Strategic Consulting and Advisory Services
Certara is the largest and most comprehensive provider of biosimulation (modeling and simulation), strategic pharmacometrics, and regulatory writing consulting services. Our multidisciplinary team works alongside clients to inform key drug development decisions and expedite the processes around achieving regulatory milestones.
Software Portfolio: 'End-to-end' Modeling
Certara biosimulation (model based drug development and informatics) software portfolio is the most wide-ranging in the industry. Certara technology is relied upon by over 1,500 biopharm companies and academic institutions for drug research and development.
Certara's Programmatic Consulting Approach Delivers Unquestionable Value to Sponsor Companies
Certara combines its industry renowned pharmacometric and regulatory consultants with our vast software portfolio to provide services that focus on specific outcomes, therapeutic areas, regulatory milestones, and specific populations.
Leading Edge Science: Resource Library
Check out the latest brochures, case studies, white papers, webinars, and more! Search by keywords and/or filter results.
Certara Scientists to Participate in 12 Sessions at the ASCPT 2016 Annual Meeting
March 04, 2016
PRINCETON, NJ – Mar. 4, 2016 – Certara®, the global biosimulation technology-enabled drug development company, today announced that its scientists will be participating in 12 sessions at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2016 Annual Meeting. This conference will be held from Mar. 8-12 at the Hilton Bayfront in San Diego, CA.
“Biosimulation (modeling and simulation) has become a trusted approach of sponsors, payers and regulatory agencies and it is now being used to optimize and increase the predictability of the most crucial R&D, regulatory and patient care decisions,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD.
“At ASCPT, we will demonstrate how physiologically-based pharmacokinetic and pharmacodynamic modeling can help determine appropriate drug dosing in vulnerable populations such as pediatric and elderly patients, pregnant women, and those who have cancer or have received an organ transplant,” said Chief Scientific Officer Amin Rostami, PharmD, PhD.
“We will also provide examples where we have used Model-Based Meta-Analysis to study the comparative effectiveness of different treatments,” added President of Certara Strategic Consulting Jaap Mandema, PhD.
Certara’s contributions to this year’s ASCPT Annual Meeting are outlined below:
Tuesday, Mar. 8
Pre-conference Sessions
8:00 a.m.-5:30 p.m.
- Quantitative Translational Approaches in Oncology – Karen Rowland Yeo (co-chair)
2:55-3:20 p.m.
- Disease Models in Oncology: Optimizing Trial Designs to Maximize POS – Rene Bruno (speaker)
Posters
8:00 a.m.-5:30 p.m.
- PC-02: Concentration-QTc Analysis of Polatuzumab Vedotin in Patients With B-Cell Hematologic Malignancies – Mathilde Marchand and Samer Mouksassi (contributing authors)
- PC-09: Application of PBPK Modeling to Assess the Victim DDI Potential of Paclitaxel in Oncology Combination Therapies – Alice Ke (presenting author)
Thursday, Mar. 10
Posters
4:30-6:30 p.m.
- PI-018: Concentration-QTc Analysis of Polatuzumab Vedotin in Patients With B-Cell Hematologic Malignancies – Mathilde Marchand and Samer Mouksassi (contributing authors)
- PI-044: Application of PBPK Modeling to Assess the Victim DDI Potential of Paclitaxel in Oncology Combination Therapies – Alice Ke (presenting author)
- PI-054: A Model-Based Meta-Analysis (MBMA) For Comparative Efficacy of Psoriasis Treatments: Dose-response Model for Psoriasis Area And Severity Index (PASI) Responses – Jaap Mandema (contributing author)
- PI-070: Prediction Of Long-term Efficacy of Anti-Diabetic Drugs on HBA1C Using Longitudinal Model-Based Meta-Analysis (MBMA) of Literature Data – Jaap Mandema (contributing author)
- PI-080: Prediction of Midazolam Pharmacokinetics in Pregnant Women with Celiac Disease Using a Pregnancy PBPK Model – Khaled Abduljalil (presenting author)
- PI-139: A Semi-mechanistic Comparator PK/PD Model for Intravenous Immunoglobulin (IVIG) Provided Mechanistic Insights and Supported A Go/ No-go Decision for Novel IVIG – Jos Lommerse (contributing author)
Friday, Mar. 11
Posters
7:00-9:00 a.m.
- PII-091: Exploring the Hypothesis that Age-related Differences in the Response to Triazolam are Due to Altered Pharmacokinetics and Increased Sensitivity to the Drug in the Elderly, Using PBPK/PD Modeling and Unbound Brain Concentrations of the Drug – Mano Chetty (presenting author)
- PII-092: Predicting the Impact of CYP3A5 Polymorphism on Tacrolimus Trough Concentrations in Black African Transplant Recipients – Krishna Machavaram (presenting author)
For additional information about this conference, please visit http://www.ascpt.org/ASCPT-2016-Annual-Meeting.
About Certara
Certara is a global biosimulation and regulatory writing company, committed to optimizing drug development decisions. Its clients include hundreds of international biopharmaceutical companies, leading academic institutions, and key regulatory agencies. Certara’s solutions, which span drug discovery through patient care, increase the probability of regulatory and commercial success by using the most scientifically-advanced modeling and simulation technologies and regulatory strategies. For more information, visit www.certara.com.
Certara Contact:
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer
Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com