Certara, UNC Eshelman School of Pharmacy and ASCPT staff leverage expertise of leading academic, regulatory and industry KOLs to judge
PRINCETON, NJ – Apr. 5, 2018 – Certara®, the global leader in model-informed drug development and regulatory science, and faculty at the UNC Eshelman School of Pharmacy today announced the winners of the first Model-informed Drug Development (MIDD) Gran Prix. The event finals were held on Mar. 24 at the 2018 American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting.
“One of Certara’s top priorities is to help train new pharmacometricians. We are delighted that the inaugural MIDD Gran Prix proved to be such a popular event and yielded such high-caliber entries. It really was an excellent venue for scientists to demonstrate their pharmacokinetic/pharmacodynamic (PK/PD) data analysis and communications skills,” said Mark Lovern, PhD, executive director of Certara Consulting Services, and MIDD Gran Prix co-chair.
“This contest provided students with very realistic examples of the power that PK/PD analysis can wield when it comes to refining the drug development decision-making process. It was a valuable learning experience and we hope to be able to offer it again next year,” said fellow contest co-chair Professor Alan Forrest, PharmD, from the UNC Eshelman School of Pharmacy, a Certara Center of Excellence.
Top student/trainee team honors went to Team Maryland, which won the judges’ vote. The other finalist team, Leiden PMX, captured the audience vote but not the judges’ ballots. Audience members voted live using the meeting’s mobile app.
Team Maryland comprised of Alejandro Perez Pitarch, PhD, ORISE, and Ken Ogasawara, PhD, ORISE from the US Food and Drug Administration (FDA); and Beatriz Guglieri Lopez, PhD, from the University of Maryland. Leiden PMX, a team fielded by Leiden University, consisted of Sebastiaan Goulooze, MSc, Linda Aulin, MSc, Sinziana Cristea, MSc, Michiel van Esdonk, MSc, and Rob van Wijk, PhD.
Among the professional teams, the Certara Supermodels beat the Genentech Modelers (GEMS). The Supermodels included Adekemi Taylor, PhD, Yuan Xiong, PhD, Leon Pheng, PhD, Benjamin Rich, PhD, and Thomas Peyret, PhD. The GEMS were Vidya Ramakrishnan, PhD, Matts Kagedal, PhD, Michael Dolton, PhD, Phyllis Chan, PhD, and Kenta Yoshida, PhD.
A blinded consideration process was employed throughout the MIDD Gran Prix to allow modelers from Certara and UNC to also participate. In addition, individuals serving as organizers and expert judges at the live competition were not permitted to compete.
The MIDD Gran Prix was devised to test teams’ ability to analyze a complex PK/PD data set, agree upon a drug development decision, and then clearly communicate both their response and rationale.
Participating teams were granted access to PK and PD data from three simulated clinical trials on Oct. 31, 2017. They were asked to develop dosing guidelines for “Drug D,” including individual dosing strategies where appropriate. They also needed to decide whether to conduct another Phase 2 or a Phase 3 study next. They had to identify critical knowledge gaps and propose ways to close them. Lastly, they had to compare Drug D with the current standard of care and assess its commercial viability.
Their responses were initially submitted for double-blinded peer review at the end of January. Then the best two professional and two student teams were invited to present their responses to a mock clinical development team of judges in person at the ASCPT Annual Meeting.
The MIDD Gran Prix judges included drug development experts from industry, academia and a regulatory agency. They were Jill Fiedler-Kelly, MS, Cognigen Corporation; Richard L. Lalonde, PharmD, Bradenton, FL; France Mentré, MD, PhD, University of Paris Diderot; Carl C. Peck, MD, University of California, San Francisco Center for Drug Development Science; and Issam Zineh, PharmD, US FDA. Julie Dumond, PharmD, MS from the UNC Eshelman School of Pharmacy served as the MC for the event. Nathan S. Teuscher, PhD, from Certara also served as an event chair.
Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies. For more information, visit www.certara.com.
Ellen Leinfuss, 609-216-9586
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Lisa Osborne, 206-992-5245
Rana Healthcare Solutions