DBT’s Response to COVID-19 Research Efforts by DBT Autonomous

DBT’s Response to COVID-19 Research Efforts by DBT Autonomous Institutes (AIs) and Public Sector Undertakings (PSUs) to combat COVID-19 Department of Biotechnology Ministry of Science & Technology Government of India 1st August, 2020

COVID-19 Research Consortium Develop biomedical tools for prevention, identification and treatment to combat the epidemic of COVID-19 through considering a holistic approach addressing critical roadblocks Vaccines Therapeutics Diagnostics Prevention Testing Development of molecular and serological tests Development of novel diagnostics Testing Hubs Mobile I-Lab Facilitating the Ecosystem Indigenization of Resources Bio-repositories Validation Centres Rapid Regulatory Framework Genomics Multi-centric genomic study for pathogen and host genomics Nasal microbiome study - Useful for epidemiological studies BCG Trial Multiple vaccine platforms Assays and animal models Clinical Trial sites Immunoassay lab Other Interventions Treatment - Plasma therapy - Monoclonal antibodies - Drug re-purposing efforts - DBT-AYUSH Phyto-pharmaceuticals Other Interventions Scaling up of manufacturingventilators, PPE, Screening and monitoring devices, disinfection and sterilization platforms 2

Support under COVID-19 Research Consortium Category Diagnostics and facilities for scale-up Therapeutics, Repurposing & supporting ecosystem Vaccines & supporting ecosystem Other Biomedical Interventions TOTAL Industry/ IndustryAcademia Collaborations 33 Scientists in Academia/ Research institutes 11 14 14 5 21 5 79 41 17

Support under COVID-19 Research Consortium Support for Start-ups and industry-academia collaborations 14 33 Vaccines and supporting ecosystem Diagnostics and facilities for scale-up 11 Therapeutics, Repurposing and supporting ecosystem 21 Other biomedical interventions Scientists in academia/ research institutes supported 5 Vaccines and supporting ecosystem 17 Diagnostics and facilities for scale-up 14 Therapeutics, Repurposing and supporting ecosystem 5 Other biomedical interventions

Supporting Vaccine Development Vaccine Candidates Clinical Trials* Discovery & Early Development Preclinical – Assay Development Preclinical Development – Animal* Process Development Vaccine Platforms DNA vaccine. Inactivated rabies vector platform rBCG vaccine for high risk group Lipid encapsulated mRNA Vaccine Intranasal Mucosal Vaccine Production of S-protein in large quantities for assay development and pseudo typed SARS-CoV-2 Lab for Neutralization/ ELISA based assays Mouse Model, Novel vaccine evaluation platform Hamster Model 5

Vaccines Candidate and Development Serum Institute of India Pvt. Ltd., Pune, Phase III CT of Recombinant BCG Prevention of COVID 19 infection in health care workers

Field Sites for Clinical Trials INCLEN Trust International Palwal, Haryana Access to Healthy cohorts of 50,000- 100,000 population at all the sites COVID Sero-epidemiology studies to be started from 01st August for serial cross sectional survey of 5000 subjects at each site KEM, Vadu, Pune ICMR-National Institute of Epidemiology, Tirunelveli, Tamil Nadu Society for Health Allied Research Education (SHARE) Hyderabad Christian Medical College, Vellore, Tamil Nadu Prospective longitudinal follow-up of cohort Electronic data capture Community engagement and good documentation practices to ensure GCP compliance for preparing the sites for population based vaccine clinical trials 7

New DHS Establishment Maulana Azad Medical College , Delhi INCLEN Trust International Shillong, Meghalaya Society for Applied Studies, Delhi ICMR-Regional Medical Research Centre, Bhuwaneshwar, Orissa Andhra Medical College, Vishakhapatnam, Andhra Pradesh urban/rural tribal Pondicherry Institute of Medical Sciences, Pondicherry, Tamil Nadu 8

Global partnerships Indo-Australia Biotechnology Fund special call for proposals on COVID -19 to support joint research for therapeutics, genomics and animal models for COVID-19 Horizon – 2020 - in partnership with European Commission (EC), co-funding call for rapid solutions to mitigate emergencies like COVID-19 ‘BRICS STI Framework Programme Response to COVID-19 pandemic’ coordinated call for BRICS multilateral projects 2020 India’s engagement in ACT Accelerator 9

Diagnostics Common/Shared facilities – DBT AMTZ COMMAND Consortia Ventilator assembly line Rapid Serological Kit PCR assembly line Portfolio of varied diagnostic formats 5 RT – PCR Kits 10 Rapid Serological Kits 5 1 AI based Detection System RNA Extraction Kit Nucleic acid extraction kits Nucleic Acid Detection Kits Components/ Reagents Primers and Probes Material transport medium Antigen Sample collection buffer 10

Diagnostics 100% self reliance for kits within 2 months 3 Lakh RT PCR Kits 90,000 ELISA Tests 70,000 antibody Tests 1 lakh RNA Extraction Kits Manufactured by AMTZ 40 Manufacturers are members of NBRIC 4 Diagnostic Technologies transferred by DBT AIs to Industry

Ensuring self-reliance for biomanufacturing Aggregate Demand created for start-ups and forward purchase Platform for connecting of component suppliers to large Diagnostic manufacturers Complete Indigenization of Diagnostic kits Supported by NBRIC is a nation-wide effort for convergence of indigenous resources, products and services towards developing diagnostics, vaccines and therapeutics for COVID-19 and beyond for self-reliance in India's biomedical capabilities. Over 35 companies have joined NBRIC to develop Made-in-India Diagnostic Kits and Reagents for COVID-19 Host Partner Industry Partners 12

City/Regional Clusters of Testing Set up in a Hub & Spoke Model; In the institutes of eminence under Central and State Governments; To utilize existing capacities for molecular biology / biosafety in the country; Key Outcomes so far: 21 clusters established with over 80 testing labs; So far over 6,50,000 samples have been tested. Hubs Testing labs Future Hubs Future Testing Labs 13

Running the last mile- testing access to rural India MOBILE INFECTIOUS LAB ( I-LAB) Main Diagnostic Facilities Per I-Lab RT-PCR ELISA Capacities 96 TESTS/ DAY 300 TESTS/DAY Reagents RT-PCR Kits for performing ELISA COVID-19 IgG/IgM for 2400 tests per month COVID-19 Kits for performing 7500 tests per month RNA Extraction Kits for performing 2400 tests per month Launch of I-Lab by Hon’ble Union Minister First I lab attached to THSTI, Faridabad Performed over 1700 tests Utility beyond Covid diagnosis to other infectious diseases 14

Therapeutics Portfolio DBT-AYUSH partnership Joint network programme, involving DBT AIs and National Medicinal Plants Board (NMPB) to harness the potential of indigenous medicinal plants for development of plant -based therapeutics to treat COVID-19; 50 plants to be screened DCGI approved First Phytopharma drug Phase II clinical trials of AQCH, a phytopharmaceutical drug, developed by DBT-ICGEB along with Sun Pharma initiated. Results expected by October, 2020 Immunoglobulin based therapeutics Commercial scale purification and clinical trials of immunoglobulin G (IgG) from convalescent individuals Therapeutic human monoclonal antibodies from B Cells of recovering patients Equine immunoglobulin therapy Resources for drug screening Organoid technology in vitro platform for drug screening and identification of new drug targets 15

DBT Supported COVID-19 Bio-Repositories Institute of Life Sciences (ILS), Institute of Life Sciences (ILS), Bhubaneswar Bhubaneswar Institute of Liver and Biliary Sciences (ILBS), New Delhi Institute For Stem Cell Science and Regenerative Medicine (InStem), Bangalore THSTI & RCB NCR Bio-Cluster, Faridabad National Centre for Cell Science, Pune

Bio-Repositories Samples Data of All the Centres Criteria Numbers Total no. of Samples Collected 44452 clinical samples 17 viral isolates No. of Samples Shared 5014 Samples shared with no. of Institutes 30 Relevant Information: 1. 3 diagnostic kits are being evaluated at THSTI, Faridabad 2. 1 diagnostic kit is being tested at ILS, Bhubaneswar

Biosafety Regulation for COVID 19 Rapid Regulatory Response Mechanism Interim Guidance Document on Laboratory Biosafety to Handle COVID-19 Specimens Guidelines for Sharing of Bio-specimen & Data for Research on COVID-19 A Rapid Regulatory Pathway for COVID Vaccine is being developed to facilitate WHO CEPI Global Trial 18

100 Covid solutions supported through BIRAC’s Incubator network Startup Solutions Identification 1000 Funding initiatives 3 50 Webinars - Fund raising Business mentoring Regulatory Guidance Re-Strategize business 10,000 Startups, entrepreneurs, stakeholders reached Supported Funding/ Regulatory/ Network 35 200 100 20 solutions 19

Other Interventions Screening and monitoring devices Contactless, affordable thermopile-based ultrasonic sensors Home Monitoring device to monitor daily lung health conditions of high risk patients Technology solution for screening of microbial/viral burden in the environment that came in contact with COVID-19 positive cases Disinfection and sterilization platform Novel colloidal silver based hand sanitizer Automatic Reprocessing System (ARS) to reprocess medical devices Long acting virus propagation inhibition coatings Contactless digital sanitation assurance Personal protective equipment Novel Personal Protective Equipment Nano-Fiber based Protective Mask Ventilators Low-cost Abmu-bag Attachment for Rapid Mass Emergency Deployment as a Ventilator – AARMED Smart Mechatronic Artificial Respiratory Therapy System (SMARTS) Portable protective device Antiviral Formulation 20

COVID 19 The Virus – Testing, Treatment, Prevention 21