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 110029IndiaKanikaram_s@yahoo.com

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