Initially drafted in January 2023 and finalized in August 2024, the US Food and Drug Administration (FDA) released guidance tied to Project Optimus, titled “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.”
The Project Optimus initiative recommends oncology drug developers move away from traditional approaches of determining the maximum tolerated dose to building dose optimization strategies into clinical development plans that balance safety, tolerability and efficacy.
Since the release of the guidance, early-phase oncology drug development has shifted dramatically, including new dose escalation designs (a 3+3 is no more), larger sample sizes, real-time PK/PD sampling, randomization between doses and global reach for patient access.
While the new guidance has led to larger sample sizes, larger global footprints and higher study costs, Project Optimus aims to ensure a more robust safety and efficacy profile early in the development cycle. This can result in streamlined later-phase studies and a more comprehensive understanding of the asset, enhancing the probability of registrational success.
In this webinar, the expert speakers will provide tangible examples and case studies of how drug development has played out in the Project Optimus era. By reviewing case studies and their experiences, they will uncover lessons learned and best practices in interpreting the guidance, in addition to exploring the changing regulatory landscape.
Register for this webinar today to explore the transformative impact of Project Optimus on oncology drug development.
Speakers
Andrew Zupnick, PhD, Vice President, Oncology Drug Development, Catalyst Oncology
Andrew Zupnick has focused exclusively on oncology for over 20 years and serves as the Vice President, Catalyst Oncology. He leads Catalyst’s full-service oncology solution, supporting study optimization, delivery oversight, training and new initiatives across the commercial and operational teams to keep Catalyst at the forefront of industry trends and cutting-edge oncology therapies.
Andrew is a Cell and Molecular Biologist with a PhD from Columbia University and a BS from MIT. Andrew began his professional career at Prologue Research, a niche oncology CRO, which was founded out of what became the James Cancer Center at The Ohio State University and acquired in 2010 by Novella Clinical.
At Novella, Andrew led the growth of the organization’s oncology division into a market-leading oncology specialty CRO. After the acquisition of Novella by Quintiles, Andrew spent nearly seven years working within the standalone CRO, which was subsequently rebranded to IQVIA Biotech in 2019.
Message Presenter
Meredith Manuel, Executive Director, Consulting, Catalyst Oncology
Meredith Manuel is a proven leader with over 30 years in the scientific industry specializing in global drug development and project management. She holds a BS in Biology from Virginia Polytechnic Institute and State University.
Over the last 30 years, Ms. Manuel has held various positions of increasing leadership responsibilities in biopharmaceutical drug development as well as in preclinical, regulatory and clinical areas of business. Her experience includes central laboratory, translational research and regulatory experience working with clients from early stage through IND and CDx submission, thus solving potential challenges for submission to the agency.
Ms. Manuel has published papers and posters in organic chemistry as well as translation research, digital pathology and AI/ML.
Gilles Gallant, BPharm, PhD, FOPQ, Chief Development Officer, Mythic Therapeutics
Gilles Gallant, BPharm, PhD, FOPQ, is an oncology expert with broad biotechnology and pharmaceutical experience in strategic cancer drug development, evaluation and innovations. He joined Mythic Therapeutics (Waltham, Massachusetts) in 2022 as Chief Development Officer and led and directed the development organization, including clinical operations, clinical sciences, regulatory affairs, clinical quality, project leadership, project management, data management, biostatistics and drug safety, responsible for developing new, smarter and safer, innovative antibody-drug conjugates (ADCs).
Prior to joining Mythic Therapeutics, Gilles was Senior Vice-President, Global Head, Oncology Development at Daiichi Sankyo. He led the development of the Daiichi Sankyo global oncology portfolio, including the clinical development and global approval of Enhertu® for multiple indications (breast cancer, gastric cancer, NSCLC), the progress of several novel ADCs and multiple other early and late clinical stage best-in-class (BIC) or first-in-class (FIC) oncology assets.
Message Presenter
Joseph Shan, MPH, Vice President, Clinical Operations, Adcentrx Therapeutics
Joseph Shan, MPH, joined Adcentrx Therapeutics as Vice President, Clinical Operations, in December 2023. Joe has close to 30 years of clinical experience in biopharma and medical device companies. Nearly 25 years were focused on clinical development of oncology therapeutics, including radiopharmaceuticals, small molecules, targeted therapy, immunotherapy and cellular therapy.
Prior to joining Adcentrx Therapeutics, Joe served as Executive Director, Clinical Development Operations and Data Management, at MEI Pharma, where he oversaw early-phase clinical studies of a CDK9 inhibitor in AML and B-cell malignancies and a mitochondrial inhibitor in colorectal cancer. Before MEI Pharma, he held leadership roles in at Elevar Therapeutics, Kiadis Pharma (formerly CytoSen Therapeutics) and was a Corporate Officer of Peregrine Pharmaceuticals where he was responsible for clinical and regulatory affairs for nearly a decade and spearheading the development of bavituximab (a novel phosphatidylserine-targeting monoclonal antibody for treatment of solid tumors) from pre-clinical through Phase III.
Hereceived his MPH with an emphasis in Epidemiology from George Washington University in Washington DC and a BS in Physiological Sciences from University of California, Los Angeles.
Message PresenterWho Should Attend?
This webinar will appeal to:
- CEOs/COOs
- Chief Development Officer
- VP Clinical Development
- Director Clinical Development
- Director of Clinical Operations
- Chief Medical Officer
- Clinical Development Consultant
What You Will Learn
Attendees will learn about:
- The Project Optimus guidelines for dose optimization in early-phase oncology drug development
- How the guidelines have impacted early-phase oncology study designs
- Lessons learned and best practices in interpreting the guidance based on tangible examples and real-world case studies
Xtalks Partner
Catalyst Oncology
Catalyst Oncology is a full-service, specialty clinical research organization (CRO) built to serve the global biotech industry. Backed by leading retention rates and a culture rooted in its core values, Catalyst Oncology provides customers with teams experienced across all functions, knowledgeable in complex drug classes and study designs, and with data-centric methodologies that help bring next-generation therapies to cancer patients. Connect with Catalyst Oncology on LinkedIn.
Catalyst Oncology is one of two established, branded solutions offered by Catalyst Clinical Research, which employs more than 1,000 staff and several offices in the United States, Europe, and the Asia-Pacific region. Catalyst’s flexible service model comes from more than a decade of listening to customers, devising customer-centric solutions, and helping customers advance clinical studies by leveraging expert teams and innovative technologies.
Visit Catalyst online at CatalystCR.com, and follow us on LinkedIn.
Catalyst is a portfolio company of QHP Capital, a leading healthcare and life sciences investment firm.
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