Bridging Gap in Global Innovation

1
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_at_yahoo.com

2
Scope of my talk

• Why partnerships?
• What were the objectives?
• Strategies
• Lessons learnt
• Way ahead

3
Long term goals

• Strengthen existing capacities in neglected
  disease RD 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
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
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.

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Develop and evaluate candidate HIV vaccines
appropriate for use in India, and neighboring
countries
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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
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.

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Role of Partners in HIV Vaccine Development
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
Min Health F W
IAVI
Harmonization of goals
NACO
HIV/AIDS Vaccine
Selection of Indian manufacturer
ICMR
Collaborate in pre-clinical trials Cohort
development Community preparedness Conduct
clinical trials
Select appropriate HIV strain Provide technical
expertise
10
MoU Agreements

• A tripartite agreement signed (December 2000)
  between
• Indian Council of Medical Research
• International AIDS Vaccine Initiative
• National AIDS Control Organization (MOHFW)
• 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

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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
Programme Management

• A joint Project Management Committee (PMC) with
  ICMR and IAVI
• PMC coordinates and monitors the periodic
  assessment, refinement and revision of RD
• The potential use of the vaccine(s) in other
  developing countries

13
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
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

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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
• Govts 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?

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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

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• Thank you