Certara Scientists to Give 22 Presentations at the AAPS Annual meeting

October 22, 2015

Their contributions include workshops, symposia, roundtables, posters, and a sunrise session

PRINCETON, NJ – Oct. 23, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that its scientists are giving 22 presentations at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition being held in Orlando, FL from Oct. 25-29.

“Our growing presence at the AAPS Annual Meeting mirrors the rapid adoption of physiologically-based pharmacokinetics (PBPK) modeling by global biopharmaceutical companies and regulatory agencies,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD. “PBPK modeling describes how drugs will be handled by the body and predicts PK in virtual patient populations. These models are increasingly used during regulatory review to help decide whether specific clinical trials are required, to inform study design, and guide appropriate labeling language.”

“PBPK modeling is also used to determine appropriate drug doses for specific patient populations such as pediatric patients, pregnant women, patients with organ impairment or comorbidities,” said Steve Toon, PhD, managing director of Certara’s Simcyp group. “Certara’s next goal is to achieve precision dosing, which will allow the company to recommend drug doses for individual patients,” he added.

Certara is releasing a video on precision dosing with AAPS TV during the conference. The video is also available at https://www.youtube.com/watch?v=lrjdB98P5z4.

Certara’s contributions to this year’s AAPS Annual Meeting are outlined below:

Sunday, Oct. 25

Workshops

8:30 a.m. - 4:00 p.m.

• Specific Population Drug Dosing Recommendations: Shifting from Clinical Studies to Predict and Confirm, Day 2 – Amin Rostami-Hodjegan (moderator)

9:20 - 9:45 a.m.

• Public/Private Partnerships Influencing Drug Development and Regulatory Decisions—European Experiences with Various Models: OrBiTo and SimCyp – Amin Rostami-Hodjegan (speaker)

Monday, Oct. 26

Posters

11:00 a.m. - 5:00 p.m.

• M1051: Mechanistic In Vitro-In Vivo Extrapolation (IVIV_E) of Dissolution Within a PBPK Framework: Extrapolation of Immediate Release Danazol Dissolution in the USP-2 Paddle Apparatus to In Vivo Dissolution – Bo Liu
• M1295: Application of Physiologically-based Absorption Modeling in the Development of an In Vitro-In Vivo Correlation (IVIVC) for Topiramate Controlled Release Matrix Tablets – Shriram Pathak

Tuesday, Oct. 27

Symposia

9:40 a.m. - 12:00 p.m.

• Where PBPK Modeling Has Not yet Been Able to Deliver In Biopharmaceutics – Nikunj Patel (moderator) – streamed live

11:10 –11:55 a.m.

• New Approaches for Better IVIVE of Dissolution and Permeability under PBPK Modeling Framework – David Turner (speaker)

Roundtable

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

• Reduction of Model Complexity, You Need More Than Wine and it Still May Not Suit Everyone’s Tastes – Amin Rostami (moderating)

Posters

8:30 a.m. - 12:00 p.m.

• T2311: Development of a Multiple Linear Regression Model of Gastric Emptying and Its Covariates – Amin Rostami

1:30 - 5:00 p.m.

• T3310: Population PK Modeling and Dosing Evaluations for Ceftazidime-avibactam (CAZ-AVI) in Children Aged >=3 months to <18 years Receiving Systemic Antibiotic Therapy for Suspected or Confirmed Infection – Mark Lovern, Russell Wada, Francesco Bellanti
• T3311: A Minimal PBPK Model of IgG Pharmacokinetics: Impact of Inclusion of 2:1 FcRn IgG Binding Stoichiometry and a Proportion of CL that is Independent of FcRn Binding – Linzhong Li
• T3317: Predicting the Higher Bioavailability Observed for Oxybutynin’s OROS Formulation Compared to the Immediate-Release Tablet Using a Novel Simplified Absorption PBPK Model – Amin Rostami

Wednesday, Oct. 28

Sunrise Session

7:30 - 8:45 a.m.

• Key to Opening the Kidney for IVIVE Entrance: the Existing Holes! – Amin Rostami (moderator)

Symposium

9:40 a.m. - 12:00 p.m.

• When and Why to Focus on QSP In Drug Development – A Question-based Approach with Vignettes – Masoud Jamei (moderator)

Roundtable

2:00 - 4:00 p.m.

• The Case For and Against the Release of Bioanalytical Data Below the LLOQ – Nathan Teuscher (moderator)

Posters

8:30 a.m. - 12:00 p.m.

• W4311: Are We Underestimating Drug Metabolism in Kidney? Higher Values for Microsomal Protein Content of Human Kidney – Amin Rostami

1:30 - 5:00 p.m.

• W5029: In Silico Prediction of Regional Passive Intestinal Permeability in Cynomolgus Monkey using ‘MechPeff’: A Mechanistic Model with Drug Physicochemical and In Vitro Parameters as Inputs – Devendra Pade
• W5030: Application of the ‘MechPeff’ Model to Predict Passive Regional Effective Intestinal Permeability in Rat Using Drug Physicochemical Parameters as Inputs – Devendra Pade

Thursday, Oct. 29

Roundtable

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

• It is Matter of Trust! Performing Cross-laboratory-cross-technique Comparison in Quantitative ADME Proteomics – Matthew Harwood (moderator)

Posters

8:00 - 11:30 a.m.

• R6298: A Mechanistic Minimal PBPK Model to Predict Distribution and Subcutaneous Absorption of Therapeutic Proteins (encore poster) – Masoud Jamei
• R6302: PK/PD Target Attainment Analyses and Assessment of Dose Adjustments for Renal Insufficiency for Ceftazidime-avibactam (CAZ-AVI) in Patients with Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI) or Nosocomial Pneumonia – Mark Lovern, Michelle Green, Joannellyn Chiu
• R6303: Population PK Modeling for Ceftazidime-avibactam (CAZ-AVI) in Patients with cIAI and cUTI – Mark Lovern, Michelle Green, Joannellyn Chiu
• R6335: Towards Unraveling the Mechanism of Cardiotoxicity of Citalopram: Utilization of Mechanistic Cardiac Electrophysiology Modeling with Simcyp Cardiac Safety Simulator to Explore Various Hypotheses – Nikunj Patel

For more information about this conference, please visit https://annual.aapsmeeting.org.

About Certara

Certara is a global biosimulation technology-enabled drug development company. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable superior drug development and regulatory decision-making through biosimulation, thus increasing R&D productivity and commercial value. 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