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Advanced Solutions for Vaccine Development

Transforming the future of vaccine science

Having robust solutions for vaccine drug development and uptake via national programs is critical to addressing global health challenges effectively. Vaccines play a vital role in preventing the spread of infectious diseases, safeguarding public health, and combating emerging threats. Advanced tools and methodologies accelerate the development process, reduce costs, and enhance the efficacy and safety of vaccines, ensuring that life-saving interventions reach those in need faster. Certara is pioneering the way you envision your vaccine development with solutions to empower vaccine developers and manufacturers across all stages—from early research to inclusion in national immunization programs or calendars.

Our innovative solutions allow you to overcome the most complex challenges in vaccine development and tender/pricing negotiations. Partner with Certara to get a tailored vaccine strategy that supports you where you need it the most.

Design Smarter, Earlier: Optimal Vaccine Study Design

Our experts assist in vaccine candidate design with cutting-edge immunology, molecular modeling, and antigen selection strategies. Collaborate with us early to set your program up for success. From antigen discovery and optimization, to adjuvant selection and formulation strategies, and immunogenicity prediction, Certara’s team can partner with you early in the process of designing your vaccine.

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Strategic Nonclinical Strategy: Characterization and Derisking

Our nonclinical drug development team of consultants support building our partners’ vaccine programs by providing strategic planning of nonclinical development plans, nonclinical safety program design and study management. Including immunogenicity and other pharmacodynamic (PD) studies, in vivo and in vitro toxicology and pharmacokinetic studies, toxicity assessment and special considerations for both prophylactic and therapeutic vaccines, to meet global regulatory requirements.

Model-Informed Vaccine Development

Vaccine development is traditionally a lengthy, costly, and high-risk process. Model-informed vaccine development (MIVD) approaches offer a data-centric perspective that reduces these uncertainties and enhances each development stage.

Optimize vaccine dosing strategies

Certara’s state-of-the-art vaccine simulator uses quantitative systems pharmacology (QSP) modeling help optimize vaccine strategies by evaluating immune responses in diverse populations for better patient outcomes. Digital twins enable the simulation of virtual patient populations, predicting individual responses to refine treatment strategies and strengthening clinical trials.

Maximize the value of your data

Certara’s pharmacometricians can help you get the most out of your data using MIVD approaches, for example through population PK-PD/ ER modelling to allow the assessment of the impact of covariates to understand variability. Model simulations can be used to compare fixed dose to weight-normalized dose and provide recommendations for future clinical trials.

Drive Go/No-Go Decisions

Leverage existing non-clinical and/or limited clinical data in the development of novel vaccines through model-based meta-analysis (MBMA) to inform Go/No-Go and study design decisions.

Model-informed vaccine development resources

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White Paper

Leveraging Biosimulation to Inform Optimal Use of COVID-19 Vaccines

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Publication

A quantitative clinical pharmacology-based framework for model-informed vaccine development

Historically, vaccine development and dose optimization have followed mostly empirical approaches without clinical pharmacology and model-informed approaches playing a major role, in contrast to conventional drug development. This is attributed...

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Publication

Application of Quantitative Systems Pharmacology to guide the optimal dosing of COVID-19 vaccines

Navigate the Global Regulatory Landscape with Ease: Regulatory Science Expertise

Leverage the expertise of regulatory experts who have supported global submissions and can provide key insights to accelerate vaccine approvals. From preparation and reviews of regulatory submissions to technology-enabled tools, our teams help build compliant documents and expedite your vaccine submissions across key markets (US, EU, Asia).

Maximize The Chances of Inclusion in Vaccination Programs through Robust Economic Evaluation and a Robust Tender Narrative

Health economic analysis and quantification of a vaccine’s potential public health impact are critical considerations in early drug development in order to design a program that generates “decision grade” evidence and demonstrates clinical differentiation. Certara Evidence & Access offers integrated solutions throughout a vaccine’s product lifecycle to enhance the likelihood of inclusion within an immunization program/calendar at the desired price. Our team works across markets to create a tailored approach based on country needs and requirements.

Conduct annual monitoring of serotype distribution and vaccine coverage, research on reasons for vaccine hesitancy, health economic analyses via the development of dynamic modelling, and tender tracking/ management
Create evidence-informed access tools including fact sheets, master files, tender shaping guides, dossiers, and narratives

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Published pieces of literature covering epidemiology, herd immunity, cross protection, burden of infections, policy changes, vaccine hesitancy, and health-economic evaluations for various vaccines

Key Benefits of Partnering with Certara

We understand the complexity of vaccine development and the unique challenges you face. Our expertise and cutting-edge solutions are designed to streamline your vaccine portfolio while helping you deliver life-changing solutions quickly and efficiently.

Accelerate Development Timelines: Optimize clinical trial designs and reduce development costs and time to delivery by leveraging advanced modeling and simulation tools.
Mitigate Risks and Improve Outcomes: Utilize predictive analytics to make data-driven decisions, ensuring every step is efficient and outcome-oriented.
Navigate Regulatory Pathways with Confidence: Gain expert guidance to meet regulatory requirements and secure approval
Communicate Vaccine Value: Prepare robust health economic argumentation to support vaccine usage among populations at the desired price
Comprehensive Support for the Entire Lifecycle: From molecule to market, Certara can help build unique programs and strategies that bridge gaps and shorten timelines.

Transforming Ideas into Impactful Vaccines

Certara is your partner in accelerating transformation and bringing vaccines to the people who need them most. Now is the time to explore how Certara can revolutionize your vaccine development process.