The maximum treatment therapies fail during translation of results from preclinical models to humans due to deficiency of robust preclinical models Generating meaningful and predictive results preclinically requires alignment of the model systems that mirror the patient context. Animal models have many facets that mimic various disease conditions in humans like systemic autoimmune diseases, rheumatoid arthritis, epilepsy, Alzheimer’s disease, cardiovascular diseases, Atherosclerosis, diabetes, etc., and many more. In doing so, the ability to conduct both forward translations, (the process of implementing basic research discoveries into practice), as well as reverse translation, (the process of elucidating the mechanistic basis of clinical observations), greatly enhances the ability to develop effective treatments.
For testing the lead molecules/ NCE/drug repurposing etc. researchers are either dependent on preclinical models from abroad or compromise on doing the studies with available model. There is need of relevant pharmacological models which may predict the intended therapeutic indications.
KEY FEATURES OF THE CALL
The objective of this request for proposal (RFP) is to establish preclinical disease models (In-vitro/In-vivo) for screening new drugs, NCE, natural compounds, vaccines etc. Robust models would be developed which would be able to offer insights into the multifaceted pathophysiology of diseases relevant to India. The developed models should be ready to be offered as a service-based platform, which researchers/ Industries across the country may access to get their molecules tested.
In view of above, a landscape report was prepared by BIRAC and main objective of the report was to prioritize the disease areas of the country based on prevailing disease burden, Existing drug-specific pipelines, contractual Research organizations, Phase I clinical trial units and repositories/library on NCEs, biologics and bio-active molecules in the country.
Detailed methodology was chosen to prioritize the diseases. According to the method opted, 19 diseases out of 130 were identified by applying high level filters. As a result of priority process which was based on two key parameters i.e. Disease potential and Impact on community, top ten (10) indications were identified and detailed reports were generated. In addition to the scoring, a high level semi-qualitative assessment among the 10 prioritized indications yielded top three key indications which were Chronic Kidney Disease, Chronic Obstructive Pulmonary Disease and Head and Neck Cancer.
The top 10 prioritized indications as per Indian Scenario are:
- Acute Ischemic Stroke (Metabolic disorder)
- Breast Cancer (Oncology)
- Chronic Kidney Disease, (Diseases and conditions that cause chronic kidney disease include: Type 1 or type 2 diabetes)
- Chronic Obstructive Pulmonary Disease, (Lung disease)
- Coronary Artery Disease (Metabolic disorder)
- Head and Neck Cancer (Oncology)
- Human immunodeficiency virus infection (Infectious Disease)
- Tuberculosis (Infectious Disease)
- Type 2 Diabetes (Metabolic disorder)
Robust models which could offer innovative insights into the multifaceted pathophysiology of unmet diseases relevant to India will be useful which may further be expanded as a service-based platform model, where researchers/ Industries across the country may access to get their molecule tested.
Therefore, there is a need for developing preclinical models in some of the prioritized areas as mentioned in scope of call
WHO CAN APPLY?
Proposals can be submitted by the stake holders (Academia or Industry) individually or in collaboration with each other. The entities who are the applicants or the collaborators shall be evaluated for eligibility criteria for which details are as below-:
- For Academia (Public or Private) i.e. University, Institute, society, NGO or Research Foundation, established in India, having a proper registration/ accreditation from a government body like UGC/ NAAC/AICTE, CSIR
/DSIR/SIRO affiliation certificate etc. is mandatory
- Company (Start up, Small, Medium or Large) incorporated under the Companies Act, 2013 having a minimum of 51% of the shares of the Company to be held by Indian Citizens (Indian passport holders), preferably with some (documented) commercially successful track record in relevant field.
- Limited liability Partnership (LLP) incorporated under the Limited Liability Partnership Act, 2008 having a minimum half of the persons who have subscribed their names to the LLP document as its Partners should be Indian citizens
(NOTE: The applicants should have adequate in-house facility /permanent facility to address the project implementation (which shall be evaluated during the proposal evaluation)).
- Application can be submitted by any of the above entities (a - c) either singly or in collaboration.
The below mentioned documents would be required for the Stake holders where ever applicable
(Academia/Industry or both)
- Scanned copies may be uploaded along with CA certified shareholding, Registration certificate, copy of self-attested Passport copy of the PIs(applicant and collaborators), establishment or incorporation documents and other relevant documents
- Applicant and Collaborator can submit Letter Of Intents (LOI), Memorandum of understanding (MOU) or support letters asscanned copies executed on relevant Letter Heads to show the mutual arrangements. Detailed signed MoU would be needed before the project is sanctioned.
- Board Resolution requirement can be substituted by resolution signed by MD/CEO/ COO along with any other executive Director or Company Secretary. Letter of Authorization requirements shall be considered adequate if signed by the Head of the Institution/ Head ofthe Department/ Principle Investigator / Dean of the Institute.
Format : In-house R& D certificate
Format : Letter of Authorization (For Institute only)
Format : CA/CS certified Shareholding Certificate