Deadline: 15-Mar-25
The BioE3 (Biotechnology for Economy, Environment & Employment) Policy for ‘Fostering High Performance Biomanufacturing’ has been approved by Union Cabinet in August 2024.This Policy lays down the framework for high-performance Biomanufacturing, to accelerate the development and scale up of bio-based products in the country.
Biomanufacturing can fundamentally transform the global economy from today’s consumptive manufacturing paradigm to the one based on regenerative principles, and will play a pivotal role promoting in ‘Green Growth’ while driving country’s Bioeconomy.
Scope of the Call
- Cell and Gene Therapy (CGT) has been identified as one of the priority areas under the ‘Precision Biotherapeutics’ vertical of the BioE3 Policy for ‘fostering high performance Biomanufacturing’. The CGT sector is a rapidly evolving field with transformative potential for treatment of a range of complex and previously untreatable diseases. The potential of this emerging therapeutic modality is highlighted by the increasing number of CGTs which have been approved and are also in the development pipeline.
- Hence, DBT and BIRAC aim to foster an innovation ecosystem for enabling the development of novel CGTs with an emphasis on improving clinical outcomes, enhancing safety, and advancing translational applications in the field.
- In view of this, DBT and BIRAC invite proposals on “Precision Biotherapeutics-Cell and Gene Therapy”, with the objective to build requisite capabilities and create necessary infrastructure for advancing this field through novel approaches/technologies, and enabling development of a pipeline of indigenous and affordable CGT candidates. The proposals are invited under the categories:
- Discovery & Application-oriented Integrated Network Research; and
- Bridging the gaps for scale-up.
Funding Information
- Projects having academic partners only will be funded by DBT. Projects involving Academia and Industry or only Industry will be supported by BIRAC.
- Extent of funding will depend on the proposed activities and will be in alignment with the “Implementation Plan for the Biomanufacturing and Biofoundry Initiative” attached as ANNEXURE-1.
- Project duration will be upto 2 years, extendable upto 5 years based on the performance.
Key Requirements for the Proposed Projects
- Plan for collaboration between academic institutions, industry partners, and clinical researchers, for enabling early translational leads and outcomes
- For proposals related to IND-enabling studies and clinical development, there should be clearly defined Product Development Plan with defined proposed activities, specific milestones & timelines, and the budget estimates depending on the stage of development.
- Details on feasibility of advancing the candidate from the current readiness state of technology/stage of development by providing a clear understanding and articulation of risks and proposed solutions to these challenges including technical, regulatory & IP risks.
- Proposals for early and late stage clinical development should include previously conducted studies and available supporting data depending on the stage of development, as described below:
- For regulatory toxicology studies: ‘Proof-of-Concept’ studies such as functional in vitro assays; animal safety and efficacy studies; batch consistency and stability data.
- After completion of regulatory toxicology studies, studies on manufacturability and stability of the CGT products, and previously conducted clinical trials in India or globally, need to be included.
- For proposals involving CGT candidates in Phase-II/Phase-III clinical trial, details of uniqueness/novelty of their proposed product from the ones already existing in the market, as well as, cost comparison with marketed products, need to be included.
- If seeking support for clinical development, then following needs to be submitted:
- Clinical assay development plan: Details of clinical assays, selected facilities or partners for conduct of assays.
- Manufacturing strategies: Details of expression platforms, cell lines, analytical assays, formulation strategy
- Clinical trial strategy: Details of the clinical development plan and clinical trial sites; Plan for utilization of DBT/BIRAC/NBM established clinical trial networks for conduct of clinical trials.
- Regulatory plan
Eligibility Criteria
- Academic Organisations:
- Proposals may be submitted by interested applicants engaged in research activities at various Institutions/Universities/Societies/ Trusts/NGOs/Foundations/ Voluntary Organizations, recognized as a Scientific and Industrial Research Organization (SIRO).
- The Principal investigator must have at least four years of the employment remaining in the institution at the time of proposal submission.
- Industry:
- Eligibility criteria for the Industries will be as per “Implementation Plan for the Biomanufacturing and Biofoundry Initiative” attached at ANNEXURE I.
- Pre-requisite documents required to be submitted by the Industry as per the BIRAC norms are as follows:
- Companies/Startups:
- Incorporation certificate
- CA/CS certified share holding pattern as per BIRAC format (Companies having a minimum of 51% Indian shareholding/individuals holding Indian passports are only eligible) mentioning UDIN number.
- Details regarding in-house R&D facility, if any; or Incubation Agreement with recognized Incubator.
- Audited financial details of latest last three financial years,
- Copy of passports of the shareholders if required (in support of 51% eligibility criteria).
- Limited Liability Partnership:
- Incorporation/Registration Certificate.
- Partnership deed; CA/CS certified certificate which states that minimum half of the partners are Indian citizens mentioning UDIN number.
- Copy of passports of Indian partners/subscribers
- Research mandate/details regarding in-house R&D facility, if any/Incubation agreement
- Audited financial details of last three financial years;
- Companies/Startups:
For more information, visit BIRAC.
