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Therapeutic Specialties

The right drug development knowledge and expertise for your novel therapy

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A special focus on your therapy

Drug development in specialized therapeutic areas requires expertise that aligns with unique challenges. Certara’s tailored solutions combine deep therapeutic domain knowledge, advanced modeling, and real-world evidence to fill knowledge gaps and drive success in your therapeutic focus.

Modalities and targets are ever expanding; many require a specific focus to bring them to market. Whether it’s improving trial design, predicting outcomes in the absence of patients, optimizing dosages for innovative modalities, or calculating value, Certara empowers you with specific insights that address the concerns of regulators and payers.

Bridge knowledge gaps

Certara provides therapeutic area-specific insights to compensate for data limitations and scientific uncertainty.

Optimize design parameters

Tailor trial designs to the unique mechanisms of action and pharmacology in your specialty.

De-risk decisions

Use predictive modeling and data integration to mitigate risks and refine clinical strategies.

500
oncology solutions provided
300
tailored therapeutic area studies completed
700
drug development scientists and experts to advance your program leveraging tech-enabled decision-making

A tailored solution for your therapeutic area and modality

Oncology

Navigate the complexities of cancer therapeutics and comply with Project Optimus. Certara’s pharmacology and biosimulation experts and tools predict dose optimization, market access tools propose payer value, to guide you on the road to approval and reimbursement.

Rare and Neglected Diseases

Overcome data scarcity challenges with our expertise in combination with MIDD tools such as PBPK and QSP. Certara can help you discern effects in small patient populations in line with regulatory expectations.

Cell and gene therapy

Modeling and simulation can give a framework for dosing, delivery, and efficacy of cell and gene therapies. Our tailored services in pharmacometrics, mechanistic modeling, regulatory science, and market access provide essential guidance to health authorities on their expected impact and value.

Pediatrics

Develop safer, more effective pediatric therapies with support from Certara’s cross-functional pediatrics development team who provide customized, model informed support from early planning through labeling.

Complex biologics & novel modalities

Leverage advanced modeling and biosimulation to predict drug behavior, interactions, and therapeutic outcomes for complex biologics and emerging modalities, such as gene therapies, RNA-based treatments, and cell therapies. This approach reduces risk, optimizes dosing strategies, and generates regulatory-ready evidence to accelerate innovation and streamline development.

Model informed vaccine development

Predict immune response variability and design better strategies for vaccine and antiviral drug development.

Drug Interaction Science

Tap into Certara’s collaborative and expert DDI team to optimize your development plan and tailor solutions to fit your specific situation and drug characteristics. Partner with the CoE in Drug Interaction Science to solve problems that wouldn’t be possible without collaboration.

How we address your challenge

With solutions that range across the entire drug development continuum, Certara orchestrates the most important strategies and tools to clear your therapy’s specific hurdles. We always propose a strategy that is in the best interest of your therapy.

Discover more about Certara’s Therapeutic Specialties

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Blog

The Role of PBPK Modeling & Simulation in Infants & Neonates

Many factors make it challenging to obtain adequate pediatric samples for use in drug development and to correctly determine doses. Age is an important factor because a drug may act...
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White Paper

Optimize Immuno-oncology Drug Discovery and Development Using QSP

A Quantitative Systems Pharmacology (QSP) approach for developing combination immune-oncology therapies can be used to better predict effective drug combinations, especially to more accurately correlate the physiological differences between preclinical models and human patients.
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Blog

8 Tips for Successfully Developing Oligonucleotide Therapies

By Eva Gil Berglund and Nathalie H Gosselin Oligonucleotide therapeutics are a validated class of drugs that can modulate a multitude of genetic targets with gene silencing to prevent expression...
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Turbocharge your therapeutic area

Let Certara’s therapeutic area and modality expertise guide your drug to market success. Contact us today to learn more.

Gain modeling, biosimulation, regulatory and market access expertise
Address dosing and trial design where therapies are new and data are sparse
Provide regulatory background for the most innovative therapies

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