The FDA’s Project Optimus is transforming oncology drug development, emphasizing optimized dosing strategies. Certara provides integrated, model-informed solutions to predict drug exposure, enhance therapeutic response, and minimize toxicity from early clinical development to regulatory submission. With cutting-edge technology and regulatory expertise, our proven quantitative methods help you navigate this evolving landscape with confidence.
Optimizing Oncology Drug Development with FDA Project Optimus
Ensure smarter dosing and regulatory success
Learn more about Project Optimus
Navigate dose optimization with Certara
Early engagement with the FDA
Begin regulatory interactions early with our expert guidance to ensure a smooth process.
Model-informed dose optimization
Leverage advanced modeling techniques to select the optimal therapeutic dose.
Regulatory expertise
Rely on our seasoned team for strategy, submissions, and global regulatory support.
Proven oncology success
Certara has supported over 30 FDA novel oncology drug approvals.
Innovative solutions for oncology drug development
Meet our experts
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Experts
Tong Zhu, PhD, FCP
VP, Global Head, Clinical Pharmacology & Translational Medicine Certara Drug Development Solutions
Dr. Tong Zhu has over 25 years of experience specializing in translational medicine, early development, and clinical pharmacology. She has a wealth of knowledge in pharmaceutical research and development. She was responsible for leading Astellas’ Primary Focus strategy in Mitochondria Biology by working globally to help identify and develop i...
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Experts
Piet van der Graaf, PharmD, PhD
Senior Vice President and Head of Quantitative Systems Pharmacology
Piet van der Graaf is Senior Vice President and Head of Quantitative Systems Pharmacology at Certara and Professor of Systems Pharmacology at Leiden University. From 2013-2016 he was the Director of Research of the Leiden Academic Centre for Drug Research. From 1999-2013 he held various leadership positions at Pfizer in Discovery Biology, P...
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Experts
Steve Sibley
Vice President Regulatory Strategy
With a career spanning more than 30 years in the pharmaceutical industry, Steve Sibley provides regulatory writing consulting services and leads the global submissions service line within Certara Drug Development Solutions (CDDS). He has led global submission teams and authored critical documentation on more than 45 marketing applications and...
ConnectWhy choose Certara for Project Optimus?
Certara leads the way in oncology drug development, offering unmatched expertise in model-informed solutions and regulatory strategy. Our cutting-edge technology and regulatory know-how help you meet FDA expectations, reduce risk, and optimize outcomes, empowering you to make informed decisions that accelerate program success.
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View allLet’s advance oncology drug development together
Certara’s integrated team of oncology experts is ready to guide your program through FDA Project Optimus. With tailored solutions, advanced modeling techniques, and regulatory expertise, we help you achieve your drug development goals efficiently.
Proven track record in oncology drug approvals
Industry-leading Simcyp Simulator technology
Expertise spanning early development to regulatory submissions
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FAQs
What is FDA Project Optimus?
Project Optimus is an FDA initiative aimed at reforming dose optimization and dose selection in oncology drug development to improve therapeutic outcomes and minimize toxicity.
How does Certara support Project Optimus?
We provide model-informed drug development and regulatory expertise to optimize dosing strategies.
Why is early FDA engagement important?
Engaging with the FDA early ensures alignment with regulatory expectations, reducing risks and delays in drug development.
