Clinical Transparency & Disclosure

New FDA Commissioner Endorses Use of M&S to Advance Drug Development

Suzanne Minton

With the swearing in of Dr. Scott Gottlieb as Commissioner of Food and Drugs in May, many have wondered as to the climate he will set for the US FDA. Certara’s mission and business thesis aligns with the FDA’s July 7 announcement regarding the steps it is taking to implement the 21st Century Cures Act. […]

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Topics: Clinical Transparency & Disclosure, Model-based Meta-analysis, PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Regulatory & Medical Writing

What are Clinical Trial Outcomes Databases? How and Why You Should Use Them

Maria Saluta

Publicly available clinical trial data represents an underutilized source of information. If properly extracted and analyzed, they provide valuable information to support drug development decisions. When you think of the volumes of public information and databases that are available to determine, for example, commercial viability of a therapeutic in development, your first inclination is—“great!” But […]

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Topics: Model-based Meta-analysis, PK/PD Modeling & Simulation

Certara Launches CODEx to Inform Comparative Effectiveness and Drug Development Decisions

PRINCETON, NJ – June 6, 2017 – Certara today launched its Clinical Outcomes Database Explorer (CODEx). An intuitive, web-based platform, CODEx enables drug development teams to easily visualize, explore, analyze and communicate content from Certara’s Clinical Trial Outcomes Databases and assess a given compound’s probability of success against competitor drugs.

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Using Model-based Meta-analysis to Inform Drug Development for Autoimmune Diseases

January 17, 2018 – MBMA helps sponsors design less costly and more precise trials with an eye toward achieving commercial success for both the drug and portfolio. Attend this webinar with Dr. Mark Lovern, Vice President at Certara Strategic Consulting, to learn how leveraging public data can provide value by abbreviating the “cash spiral” inherent to proprietary data.

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How MBMA Can Help You Make Smarter Drug Development Decisions

Leon Bax

Successful drug development depends on making wise decisions about portfolios, clinical trials, marketing, etc. We’re continuously faced with the challenge of deciding whether to continue development or stop it. To support those decisions, we gather data, typically through clinical trials. We analyze the data from those clinical trials, and then we use these analyses to […]

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Topics: Model-based Meta-analysis, PK/PD Modeling & Simulation

Abundance of Hepatic Transporters in Caucasians: A Meta-analysis

The aim of this study was to derive quantitative abundance values for key hepatic transporters suitable for in vitro-in vivo extrapolation (IVIVE) within a physiologically-based pharmacokinetic modeling framework. A meta-analysis was performed whereby abundance measurements, sample preparation method and donor demography were collated from literature. In order to define values for a healthy Caucasian population, […]

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Model-Based Meta-Analysis of the HbA1c Lowering Effect Of PF-04971729, a Sodium Glucose Co-Transporter-2 Inhibitor (SGLT2i), In Comparison to Other SGLT2i And Anti-Diabetic Agents (ADA)

PF-04971729 is a potent, selective SGLT2i in development for treatment of type 2 diabetes mellitus (T2DM). Since there is growing recognition of the need for comparative effectiveness of various ADA, a model was developed to quantify time course of dose vs HbA1c response of PF-04971729 relative to other ADA including SGLT2i, DPP4 inhibitors (DPP4i), GLP-1 […]

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Model-Based Meta-Analysis of the Effect on Body Weight of PF-04971729, a Sodium Glucose Co-Transporter-2 Inhibitor (SGLT2i), in Comparison to other SGLT2i and Anti-Diabetic Agents (ADA)

PF-04971729 is a potent, selective SGLT2i in development for treatment of type 2 diabetes mellitus (T2DM). Since there is growing recognition of the need for comparative effectiveness of various ADA, a model was developed to quantify the time course of dose vs body weight change for PF-04971729 relative to other ADA including SGLT2i, DPP4 inhibitors […]

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Using Model-based Meta-analysis to Improve Decision-making in Drug Development

Making the right choices in drug development often means the difference between getting a new medication to patients and it ending up in the scrap heap of failed programs. There is a surfeit of publicly available information on approved drugs as well as those currently in development. How can sponsors turn clinical trial data into understanding that helps chart the course for investigational drugs?

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Short-term Efficacy Reliably Predicts Long-term Clinical Benefit in Rheumatoid Arthritis Clinical Trials as Demonstrated by Model-based Meta-analysis

The objective of this study was to assess the relationship between short-term and long-term treatment effects measured by the American College of Rheumatology (ACR) 50 responses and to assess the feasibility of predicting 6-month efficacy from short-term data. A rheumatoid arthritis (RA) database was constructed from 68 reported trials. We focused on the relationship between […]

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Partnering for Pharmacometric Impact

• Quantifying clinical trial efficacy, tolerability, and safety information to enable informed drug development decisions
• Incorporating quantitative pharmacology models for the effects of treatment, time, and patient characteristics on therapeutic outcome
• Competitive positioning, quantitative definition of Best-in-Class, assessment of drug class characteristics, and optimizing clinical trial designs

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That’s So Meta: How Model-based Meta-analysis Informs Drug Development

Mark Lovern

Making the right choices in drug development often means the difference between getting a new medication to patients and it ending up in the scrap heap of failed programs. There is a surfeit of publically available information on approved drugs as well as those currently in development. How can sponsors turn clinical trial data into […]

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Topics: Model-based Meta-analysis
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