Considerations for the Next Wave of COVID-19 Development

With shifting case numbers, fluid geographic hotspots and reprioritization of studies – how do Sponsors move their COVID-19 therapies forward?

The onset of the COVID-19 pandemic created a global health emergency and a rush by the biopharma industry to develop therapeutics. The next wave of development will come from sponsors observing the evolving situation and making their own calculated assessments on how to make their contribution in the fight against SARS-CoV-2.

What did we learn from the first wave of COVID-specific studies that can be applied to those studies that will follow? Medpace has gathered some of its medical and operational team experts who have been on the front-line in designing and conducting trials for SARS-CoV-2 to answer some frequently asked questions, trends they see emerging and considerations for future development.

Some questions to be addressed include:

• What are the important study design considerations?

  • What characteristics define a case (e.g., suspected, probable, confirmed)?
  • What are the risk factors for death or severe illness (e.g., scoring systems such as SOFA, APACHE, hemophagocytosis)?
  • What are the comparators allowed in COVID-19 RCTs (e.g., placebo vs. standard of care/best available therapy vs. novel COVID-19 therapies)?
• What are the predictors, biomarkers and virology endpoints to consider?
  • What are the endpoints that the regulatory agencies will accept for an indication for COVID-19?
  • Can viral shedding be used as an endpoint?
• With so many products in development, what does the competitive landscape look like and what should Sponsors be thinking about as they move forward?
  • • What types of adaptations and flexibility need to be planned?
      • Differences in treatments, clinical presentation and complications
    • What factors should be considered during the setup phase to maximize recruitment?
      • Geography (e.g., shifting hotspots, potential for re-emergence)
      • Seasonality (e.g., will mirroring seasonal clinical trials be a valid strategy?)
      • Site restrictions and logistic challenges (e.g., supplies, patient access, ever-changing policies)
      • Public education (e.g., risk to participation in clinical research for COVID-19 and/or during a pandemic)

Speakers

Brian Murphy, MD, MPH, FIDSA, Vice-President, Medical Department, Medpace

Dr. Brian Murphy is board-certified in infectious disease, internal medicine, as well as pediatrics and has more than 17 years of experience as a medical lead or Principal Investigator (PI) of clinical trials for anti-infectives and vaccines. He has worked with multi-disciplinary translational/clinical research teams as the PI or consultant on numerous trials investigating the pathogenesis and management of infections in adult and pediatric hospitalized patients and outpatients, including COVID-19 trials, trials in genitourinary, gastrointestinal, respiratory and skin and skin structure infections; fungal diseases; HIV, HBV, HCV; infections in the immunocompromised host; vaccine development; anti-bioterrorism agents; and immunotherapeutics.

Message Presenter

Hervé Momméja-Marin, MD, Vice-President, Medical Department, Medpace

Dr. Hervé Momméja-Marin is an internal medicine and infectious disease specialist, trained in Paris, France. Dr. Momméja-Marin has more than 15 years of clinical research experience working for both the pharmaceutical industry and contract research organizations. He has acted as project leader for numerous antiviral (including compounds targeting HIV, hepatitis B, hepatitis C, smallpox, double stranded DNA infections in transplant recipients and other immunocompromised patients), antifungal, antibacterial and vaccine programs (including vaccines targeting meningitis, pneumonia and influenza), in patient populations ranging from neonates to the elderly. He has designed and conducted numerous clinical trials from Phase I through IV, including expanded access, leading the regulatory interactions with FDA, EMA and multiple competent authorities/reimbursement bodies globally. He has contributed to multiple NDAs, MAAs and INDs.

Message Presenter

Jennifer Gehlhar, MS, Vice-President, Clinical Trial Management, Medpace

Ms. Gehlhar has 20 years of clinical research experience, with more than 16 years at Medpace.  During her tenure at Medpace, she spent 12 years in our Munich, Germany office. Her time abroad was invaluable in terms of understanding the dynamic and ever-changing global arena. Her operational experience ranges from small single country trials to large global complex studies and programs. She currently oversees and is responsible for trial management activities in the therapeutic areas of infectious disease, ophthalmology and CNS.

Message Presenter

Carrie Sheil, Sr. Director, Clinical Trial Management, Medpace

Ms. Sheil has more than 15 years of experience in clinical research, including clinical monitoring and global trial management of Phase 1-4 studies, and programs with BARDA funding. Ms. Sheil has experience in various therapeutic areas, including ID. Her expertise is managing complex global infectious disease programs including multi-drug resistant pathogens, HABP, VABP, cUTI/AP, cIAI, and skin infections. Ms. Sheil’s is adept at ensuring quality, efficient, consistent results across multiple studies within a program.

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