With unique and multi-disciplinary expertise in the field of drug-drug interactions (DDIs), Certara’s Center of Excellence (CoE) in Drug Interaction Science paves the way for leading experts across multiple teams to work in concert and solve even the most complex DDI scenarios from early development to regulatory approval.
Center of Excellence in Drug Interaction Science
Support for your full DDI development plan and submission
DDI solutions made possible through collaboration
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.
Enabled by technology
Ground-breaking, proprietary technology like SimcypTM, the Drug Interaction Database (DIDB) and real-world data at the fingertips of a cross-functional team
No siloes
No siloes to stand in the way of a shared scientific mission
Creative and complete solutions
A higher likelihood that unencumbered collaboration gives rise to the most creative and complete solutions
Unfettered access to experts
Direct access to a full team of highly experienced experts focused on the latest DDI scientific techniques, science and regulatory demands
What types of support does the CoE in Drug Interaction Science offer?
Simcyp PBPK
- In vitro and/or clinical data used to build a PBPK model
- Simulate unstudied scenarios in target populations
- Replace clinical studies with simulations when possible
- Provides mechanistic understanding and answers to “what if” questions
- Labeling support
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Drug Interaction Database
- Mechanistic assessment of DDI risk
- Evaluation of PK variability (with comedication, food, natural products, excipients, polymorphism, hepatic and renal impairment)
- Insight on complex DDI mechanisms
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Clinical Pharmacology
- In vivo DDI studies – separate and nested
- hAME
- Human PK and PD characteristics
- Feasible yet optimized design
- Mechanistic interpretation for full program
- Clinical relevance and monitoring
- Protocol comeds monitoring
Pharmacometrics
- Use population PK, PK/PD and exposure-response analyses to quantify the extent and impact of DDIs
- Provide labeling support
- Inform study design for effective DDI assessment
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DMPK
- In vitro metabolism, transport, permeability, inhibition and induction studies
- Pharmacology and PD DDIs
- Mechanistic studies
- Regulatory compliance
Real World Evidence
- Label expansion (target population, indication, combinations)
- Impact of DDIs on drug safety and efficacy
- DDI detection post-approval
- PMRs
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DDI Regulatory Strategy
- Labeling and review consequences of different development scenarios
- Tailored DDI development strategies and justifications
- Regulatory interactions and submissions support
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How does an engagement with the CoE in Drug Interaction Science work?
Strategize and Scope
Outline what you’re trying to accomplish at any phase of drug development and our drug interaction science experts will recommend a tailored approach as a starting point.
Assemble the team
Based on your specific needs, we’ll build a project team from a diversity of scientific disciplines like DMPK, clinical pharmacology, PBPK, QSP, and RWE (just to name a few) to support your full DDI development and submission plan.
Provide a single point of contact for seamless project delivery
Your project will originate and run from the CoE to improve communication, collaboration and efficiency.
Unleash the largest scientist-curated database to assess drug interactions and safety
By leveraging the in vitro and clinical datasets, a marker studies knowledge base, drug monographs and more all found on the Drug Interaction Database (DIDB) platform, teams have an even greater ability to solve the most complex drug interaction challenges.
Related resources
View allMeet the CoE in Drug Interaction Science leadership team
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Experts
Eva Gil Berglund
Sr Director, Clinical Pharmacology and Regulatory Strategy
Dr Eva Gil Berglund joined Certara Drug Development Support in 2019 as Senior Director in Clinical Pharmacology and Regulatory Strategy. Eva supports companies in Clinical Pharmacology Regulatory Strategy. She has 20+ experience as Clin Pharm Reviewer and Senior Expert at the Swedish Medical Products Agency, and has been lead writer of several E...
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Experts
Hannah Jones
SVP, Simcyp PBPK Consultancy
Hannah has over 20 years of experience in global organizations with a background in translational sciences. She has experience working in a range of modalities from small molecules to biologics, and cell and gene therapies across many therapeutic areas. She has over 70 publications in PBPK and PKPD modeling and other DMPK related topics. She was...
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Is your drug’s victim or perpetrator profile complex or are conventional studies difficult to perform? Certara’s CoE in Drug Interaction Science tailors solutions by applying the latest scientific techniques in the context of evolving regulatory demands. Schedule a meeting to tell us more about your project.
Highly-experienced DDI experts representing in vitro, biosimulation, clinical trials and RWE to regulatory assessment and labeling
Seamless collaboration to support your full DDI development plan and submission
Diversity of disciplines across senior DMPK, clinical pharmacology, PBPK, QSP and RWE scientists with deep scientific and global regulatory knowledge
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