PRINCETON, NJ - Mar 13, 2019 - Certara®, the global leader in model-informed drug development, regulatory science, real-world evidence and market access services, today announced that its pharmacokinetic/pharmacodynamic (PK/PD), quantitative systems pharmacology (QSP) and physiologically-based pharmacokinetic (PBPK) modeling experts will participate in 21 sessions at the American Society for Clinical Pharmacology & Therapeutics (ASCPT) 2019 Annual Meeting. This year’s conference will be held from Mar. 13-16 at the Washington Marriott Wardman Park in Washington, DC.

“Certara is proud to support ASCPT and the valuable role it plays in helping to educate new pharmacometric scientists,” said Certara Senior Vice President, QSP Professor Piet van der Graaf, PharmD, PhD. “As global regulators and pharmaceutical companies increasingly recognize the importance of model-informed drug development (MIDD) for building confidence into the development cycle, we need progressive, educational venues like the ASCPT Annual Meeting to share the ever-changing knowledge.”  

Professor van der Graaf has demonstrated his strong commitment to ASCPT for many years. He was recently named Editor-in-Chief of ASCPT’s Clinical Pharmacology & Therapeutics journal and previously served as Editor-in-Chief of CPT: Pharmacometrics & Systems Pharmacology. He was a member of ASCPT’s 2015-2020 Strategic Planning Task Force and is chair of the 2019 Annual Meeting Scientific Program Committee.

One of this year’s highlights is a focus on QSP, beginning with a full-day program. QSP is following a similar adoption curve to PBPK modeling and will soon become an essential field of study for new drug development scientists. Certara already has two QSP Consortia, one focused on immunogenicity and the other on immuno-oncology, which allow pharmaceutical companies to work together in a pre-competitive environment to develop population-based simulators to address those areas.

QSP combines computational modeling and experimental methods to examine the mechanistic relationships between a drug, the biological system, and the disease process. QSP integrates quantitative drug data with knowledge of the drug’s mechanism of action. It facilitates the evaluation of complex, heterogeneous diseases such as cancer, immunological, metabolic and central nervous system diseases that require multiple therapies.

Underscoring Certara’s desire to promote information sharing and help to educate the industry on the newest successes in MIDD, the company will host a quiz via smart phones to test attendees’ knowledge during the Special Populations and Early Career Communities joint meeting from 7-8 a.m. on Thursday, Mar. 14. Attendees with the highest scores will receive prizes to be presented at Certara booth #6 at 10:15 a.m. on that morning.

Certara will also contribute to the following sessions:

Wednesday, Mar. 13

Pre-conference Presentations

8:15-10:15 a.m.

• Introduction to QSP in Drug Discovery and Development: A Historical, Current, and Future Perspective - Piet van der Graaf

11:00-11:20 a.m.

• PBPK Modeling of Dermally Applied Drug Products to Support Clinical Development and Regulatory Assessment - Nikunjkumar Patel

1:30-1:50 p.m.

• Ophthalmic Drug Products - David Wesche (moderator)

Poster

5:00-6:30 p.m.

• PT-010: Prediction of Fetal Exposure to Acetaminophen and its Metabolites Using PBPK Modeling - Marc Pfister (contributing author)

Thursday, Mar. 14

Posters

5:00-6:30 p.m.

• PII-018: Exposure-response Analyses to Support Dose Justification of DS-8201A, a HER2-Targeting Antibody-Drug Conjugate, in HER2-Positive Breast Cancer Patients - Russ Wada, Helen Kastrissios (contributing authors)

• PII-019: Population Pharmacokinetic Analysis of DS-8201a, a HER2-Targeting Antibody-Drug Conjugate, in Patients with HER2-Positive Breast Cancer or Other Solid Tumors - Yuan Xiong, Russ Wada (contributing authors)

• PII-040: Simulating the Impact of the Interplay Between CYP2C19 Polymorphisms and Ethnicity on Response to Clopidogrel Using PBPK-PD Models - Manoranjenni Chetty, Khaled Abdujalil

Friday, Mar. 15

Presentation

10:30 a.m. - 12:00 p.m.

• Innovation Forum - Piet van der Graaf (chair)

Posters

11:30 a.m. - 1:00 p.m.

• PIII-011: Relationship of Ivosidenib Plasma Concentration to Heart Rate-Corrected QT Interval in Patients with IDH1-Mutant Advanced Hematologic Malignancies - Bill Poland (contributing author)

• PIII-012: Exposure-response Analysis of Ivosidenib in Patients with IDH1-Mutant Relapsed or Refractory Acute Myeloid Leukemia - Huub Jan Kleijn (contributing author)

• PIII-041: PBPK Model-Based Assessments of CYP3A Expression Using Tacrolimus PK Data Observed in Adult Obese and Pediatric Renal Transplant Patients - Trevor Johnson (contributing author)

• PIII-067: Evaluation of Maternal Drug Exposure Following Administration of Dexamethasone and Betamethasone During Pregnancy Using PBPK Modeling - Alice Ke

• PIII-077: Validation of the Pharmacokinetic/Pharmacodynamic Model Used for Dose Selection of Andexanet Alfa for Reversal of Anticoagulation - Yuan Xiong, Mark Lovern (contributing authors)

• PIII-087: PBPK Modeling to Characterize Acetaminophen Target Attainment and Hepatotoxicity in Non-pregnant and Pregnant Women - Marc Pfister (contributing author)

• PIII-094: Development of a PBPK Model for Topical Lidocaine in Order to Predict Systemic Absorption in Healthy Volunteers, Geriatrics, and Pediatrics - Nikunjkumar Patel, Farzaneh Salem, Sebastian Polak

• PIII-116: A Semi-mechanistic Model for the Quantification of Stimulated Growth Hormone Secretion - Piet van der Graaf (contributing author)

• PIII-117: Improving Clinical Translation of Neuroblastoma Treatment Effects by Integration of Preclinical Experimental Innovation and Computational Modeling - Piet van der Graaf (contributing author)

• PIII-118: Population PK of TAK-659, An Investigational Dual Inhibitor of SYK and FLT-3, in Patients with Hematologic Malignancies or Solid Tumors - Yuan Xiong, Paul Matthias Diderichsen (contributing authors)

Saturday, Mar. 16

Presentations

9:30-11:30 a.m.

• Patient Forum - Piet van der Graaf (chair)

9:30-11:30 a.m.

• The Development of a Consortium QSP Model of Immunogenicity with Case Examples - Andrzej Kierzek

12:30 - 2:30 p.m.              

• The Ideal MID3 Scientist for the Future - Piet van der Graaf

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

About Certara

Certara enables superior drug development and patient care decision-making through model-informed drug development, regulatory science, real-world evidence solutions and knowledge integration. As a result, it optimizes R&D productivity, commercial value and patient outcomes. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.