HIV Déjà Vu? Optimizing Cocktail Therapies for COVID-19

Edward Mills, PhD, Vice President of Real World Evidence and Senior Principal Scientist at Cytel
Michael Dodds, PhD, Executive Director Integrated Drug Development at Certara
Suzanne Minton, PhD, Director of Content Strategy at Certara
        Rajesh Krishna, PhD, Senior Director, Clinical Pharmacology at Certara
Date: June 18, 2020
Time: 1:00 pm ET
Duration: 1 hour

With a vaccine likely a year or longer away, there is urgency around determining the right therapeutic at the right dose to fight COVID-19. Results from clinical trials of monotherapies have been a mixed bag to date, and there has not been a clear leading and proven therapeutic in this race. Monotherapy treatment must be initiated very early in viral infection and be quite potent. A combination therapy where different steps of the SARS-CoV-2 life cycle are modestly impacted may be a better strategy. A cocktail of antiviral drugs or a mix of antivirals and anti-inflammatory medicines could be more effective against COVID-19 than monotherapies, which is what we learned with HIV. We propose that combinations of drugs that act at multiple sites in the viral life cycle should be evaluated in randomized controlled clinical trials.

In this webinar, experts in drug development in a pandemic setting will discuss:
  • Combination therapies that act at multiple sites on the viral life cycle
  • Viral-kinetic modeling to understand the disease course and predict therapy outcomes
  • Learnings to date from a combination therapy trial with hydroxychloroquine and lopinavir/ritonavir
  • Drug-drug-interaction considerations
  • Efficient new strategies for clinical trials

About Our Speakers

Edward Mills is a Principal Scientist at Cytel. He is a Professor at McMaster University Department of Health Research Methods, Impact, and Evaluation and the University of Rwanda, School of Public Health. He is trained as a Clinical Epidemiologist and Statistician and has spent the past twenty years leading large clinical trials and mega-cohort evaluations, particularly on issues relevant to resource-limited settings.

Mike Dodds is an executive director at Certara’s Integrated Drug Development group. Previously, he has served as a pharmacometrics subject matter expert at ZymoGenetics, Amgen, and Quantitative Solutions (now part of Certara). Mike has authored 20+ peer-reviewed articles and holds two patents. He received his BS in Chemical Engineering and BS in Biochemistry from North Carolina State University, MS in Chemical Engineering from Montana State University, and PhD in Bioengineering from the University of Washington.

Suzanne Minton is Director of Content Strategy at Certara. Dr. Minton has seven years of experience in corporate scientific communications and content strategy. Her expertise is in adeptly conveying the business and scientific value of biopharmaceutical products. Suzanne earned a doctorate in pharmacology from the University of North Carolina at Chapel Hill and a bachelor’s degree in biology from Duke University.

Rajesh Krishna is Senior Director, Clinical Pharmacology at Certara. Dr. Krishna has more than 20 years of drug development experience. His past appointments include leadership roles in product value enhancement and quantitative clinical pharmacology, which he founded (Merck), clinical PK/PD and modeling and simulation (Aventis), and in drug development metabolism and pharmacokinetics (Bristol-Myers Squibb). He has extensive experience in development of therapeutics, regulatory interaction experience with all major global health authorities, multiple filings, due diligences, project and program leadership, managing projects of high complexity and alliance teams, and cross-company integration activities.

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