strain Provide technical expertise Collaborate in pre-clinical trials Cohort development Community preparedness Conduct clinical trials NACO

10. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 MoU & Agreements A tripartite agreement signed (December 2000) between:  Indian Council of Medical Research  International AIDS Vaccine Initiative  National AIDS Control Organization (MOH&FW) Other Agreements  Clinical Trial Agreement - ICMR & IAVI  Material Transfer Agreement - ICMR & Therion  Confidentiality Agreement - ICMR & Therion  Co-exclusive Licensing Agreement - GOI & IAVI  Licensing Agreement - ICMR & Indian Manufacturer

11. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Strategic IP management  Strategy for handling the existing and new IP generated  Existing and new IP generated should serve the overall objective of the project  Balance public and private interests  IPR jointly owned by Govt. of India – ICMR and the IAVI  Govt. of India-ICMR shall have exclusive rights to use all patents and other IP in India and neighboring SAARC countries  ICMR grants IAVI a non-exclusive, worldwide, royalty free sub-licensable license to all new patents and other intellectual property

12. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Programme Management  A joint Project Management Committee (PMC) with ICMR and IAVI  PMC coordinates and monitors the periodic assessment, refinement and revision of R&D  The potential use of the vaccine(s) in other developing countries

13. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Current status  Therion has assisted ICMR develop a multigenic recombinant MVA-based AIDS vaccine candidate for India  Phase I trials are have been successfully concluded

14. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Lessons learnt  There is a need to work together  Critical role of International philanthropic institutions for meeting neglected health needs  Partnership to be based on transparency, mutual trust and faith  Sensitize Govt on IP issues  Strategic management of IP  Best IP management practices  Policy space for mid-course changes

15. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Conclusions  Strategic partnerships can be successful for meeting the health needs of the most vulnerable  PDPs can beneficially harness the innovation capacity of the commercial sector  Govt’s engagement is essential  Ethical testing of new products  Decisions about their introduction and use  Civil society participation  Independent evaluation and monitoring necessary  Product innovation and introduction must be complemented by policy and financial support for integration into health systems  As a long term strategy?

16. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Other drugs for neglected diseases  Clinical trials with Miltofocin, and paromomycin trial for kala-azar (with iOWH)  Sudoterb - a new molecule for TB from Lupin MNITLI Programme  Ranbaxy has just announced completion of phase II clinical trials of a new anti- malarial  Clinical trials for a HPV vaccine – Gardacil Merck under consideration

17. Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007 Thank you