Call For Proposal

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 : Translational Research Consortium (TRC)

Background:

Vaccines have been one of the most successful cost-effective interventions in global health. Majority of the current successful vaccines have been developed empirically through an ‘isolate, inactivate, attenuate or subunit approach’.

However, traditional vaccine development has proven insufficient to deal with some pathogens.  Additionally, in recent times, many vaccine candidates have failed in Phase II/III clinical trials. They yielded less than optimal results and efficacy despite promising preclinical efficacy data. These late-stage failures render the time and resources spent towards the vaccine development futile.

The hurdles in developing effective vaccines against important pathogens have been many, such as identifying conserved epitopes, identifying early markers of vaccine efficacy, defining correlates of protection and analyzing mechanisms of long lasting protective immune response. Understanding the human immune system as it responds to infection, vaccination, and other antigenic challenges, is essential for establishing a robust pipeline of vaccine candidates. But, immunoprofilling is highly complex, and its elucidation requires understanding of multiple disciplines of biology.

However, rapid emergence of high-throughput technology platforms in biology and the use of systems-based approaches to analyze large and varied sets of ‘omics’ data have led to broader and deeper understanding of complex immune response pathways. With major advances in platform technologies that include cell phenotyping, genomics, epigenomics, transcriptomics, metabolomics and proteomics, it is now possible to rapidly characterize various types of immune cells.

Results of such immunoprofilling studies using well established endemic cohorts or challenge models where possible, will create a foundation to identify potential targets for development of new vaccines, establish key gate-criteria for advancing candidates to next step, predict vaccine usefulness in different populations well in advance of efficacy studies, develop correlates of vaccine efficacy, and signatures to detect adverse events triggered by vaccination.

Objective:

The purpose of this RFP is to stimulate discovery, and/or early translational research to enable and accelerate the development of novel vaccine candidates. Cross-fertilization of ideas and collaboration among clinicians, immunologists, molecular and cell biologists, protein chemists, bioinformaticians capable of big data analytics, structural biologists and other domain experts is highly encouraged. To enable this, the National Biopharma Mission plans to establish Translational Research Consortium (TRC) in each of the disease focus areas as mentioned below.

Applications are hence solicited from multi-disciplinary teams to apply for establishment of a Translational Research Consortium.

Scope:

A.   Depending on the maturity of research and the product pipeline landscape of vaccines against Respiratory Syncytial Virus (RSV), Hepatitis E Virus and Plasmodium spp, the respective consortium’s scientific research question should focus on the following:

1. Epitope identification and validation using concepts of Rational Vaccine Design like novel technologies for deep, high-throughput analysis of human immune responses in disease cohorts or cohorts from challenge trials that can clearly define protected individuals, advances in structural biology and protein design resulting in structure-guided immunogen design and development of better fit-for-purpose animal models such as humanized mice capable of mimicking human responses etc.

           Examples of research questions include, but not limited to:

               - Identifying neutralizing epitopes through in silico analysis and experimental evaluation based on MHC and antibody binding.

              - Predicting epitopes through docking and modelling studies based on structures of viral proteins/ antigens, antibody-antigen complexes.

             - Identifying sequences through bioinformatics approach that should be excluded due to risk of autoimmune responses.

               And/Or

         2.  Candidate prioritization to further the development of vaccine candidate

                 -   Developing and utilizing functional assays to assess immunogenicity of the vaccine candidate.

                -   Evaluation of the developability of the vaccine construct to down-select potential vaccine candidates.

B.  This Call would support collaborative proposals that combine complementary and synergistic research strengths for establishment of Translational Research Consortium for any one of the above-mentioned pathogens  (i.e. Respiratory Syncytial Virus (RSV), Hepatitis E virus or Plasmodium spp.)

The proposals can be submitted:

- 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. 

Note: Sole Applicants are not eligible to apply for Translational Research Consortium (TRC).

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 :    13th March, 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: 09-05-2020 05:00 PM