Trial Simulator 2.3

November 29, 2018

Phoenix 8.0 Product Notifications

December 18, 2017

Phoenix 8.0 Release Notes

October 02, 2017

Phoenix 8.0 Getting Started Guide

October 02, 2017

Phoenix 8.0 Release Version

October 02, 2017

Phoenix WinNonlin Validation Suite 7.0.1 for Windows 10

December 05, 2016

Phoenix WinNonlin Validation Suite 7.0

December 05, 2016

Phoenix 7.0 Product Notifications

October 31, 2016

Phoenix 7.0 Release Notes

August 09, 2016

Phoenix 7.0 Getting Started Guide

August 09, 2016

Phoenix 7.0 Release Version

August 09, 2016

Certara Launches SIVA Toolkit 2.0 to Improve In Vitro Drug Development Data Analysis

April 12, 2016

PRINCETON, NJ – Apr. 12, 2016 – Certara®, the global biosimulation technology-enabled drug development company, today launched the Simcyp In Vitro (Data) Analysis (SIVA) Toolkit 2.0 to assist drug development researchers with the analysis of complex in vitro studies. These studies are used to assess candidate drugs’ metabolism, transport and formulation properties.

“Global regulatory agencies are increasingly expecting sponsors to have a strong mechanistic understanding of drug metabolism, transport, and solubility/dissolution,” said Steve Toon, BPharm, PhD, President of Simcyp. “And the broader scientific community, including The International Transporter Consortium, which contains members of the U.S. Food and Drug Administration, are advocating the use of model-based approaches to maximize the value of data arising out of in vitro ADME studies. The SIVA Toolkit supports these types of data analyses which also in turn maximize the Simcyp® Population-based Simulator’s predictive capabilities.”

The most valuable biosimulation models have two things in common – they are built using the most appropriate and highest quality data. The SIVA Toolkit provides better, richer and more relevant data from in vitro ADME experiments.

For example, permeability/transport assays measure how drugs move through the body, pass through cells, use transporters, get metabolized or a combination of all of them. While conventional in vitro analysis provides a single, global permeability value, the SIVA Toolkit generates parameters describing each of those physiological processes. SIVA’s approach ensures that researchers don’t lose any of that valuable information, which makes the resulting PBPK models more complete, powerful and relevant.

A standalone product, the SIVA Toolkit also allows researchers to optimize their in vitro ADME experiments, reducing the number of experiments and thus saving both time and money. It also gives sponsors more confidence to make important clinical trial decisions, such as determining whether they need to conduct certain studies.

It is a very user-friendly solution which features a predefined library of models for assessing drug metabolism, inhibition, transport and pharmaceutical formulation.

The SIVA Toolkit 2.0 now offers models for enzyme inhibition, allowing researchers to predict drug-drug interactions more accurately. It also includes Pharmaceutics-USP IV, Serial Dilution, Transfer and Two Phase Dissolution models.

Certara is also hosting a complimentary one-hour webinar entitled “SIVA Toolkit: Get the most from your in vitro data” on Thursday, April 14 at 11 a.m. EDT. Register for this event.

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

Senior/Principal Scientist

April 05, 2016

Marketing Admin/Database Administrator

March 24, 2016

Certara’s Synchrogenix Unit Provides Solution to Enable Pharma Compliance with EMA Policy 70

March 24, 2016

PRINCETON, NJ – Mar. 24, 2016 – Certara®, the global biosimulation technology-enabled drug development company, today announced that its regulatory and medical consultancy, Synchrogenix, has introduced an artificial intelligence (AI) -enabled solution to meet the data transparency requirements of the clinical and drug development market. Those detailed requirements were published by the European Medicines Agency (EMA) on Mar. 2, 2016 as Policy 70 (http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2016/03/WC500202621.pdf).

EMA has been working with the industry for several years to develop a set of rules to make clinical trial data more public. In January 2015, the agency released new transparency and disclosure rules related to clinical study reports contained in marketing authorization applications submitted on or after that date. The first reports are expected to be made publicly available in September 2016. The rules that EMA published earlier this month expand the breadth and depth of the original rules, and provide detailed requirements for companies to follow.

“Disclosing clinical trial information so that researchers can build upon prior knowledge is an important step in bringing new therapies to patients, and fostering the industry’s commitment to the patients it serves,” said Synchrogenix President Kelley Kendle. “At the same time, we must protect the confidential patient and personal information contained in the myriad clinical reports to be published under Policy 70, which are often hundreds of pages long. In anticipation of these regulations and concerns around protecting patient privacy, Synchrogenix has developed technology that automates the redaction of personally-identifiable information, patient-protected data, and company-confidential information with 99 percent accuracy.”

Synchrogenix’s technology is the only AI-enabled solution in the biopharmaceutical industry. Built on natural language processing and recognition, this technology is able to identify individual words, parts of speech, and word and phrasing combinations automatically to determine context. This technology supports drug companies’ need to redact and de-identify datasets in their clinical study reports, patient narratives, patient data listings, and submission documents, in order to publish their clinical study information publicly. Synchrogenix’s technology is scalable and has already been successfully applied at both large pharma and smaller biotech organizations, quickly delivering accurately redacted documents.

About Certara

Certara Contact:
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer

Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com

Biosimulation Supports Label Claims for New Combination Treatment for Oncology

March 22, 2016

Taking drug development into the virtual world

March 22, 2016

Biosimulation Supports Label Claims for New Combination Treatment for Oncology

March 21, 2016

Taking drug development into the virtual world

March 21, 2016

Pre-Consortium Focused Workshops

March 21, 2016

17th Simcyp Consortium Meeting

March 21, 2016

17th Simcyp Consortium Meeting Flyer

March 21, 2016

2016 Phoenix Roadshow

March 16, 2016

2016 Drug Label Optimization Breakfast Series

March 16, 2016

Associate Director, Modeler

March 14, 2016

Senior Director, Modeler

March 14, 2016

Case study form Biosimulation Supports Label Claims for New Combination Treatment for Oncology

March 10, 2016

2016 Phoenix Roadshow- Cambridge, MA Reg form

March 10, 2016

2016 Phoenix Roadshow- Cambridge, MA

March 10, 2016

2016 Phoenix roadshow- lincolnshire reg form

March 10, 2016

2016 Phoenix Roadshow- Lincolnshire

March 10, 2016

2016 Phoenix Roadshow- San Diego reg form

March 10, 2016

2016 Phoenix Roadshow- San Diego

March 10, 2016

2016 Phoenix Roadshow- RTP, NC reg form

March 10, 2016

2016 Phoenix Roadshow- RTP, NC

March 10, 2016

2016 Phoenix Roadshow- Princeton reg form

March 10, 2016

2016 Phoenix Roadshow- Princeton

March 10, 2016

2016 Drug Label Optimization Breakfast: Cambridge UK reg form

March 09, 2016

2016 Drug Label Optimization Breakfast: Basel, Switzerland form

March 09, 2016

2016 Drug Label Optimization Breakfast Seminar: Cambridge MA

March 09, 2016

2016 Drug Label Optimization Breakfast Seminar Series

March 09, 2016

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 Contact:
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer

Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com

2016 Phoenix Roadshow- Cambridge Registration form

March 04, 2016

2016 Phoenix Roadshow- Cambridge

March 04, 2016

2016 Phoenix Roadshow- Basel Registration form

March 04, 2016

2016 Phoenix Roadshow- Basel

March 04, 2016

certara brochure optimizing drug development decisions

March 04, 2016

2016 Phoenix Roadshow Registration Form

March 03, 2016

2016 Roadshow: Leveraging the Power of Phoenix Agenda

March 03, 2016

2016 Roadshow: Leveraging the Power of Phoenix

March 03, 2016

AI & Clinical Transparency Webinar

February 25, 2016

Certara Introduces Phoenix Technology Services to Optimize Pharma R&D Productivity

February 25, 2016

New Services Portfolio Supports Users of Certara’s Gold Standard Phoenix Software

PRINCETON, NJ – Feb. 25, 2016 – Certara®, the global biosimulation technology-enabled drug development company, today announced the introduction of Phoenix® Technology Services. These services, led and implemented by Certara’s professional team of biosimulation (modeling and simulation) experts, include customized and ready-to-use solutions that span the breadth of the Phoenix platform. Phoenix is the industry’s premier software platform for managing, analyzing and reporting pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) data. Certara has developed these services to leverage the enormous power of Phoenix by systematizing the ‘best practices’ of its more than 6,000 users and making those practices available to all biopharm organizations.

“Biosimulation has had a profoundly positive impact on drug development and is now expected by global regulators. In fact, 95 percent of the 45 new drugs approved by the US Food and Drug Administration (FDA) in 2015 used the technology to inform label claims. Additionally, the industry trend is toward moving R&D decision-making around drug viability earlier in the development process and using biosimulation to inform that process,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD. “The Phoenix Technology Services portfolio is being introduced to help our clients leverage Phoenix software to take advantage of these trends in both pre-clinical and clinical development.”

Certara is introducing several new services within the Phoenix Technology Services portfolio:

Phoenix Workflow Template Services have been developed to optimize R&D productivity, analysis time, standardize calculations and output, minimize quality control checks, and achieve regulatory compliance. Although any Phoenix workflow can be saved as a template, creating reusable templates for handling large amounts of data sets across different studies with varying numbers of treatments, analytes, matrices, and doses requires expertise and significant development time. Templates for discovery PK, pre-clinical and clinical PK are now available ready to use or can be customized for specific workflows and parameters. These pre-packaged templates include serial and sparse sampling for TK studies and CDISC SEND, which will provide sponsors and CROs with more effective knowledge transfer between databases and enable robust protocols for regulatory submission.
Phoenix Plugin Services, such as PopPK data preparer, First-in-Human allometric scaling, CDISC data preparer, and dosing/treatment randomization builder, streamline data flow by providing access to data required for analysis and regulatory submission. These plug-ins integrate Phoenix with both upstream and downstream systems such as LIMS, study protocol, compound management, dosing/treatment, randomization, and CDISC submission.
PKS Repository Services support client installations on Phoenix Knowledgebase Server™ (PKS) and PKS Online products, which provide a 21 CFR Part 11 compliant repository with full audit trail and version control for the storage of Phoenix biosimulation data. These service solutions cover implementation, migration, integration, and validation support which optimizes regulatory readiness.
Validation Services for Phoenix WinNonlin®, NLME™, and PKS leverage Certara’s team of in-house validation experts for IQ and OQ documentation, thus eliminating the burden on a client’s internal project team to meet regulatory compliance requirements for computer system validation.

Clients can learn more about these services at www.certara.com/software/about-our-software-services/ and by attending the 2016 Phoenix Roadshow to be held in Basel, Switzerland; Cambridge, UK; Raleigh, NC; San Diego, CA; Chicago, IL; Princeton, NJ; Boston, MA; Shanghai, China; and Osaka and Tokyo, Japan.

About Certara

Certara Contact:
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer

Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com

Phoenix Technology Services Brochure

February 24, 2016

Getting at the HAART Webinar

February 22, 2016

Physiologically-Based Pharmacokinetics Webinar

February 22, 2016

Simcyp In Vitro Analysis Webinar

February 22, 2016

Automated Prediction Webinar

February 22, 2016

Best of blogs 2015 Sidebar

February 19, 2016

Best of blogs 2015 Sidebar

February 19, 2016

Best of blogs 2015 Sidebar

February 19, 2016

Best of Blogs 2015

February 19, 2016

Modelling and Simulation Sidebar

February 17, 2016

A Breakfast Seminar for Innovative R&D Professionals

February 17, 2016

ASCPT Event Sidebar

February 16, 2016

Optimize Your Drug Development Decisions with Certara

February 16, 2016

Drug Safety for a Targeted Cancer Treatment

February 11, 2016

Drug Safety sidebar

February 11, 2016

Precision Dosing Webinar

February 08, 2016

Best Practices Webinar

February 08, 2016

Connecting Phoenix Webinar

February 08, 2016

Phoenix Workflows Webinar

February 08, 2016

Certara Expands Its Quantitative Systems Pharmacology Group; Appoints Professor Andrzej Kierzek

February 03, 2016

PRINCETON, NJ – Feb. 3, 2016 – Certara^®, the global biosimulation technology-enabled drug development company, today announced that it has appointed Andrzej Kierzek, PhD, as head of systems modeling in its Simcyp^® Quantitative Systems Pharmacology (QSP) Group. He joins Certara from the University of Surrey, UK, where he serves as professor of systems biology.

Certara established its market-leading position in QSP with the acquisition of XenologiQ, a UK-based QSP consultancy, in December 2015.

QSP bridges the gap between pharmacometric modeling and simulation, and systems biology. QSP combines computational modeling and experimental methods to examine the mechanistic relationships between a drug, the biological system, and the disease process. In combination with physiologically-based pharmacokinetics (PBPK), QSP forms the basis for precision medicine and can assist in identifying the best dose and combination of drugs for an individual patient. QSP is expected to have an immediate impact not only in large therapeutic areas like oncology, immunology/inflammation and cardiometabolic diseases, but also in rare diseases and safety/toxicology.

“QSP is a relatively new discipline with the potential to dramatically improve pharma R&D productivity,” said Steve Toon, BPharm, PhD, president of Simcyp. “We are delighted to have a systems modeler of Andrzej’s caliber join our rapidly-growing QSP team. This is an incredibly exciting stage in the development and adoption of QSP and we aim to have all the brightest minds on board.”

Professor Kierzek has 20 years’ experience developing computer simulations of biological systems. He co-presented the first dynamic simulations, including regulatory mechanisms and a genome scale metabolic network, in a human cell. He is now working to apply this method of mechanistic modeling to cancer. He also developed the software to create computer simulations of genome scale metabolic networks in bacterial pathogens. Professor Kierzek has had 50 papers published to date in leading life sciences journals.

Professor Kierzek received a PhD in biophysics from the Polish Academy of Sciences, and a Dr. hab. (Habilitation) in biological sciences and biochemistry from the Polish Academy of Sciences.

“Andrzej is a tremendous asset for our rapidly-growing organization, which already has teams in Canterbury and Sheffield, UK. His expertise in multi-scale modeling of oncology and immunology networks will be invaluable as we maximize our impact in these areas of highest need,” said Professor Piet van der Graaf, PharmD, PhD, vice president and head of Simcyp QSP.

Certara’s Simcyp Group is the industry-leading mechanistic and PBPK modeling organization and counts the majority of the top-40 pharma companies as its clients and members of the Simcyp Consortium. Key academic institutions, and global regulators, including the US Food and Drug Administration, European Medicines Agency, and Japanese Pharmaceuticals and Medical Devices Agency are consortium affiliates.

About Certara

Certara Contact:

Ellen Leinfuss, 609-216-9586
Chief Marketing Officer

Media Contact:

Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com

Sr. Systems Administrator

February 02, 2016

2016 Workshops

January 21, 2016

Japan Workshop August 2016

January 20, 2016

Japan August 2016 Sidebar

January 20, 2016

Japan Workshop August 2016

January 20, 2016

This event runs from 1st – 5th August 2016 in Tokyo, Japan

By participating in this workshop, you can learn how to predict the following items.
Drug metabolic clearance (CL) Drug interactions was through the metabolism · (DDIs)
The first pass in the gastrointestinal tract And absorption after oral administration (including the effects of diet and dosage forms)
Pharmacokinetics and DDI impact of transporters and intestines liver ring against
Distribution of the drug to the various tissues -Individual differences in drug blood concentration transition in a certain population
Specific population (children, race, various diseases) the difference in the body dynamics in · Various drug pharmacodynamic (PD) And plasma concentrations remained consistent with the measured value of the clinical trial (parameter identification (use of IVIVE and PBPK in PE)

How do I register?

Online booking for Simcyp events is now handled through the Simcyp Members’ Area. Your saved profile is automatically captured on the booking form so there is no need to re-enter your contact details. Click here to link to the booking forms – you will be prompted for your Simcyp Members’ Area user name (email address) and password. If you have forgotten your log-in credentials please follow the instructions on-screen.

If you have not yet registered for the Members’ Area please sign up now.

Sheffield Workshops Sidebar 2016

January 20, 2016

Boston July Workshop

January 20, 2016

Boston Workshop: July 2016

January 15, 2016

Sheffield Focused Workshops

January 15, 2016

Certara Launches a Strategic Drug Development Consulting Company in China

January 12, 2016

PRINCETON, NJ – Jan. 12, 2016 – Certara^®, the global biosimulation technology-enabled drug development company, today announced the launch of Certara Strategic Consulting China in Shanghai. This new company is being led by President and CEO Christine Yuying Gao, MD, PhD, former vice president of consulting services at Quantitative Solutions, a global pharmacometrics consulting company. Quantitative Solutions merged with Certara’s Pharsight Consulting Services in July 2015 to form Certara Strategic Consulting.

“The recent announcement that the China Food and Drug Administration has introduced new procedures for drug registration and approval demonstrates China’s commitment to increasing innovation in its healthcare system. Biosimulation is an innovation that will not only expedite bringing safer therapies to market, but also will support China’s expansion of its fast-track drug approval process. We are delighted to be able to provide biosimulation consulting support for our clients in China,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD.

Certara Strategic Consulting provides outsourced drug discovery and development modeling and simulation, and strategic pharmacometric services to more than 100 biopharm companies, non-profit foundations, and regulatory agencies worldwide. It also uses model-based meta-analysis to increase drug development productivity, quantitatively inform portfolio management, and improve clinical trial success. In addition, the organization’s unique clinical outcomes databases enable it to analyze the comparative effectiveness of a new drug within its competitive landscape.

“We are just starting to see the profound impact that biosimulation, model-based meta-analysis, and comparative effectiveness analysis can have on a drug candidate’s development, regulatory review, and clinical application. Certara can assist clients in maximizing their efforts at each of these stages,” said Dr. Yuying Gao.

Certara Strategic Consulting’s therapeutic areas of expertise include oncology, cardiovascular, orphan/rare diseases, central nervous system, pediatrics, immunology, infectious disease, metabolic and endocrine disease, women’s health, pain, respiratory and ophthalmology.

Dr. Yuying Gao has more than 20 years’ experience in clinical pharmacology research and drug development. She has partnered with more than 50 pharmaceutical companies and modeled more than 100 compounds in clinical development.

Dr. Yuying Gao conducted her postdoctoral fellowship in clinical pharmacology at the Department of Anesthesia, Stanford University School of Medicine. She received her PhD in clinical pharmacology from the Jiaotong University School of Medicine and her MD in medical science from the Shanxi Medical University in China.

About Certara

Certara Contact:
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer

Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com

Certara Honored with 2015 R&D 100 Award for Its Muse Invent Software

December 14, 2015

PRINCETON, NJ – Dec. 14, 2015 – Certara^®, the global biosimulation technology-enabled drug development company, today announced that it has been honored with a 2015 R&D 100 Award in the Software/Services category for Muse^® Invent™. This awards program recognizes the 100 most innovative technologies and services of the past year.

Muse Invent allows researchers to create drug candidates with novel structures, scaffolds, or side-chains that meet multiple design objectives. It enables them to create parent structures and then score each generation of offspring until only the strongest drug candidates, those that satisfy all the design criteria, survive. Muse Invent can then describe the synthesis pathway required to create those newly-designed molecules. It is a revolutionary product that successfully bridges the gap between molecular design and synthetic chemistry.

“We are very proud that R&D Magazine chose to recognize Muse Invent’s innovative design with a 2015 R&D 100 Award. It really is an exciting product that enables researchers to design their dream molecules and then quickly determine if they are synthetically feasible. It’s both a creative and a practical tool,” said Brian Masek, a product manager at Certara.

When describing Muse Invent’s potential, R&D Magazine reported: “A successful drug design candidate exploits multiple parameters—potency at the target, selectivity, good ADME properties and minimal toxicity. Certara’s Muse Invent generates new ideas that satisfy these multiple drug design parameters, while empowering chemists to integrate additional computed properties and use them for design optimization.”

About the R&D 100 Awards

Since 1963, the R&D 100 Awards have identified revolutionary technologies newly introduced to the market. Widely recognized as the “Oscars of Invention,” the R&D 100 Awards identify and celebrate the top technology products of the year. Past winners have included sophisticated testing equipment, innovative new materials, chemistry breakthroughs, biomedical products, consumer items, and high-energy physics spanning industry, academia, and government-sponsored research. For more information, visit http://www.rd100awards.com.

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

Certara Launches Version 15 of its Simcyp Population-based Simulator

December 08, 2015

PRINCETON, NJ – Dec. 8, 2015 – Certara^®, the global biosimulation technology-enabled drug development company, today announced the release of version 15 of its Simcyp^® Population-based Simulator. The Simcyp Simulator is the pharmaceutical industry’s most sophisticated physiologically-based pharmacokinetic (PBPK) modeling and simulation platform for determining first-in-human dose selection, predicting drug-drug interactions (DDIs), understanding drug disposition in special populations, including pediatrics, and bridging to virtual ethnic populations. The Simcyp Simulator has increasingly been used to inform drug label language, with regulatory acceptance from the US Food and Drug Administration, the European Medicines Agency, and the Japanese Pharmaceuticals and Medical Devices Agency.

“Our work provides a framework for assessing inter-individual variability in pharmacokinetics and pharmacodynamics using virtual human populations and integrating general knowledge of the physical chemistry of a drug with human biology, anatomy, physiology and genetics,” said Simcyp President Steve Toon, PhD. “The Simcyp Simulator allows us to accurately model drug disposition within human and various animal species so that we can inform on dose and dose regimen selection, DDIs, assess the impact of food effect on orally-administered medicines and evaluate impacts of disease and lifestyle factors.”

The Simcyp whole body simulation methodology can predict the pharmacokinetics and pharmacodynamics of small molecule and biological medicines using laboratory-derived data. The simulator includes a unique set of genetic, physiological and epidemiological databases that facilitate the simulation of virtual populations of differing demographies and ethnicities.

The majority of the top-40 pharma companies (including all of the top 10) are members of the Simcyp Consortium. The Simcyp Simulator v15 contains several new models and features requested by the Simcyp Consortium, including:

Simcyp Simulator v15 now offers a physiologically-based pharmacokinetic model for antibody drug conjugates (ADCs). ADCs are a new class of targeted therapies for oncology. They combine the ability of monoclonal antibodies to target cancer cells with the tumor cell killing ability of chemotherapy drugs. This new, scientifically complex therapeutic approach can have a breakthrough impact on the oncology market. According to the report “Global Antibody Drug Conjugate Market Outlook 2020,” the ADC market is anticipated to reach around $12.7 billion by 2020. This new Simcyp Simulator model enables mechanism-driven studies of ADCs and DDIs.

Certara has also enhanced Simcyp Simulator’s ADAM (Advanced Dissolution Absorption Metabolism) model. ADAM now adjusts for factors such as particle shape. ADAM also now contains a new precipitation model that includes lag time. In addition, the multi-layer gut wall within ADAM (M-ADAM) can model drug concentrations within the unstirred boundary layer, enterocyte compartments, active and passive drug permeation, transporter DDIs at both the apical and basolateral membranes, and lymphatic absorption from the intestinal interstitial fluid to the systemic circulation. The enhanced ADAM model helps sponsors develop more physiologically accurate and flexible models of drug disposition in the gut. These improvements also facilitate understanding the role of transporters in influencing bi-directional drug distribution across the gut wall.

Certara is a trailblazer in modeling pediatric patient populations and biologics. The latest version of the Simcyp Simulator facilitates modeling of biologics in pediatric populations. It incorporates age-related changes in system parameters such as IgG and IgE levels. Researchers can use this model to define population age, weight and height relationships. This new model provides unique insight into understanding the disposition of biologics in young children, an especially sensitive patient population.

Certara has also added a multiple-compartment permeability-limited lung model to the Simcyp Simulator. It models active and passive drug disposition in the lungs. This model helps sponsors gain a better understanding of drug absorption and metabolism in the lung. This development is partly supported by the Critical Path to TB Drug Regimens initiative. The lung model complements the previously developed models of the brain, liver, and kidney.

The Simcyp Simulator now comes bundled with a command line console which supports the Innovative Medicines Initiative’s DDMoRe Project Interoperability Framework. This new functionality will allow DDMoRe partners with a Simcyp Simulator license to run simulations in scripted workflows with other software such as NONMEM and PSN, Monolix, PFIM, and PopED. The console may be used independently of DDMoRe facilities, and users will benefit from the Simulator’s vast databases of populations, compounds and PBPK models through other platforms such as Matlab and R.

Further information about Simcyp Simulator v15 is available at http://www.certara.com/software/pbpk-modeling/simcyp-simulator. The Simcyp Simulator v15 can also be downloaded now.

About Certara

Certara Contact:

Ellen Leinfuss, 609-216-9586
Chief Marketing Officer

Media Contact:

Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com

Leading the Biosimulation Revolution Sidebar

December 08, 2015

Leading the Biosimulation Revolution Form

December 08, 2015

Leading the Biosimulation Revolution

December 08, 2015

Label Optimization Pyramid

December 08, 2015

Certara Acquires Quantitative Systems Pharmacology Consultancy, XenologiQ

December 01, 2015

PRINCETON, NJ – Dec. 1, 2015 – Certara^®, the global biosimulation technology-enabled drug development company, today announced that it has acquired XenologiQ, a UK-based quantitative systems pharmacology (QSP) consultancy.

“This transaction strengthens Certara’s modeling and simulation capabilities, increases its leadership in mechanistic pharmacology, and supports the company’s precision medicine vision,” said Certara Chief Executive Officer Edmundo Muniz, M.D, Ph.D. “It also gives us access to the emerging QSP technology, which integrates quantitative knowledge about a compound with the understanding of the mechanism of action for a specific disease. QSP focuses on the behavior of biological systems as a whole, versus the behavior of individual components.”

The XenologiQ team will join Certara’s Simcyp^® division. The directors of XenoloqiQ will take up leadership positions within the Simcyp QSP organization. Piet van der Graaf, PharmD, PhD, (currently professor of systems pharmacology, Leiden University, Netherlands) will become vice president QSP, and Neil Benson, PhD, (formerly head of systems pharmacology, Pfizer, Sandwich, UK) will become head of QSP operations. Professor van der Graaf is a global leader in QSP, holds several patents in the field of target discovery, and has authored more than 100 scientific papers and book chapters in the area of quantitative and translational pharmacology. He is also Editor-in-Chief of CPT: Pharmacometrics & Systems Pharmacology, the American Society for Clinical Pharmacology & Therapeutics’ journal.

Simcyp is the industry-leading mechanistic and physiologically-based pharmacokinetic (PBPK) modeling organization and counts the majority of the top-40 pharma companies as its clients and members of the Simcyp Consortium. Key academic institutions, and global regulators, including the US Food and Drug Administration, European Medicines Agency, and Japanese Pharmaceuticals and Medical Devices Agency are consortium affiliates.

QSP is an emerging biosimulation discipline that 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. QSP modeling demonstrates, in a precise, predictive manner, how drugs modify cellular networks in space and time and how they impact and are impacted by human pathophysiology. Additionally, QSP facilitates the evaluation of complex, heterogeneous diseases such as cancer, immunological, metabolic and CNS diseases that require the combination of multiple therapies.

“Certara’s move into QSP is a natural extension of its leading position in biosimulation,” said Simcyp President Steve Toon, PhD. “The acquisition of XenologiQ signals the start of Certara’s commitment to become a world leader in the QSP space, furthering our objective of providing technology solutions that improve all aspects of the drug development process.”

“Combining PBPK with systems pharmacology is a natural fit. We see systems pharmacology models evolving alongside PBPK ones as new data becomes available to further inform crucial go/no-go decisions throughout the drug development continuum,” said Professor van der Graaf. “We look forward to joining Certara’s Simcyp team and increasing the depth of human disease biology included in its biosimulation modeling.”

Financial details about the transaction were not disclosed.

About XenologiQ

XenologiQ is a UK-based consulting company. Its mission is to productively implement state-of-the-art modeling and simulation in medical and life sciences research. Its value proposition is to achieve this via the optimal integration of experience, technical excellence and global talent. Its consultants have decades of experience in reducing modeling and simulation to effective practice in blue chip pharmaceutical R&D, in particular in pharmacokinetic/pharmacodynamic modeling and applied systems biology/systems pharmacology. For further information, visit www.xenologiq.com.

About Certara

Certara Contact:
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer

Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com

Certara Appoints Prof. Piet van der Graaf to Lead New Quantitative Systems Pharmacology Organization

December 01, 2015

PRINCETON, NJ – Dec. 1, 2015 – Certara®, the global biosimulation technology-enabled drug development company, today announced that it has appointed Professor Piet van der Graaf, PharmD, PhD, as its vice president of quantitative systems pharmacology (QSP) and the head of its new Simcyp® QSP organization.

Van der Graaf is professor of systems pharmacology, chair of pharmacology, and director of the Leiden Academic Centre for Drug Research at Leiden University in the Netherlands. He is also a former director of XenoloqiQ, the UK-based QSP consultancy, which Certara just acquired.

QSP combines computational modeling and experimental methods to examine the mechanistic relationships between a drug, the biological system, and the disease process.

“Certara recognizes the critical role that QSP is going to play in the global drug development and regulatory decision making processes. This innovative modeling approach provides a mechanistic understanding of the relationships between dose and pharmacological response and the inter-relationship with the disease and its progression,” said Simcyp President Steve Toon, PhD. “Piet is a global authority on QSP and the ideal person to head up our new Simcyp QSP organization. We are delighted to have him join our team.”

In the past, medical researchers thought that a single target – a receptor, channel, protein or enzyme – was responsible for causing a particular disease. However, that was found to be true in only a limited number of cases, most of which have been addressed. The remaining diseases are all manifestations of several changes in the system.

QSP helps to draw a map of biological networks and identify hot spots that need to be hit simultaneously to generate the desired effect. It provides vital intelligence for the drug discovery process by showing researchers what combined effects a successful drug candidate needs to have.

QSP can also assist in identifying the best dose and combination of drugs for an individual based on their own phenotypic traits, which are derived using a variety of tests.

“Certara is a leader in biosimulation and we have a shared vision of QSP’s potential,” said Professor van der Graaf. “We plan to add biological systems and disease process data to Certara’s Simcyp Simulator and further inform its population-based pharmacokinetic modeling and simulation. This will have a major impact on the industry.”

Professor van der Graaf is Editor-in-Chief of CPT: Pharmacometrics & Systems Pharmacology, the American Society for Clinical Pharmacology & Therapeutics’ journal, and a fellow of the British Pharmacological Society. He holds several target discovery patents and has (co-)authored more than 100 papers and book chapters on quantitative and translational pharmacology. He has given around 100 lectures at international symposia and workshops on these topics.

Professor van der Graaf has a PhD in clinical medicine. He received his doctorate training in quantitative receptor pharmacology with Nobel laureate Sir James Black at King's College London.

About Certara

Certara Contact:
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer

Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com

Certara Acquires Quantitative Systems Pharmacology Consultancy XenologiQ

November 27, 2015

Scientific webinar series

November 18, 2015

Biosimulation Paves the Way for Precision Dosing

November 09, 2015

IT Support Specialist

November 03, 2015

FDA Equips its Pharmacometrics Teams with Certara’s Phoenix Software

November 02, 2015

Partnership provides pharmacometric biosimulation solutions for multiple FDA centers

PRINCETON, NJ – Nov. 2, 2015 – Certara^®, the global biosimulation technology-enabled drug development company, today announced that the United States Food and Drug Administration (FDA) has outfitted its pharmacometrics teams with Certara’s Phoenix^® software. Phoenix is the industry’s premier software platform for managing, analyzing and reporting pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) data.

Certara’s partnership with the FDA dates back to 2001, when its Pharsight division (pharmacometric biosimulation software) formed a Cooperative Research and Development Agreement (CRADA) with the FDA Center for Drug Evaluation and Research (CDER). That CRADA directly supported the FDA’s Critical Path Initiative, which advocates increased use of drug-disease modeling and simulation to improve the efficiency of the drug development process.

“We are extremely proud of our partnership with FDA, which not only includes the expanded use of Phoenix software for PK/PD, but leverages the Simcyp^® Simulator for physiologically-based PK (PBPK) in regulatory review,” said Certara Chief Executive Officer Edmundo Muniz, M.D., Ph.D. “We routinely meet with the agency to collaborate and educate one another on the ever-increasing applications for biosimulation in drug development. Today’s announcement affirms the agency’s commitment to achieving its Critical Path Initiative goals via innovative technology.”

FDA has purchased almost 300 Phoenix licenses of Phoenix WinNonlin, Phoenix NLME and additional Phoenix tools for use across multiple divisions, including the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Veterinary Medicine, Center for Tobacco Products, Center for Food Safety and Applied Nutrition, Office of Generic Drugs, and Office of New Drug Products.

In its recently-published paper, Catalyzing the Critical Path Initiative: FDA’s Progress in Drug Development Activities, the agency identified computer-based predictive models for safety, efficacy, and disease progression as a key innovation toward improving health. Specifically, the article says, “Modeling and simulation [M/S] tools for drug exposure and its response have been useful in both pre- and post-market settings when questions related to safety and efficacy of therapeutic products arise. M/S has served as a useful predictive tool for dose selection for pivotal trials, dosing in select populations such as pediatrics, optimization of dose and dosing regimen in a subset patient population, prediction of efficacy and dosing in unstudied patient population in clinical trials, characterizing exposure and dose-related QT interval prolongation, and including PBPK modeling in predicting drug-drug interactions.”

About Certara

Certara Contact:
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer

Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com

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 Contact:

Ellen Leinfuss, 609-216-9586

Chief Marketing Officer

Media Contact:

Lisa Osborne, 206-992-5245

Rana Healthcare Solutions

lisa@ranahealth.com

Japanese Medical Research and Development Agency Selects Phoenix WinNonlin Software

October 20, 2015

PRINCETON, NJ – Oct. 20, 2015 – Certara^®, the global biosimulation technology-enabled drug development company, today announced that Japan’s new Agency for Medical Research and Development (AMED) has selected Certara’s Phoenix^® WinNonlin^® software for pharmacokinetic/pharmacodynamic (PK/PD) modeling and non-compartmental analysis of new drug candidates. AMED was launched on April 1, 2015 and fulfills a similar role to the National Institutes of Health in the United States.

“Considered the gold standard for PK/PD and non-compartmental analysis, Phoenix WinNonlin is being used by more than 6,500 researchers at more than 1,500 biopharm companies, academic institutions and global regulatory agencies,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD. “In fact, Phoenix WinNonlin is relied upon by 100 percent of leading pharma companies, according to survey results published in the January 2015 IQ Consortia report on preclinical PK/PD modeling. We are delighted that AMED chose to start working with Certara right away as the Agency expands its drug development analysis capabilities.”

Prime Minister Shinzo Abe is counting on AMED to move drugs from the bench into the clinic and onto the market. AMED is expected to employ Phoenix WinNonlin to create PK profiles, and assess bioavailability for new drug candidates in its preclinical program. These data will help AMED’s domestic and international biopharmaceutical partners to identify which molecules hold the most therapeutic potential and should be progressed into clinical trials. AMED is currently testing about 200,000 samples provided by 10 biopharmaceutical companies. However, it plans to open the program to additional biopharmaceutical partners shortly. Its initial focus is on the development of drugs for cancer and infectious diseases. AMED will flag promising molecules for its partners and request that they develop them further.

Phoenix WinNonlin is the trusted, long-time industry standard software tool for PK/PD modeling, non-compartmental and compartmental analysis. It is easily validated, delivering accurate, reproducible and traceable results. WinNonlin has powerful graphics, an extensive model library, and its results can readily be shared in a single file with collaborators. It can also perform a bioequivalence analysis, or create a simulation of multiple doses, from single-dose data.

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

Certara Scientists Participate in 9 Presentations at the North American ISSX Meeting

October 19, 2015

Diverse agenda underscores the widespread adoption of PBPK approaches throughout the drug development process

PRINCETON, NJ – Oct. 19, 2015 – Certara^®, the global biosimulation technology-enabled drug development company, today announced that its scientists are presenting 9 seminars and poster sessions at the twentieth International Society for the Study of Xenobiotics (ISSX). This annual ISSX conference will be held in Orlando, FL from Oct. 18-22, 2015. A xenobiotic is a chemical that does not occur naturally in an organism, such as a drug or a pesticide.

“The mission of ISSX is to uncover the metabolism and disposition of chemicals in biological systems. This focus dovetails perfectly with our Simcyp^® Simulator technology, which uses mechanistic approaches to predict the effects of drugs in virtual populations,” said Certara Chief Marketing Officer Ellen Leinfuss.

Speakers

Amin Rostami ‘Variability in Pharmacokinetics and Its Sources’ Plenary Session 1: Sources of Variability in PK and PD, 9:00am - 11:00am on Monday, October 19, 2015
Sibylle Neuhoff ‘Translating Transporter Data: In vitro – in vivo Extrapolation to Assess Pharmacokinetics, Pharmacodynamics and Drug-drug Interactions’ Short Course 3: Methodological Aspects of Transporter Measurements. 1:30pm - 4:45pm on Sunday, October 18, 2015
Sibylle Neuhoff: Application of a physiologically based Pharmacokinetic/Pharmacodynamic (PBPK/PD) model for prediction of drug-drug interactions (DDIs) involving the Jak1/2 inhibitor Ruxolitinib in Caucasians and Japanese, 15:30 – 15:45 as part of Parallel Symposium 2: Preclinical Applications of Systems Pharmacology in Drug Development, chaired by Mirjam Trame, University of Florida, Orlando, Florida, USA to be held on Monday, October 19 from 2:00 p.m. - 4:00 p.m

Posters

Ariane Emami Riedmaier, Howard Burt, Kate Gill, Matthew Harwood and Sibylle Neuhoff: Abundance of hepatic transporters in Caucasians: A meta-analysis Poster number P244. Poster Session 2 on Wed, Oct 21 from 12:45p.m. – 1:30p.m.
Howard Burt and Sibylle Neuhoff: In silico modelling of in vitro bidirectional transport studies and comparison to conventional data analysis, Poster number P166. Poster Session 2 Wed, Oct 21 from 12:45p.m. – 1:30p.m.
Oliver Hatley, Nikunjkumar Patel, Lu Gaohua, Howard J. Burt, Sibylle Neuhoff, Klaus Romero, Debra Hanna, David Hermann, Iain Gardner, Masoud Jamei: Application of a multi-compartment permeability-limited lung model to predict lung concentrations of Moxifloxacin in virtual human subjects
Sibylle Neuhoff and Iain Gardner: Application of a physiologically-based Pharmacokinetic/Pharmacodynamic (PBPK/PD) model for prediction of drug-drug interactions (DDIs) involving the Jak1/2 inhibitor Ruxolitinib in Caucasians and Japanese, Poster number P225. Poster Session 1 on Tues, Oct 20 from 12:45p.m. – 1:30p.m.
Lisa Almond, Suzanne Tay, Susan Wong, Sophie Mukadam, Iain Gardner, Karen Rowland-Yeo, Jane Kenny: he relationship between mRNA and activity following induction of CYP3A4 and CYP2B6 across a range of prototypical inducers
Lisa Almond, Alice Ke, Zoe Barter and Karen Rowland-Yeo: Development of a PBPK model For Efavirenz that accounts for auto-induction and its effect on the CYP2B6 substrate bupropion

For further information about this conference, please visit: https://issx.site-ym.com/page/20NAISSXInvite/?

Certara Contact:
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer

Media Contact:
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions
lisa@ranahealth.com

Certara Joins EU-ToxRisk – A Program Driving Mechanism-based Toxicity Testing and Risk Assessment

October 12, 2015

In a large (30 Million €) H2020-supported collaborative project, academia joins forces with small and medium-sized enterprises (SMEs), large industry, contract research organizations (CROs) and regulatory bodies to achieve a paradigm shift in toxicology towards a more efficient and animal-free chemical safety assessment.

PRINCETON, NJ, Oct. 12, 2015

An international consortium of 39 partner organizations will be funded by the European Commission to work on the integration of new concepts for regulatory chemical safety assessment. These new concepts involve cutting-edge human-relevant in vitro non-animal methods and in silico computational technologies to translate molecular mechanistic understanding of toxicity into safety testing strategies. The ultimate goal is to deliver reliable, animal-free hazard and risk assessment of chemicals.

Coordinated by Bob van de Water, Professor of Toxicology at Leiden University (The Netherlands), EU-ToxRisk intends to become the European flagship for animal-free chemical safety assessment. The project will integrate advancements in cell biology, omics technologies, systems biology and computational modeling to define the complex chains of events that link chemical exposure to toxic outcome. The consortium will provide proof of concept for a new mechanism-based chemical safety testing strategy with a focus on repeated-dose systemic toxicity as well as developmental and reproductive toxicity. Importantly, novel mechanism-based test methods will be integrated in fit-for-purpose testing batteries that are in line with the regulatory framework and will meet industrial implementation. EU-ToxRisk will develop new quantitative risk assessment approaches based on understanding of so-called “Adverse Outcome Pathways” incorporating all mechanistic toxicity data available in the public domain. It will also achieve a rapid improvement of so-called “read across” approaches as the most important data-gap filling and hence animal-saving alternative method at present. Thus, the project strives towards faster safety evaluation of the many chemicals used by industry and society.

“Certara is proud to participate in this international effort to develop reliable, efficient, animal-free toxicology tests for agrochemicals, industrial chemicals, and cosmetics,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD. “We plan to demonstrate the pivotal role that physiologically-based pharmacokinetic modeling and simulation can play in improving toxicology testing.”

Dr. Susanne Hougaard Bennekou from the Danish Environmental Protection Agency explained: “Safety evaluation is largely based on animal testing. This is the best we have today. However, there are widely recognized limitations, these being that the sensitivity and specificity of animal-based safety testing could lead to wrong predictions of chemical-induced human adversities. Whilst false-negative results compromise human safety, false-positive animal tests and use of unnecessarily large safety factors may lead to the loss of beneficial and safe chemicals and drugs.” Professor Marcel Leist, head of the Center for Alternatives to Animal Testing in Europe (CAAT-Europe) in Konstanz, Germany, added: “Ethical issues related to the use of experimental animals as well as economic considerations (high costs, time delay by testing) demand a paradigm shift, away from ‘black box’ animal testing towards a toxicological assessment based on responses observed in human cells and a comprehensive mechanistic understanding of cause-consequence relationships of adverse chemical effects.”

EU-ToxRisk builds on testing strategies and knowledge developed in previous national and European projects, including the SEURAT-1 program, a cluster of seven projects in the field of animal-free safety assessment: 2010-2015 (http://www.seurat-1.eu). The EU-ToxRisk consortium includes many of Europe’s leading toxicologists and experts in related fields such as cell and developmental biology, genomics, computational biology, cheminformatics, bioinformatics, biostatistics, regulatory sciences, as well as management and dissemination, from a range of organizational backgrounds and covering several industry sectors. This breadth of expertise will allow EU-ToxRisk to develop efficient and innovative safety testing strategies, covering the whole range of stakeholders, to ensure fit-for-purpose solutions, practical routine applicability and quick uptake of results. EU-ToxRisk will establish strong ties with the European Union Reference Laboratory for alternatives to animal testing (EURL-ECVAM), hosted by the Joint Research Centre (JRC), Institute for Health and Consumer Protection, to establish novel alternative testing strategies that are fit for regulatory purposes. In addition, the project will strongly collaborate with ongoing safety and risk assessment initiatives across the globe, including the Tox21 initiative in the United States.

Dr. Rob Taalman, Science and Research Director at Cosmetics Europe, the Brussels-based Personal Care Association, which co-funded the SEURAT-1 cluster with the European Commission, said: “We are thrilled to be part of this strategic EU project. This joint action restates our long-held commitment to be at the forefront of research into alternatives to animal testing. For more than 20 years, the industry has been pushing the boundaries of cutting-edge science to develop technologies that would feed into novel, sustainable safety testing strategies in line with the European regulatory framework. Since the ban on animal testing within the cosmetics industry, there is the wish and the scientific capabilities to improve safety assessment approaches based on alternatives.”

Overall, EU-ToxRisk intends to evolve a new era for European safety sciences. At the end of the project the novel risk assessment strategies should find wide application in various regulatory contexts, across industry sectors, and for different population groups, such as patients, workers, consumers, and the society at large. Altogether, EU-ToxRisk expects to have a strong impact on the future regulatory chemical safety and risk assessment in Europe as well as the rest of world.

The EU-ToxRisk project will kick-off in January 2016 in Leiden, The Netherlands, and will run for six years.

Project Partners

Universities

Leiden University, The Netherlands
Leiden University Medical Centre, The Netherlands
Konstanz University, Germany
Katholieke Universiteit Leuven, Belgium
Maastricht University, The Netherlands
Medical University of Innsbruck, Austria
Ruprecht-Karls-Universität Heidelberg, Germany
University of Copenhagen, Denmark
Universitat Pompeu Fabra, Spain
University of Vienna, Austria

Research Institutions

Center for Alternatives to Animal Testing in the Johns Hopkins Bloomberg School of Public Health, United States of America
EMBL/European Bioinformatics Institute, United Kingdom
Forschungsgesellschaft für Arbeitsphysiologie und Arbeitsschutz (IFADO), Germany
Fraunhofer Society – Fraunhofer ITEM, Germany
Fundación para la Investigación del Hospital Universitario La Fe de la Comunidad Valenciana, Spain
Institut National de l’Environnement et des Risques, France
Istituto di Ricerche Farmacologiche Mario Negri, Italy
Karolinska Institutet/Swedish Toxicology Sciences Research Center, Sweden
TNO, The Netherlands

Large industry

BASF, Germany
Cosmetics Europe, Belgium
F. Hoffmann – La Roche, Switzerland
L’Oreal, France
Simcyp, a Certara company, United Kingdom
Steinbeis CAAT-Europe at the University of Konstanz, Germany
Unilever, Safety and Environmental Assurance Centre, United Kingdom

SMEs

ARTTIC, France
BioDetectionSystems, The Netherlands
BioTalentum, Hungary
Cyprotex Discovery Ltd, United Kingdom
Douglas Connect, Switzerland
InSphero AG, Switzerland
Lhasa Limited, United Kingdom
Open PHACTS Foundation, United Kingdom
TissUse, Germany

Regulatory bodies

Federal Institute for Occupational Safety and Health, Germany
Istituto Superiore di Sanità, Italy
The Danish Environmental Protection Agency, Denmark

Research funder

National Centre for the Replacement, Refinement & Reduction of Animals in Research, United Kingdom

For further information on EU-ToxRisk and the project partners see: www.eu-toxrisk.eu

For more information on the H2020 programme, visit:
http://ec.europa.eu/programmes/horizon2020/

Press contacts

Prof. Bob van de Water
Division of Toxicology
Leiden Academic Centre for Drug Research (LACDR)
Leiden University
Einsteinweg 55 / P.O. Box 9502 / 2300 RA LEIDEN / The Netherlands
Office: +31-71-5276223 / Secretariat: +31-71-5276270 / E-mail: b.water@lacdr.leidenuniv.nl

Ellen Leinfuss
Chief Marketing Officer
Certara
Office: 609-216-9586

Lisa Osborne
Media Contact
Rana Healthcare Solutions
Office : 206-992-5245 / Email : lisa@ranahealth.com

Email: eu-toxrisk@eurtd.com
Website: www.eu-toxrisk.eu

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