The early-phase oncology clinical trial landscape is constantly evolving, influenced by shifts in regulatory guidance such as Project Optimus and multiregional clinical development programs.
Project Optimus emphasizes dose optimization earlier in the trial process, leading to more complex study designs that require larger sample sizes and a broader global footprint. Initiatives to refine dosing strategies to enhance patient safety and efficacy necessitate more intricate planning and execution of clinical trials.
The focus on dose optimization means that researchers must carefully balance the need for robust data with the practicalities of patient recruitment and retention, often across multiple countries and regulatory environments. Operational execution of these trials involves coordination of numerous factors, especially during study startup and planning of trial logistics.
Managing early-phase oncology clinical trials has become increasingly complex, necessitating a strong command of country- and site-level feasibility, ethics, and informed consent to ensure success. Getting global study teams up and running, then requiring them to successfully navigate cultural differences and be well-versed in local regulatory, data privacy, and ethical requirements, can impact study startup, site selection, and patient recruitment.
The ability to adapt to varying regulatory landscapes and ensure compliance with local laws is crucial for the smooth trial initiation and progression. Additionally, understanding the nuances of data privacy regulations in different regions helps in safeguarding patient information and maintaining trust.
Enrollment and cohort management are particularly challenging in global trials with strategic multiple sites across various regions and time zones. Teams must be proficient in protocol inclusion and exclusion criteria while understanding diversity and study design requirements such as multiple treatment arms, varying dosages, prevalence and prominence of the indication and adaptive design considerations.
Ensuring that all sites are adequately staffed and equipped to handle the specific needs of different cohorts is logistically demanding. This includes coordinating the availability of specialized medical personnel, ensuring the proper functioning of medical equipment and maintaining a steady supply of necessary materials.
Additionally, layering in risk-based monitoring, safety review, vendor management, investigational product logistics and sample management create additional complexities on a global scale. Effective communication and coordination among all stakeholders are essential to address these challenges and ensure a trial’s success.
Understanding these numerous factors and mitigating various risks are essential for early-phase oncology trials to ensure patients benefit throughout because they represent the end goal. In this webinar, the expert speakers will share lessons learned, best practices and tangible examples from their experiences in operationalizing global, complex early-phase oncology trials. This event will provide valuable insights into overcoming the common hurdles faced in these trials and offer strategies to enhance efficiency and effectiveness.
Register for this webinar today to gain actionable strategies, lessons learned and best practices to enhance the success of complex early-phase oncology trials.
Speakers
(Moderator) Keya Watkins, Senior Vice President, Catalyst Oncology, Catalyst Clinical Research
Keya Watkins brings 25 years of experience in drug development with both biopharma and clinical service providers. As Senior Vice President of Catalyst Oncology, Keya is responsible for the execution of the Oncology CRO Operations. Keya has built and provided oversight of multidisciplinary teams across clinical development operations, which is inclusive of clinical operations, data sciences and trial support services previously.
She also served as an executive in both operational and commercial roles and has been involved in several complex, global trials in various therapeutic areas and phases with a concentration on oncology and hematology programs. Keya prides herself on building and managing high-functioning teams that deliver excellence while ultimately bringing meaningful therapies to patients in need.
Keya earned her degree from Temple University, Philadelphia, Pennsylvania, and also maintains her certification as a Project Management Professional.
Message Presenter
Marcia Milholen, Vice President, Central Site Services, Catalyst Clinical Research
Marcia Milholen is VP of Central Site Services and responsible for Site ID and Selection, Site Start up and eTMF management, oversight and maintenance. Marcia has over 24 years of industry experience, focused in CRO services. Her experience is across areas of country and site feasibility, site selection and activation, clinical monitoring and project management.
Previously, Marcia served as Vice President, Project Delivery, People Management and Resource Head – Vaccines at PPD, part of Thermo Fisher Scientific. Marcia holds a BSc in Medical Technology from East Carolina University.
Message Presenter
John McAdory, MHA, Vice President, Clinical Operations, CG Oncology
John McAdory, MHA has a strong background in clinical operations and project management in the healthcare industry. John is currently serving as the Vice President of Clinical Operations at CG Oncology (Cold Genesys).
John has spent the last 20 years in global clinical research and specialized in the development of novel oncolytic therapies. He has led global clinical operations from clinical study design to submission of final study report including BLA filing.
John has expertise in strategy development, risk management, project planning and execution and consistently achieving program goals. With a Six Sigma Green Belt, John specializes in identifying key area to find efficiency in clinical study conduct to save time and reduce cost.
John previously held leadership and management positions at SillaJen, Inc, Janssen, Inc and Amgen. John is a graduate of Hampton University with a BS in biology and has a Masters in Health Administration from the University of North Carolina, Chapel Hill.
Message Presenter
Dora Ferrari, Vice President, Clinical Operations, Curis
Dora Ferrari is Vice President of Clinical Operations at Curis. Ms. Ferrari is an end-to-end drug development professional with twenty years of biotech industry experience. Previously, she led program management and clinical operations at Aileron Therapeutics as Vice President, Clinical Development and Program Management. Earlier, Ms. Ferrari had a lengthy tenure at ArQule, working in positions of increasing responsibilities within clinical operations and clinical development in both oncology and rare disease.
While at ArQule, Ms. Ferrari was responsible for leading programs from pre-IND through all stages of clinical development. Of note, Ms. Ferrari led the development team responsible for ArQule’s BTK program from IND enabling through early-stage clinical operations leading to the acquisition of ArQule by Merck. Prior to ArQule, Ms. Ferrari worked at Ziopharm Oncology and Epix Pharmaceuticals where she was part of the team leading to the FDA approval of Vasovist. She earned her Bachelor of Science degree from the University of Massachusetts, Amherst.
Message PresenterWho Should Attend?
This webinar will appeal to:
- CEOs/COOs
- VP, Clinical Development
- Director, Clinical Development
- Director of Clinical Operations
- Chief Medical Officer
- Clinical Development Consultant
What You Will Learn
Attendees will learn about:
- Critical considerations for an early-phase oncology study startup
- Logistics of trial management, including the distribution of materials such as investigational products, lab kits and ancillary supplies
- Operational excellence in the execution of early-phase oncology trials, focusing on the critical paths for delivery
- How a patient-centric approach will ensure coordination and criticality to benefit patients
Xtalks Partner
Catalyst Oncology
Catalyst Oncology is a full-service, specialty contract 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.
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