Project Optimus: Early-stage haste can lead to waste


September 27, 2022

Virtual |

The study designs and dose selection strategies that have supported decades of oncology drug development are now crumbling as the FDA’s Project Optimus takes full effect. The agency is now scrutinizing Phase 1 and 2 studies to see whether they pinpoint the dose that is biologically effective and maintains a truly acceptable safety profile. The added time and cost to achieve this objective will pay off in products with a defined risk-benefit profile, smoother regulatory path, better long-term patient adherence, and improved quality of life. In turn, this will sustain uptake and market share. In this webinar we will share several techniques, which we’ve found in our work with clients that can help companies achieve this new standard, including:

  • Using smarter, adaptive designs to conduct robust, randomized, and data-rich early dosing studies, combined with modeling techniques that integrate pharmacokinetics, safety, pharmacodynamics and efficacy
  • Complementing the evidence dossier with data on dynamic endpoints, such as tumor growth rate (TGR), tumor growth kinetics (TGK), and circulating tumor DNA (ctDNA)
  • Gathering toxicity data directly from patients using tools such as the NCI’s Patient-Reported Outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Hear from Parexel

Amy McKee Headshot.png

Amy McKee | Chief Medical Officer and Global Head, Oncology Center of Excellence

Amy is a former U.S. FDA regulator, in the role of Deputy Center Director, Oncology Center of Excellence (OCE) and Supervisory Associate Director, Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER). She was the signatory authority for products within OHOP, responsible for four divisions performing the scientific review and evaluation of hematology and oncology therapeutic drugs and biologics subject to regulation by the CDER.


Simona Stankeviciute headshot.png


Simona Stankeviciute | Principal Consultant, Parexel

Simona is a former clinical assessor from the EMA where she assessed the clinical part of Marketing Applications (MAAs), line extensions, Type II variations, and provided Scientific Advice. Simona served as an alternate member of the CHMP. She also trained in health technology assessment (HTA) for medicines and served as an assessor for HTA submissions.


David McDougall.jpg


David McDougall, PhD | Senior Director

David is a pharmacometrician with over 10 years of experience in PKPD modeling, simulation, exposure-response analyses, optimal design, and statistical modeling. David has experience across the full drug development process from pre-clinical through to phase III regulatory submission work in many therapeutic areas with the goal of leveraging pharmacometric principles to support optimal dose selection and expedite the drug development process.


Kris Jamsen.png


Kris Jamsen, PhD | Senior Director

Kris is a biostatistician and pharmacometrician with a total of 20 years of experience in academia and the pharmaceutical industry. He has experience in several therapeutic areas, including tropical medicine, cardiovascular diseases, infectious diseases, and oncology. Within the past 10 years much of his work has focused on advanced population pharmacokinetic/pharmacodynamic and exposure-response analyses, as well as study design development, evaluation, and optimization.  

Register now using the link below!


We are always available for a conversation.


We are always available for a conversation.


Communication Preference

Communication Preference