Strategies for Managing Innovation for Neglected Health Needs

Bridging Gap in Global Innovation – From need to Access,

Said Business School, University of Oxford 9-13 September 2007

Strategies for Managing Innovation forNeglected Health Needs: Someexperiences 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

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

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&Din India

Set up and strengthen capability for conduct of clinicaltrials as per GCP norms – Regulatory/Ethics

Secure the market for, and thus the use of, newmedicines

Encourage industry to be more engaged in neglecteddiseases and to find innovative ways to share theirenormous 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 shapesuccessful technology partnering for publichealth 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 pharmaceuticalcompanies, provide access to affordable,HIV vaccine for India and other developingcountries

Collaborate with the private sector to secureand access new vaccine technologies

Participate in the development of one ormore projects for developing safe andeffective 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 HIVvaccines 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 MVAbased clade C vaccine, initially in phase I clinical trials

Conduct clinical trials for safety, immunogenecity andefficacy profile of the vaccine in HIV seronegetive highrisk volunteers

Establish partnerships to design, develop and evaluatecandidate AIDS vaccines appropriate for use in India

Assist in conduct of Phases - II and III

Technology transfer, including transfer of manufacturingtechnology 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 vaccinedevelopment, and conduct clinical trials.

IAVI has experience in AIDS vaccinedevelopment and evaluation, and willing to help.

Indian manufacturing units have GMP facilitiesfor producing world class vaccine.

Development of safe and effective vaccinefor 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 inHIV Vaccine Development

HIV/AIDS

Vaccine

IAVI

Min Health& F W

ICMR

Design, develop andevaluate candidatevaccines appropriatefor India

Capacity building,advocacy, training forvaccine trials

Transfer oftechnology formanufacture ofvaccine in India

Facilitatepermissions andpermits

Harmonization ofgoals

Selection of Indianmanufacturer

Select appropriateHIV strain

Provide technicalexpertise

Collaborate in pre-clinical trials

Cohort development

Community preparedness

Conduct 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 IPgenerated

Existing and new IP generated should serve theoverall objective of the project

Balance public and private interests

IPR jointly owned by Govt. of India – ICMR andthe IAVI

Govt. of India-ICMR shall have exclusive rights touse all patents and other IP in India andneighboring SAARC countries

ICMR grants IAVI a non-exclusive, worldwide,royalty free sub-licensable license to all newpatents 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 theperiodic assessment, refinement andrevision of R&D

The potential use of the vaccine(s) inother 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 amultigenic recombinant MVA-based AIDSvaccine candidate for India

Phase I trials are have been successfullyconcluded

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 philanthropicinstitutions for meeting neglected healthneeds

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 meetingthe health needs of the most vulnerable

PDPs can beneficially harness the innovationcapacity 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 becomplemented by policy and financial support forintegration 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, andparomomycin trial for kala-azar (withiOWH)

Sudoterb - a new molecule for TB fromLupin MNITLI Programme

Ranbaxy has just announced completionof phase II clinical trials of a new anti-malarial

Clinical trials for a HPV vaccine – GardacilMerck under consideration

Bridging Gap in Global Innovation – From need to Access,

Said Business School, University of Oxford 9-13 September 2007

Thank you