Combination therapies are reshaping the future of oncology, but optimizing their dosing remains one of the field’s most complex challenges. This panel discussion explores how biotech and pharma teams can move beyond the traditional maximum tolerated dose (MTD) paradigm to embrace innovative, model-informed strategies that align with FDA’s Project Optimus.
Attendees will gain insights into designing effective combination trials, leveraging biomarkers and pharmacologic data and applying simulation tools to streamline the development process. Whether planning a first-in-human study or expanding a global trial, this session will equip attendees with the knowledge to navigate regulatory expectations and deliver better outcomes for patients.
Register now to explore how innovative trials are shaping the future of clinical research and enhancing patient outcomes.
- Biomarkers ,
- Clinical Research ,
- Clinical Trial Design ,
- Clinical Trials ,
- Combination Therapy ,
- CRO ,
- Drug Development ,
- Drug Dose ,
- FDA ,
- Maximum Tolerated Dose ,
- Oncology ,
- Oncology Clinical Trials ,
- Oncology Drug Development ,
- Oncology Drugs ,
- Oncology Trials ,
- PK ,
- Regulatory ,
- Therapeutic Areas ,
- Trial Protocol
Speakers
Jeff Hodge, MS, Vice President Early Phase Oncology, Hematology-Oncology Center of Excellence, IQVIA
Jeff Hodge is the Vice President of Early Phase Oncology in the Hematology-Oncology Center of Excellence at IQVIA. Jeff has 30 years of experience in drug development within the oncology field. Before joining IQVIA, Jeff worked at GlaxoSmithKline for over 16 years in various roles, leading the early clinical development of 10 molecules from first-in-human to proof-of-concept. While at GSK, Jeff was involved in 10 INDs and 5 NDAs. He has published more than 100 abstracts and papers in peer-reviewed journals and at international meetings in the field of oncology.
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Michael Brave, MD, Vice President, Regulatory Strategy, IQVIA
Dr. Michael Brave is the Therapeutic and Regulatory Strategy Lead at IQVIA, bringing over 30 years of combined clinical and regulatory experience as a medical oncologist. In this role, he draws on his deep clinical insight and regulatory expertise to guide therapeutic development strategies and support innovation in oncology research.
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Before joining IQVIA, Dr. Brave served for more than two decades as a Medical Officer at the U.S. Food and Drug Administration (FDA) where he led the regulatory review of over 1,000 submissions, including Pre-Investigational New Drug (Pre-IND) applications, Investigational New Drug (IND) applications, New Drug Applications (NDAs), Biologics License Applications (BLAs), and their amendments and supplements. He contributed to several key public-facing guidance documents and played a pivotal role in the review of multiple first-in-class therapies, including PARP inhibitors for prostate cancer, immuno-oncology agents for renal cell carcinoma, and gene therapies for bladder cancer.
Throughout his career, Dr. Brave has remained committed to evidence-based decision making, scientific rigor, and ethical trial design. He continues to serve as a trusted strategic advisor to cross-functional teams, applying his expertise to accelerate the development of safe, effective oncology therapies and to improve outcomes for patients worldwide.
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Howard “Skip” Burris, MD, President, Sarah Cannon Research Institute
Dr. Howard A “Skip” Burris, III, MD, serves as president of SCRI, one of the world’s leading oncology research organizations conducting community-based clinical trials. In addition to his clinical expertise, Dr. Burris is known for his leadership in business strategy. Most recently, Dr. Burris helped to lead the formation of SCRI’s joint venture with US Oncology Research in 2022 to expand access to clinical trials for patients seeking the latest treatment options close to home.
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Dr. Burris received his undergraduate degree at West Point, his medical degree from the University of South Alabama in 1985, and performed his residency and fellowship in hematology/oncology at Brooke Army Medical Center in San Antonio. While there, he served as director of clinical research at the Institute for Drug Development of The Cancer Therapy and Research Center, and was an associate professor at The University of Texas Health Science Center. He attained the rank of lieutenant colonel in the US Army, and among his decorations, he was awarded a Meritorious Service Medal with oak leaf cluster for his service in Operation Joint Endeavor.
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Zheng Liu, PhD, Director of Quantitative Clinical Pharmacology, IQVIA
Zheng Liu is now leading the PK/PD modelling team in IQVIA and also a member in IQVIA’s Early Phase Oncology Expert Team focusing on trial design optimization. He was trained as a mathematic modelling specialist in his PhD and has more than 10 years’ experience in PK/PD modelling field. Before he joined IQVIA in 2020, he worked in Certara as a modelling consultant, and also worked as a modelling expert in several institutes including Melbourne Royal Children’s Hospital, University of Newcastle in Australia, Otago University in the New Zealand and International Atomic Energy Agency.
Message PresenterWho Should Attend?
This panel-led webinar brings together trial design experts from IQVIA Biotech and IQVIA to explore the practical applications of master protocols in clinical research. The discussions will highlight how this approach can offer significant advantages, including increased efficiencies, faster decision-making and improved coordination, while also addressing the challenges to operationalization without the proper planning and support.
This webinar is intended for C-suite and clinical development/operations executives at small, mid and large pharma and biotech companies.
What You Will Learn
Attendees will:
- Understand the shift from maximum tolerated dose (MTD) to model-informed dose optimization and how this impacts trial design and regulatory expectations under FDA’s Project Optimus
- Learn how to design and operationalize combination therapy trials using innovative escalation models, biomarker strategies and global feasibility planning
- Explore how modeling and simulation tools can enhance decision-making in dose selection, reduce trial inefficiencies and improve patient safety and outcomes
- Obtain a Key Opinion Leader perspective on dose optimization with combinations with novel therapies – challenges and solutions
Xtalks Partner
IQVIA
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. IQVIA creates intelligent connections to deliver powerful insights with speed and agility — enabling customers to accelerate the clinical development and commercialization of innovative medical treatments that improve healthcare outcomes for patients. With approximately 82,000 employees, IQVIA conducts operations in more than 100 countries. Learn more at www.iqvia.com.
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