The National Institute of Statistical Science (NISS) and Merck are sponsoring a Virtual Meet-Up on SARS-COV-2 Vaccine Development.
With the COVID pandemic having such a profound effect, everyone is hoping for a vaccine soon. At our last meet-up we examined how vaccines are developed with some emphasis on the current pandemic (NISS-Merck_meet-up_Vaccine_Development). In this meet-up we will dig a little deeper into study design for vaccines to SARS-COV-2 considering general efficacy trial design and some thoughts for measuring response. We will also examine some of the largest current studies to look at how some of these considerations play out in practice.
Natalie Dean (University of Florida)
“Vaccine efficacy trial design for emerging pathogens.”
Jonathan Hartzel (Merck)
“The Statistics behind the COVID-19 Efficacy Trials”
Kert Viele (Berry Consultants)
“Trust and Hesitation in COVID-19 Vaccine Trial Interim Analyses - What do we know and when do we know it?”
After you register, NISS will email you a links and reminders for the meet-up. The Meet-Up will use Zoom software and is free to the public. Zoom users will be prompted to download and run a small Zoom meeting launcher.
Previous NISS-Merck Meet-Ups can be viewed on the NISS website. (link)
Registered attendees are view-only participants.
Use the Question & Answer (Q&A) feature to ask questions during the meet-up.
Click on the Q&A icon at the bottom of the Zoom window, type in your question for the panelist and click ‘Enter’.
When a speaker is sharing his/her screen you can minimize the video displays of the other speakers by clicking on the dash button that appears on top of the panel showing all of the speakers.
About the Speakers
Natalie Dean, (University of Florida)
Dr. Natalie Dean is an assistant professor in the Department of Biostatistics at the University of Florida specializing in infectious disease epidemiology and study design. She is principal investigator on an NIH R01 to develop and evaluate innovative trial and observational study designs for assessing the efficacy of vaccines targeting emerging pathogens. She previously worked on the design and analysis of a Phase 3 Ebola vaccine trial in Guinea that used a novel ring vaccination strategy. Her current research focuses on the use of core protocols, adaptive designs, multi-outbreak trials, and test negative designs in outbreaks. Dr. Dean received her PhD in Biostatistics from Harvard University. She has been active in science communications during the COVID-19 pandemic, with published pieces in the Washington Post, New York Times, BMJ Opinion, Boston Review, and Medscape.
Jon Hartzel (Merck)
Dr. Hartzel is Executive Director at Merck & Co, Inc. supporting vaccine trials. Besides SARS-COV2, he has worked on a variety of vaccines including Staphylococcus, Measles, Mumps, Rubella, Varicella, and Pneumococcal conjugate. His research includes work on design of vaccine clinical trials, interval censored data, and random effects in logit regression. Dr. Hartzel earned his PhD in Statistics from Univ. Florida 2009 working under Alan Agresti.
Kert Viele (Berry Consultants)
Dr. Viele is a Director and Senior Statistical Scientist with Berry Consultants, where he leads Berry Consultants’ research enterprise. He is a leader in clinical trial implementation of Bayesian hierarchical modeling, with expertise in platform and basket trials as well as clinical trials incorporating the use of historical information. Prior to joining Berry Consultants in 2010, he was a faculty member at the University of Kentucky, where he received the Provost’s Award for Outstanding Teaching and was an investigator for NSF and NIH funded research. He has developed over 100 custom Bayesian adaptive clinical trials for clients in industry, government, and academia, and currently serves on several data safety monitoring boards for randomized clinical trials. A former editor of the journal Bayesian Analysis, Dr. Viele is also an author of FACTS (Fixed and Adaptive Clinical Trial Simulator), clinical trial simulation software currently licensed to multiple pharmaceutical, academic, and government organizations.