Pharmacometrics Skills Competition MIDD Gran Prix

Julie Dumond

Sitting around the Certara’s Raleigh office conference room, sketching out a pitch for a pharmacometrics contest at a national meeting, none of us were overly confident in its viability. Mark Lovern had been talking about the importance of communication skills for pharmacometricians. For them to influence critical drug development decisions, they should be able to […]

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Topics: PK/PD Modeling & Simulation

About Certara

Changing the Game in Drug Development and Patient Access At Certara, we are innovators, dedicated to helping our clients develop new therapies and target unmet medical needs, expand existing therapies to other subpopulations, communicate scientific information in the language of regulatory success and market access, balance risk-benefit profiles, differentiate therapies from the competitive landscape, and […]

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FDA Reauthorization Act (FDARA) Affirms Commitment to Innovative MIDD Strategies

Ellen Leinfuss

Quietly, without any political rancor, the FDA Reauthorization Act of 2017 (FDARA) was passed by the US Congress and was signed into law by President Trump in late August. The FDARA reauthorizes the Prescription Drug User Act Fee Amendments (PDUFA) for the fifth time, the Medical Device User Act Fee Amendments (MDUFA) for the third […]

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Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation, Systems Pharmacology

Pharmacology to Payer

Focus on Patient Centricity In traditional drug development, limited engagement—or engagement too late in the development program—between sponsors, regulators, and payers can result in unacceptable delays of patient access to life-saving medicines. While alternative approaches such as Adaptive Licensing, which includes staggered approval, managed entry, and progressive authorization have expedited the process, it addresses only […]

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Quantitative Systems Toxicology

Integrating In Vitro and In Vivo Toxicity Data with Computational Modeling to Achieve a Pathway-based Approach to More Efficient Chemical Risk Assessment A major challenge in developing efficacious and safe drugs is the ability to understand and effectively predict adverse effects of xenobiotic substances on extremely complex biological systems early in the drug discovery process. […]

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Drug Development Gap Analysis

Setting the Right Strategy As drug development has become more complex, with a higher risk of failure, greater uncertainty, and increased expense, the need for a quantitative and regulatory science-based strategy becomes clear. The first step in that performing that strategic assessment is a gap analysis and roadmap. Certara’s solution evaluates the 40 different questions […]

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Drug Development and Clinical Pharmacology Strategy

Changing the Game in Drug Development through a Strategic and Programmatic Approach Far too many cases treat drug development like a relay race, with the baton handed from one participant to the next. But, this approach risks missing opportunities to develop medicines faster and better. And lacking a holistic and strategic roadmap to achieve milestones […]

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Quantitative Solutions

QuantitativeSolutions.net has moved to Certara.com Certara has acquired Quantitative Solutions, a global pharmacometrics consulting company headquartered in Menlo Park, California. This merger further strengthens Certara’s position in the burgeoning modeling and simulation/pharmacometric services field, broadening its modeling capabilities, deepening its therapeutic areas of expertise and adding new value-added services and clinical outcomes databases. The resulting organization is called Certara Strategic […]

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Quantitative Systems Pharmacology

Quantitative Systems Pharmacology (QSP): Integrating Quantitative Drug Data with Knowledge of Its Mechanism of Action One of the biggest challenges—and, hence, the biggest opportunity for QSP—is drug attrition in Phase 2 clinical trials. Investigational medicines are usually tested for the first time in patients in Phase 2 clinical trials. This is the point when many […]

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Therapeutic Areas

Therapeutic Areas of Expertise: Strategic Drug Development Services Certara’s global consulting team has unparalleled experience across all development phases and in all major therapeutic areas. We have collaborated with sponsors, both large and small, to provide insight into key decisions, including dosing and toxicity, efficacy and biological impact, comparative effectiveness, clinical trial design, regulatory strategy, and […]

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Orphan Drug Development

Orphan Drugs: Unique Challenges Require Unique Development Approaches Developing drugs for rare diseases poses a range of clinical, regulatory and commercial challenges. The small number of patient populations are difficult to identify and recruit for clinical trials. Many orphan diseases are genetic. Often these patients have complex phenotypes that react very differently to proposed treatment […]

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Pediatric Drug Development

Understanding Drug Effects in Children Pediatric drug development continues to be a vexing challenge, yet pediatric research is increasingly being mandated by regulators and patients alike. Traditional development methods can be problematic for ethical and logistical reasons. Children are a heterogeneous population, especially neonates and infants, as organ maturation affects drug exposure and response. Leveraging […]

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Label Optimization

Drug Label Optimization Using Proven Modeling and Simulation Methodology The drug label is the culmination of years of work and millions, if not billions of dollars. Every inclusion and exclusion on that label will have a direct impact on the drug’s profitability. While modeling and simulation have been an important element in drug development for some time, […]

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Benefits of Modeling and Simulation

The Benefits of Modeling and Simulation in Drug Development Modeling and simulation, also known as “model-informed drug development,” has already had a profound impact on drug development, yet its full impact is just now coming to light.  Modeling and simulation (M&S) has the proven ability to influence every phase of the drug development process, including […]

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Model-based Meta-analysis

An Innovative Strategy to Make Better Use of Available Data The difference between getting a new medication to patients, and it ending up in the scrap heap of failed programs lies in making the right choices. There is a surfeit of publicly available information on approved drugs as well as those currently in development. How […]

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PK/PD Analysis

PK/PD Support for Drug Approvals Pharmacometrics: From “nice to have” to “must have” technology Model informed drug development and discovery—which includes both top-down pharmacokinetic/pharmacodynamic (PK/PD) modeling and bottom-up, mechanistic approaches―continues to profoundly impact drug development by informing key decisions and labeling. Key benefits of this approach include: Making data-driven decisions at all stages of drug […]

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Pharmacometrics Regulatory Strategy

Predictive Disease-Drug-Trial Modeling and Simulation A well-designed pharmacometrics regulatory strategy satisfies multiple goals. First, the strategy prioritizes the needs of the program and details when and how they will be met. Next, a strategic road map provides direction that ensures that studies and analyses will be fit-for-purpose and add value to the program. Finally, a […]

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Certara Centers of Excellence

Academic Centers of Excellence for Model-informed Drug Development (MIDD) As regulators and sponsors recognize the growing importance of model-informed drug development (MIDD), Certara is committed to educating the next generation of experts in this field, on a global basis. We are achieving that goal by partnering with eminent scientists at designated academic Centers of Excellence […]

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