Call For Proposal

BIRAC Announces Request for Proposals for Clinical Development of novel/new/next-generation vaccine under National Biopharma Mission Last Date : 9th March, 2020 05:00 PM

National Biopharma Mission Program: An Industry-Academia Collaborative Mission of Department of Biotechnology (DBT) for Accelerating Early Development for Biopharmaceuticals; to be implemented by Biotechnology Research Assistance Council (BIRAC)-a Public Sector Undertaking of DBT.

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The National Biopharma Mission was approved by the Cabinet for implementation in May 2017 with a total cost US$ 250 million which is co-funded by World Bank 50%.

Mission of the Programme:
To enable and nurture an ecosystem for preparing India’s technological and product development capabilities in biopharmaceuticals to a level that will be globally competitive over the next decade, and transform the health standards of India’s population through affordable product development

RFP 1: Clinical Development of novel/new/next-generation vaccine candidates

Background:

Vaccines are one of the most cost-effective means available for managing infectious diseases, many of which, such as pertussis, measles, mumps, rubella and polio, had been principal causes of mortality and morbidity in the past. Additionally, past 20 years have seen a rejuvenation of innovation in vaccines.

There are many existing preventable infectious and emerging/ re-emerging diseases that impact Indian population. Despite public health importance, they are not prioritized by Global policy makers, research and pharma companies. To address this, it becomes important that novel/ new/ next generation vaccines are developed that are appropriate for Indian population and align with Indian public health needs.

Objective:

Vaccine candidates for many of the diseases relevant to India exist in early development stages in the portfolio of Indian companies. The Mission thus aims to facilitate clinical development of promising novel/new/next-generation vaccine candidates by the Indian industry by de-risking clinical development. This call seeks proposals that would benefit acceleration of cost effective, safe and efficacious vaccines through direct funding of clinical trials and providing access to a group of experts from industry and academia with relevant expertise that would help define and streamline clinical development pathway for efficient and quicker product development.

Proposals are thus invited by applicants who have vaccine candidate(s) in clinical development stage and are interested in seeking support in accelerating its development.

Scope of the Call:

The call seeks proposals for development of novel/new/next-generation vaccine candidates that are either currently in clinical stage of development or clinical trials are about to be commenced (completion of pre-clinical studies by March 2020).
The vaccine should be developed for disease with high burden in India, with clear economic and public health need and for diseases with potential of outbreak.
In-licensing of vaccine candidates and further clinical development in country may be considered with appropriate justification provided for in-licensing. 
The call will fund activities related to design and conduct of clinical trials in India including:
   - Clinical assay development.
   - Design and conduct of Phase I, II, and/or III clinical trials.
   - Evaluating possible laboratory correlates of immune protection in the context of Phase IIb/III clinical trials that demonstrate significant vaccine efficacy.
   - Manufacturing and scale-up of Pilot Scale and large-scale clinical trial batches.

 

The proposals can be submitted:

 

- Solely by Indian Company / Non-profit organizations/ LLP/ Society/ Trusts/ Foundation/ Associations/ Government entities/ Institutes/ R&D Organizations/ which is a legal entity OR

- Jointly by Indian Companies/ Non-profit organizations / LLP/ Societies/ Trusts/ Foundation/ Associations/ Government entities/ Institutes/ R&D Organizations/ OR

- By a consortium of Indian Companies/ Non-profit organizations/ LLP/ Societies/ Trusts/ Foundation/ Association/ Government entities/ Institutes/ R&D Organizations

- Indian Start-up companies in collaboration with Industry/Academia/research institutes/ are specially encouraged to apply.

Proposals are required to be submitted online only. For submission of proposals, applicants need to register with BIRAC through “User Registration”. Additional information on user registration and proposal submission are available online at BIRAC website at www.birac.nic.in.

No Hard Copy to be submitted. Proposals submitted online only would be considered.

Last date for Submission of Proposals :    28th Feb, 2020 05:00 PM

BIRAC will ensure maintenance of strict confidentiality of the proposals as per DBT norms.

For any queries, please contact:

Head – Investment: technical.birac@gov.in, nbm2.birac@nic.in

Announcement Date: 31-01-2020
Last Submission Date: 09-03-2020 05:00 PM

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