The Changing Paradigm of Dose Selection in Oncology Drug Development

With FDA’s initiative, Project Optimus, the landscape of phase I oncology is changing. In this webinar, IQVIA oncology experts will highlight major principles for dose optimization and review examples of recent FDA approvals that illustrate how investigation of dose- and exposure-response relationships and use of randomized dose trials can support dose optimization.

Register Free: http://www.appliedclinicaltrialsonline.com/act_w/dose_selection

Event Overview:

Dose optimization is essential to ensure that patients receive therapies that maximize efficacy while minimizing toxicity. Poor dose optimization can have negative consequences for patients, most notably, toxicities leading to poor quality of life, and inability to tolerate a given regimen. Although there has been some progress, dose optimization through randomized dose evaluation in oncology trials is not routinely conducted.

With FDA’s Project Optimus initiative, the landscape of Phase I oncology trials is changing. In this webinar, IQVIA oncology experts will highlight major principles for dose optimization and review examples of recent FDA approvals that illustrate how investigation of dose- and exposure-response relationships and use of randomized dose trials can support dose optimization. Join this timely webinar and learn:

• Historical perspective of dose-finding studies and why the need for change
• Key considerations for selecting appropriate dose optimization strategies in oncology
• The implications for oncology drug development

Speakers:

Jeffrey Keefer
Vice President and Head of Hematology/Oncology Center of Excellence
IQVIA

Dr. Jeffrey Keefer is the Head of the Hematology/Oncology Center of Excellence at IQVIA. He is a pediatric hematologist and oncologist with 12 years of academic faculty experience at the Johns Hopkins University School of Medicine. Prior to his current role, he led the Pediatric and Rare Diseases Center of Excellence at IQVIA.

David Alsadius
Senior Medical Director in the Oncology Center of Excellence
IQVIA

Dr. David Alsadius is a Senior Medical Director for the Oncology Center of Excellence at IQVIA. He is a board-certified clinical oncologist with 18 years of oncology experience. In his current role, David advises pharmaceutical and biotechnology companies on the development of oncology products, with a focus on breast cancer and gynecologic malignancies.

Jeffrey Hodge
Vice President of Precision Medicine in the Oncology Center of Excellence
IQVIA

Jeffrey Hodge is the Vice President of Precision Medicine Oncology within the Oncology Center of Excellence at IQVIA, has 28 years of oncology drug development experience. In his current role, Jeffrey helps to oversee the creation of high-quality clinical development plans, study protocols, headline data summaries, regulatory documents and publications to support oncology and neurology assets in development for pharmaceutical and biotech companies.

Matthew Simmons
Global Head, Oncology Strategy
IQVIA Biotech

Matt Simmons is Global Head of Oncology Strategy at IQVIA Biotech where he provides strategic guidance to the oncology operational teams as well as consultative oversight for biopharma and biotech sponsors developing therapeutics to treat cancer. He has more than 25 years of experience across all phases of drug development with small and large pharma, CROs, consulting and software companies, as well as managing a leading oncology Phase I clinical research unit in central London.
Matt holds a Bachelor of Science in Molecular Biology with Industrial Experience from the University of Manchester.

Times and Date:

Tuesday December 6th, 2022 at 11am EST | 8am PST | 4pm GMT | 5pm CET

Sponsor:

IQVIA

Register Free: 
http://www.appliedclinicaltrialsonline.com/act_w/dose_selection