bridging gap in global innovation – from need to access, said business school, university of...
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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. SatyanarayanaSr Deputy Director-General &Chief, Intellectual Property Rights UnitIndian Council of Medical ResearchNew Delhi [email protected]
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?StrategiesLessons learntWay ahead
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
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
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.
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
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
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.
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/AIDSVaccine
IAVIMin 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 developmentCommunity preparednessConduct clinical trials
NACO
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
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
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
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
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
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?
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
Bridging Gap in Global Innovation – From need to Access, Said Business School, University of Oxford 9-13 September 2007
Thank you