September 27
11:00 am - 12:00 pm EDT

LOCAL TIME

Project Optimus: Early-stage haste can lead to waste

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:

  1. 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
  2. Complementing the evidence dossier with data on dynamic endpoints, such as tumor growth rate (TGR), tumor growth kinetics (TGK), and circulating tumor DNA (ctDNA)
  3. 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)

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Amy Mckee

Amy Mckee

Chief Medical Officer and Global Head, Oncology Center of Excellence, Parexel

Amy Mckee, M.D., 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

Simona Stankeviciute

Principal Consultant, Parexel

Simona Stankeviciute, M.D., 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

David McDougall

Senior Director, Parexel

David McDougall, Ph.D., 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 pharmacometrics principles to support optimal dose selection and expedite the drug development process.

Kris Jamsen

Kris Jamsen

Senior Director, Parexel

Kris Jamsen, Ph.D., 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.

Arsalan Arif
moderator

ARSALAN ARIF

FOUNDER & PUBLISHER, ENDPOINTS NEWS

Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.