Covid-19 (ARDS) Experience March 2020-21 - Drugs
Itolizumab – Biocon Ltd. novel drug (Alzumab) approved in 2012 for Psoriasis and manufactured in India March 2020. During pandemic lockout 1.0 Bioinnovat conducted Phase III clinical Trial for repurposing for ARDS for moderate to severe hospitalized patients prior to ventilator. Bioinnovat managed the sites in Delhi recruiting more than half of the enrolment and supported EUA approval within 2 Months by July.
The clinical study included three reviews by DCGI, protocol amendments and a global benchmarking audit. Bioinnovat was responsible for entire end to end management of the study in Delhi under Dr. Suresh Kumar, Medical Director Lok Nayak Hospital and Dr. Randeep Guleria, Director, AIIMS for almost half the trial subjects. The other major Mumbai contributors were Dr. Rosemarie D Souza, Nair Hospital and Dr. Wasim Khot, KEM Hospital, Mumbai. This Phase III study in India led to a global study approval in USA for Itolizumab which has not been conducted by Biocon partner Equillium. (Currently Bioinnovat is engaged by Equillium in India for a Lupus Nephritis study for Itolizumab for Phase Ib/II)
Regulatory support and follow up to FDA/DCGI for each Phase including recommendation from leading PI’s. Currently engaged in bringing Itolizumab on the countries National Protocol ICMR like Tocilizumab.
Supporting Phase IV Clinical Trial with resourcing of site coordinators for study of 300 patients being conducted by IQVIA.
The clinical study included three reviews by DCGI, protocol amendments and a global benchmarking audit. Bioinnovat was responsible for entire end to end management of the study in Delhi under Dr. Suresh Kumar, Medical Director Lok Nayak Hospital and Dr. Randeep Guleria, Director, AIIMS for almost half the trial subjects. The other major Mumbai contributors were Dr. Rosemarie D Souza, Nair Hospital and Dr. Wasim Khot, KEM Hospital, Mumbai. This Phase III study in India led to a global study approval in USA for Itolizumab which has not been conducted by Biocon partner Equillium. (Currently Bioinnovat is engaged by Equillium in India for a Lupus Nephritis study for Itolizumab for Phase Ib/II)
Regulatory support and follow up to FDA/DCGI for each Phase including recommendation from leading PI’s. Currently engaged in bringing Itolizumab on the countries National Protocol ICMR like Tocilizumab.
Supporting Phase IV Clinical Trial with resourcing of site coordinators for study of 300 patients being conducted by IQVIA.
Supported regulatory approval of Bharat Serum Drug Ulinastatin for ARDS.
Fulvic Acid Phase II Mild to moderate patients and is under Regulatory review.
Lilly Baricitinib Phase IV EUA as combination with Remdesivir in May 2021. Currently under Regulatory review for Covid only indication in EU and India.
Lilly antibody EUA approval of bamlanivimab-etesevimab in India for Mild to moderate home-based patients in May 2021
Lilly – Supported arrangement of acceptance of donations by NITI Aayog/Red Cross Of India
Baricitinib antibody combination bamlanivimab-etesevimab
Fulvic Acid Phase II Mild to moderate patients and is under Regulatory review.
Lilly Baricitinib Phase IV EUA as combination with Remdesivir in May 2021. Currently under Regulatory review for Covid only indication in EU and India.
Lilly antibody EUA approval of bamlanivimab-etesevimab in India for Mild to moderate home-based patients in May 2021
Lilly – Supported arrangement of acceptance of donations by NITI Aayog/Red Cross Of India
Baricitinib antibody combination bamlanivimab-etesevimab
2020 – Supported and obtained test (R&D) and import licenses (40+) of Covid 19 PCR detection kits (TaqPath), RNA extraction extraction, Primers probes and Mixes (reagents) VTM Tubes, since then and support the supply chain of Thermo Fisher in this Covid crisis.
2021 – Supporting Regulatory approval of Covipath for indigenous manufacturing in Thermo Fisher Bangalore Feb 2021. Imports of Mutant panels, antibody tests and aerosol aerosense
Supported donation of Thermo Fisher to Indian Govt. in May of USD 10 Million equivalent of VTM tubes etc.
Bioinnovat has helped Hyundai Foundation India in donating Solgent COVID-19 CE-IVD diagnostic kits from South Korea by obtaining test licenses for testing at ICMR-NIMR, Delhi. Regulatory approval Premas Biotech of 10+ Licenses for Import of South Korean companies. Supported Indigenous development of diagnostic kits of Syngene, Medgenome etc.
2021 – Supporting Regulatory approval of Covipath for indigenous manufacturing in Thermo Fisher Bangalore Feb 2021. Imports of Mutant panels, antibody tests and aerosol aerosense
Supported donation of Thermo Fisher to Indian Govt. in May of USD 10 Million equivalent of VTM tubes etc.
Bioinnovat has helped Hyundai Foundation India in donating Solgent COVID-19 CE-IVD diagnostic kits from South Korea by obtaining test licenses for testing at ICMR-NIMR, Delhi. Regulatory approval Premas Biotech of 10+ Licenses for Import of South Korean companies. Supported Indigenous development of diagnostic kits of Syngene, Medgenome etc.
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