Press Releases

PRINCETON, NJ - Mar 12, 2018 - Certara®, the global leader in model-informed drug development and regulatory science, today announced that it is partnering with faculty at the UNC Eshelman School of Pharmacy to launch the Model-informed Drug Development (MIDD) Gran Prix at the 2018 American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting. This conference will be held from Mar. 21-24 at the Hilton Orlando in Orlando, FL.

“Certara is very committed to helping train new pharmacometricians. We are also emphasizing the growing importance of having both strong data analysis and communications skills. At this year’s ASCPT Annual Meeting, we are taking a more hands-on, interactive approach - co-chairing the inaugural MIDD Gran Prix - in addition to describing our latest advances in physiologically-based pharmacokinetic (PBPK) modeling, and model-based meta-analysis (MBMA) in presentations and posters,” said Mark Lovern, PhD, executive director of Certara Consulting Services, and MIDD Gran Prix co-chair.

“We are always looking for novel ways in which to educate students about the art and science of pharmacokinetic and pharmacodynamic modeling and the value they possess in improving decision making throughout the drug development continuum,” said fellow contest co-chair Professor Alan Forrest, PharmD, from the UNC  Eshelman School of Pharmacy, a Certara Center of Excellence. “The first MIDD Grand Prix is proving very popular and we have received some excellent entries.”

The MIDD Gran Prix is designed to test teams’ ability to analyze a complex pharmacokinetic/pharmacodynamic data set, agree upon a drug development decision, and then clearly communicate both their response and rationale.

The contest scenario and data set, which were simulated by Drs. Lovern and Forrest, were sent to contestants several months ago. The teams were tasked with formulating a drug development decision, supported by their data analysis, and submitting it for peer-review.

The top two professional and two student teams will now present their decisions to a mock clinical development team of judges during a special session at the conference. Cash prizes will be awarded to the winners.  

In addition to co-chairing the MIDD Gran Prix, Certara will participate in the following presentation and poster sessions during the ASCPT Annual Meeting:

Wednesday, Mar. 21
Pre-conference Session: Pharmacometrics Meets Health Economics: Quantitative Approaches in the Translation from Efficacy to Real World Effectiveness and to Cost-effective Patient Care
1:00-5:00 p.m.

Presentation
• Understanding Comparative Efficacy and Effectiveness Via MBMA: Pharmacometrics Approach (Jaap Mandema)

Friday, Mar. 23
Oral Abstract
11:30 a.m. -12:30 p.m.
• Assessing the Role of Heart Tissue Concentration in Bottom-up Mechanistic Prediction of QT
Prolongation by Moxifloxacin Using PBPK-QST Modeling - Nikunjkumar Patel (speaker), Masoud Jamei, Sebastian Polak

Workshop
1:15-2:45 p.m.
• Translational Medicine and Clinical Pharmacology Strategies Supporting Acceleration of Development of Anti-infective Drugs - David Wesche (chair)

Special Session
4:45-6:15 p.m.
• Career Development for Everyone - Piet van der Graaf (panelist)

Posters
7:00-8:30 a.m.
• PII-029: Exploring the Impact of Smoking on the Response to Clopidogrel: A PBPK/PD Study - Manu Chetty, Khaled Abduljalil, Karen Rowland Yeo

• PII-041: Impact of Hepatic OCT1 Ontogeny on Morphine Clearances in Neonates and Small Infants: Comparison of Bottom-up and Top-down Modeling and Simulation - Trevor Johnson, Sibylle Neuhoff

• PII-044: Application of PBPK Modeling for Prediction of CYP-mediated Drug-drug Interactions (DDIs) Involving Ethinylestradiol - Udoamaka Ezuruike, Helen Humphries, Maurice Dickins, Sibylle Neuhoff, Iain Gardner, Karen Rowland Yeo

• PII-052: Translational PBPK Modeling of IDH305, an Inhibitor and Inducer of CYP3A4 - Virna Schuck (contributing author)

• PII-069: Evaluation of Clinical DDI Potential of Methotrexate Using PBPK Modeling - Alice Ke, Krishna Machavaram, Karen Rowland Yeo

• PII-070: An Open-label, 2-period, Fixed-sequence Study to Evaluate the Effect of Loperamide on the PK of Neratinib in Healthy Subjects - Igor Rubets (contributing author)

• PII-084: Prediction of Human PK of Antibody Drug Conjugates from Non-clinical Data - Yuying Gao (contributing author)

• PII-119: A Mechanistic Model of Creatinine Renal Disposition Accounting for Role of Multiple
Transporters and Passive Permeability - Amin Rostami

• PII-146: Exposure-response Relationship for Bezlotoxumab and CDI Recurrence: The Importance of Patient Factors in Explaining Exposure-response - Huub Jan Kleijn (contributing author)

Saturday, Mar. 24
7:00-9:00 a.m.
• Pharmacometrics Skills Competition: MIDD Gran Prix - Mark Lovern, Nathan Teuscher (chairs)

Further information about the ASCPT Annual Meeting is available at https://www.ascpt.org/Meetings/Annual-Meeting.

About Certara
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.