Shahin Gharakhanian MD 2020 COVID-19 Activities’ REPORT

January 7, 2021

On 30 December 2019 a ProMed email from the International Society of Infectious Diseases (IDSA) contained information on <Undiagnosed pneumonia in China>, thus alerting the world to what was to become the worst health crisis in 100 years. On 24 January 2020, the New England Journal of Medicine (2020, 382: 727-733) published a brief report from the China Novel Coronavirus Investigating and Research Team. That same day The Lancet (2020, 395:497-506) published the clinical features of patients in Wuhan “The 2019-nCoV infection caused clusters of severe respiratory illness similar to severe acute respiratory syndrome coronavirus and was associated with ICU admission and high mortality. Major gaps in our knowledge of the origin, epidemiology, duration of human transmission, and clinical spectrum of the disease need fulfilment by future studies”. The pandemic that followed has been compared to major events in human history and has had profound economic, political, psychological and sociological effects.

We have worked in close collaboration with Academic infectious diseases experts, CROs, Regulatory agencies, three Sponsor Companies US and EU-based, from January to December 2020 to handle numerous workflows and carry out the following projects:

Covid-19 Clinical Research & Development

  • Acticor-Biotech’s GARDEN Study: Glenzocimab in SARS-Cov-2 Acute Respiratory DistrEss syndrome. A randomized, double-blind, multicenter, placebo-controlled, fixed dose, exploratory efficacy and safety study of Glenzocimab (humanized monoclonal anti-body t platelet GPVI: Glycoprotein VI) in SARS-CoV-2-relatd acute respiratory distress syndrome.
  • Research and clinical trial on treatment of mild-moderate Covid-19 with an oral agent.
  • Research and clinical development planning on an individual agent for prevention of transmission Covid-19

Covid-19 Knowledge Management

  • Organization and Program Chair for the 4th Boston Biotechnology Summit dedicated to Covid-19 with the participation of leading experts from Boston MA and Paris, France.
  • Monitoring and scientific reporting of medical publications and news on Covid-19 to a broad audience including experts.

Covid-19 Medical Advisor

  • Acting Medical Advisor and Expert to Public Policy Task Force groups as well as the MassCONNECT program of MassBIO and other professional organizations.
  • Executive Medical Advisor on specific Covid-19 issues, questions and topics to Biotechnology companies.
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