Free Webinar | Remdesivir for COVID-19: Case Study and Clinical Trial Design

July 16, 2020 | 1:30-3:00 pm EDT

Chairperson: Anu Osinusi, MD, MPH, Executive Director, Clinical Research, Gilead Sciences

1:30 Remdesivir for COVID-19: Challenges in Trial Strategy and Design

Anu Osinusi, MD, MPH, Executive Director, Clinical Research, Gilead Sciences

1:40 Broad Spectrum Antiviral Remdesivir for the Treatment of Emerging Viral Infections with High Outbreak Potential

Danielle Poulin Porter, PhD, Director, Clinical Virology, Gilead Sciences

Remdesivir is a nucleotide prodrug with potent in vitro and in vivo antiviral activity against multiple emerging virus families with high outbreak potential including filoviruses (e.g., Ebola and Marburg), coronaviruses (e.g., MERS-CoV, SARS-CoV, and SARS-CoV-2) and paramyxoviruses (e.g., Nipah). The preclinical profile of remdesivir supports its further development as an antiviral for COVID-19 as well as potentially other emerging viral infections with significant outbreak potential.

2:00 Optimizing Study Site Selection for SARS-CoV-2 Antiviral Trials

Frances Oko, RN, Senior Director, Integrated Solutions, Infectious Disease, Parexel

Through our expanding experience in the emerging COVID-19 therapeutic field, Parexel has gained insight into best strategies for optimizing site selection for COVID-19 antiviral trials. We will discuss how site identification for these studies depends on several factors including projected local disease activity, regulatory guidelines and timelines, competitive landscape, and evolving standard-of-care.


2:20 Remdesivir for Treatment of COVID-19: Clinical Trials and Beyond

Jason D. Goldman, MD, MPH, Infectious Disease and Organ Transplant, Swedish Medical Center; Clinical Assistant Professor, Division of Allergy & Infectious Diseases, University of Washington

Remdesivir is the first treatment to show clinical efficacy in the treatment of patients with COVID-19. I will review the clinical trial results of remdesivir in patients with SARS-CoV-2 infection and address current gaps in knowledge. Finally, I will make recommendations about appropriate use of remdesivir in the context of the ongoing global pandemic and limited drug supply.

2:40 Q&A

Speaker Biographies

Anu Osinusi, MD, MPH
Executive Director, Clinical Research, Gilead Sciences

Anu Osinusi, MD, MPH is an infectious disease physician and clinical researcher who is currently an executive director leading the Emerging and Respiratory Viruses group in the Virology therapeutic area at Gilead Sciences, Inc. She has over 15 years of experience in infectious diseases, liver diseases, public health, and drug development. Prior to joining Gilead in 2014 she led the Hepatitis branch clinical research and subspecialty medical services for the DC Partnership for HIV/AIDS Progress at the National Institutes of Health. At Gilead she has served as the project or clinical lead for multiple products including Sovaldi, Harvoni and Epclusa that revolutionized the field of Hepatitis C. In her current role she is the project team lead for remdesivir leading efforts across various indications including COVID-19. She is the author of over 60 scientific publications and has a passion for rapidly advancing transformative therapies.

Danielle Poulin Porter, PhD
Director, Clinical Virology, Gilead Sciences

Danielle Porter is a Director of Clinical Virology at Gilead Sciences. She obtained her undergraduate degree in biology at Dartmouth College and earned a PhD in virology from Harvard University. After spending several years at Novartis and then Lawrence Livermore National Laboratory, she joined Gilead in 2010. During her time at Gilead, she has worked on clinical trials for novel HIV and RSV therapeutics as well as emerging viral diseases. Most recently, she has been leading the nonclinical program for remdesivir, which is currently under development for the treatment of COVID-19.

Jason D. Goldman, MD, MPH
Infectious Disease and Organ Transplant, Swedish Medical Center; Clinical Assistant Professor, Division of Allergy & Infectious Diseases, University of Washington

Jason D. Goldman, MD, MPH is an Infectious Disease physician, Epidemiologist and Clinical Researcher with a focus on infections in immunocompromised hosts. Predominant expertise is in solid organ transplant patients, with interest in other settings such as HIV and cancer populations. Dr. Goldman trained at Duke University, the University of Pennsylvania, and University of Washington. He currently works at Swedish Medical Center in Seattle, WA and is appointed as Clinical Assistant Professor in the Division of Allergy and Infectious Diseases at the University of Washington. Collaborative research in clinical and translational trials include infections in solid organ transplant recipients, and viral infections such as herpesviruses, hepatitis viruses and HIV. Dr. Goldman has taken a lead role with local institutions and clinical trials to address the SARS-CoV-2 pandemic.

Frances Oko, RN
Senior Director, Integrated Solutions, Infectious Disease, Parexel

Frances (Fran) is a Senior Solutions Consultant Director with a background in Infectious Diseases and Immunology. Fran has over 20 years of experience in clinical research including hospital-based pathogen driven studies. Prior to joining Parexel in 2011 she held the position of Director, Global Clinical Operations in a mid-sized CRO supplying upper management oversight to global drug developmental ID programs, working with clinical, financial, and operational teams. Her background as a Critical Care RN with experience in hospital studies enables her to address research from multiple perspectives. Fran holds a Bachelor of Science in Nursing.