News Description

1.    Background

 

It is proposed to launch a Contract Research/Service Scheme (CRS) in the Biotech Sector which would facilitate the academia-industry interaction to take forward the research leads of Academic Universities and Research Institutes through validation and translation by industry.  This scheme would encourage the lab scale technology of the academia to reach the commercial scale along with the industry under a specific contract and fee structure.

 

Numerous lab scale research leads have been/are being generated in the academic sector through funding from various agencies like DBT, CSIR, DST, DRDO etc., which have the potential for validation and translation into products.Currently the academia is capable of limited translational research, however, product development is generally not a part of their mandate. Moreover, they may not have the required infrastructure to take on product development and commercialization activity.  It is, therefore, important to take the industry on board to validate such research leads for pilot studies through Contract Research Agreements.

 

The scheme specifically involves supporting the Proof of Concept with translational attributes. Exploratory Research or fundamental discovery not having commercial potential will be discouraged. In many cases, if the Academic group requires some specific services from the industry which form a part of validation of the PoC could also be supported under this scheme.

 

For all purposes, the term academia refers to the eligible applicants from academic sector (research institutes, universities, public funded research laboratories, governmental organizations, research foundations involved in research and education).

 

2.   Principles of the Scheme

 

The contract research and service opportunity for validating academic technologies would have the following principles

 

2.1       Contract Research

Applicants will provide the Proof-of-Concept (POC)/leads to the industry which in turn would validate it functionally.

 

2.2       Contract Service

            The requirements of the Academic groupsfor some specific services from the industry such as toxicology, sequencing, use of specific equipment etc. could also be support under this scheme.

 

2.3       The Contract Research andService would be undertaken after executing necessary Agreements for Non-Disclosure, Material Transfer, etc. as required.

 

3.         Eligibility:

 

Public and/or Private Universities and Research Institutes can apply under the Contract Research Scheme with pre-determined company partner having a DSIR recognized R&D unit.

 

(i) Eligibility for Participating Academia

 

Any Institute or University having a well established research support system, for basic or applied research is eligible under this scheme.

 

(ii) Eligibility for Collaborating Company

 

Only Indian Company (ies), registered under the Indian Companies Act 1956  with atleast 51%  Indian shareholding and having DSIR* recognised in-house R&D unit, which is interested to perform such a contract research service with academic partner.

(*companies in the process of obtaining DSIR recognition may also apply along with the proof of application to DSIR. However, the final decision on such applications would be subject to their getting DSIR recognition)

 

 

(iii) Eligibility of Leads

 

The proposal from academia should come with pre-existing scientifically established proof of concept and should propose the specific research and validation/translation process to be performed by a company partner within a specific time frame.

 

Contract Research

The validation should be at a level which provides sufficient data and evidence to be able to move forward towards scale up/validation/Product Development and may fall under the following categories but not limited to:

 

       I.            Exploratory validation of technology i.e. creation of a prototype or moving the lab scale level quantity to a batch level quantity for validation

    II.            Small scale contract research, resulting in generating several batches of process or creation of multiple prototypes to engage in comparative evaluation and process refinement while fixing standard parameters

 III.            Large scale validation, which augmenting the prototype to commercial design in case of design related research or moving the process parameters to optimized process efficiency that can be accomplished in commercial batch size in any of the biotech sector.

Contract Service

For the contract service there should be a clear justification for services to be outsourced. The competence of the identified company in conducting such services should be highlighted alongwith the details of facilities available.

 

4.         Parameters for Evaluation

 

                      I.             Data analysis and data creation approaches with detailed description of the ability in generating reliable data

                   II.            Facilities for carrying out contract research in detailed description and key resources available or accessible

                III.            Nature and form of contract research results that will be provided as tangible output as well as analytical results

                IV.            Competency of research team, in addition to the core researchers, technicians and process specialists.

                   V.            Reflection of cost structure with associated deliverables.

 

5.         Modalities of Funding

 

The academia / public sector will be given a Grant-in-aid for the research, if any required to be done.  The validation and contract research and service component to be conducted by industry will be funded as grant provided through the Academic partner involved. Funds disbursement will be milestone based.

 

6.      Terms and Conditions of the Contract

 

BIRAC through its Legal and Contracts Cell will provide the necessary support to facilitate and finalize the necessary agreements including the following; 

v  Non-Disclosure Agreement (NDA)/ Confidentiality Agreement

v  Material Transfer Agreement (MTA)

v  Contract Research Service Agreement

.

The BIRAC through its IP cell will work closely with Academic and Industry Partners to assist in the FTO analysis and to ensure that all necessary patents of the background and new IP are well protected. All IP rights shall remain rested with the academia partner and in the event of technology licensing/product development, the collaborating company will have the first right of refusal.

 

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