The Department of Biotechnology (DBT), Translational Health Sciences and Technology Institute, Regional Centre for Biotechnology and National Institute of Immunology will soon launch a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support service called National Development Service Agency (NDSA) for small and medium enterprises (SMEs) and other relevant bodies.
Dr T S Rao, Advisor, DBT, said that this society will provide a supportive and focused environment to host world class clinical translation through a collaborative network of clinical research sites (centres of excellence). It will tend enterprises, particularly SMEs, involved in new technology innovation to facilitate translation of scientific know-how into viable products. NDSA shall also undertake, aid and promote training duly accredited by an appropriate body in preclinical and clinical product development.
The NDSA will be governed by a governing body set up under Rule 24 of the Society Rules and Regulations whose members will be nominated by the DBT and chaired by secretary of the DBT or his/her nominee. The responsible body for executing the functions of the NDSA will be the Executive Management Committee (EMC) comprising of a chief operating officer and representatives of the partner organizations.
To help manage and execute its services, the NDSA seeks to form a consortium with three associate organizations. The DBT has already invited proposals in this regard. The partners need to be esteemed departments, units or centres of institutions or organizations governed through an autonomous society or a section 25 company recognized by DSIR. They should have a designated leader with an established academic and business reputation in product development and a team of at least three to four full time researchers and other experienced and accredited clinical research professionals.
The researchers should have research publications in peer reviewed journals and experience of attracting independent grants from national/international agencies. The organization should have an experience in conducting preclinical and/or phase II-IV clinical product development trials (including population based studies/field trials) for vaccines, drugs, medical devices and other biopharmaceutical products and also audited by international agencies for compliance to ICH. Ownership or in-partnership ability for managing/conducting phase-I trials would be helpful.
The partners shall enter into an agreement for a minimum duration of 10 years. NDSA shall provide a core grant to the partners towards capacity building, training and maintenance of their personnel and building a suitable infrastructure for the services provided by them, keeping in mind the evolution in life sciences and requirement of a globally operating Indian industry.
In return, the partners shall be responsible for preferential conduct of project related services being executed by NDSA for which the expertise and ability resides with them and to contribute to human resource development activities. The consortium shall work in an autonomous manner, build collaborations nationally and globally and emphasize low cost health care product development. The NDSA partners will maintain their independence to provide and execute their services in areas that are not under the mandate of NDSA.