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From Concept to Market: Value of MIFD & Simcyp Biopharmaceutics for Streamlined Drug Formulation and Approvals

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Tuesday, July 9, 2024

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“Certara’s contribution to the drug development program for Nurtec ODT was substantial. Their clinical pharmacology representative worked seamlessly with the Biohaven Development Team. Certara’s considerable expertise in clinical pharmacology and pharmacometrics and flawless execution supported Nurtec’s clinical development team and helped to prepare the clinical pharmacology NDA components.” Richard Bertz, PhDVice President, Clinical Pharmacology & Pharmacometrics

LATEST CONTENT

Modeling the Future of Drug Development

Using model informed drug development strategies, advanced data, analytics and AI, and scientific expertise, we are committed to sharing our thought leaders’ insights and findings to question current approaches and envision what the future holds for biosimulation and public health.

RESOURCE LIBRARY

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From Concept to Market: Value of MIFD & Simcyp Biopharmaceutics for Streamlined Drug Formulation and Approvals

Free Webinar for Biopharmaceutics and Drug Formulation Scientists Join us for an insightful discussion with Pfizer experts Vivek Purohit, Sr. Director and Pharmacometrics Team Leader for Inflammation and Immunology, and Kazuko Sagawa, Research Fellow in the Biopharmaceutics Group, along with Ioannis Konstandtinidis, Principal Scientist II Modeling &amp; Simulation, PK Sciences at NIBR at Novartis. We&#8217;ll &hellip; <a href="https://www.certara.com/webinar/from-concept-to-market-value-of-mifd-simcyp-biopharmaceutics-for-streamlined-drug-formulation-and-approvals/">Continued</a>

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The 51st Annual Meeting of the Japanese Society of Toxicology (JSOT 2024)

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Market Access, Pricing and Reimbursement for Digital Health Technologies (DHTs) in Europe
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Categorizing & Managing Risks in Aggregate Safety Reports 

Categorizing Risks  From a sponsor’s first authorization to conduct a clinical drug trial in any country worldwide, they must prepare and submit development safety update reports (DSURs) annually. The purpose of the DSUR is to present a comprehensive evaluation of safety information related to the sponsor’s investigational drug.1   A mandatory part of this safety evaluation … Continued

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Drug Development and Regulatory Strategy and Stewardship

Drug Development and Regulatory Strategy and Stewardship

From candidate selection to market we provide global, multi-functional development strategy and decision making, as well as program design and execution

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Biometrics and Data Sciences

Biometrics and Data Sciences

Leverage innovative approaches like adaptive trial design and advanced biostatistics for more rapid, better informed clinical decisions.

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Regulatory Services & Medical Communications

Regulatory Services & Medical Communications

Accelerating the approval of medical innovations through a unique combination of technology-enabled document authoring with deep regulatory, scientific, and operations expertise.

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Pharmacometrics - Modeling and Simulation

Pharmacometrics - Modeling and Simulation

Enable key decisions from First-in-Human to approval with Certara's leading quantitative analysis and predictive modeling solutions

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Evidence and Access

Evidence and Access

Demonstrate product value with market access strategies, analytics-driven evidence generation, advanced modeling and RWD solutions.

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MODEL INFORMED DRUG DEVELOPMENT SOLUTIONS

Unmatched Expertise

Certara delivers advanced drug development solutions, empowering pharmaceutical and biotechnology companies to accelerate the journey from early research to successful market approval. Certara experts include some of the leading scientists in the world with seven of our scientists recognized as the top 2% most cited in their field*. The value to clients is working with the industry’s largest team of model informed drug developers to derisk projects, shorten timelines, reduce costs and enhance scientific understanding of how new therapies impact patients. With flexible operating models that support both expert teams of modelers in large pharma organizations to serving as a comprehensive drug development steward for emerging biotech startups, Certara delivers exceptional value that moves you forward faster.

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MIDD SOFTWARE PRODUCTS

Modern, AI-Enabled Software for Discovery & Development

Certara software products include industry gold standard offerings that have been used by more than 60,000 end users around the globe. Our goal is to lead the industry with advanced computing capabilities that change the model of drug development across discovery, biosimulation, and clinical data automation.

EXPLORE SOFTWARE

Pinnacle 21 Clinical Data Management & Automation Suite

Pinnacle 21 Clinical Data Management & Automation Suite

Cloud suite of unified clinical data standardization, compliance and automation solutions to increase the speed and quality of clinical trial submission data.

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Phoenix™ Pharmacokinetic / Pharmacodynamic Platform

Phoenix™ Pharmacokinetic / Pharmacodynamic Platform

The global leader in software for preparing clinical trial data for regulatory submission.

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Simcyp™ Physiologically Based Pharmacokinetic (PBPK)

Simcyp™ Physiologically Based Pharmacokinetic (PBPK)

Simcyp PBPK models describe the behavior of drugs in different body tissues, with each tissue considered a physiological compartment.

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D360™ Scientific Informatics Platform

D360™ Scientific Informatics Platform

The platform, used by over 6,000 discovery scientists for small molecule and biologics research, provides self-service data access and integrated analysis solution.

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Certara.AI Platform

Certara.AI Platform

Certara.AI allows you to solve data silo problems while improving analytics capabilities that drive productivity and accelerated data discovery across life science R&D.

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Case Study. Enhancing HEOR Global Knowledge Sharing
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FEATURED CASE STUDIES

From Molecule to Market Accelerating Medicines Together

More than 2,300 life sciences companies including 23 global regulatory agencies worldwide choose Certara as their partner for MIDD solutions including biosimulation, data sciences software and expert drug development services. See how we have helped companies like yours redefine what’s possible for safe and effective modern medicine.

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