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With the launch of Project Optimus, the FDA is reforming the dose optimization and dose selection paradigm in oncology drug development. Why? Poorly characterized dose and schedule may lead to selection of a dose that provides more toxicity without additional efficacy.

What does this mean for drug developers?  Drug developers may have to:

  • Redirect early clinical development objectives
  • Re-think recommended Phase 2 dose justifications
  • Understand and manage immunogenicity of biologics
  • Assess impact on time and cost
  • Navigate uncertain regulatory landscape and expectations

With deep experience in model-informed oncology drug development, dosing and regulatory strategy and submission, Certara has helped to advance hundreds of oncology programs. Our proven, integrated approach using quantitative methods can help you to navigate this regulatory change. The key lesson is to start early, including engaging with the FDA sooner than later.


Solutions to Help You Prepare for Optimus

Get the dose right the first time

Getting your dosing strategy right is now even more imperative with Project Optimus.  How do we improve therapeutic response and lower the risk of toxicity for cancer patients?  We believe that the best way to determine and refine your dosing strategy is through model-informed drug development.   Our quantitative, model-informed approaches have helped to predict drug exposure and response, determine first-in-human dosing and optimize trial design, advancing hundreds of oncology programs.

  • Dose finding using quantitative methods, such as Simcyp PBPK modeling and simulation or population PK analysis
  • Clinical pharmacology gap analysis
  • Early development, IND-enabling support
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Get the dose right the first time
Navigate the changing regulatory landscape

Navigate the changing regulatory landscape

It is essential to engage early with the FDA in this evolving environment.  How?  Our integrated team of regulatory experts provides regulatory strategy, consulting and submissions support to advance your program.

Regulatory Strategy:  Increase your oncology product’s chance of approval with guidance from our seasoned regulatory experts specializing in regulatory intelligence, policy and strategy.  With Project Optimus, the integration of model-informed drug development and regulatory strategy early on in development is critical to your success. 

Regulatory Submissions:  Without careful planning, anticipation of risks, expert execution and ability to navigate unexpected challenges, your oncology submission may fall off track.  Rely on our around-the-clock support, expert team and advanced regulatory technology to support you every step of the way.

  • Accelerated, Fast-track, PRIME and Breakthrough Therapy Designations
  • Global and parallel submission preparation and leadership
  • Regulatory writing powered by technology to increase consistency, quality and speed
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Get the Simcyp Advantage

The Simcyp Simulator is the industry’s most sophisticated physiologically-based pharmacokinetic (PBPK) platform for determining first-in-human dosing, optimizing clinical study design, evaluating new drug formulations, setting the dose in untested populations, and predicting drug-drug interactions.  The Simcyp Simulator has been used to inform more than 30 novel oncology drug approvals by the FDA.  Using quantitative systems pharmacology, our IO and IG Simulators are state-of-the-art technology that help to inform critical decisions in oncology drug development.

Immuno-oncology Simulator:   Our IO Simulator incorporates compounds’ pharmacokinetics, target binding, and mechanisms of action as well as existing knowledge on the underlying tumor and immune system biology to predict clinical results for novel combinations and complex biologics.

Immunogenicity Simulator:   Our IG Simulator, adopted by the FDA and developed in partnership with 8 leading pharmaceutical companies, predicts immunogenicity incidence of therapeutics in development and potential impacts on pharmacokinetics and pharmacodynamics.

Learn about Simcyp Simulator
Get the Simcyp Advantage
IND-enabling regulatory and drug development

IND-enabling regulatory and drug development

The early drug development process is complex, and with Project Optimus, it is critical to work with an experienced team to deliver a robust first-in human (FIH)-enabling study design and regulatory strategy and meeting support.  Our oncology experts support the full range of early development disciplines (ADME, bioanalytical, toxicology and drug safety, and CMC) for small and large molecules.

How are we different? Our deep expertise and quantitative approaches inform your most critical decisions with confidence.  Since 2019, Certara’s services supported our clients as they have raised more than $65 billion in funding from venture capital and acquisitions

Get peace of mind now. Benefit from complete ADME packages as well as an optimized GLP toxicology/safety pharmacology and regulatory program tailored for Project Optimus to advance your IND.

FIH Strategies

Modeling and simulation for oncology dose evaluation

Modeling and simulation (M&S) approaches can improve dose selection and provide a risk-benefit assessment when developing an oncology drug.  Considerations and analyses such as:

  • PK sampling
  • PK/PD relationships
  • Exposure-response analyses
  • Body weight-based dosing, and
  • Food effect

help ensure the right dose is administered at the right time to the right patient.

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Modeling and simulation for oncology dose evaluation
Bio Pic JulieBullock
Julie Bullock, PharmD Senior Vice President, Global Head of Clinical Pharmacology & Translational Medicine

Julie has over 10 years of drug development experience within the FDA and contributed to over 14 new molecular entity approvals. She has unique insights into pediatric development, PK/PD analysis and approaches for biologics, oncology dosing strategy, and development of breakthrough therapies and accelerated approvals.

Bio Pic PietGraaf
Piet van der Graaf, PharmD, PhD Senior Vice President, Quantitative Systems Pharmacology

With over 20 years of experience working in the pharmaceutical industry at Sanofi and Pfizer, Piet brings considerable skill and experience to QSP projects and contributes to the strategic development of Certara.  He is also Editor-in-Chief of CPT.

Steve Sibley
Steve Sibley Vice President, Synchrogenix Regulatory Science

With a career spanning more than 30 years in the pharmaceutical industry, Steve has extensive experience across regulatory writing, consulting, and project leadership roles. He has successfully supported projects from discovery through approval and life cycle management, including holding significant roles in more than 75 submissions and, in several cases, leading the entire submission team, overseeing all documentation from Modules 1 through 5, publishing, and transmission to Regulatory authority.

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