Webinar

Ensuring Operational Feasibility in Next-Generation Oncology Trials

Available on-demand

60 Minutes

Rapid advances in oncology such as cell therapies, antibody-drug conjugates, biomarker-driven treatments, and increasingly adaptive trial designs (including basket, umbrella, and platform studies) are transforming how cancer drugs are developed. While these breakthroughs hold enormous promise, they also introduce new operational challenges related to patient identification, evolving protocols, specialized sites, complex logistics, and trial execution across multiple cohorts and arms.

As innovation accelerates, clinical operations teams must ensure study designs remain feasible for sites and accessible for patients, while managing the added complexity of adaptive frameworks that require ongoing coordination of data, sites, and regulatory oversight. In this session, leaders discuss strategies for translating cutting-edge oncology science and novel trial designs into operationally executable trials.

Key Discussion Points

Operational implications of emerging oncology modalities, precision medicine approaches, and adaptive trial designs
Managing biomarker screening, specialized sites, evolving protocols, and complex trial logistics
Coordinating sites, data flow, and oversight across multi-arm and platform studies
Aligning protocol design with site capacity and patient access
Balancing scientific innovation and trial flexibility with operational feasibility in oncology trials

Speakers

Kate Rochlin, Ph.D.

President and Chief Operating Officer

IN8bio

Kate has served as Chief Operating Officer of IN8bio since December 2021. She previously served as the VP and AVP of Operations and Innovation since August 2020. She has over 15 years of extensive expertise in early-stage biotechnology and company development, including conducting scientific research, managing intellectual property (IP) strategy, overseeing strategic & business development and managing company operations including corporate strategy, partnering and team buildout. Prior to IN8bio, Kate held various senior roles at Curadigm, a Cambridge, MA-based biotechnology company.

Dr. Rochlin also serves as an executive board member to The Solution Lab, a New York-based non-profit organization dedicated to providing Ph.D. and MBA students with real-world consulting experiences. Crain’s New York Business recognized Kate as one of the top women in tech in 2019. Dr. Rochlin earned a Ph.D. in Molecular Biology and Genetics from Weill Cornell Medical College, conducting research at Sloan Kettering Institute, and a BA in Biology from the University of Pennsylvania.

Erin Lynch, MS, CCRP

Administrative Director

Medical College of Wisconsin Cancer Center Clinical Trials Office

Erin Lynch is an experienced clinical trial professional and leader with a demonstrated history of successful conduct of oncology clinical trials at community and academic sites. Erin holds a Bachelor of Science in Education and a Master of Science in Clinical Trial Regulatory Affairs and has been a SOCRA Certified Clinical Research Professional since July 2010. She has served as Lead Administrator in planning and implementation of an enterprise-wide Part 11 validated eRegulatory Management System and has participated in multiple national committees for research and oncology, supporting and educating on best practices for clinical research professionals.

Following more than a decade in regulatory leadership roles at the NCI-designated Comprehensive Dartmouth Cancer Center, Erin became the Administrative Director of the Medical College of Wisconsin Cancer Center Clinical Trials Office in early 2024, where she leads a team of 150+ research professionals supporting a portfolio of more than 400 trials and 500 therapeutic accruals per year.

Jason Luke, MD, FACP

Chief Medical Officer

Strand Therapeutics

Jason Luke is a physician-scientist-executive and Chief Medical Officer of Strand Therapeutics where he leads clinical development and medical affairs. Prior to joining, he was an academic and administrative leader as faculty at the University of Pittsburgh and Associate Director for Clinical Research of the UPMC Hillman Cancer Center. There he oversaw enterprise scale research, providing physician leadership of ~800 clinical trials and associated infrastructure budget. On a scientific level, Jason was Principal Investigator of >100 clinical trials from Phase I-IV, including global PI for registrational studies in melanoma.

He received his MD from Rosalind Franklin University of Medicine and Science/Chicago Medical School and thereafter completed internal medicine residency at Boston University Medical Center as well as medical oncology fellowship at Memorial Sloan-Kettering Cancer Center. He additionally held faculty positions at Harvard Medical School and Dana-Farber Cancer Institute as well as the University of Chicago.

Christine Senn, Ph.D.

Senior Vice President of Site-Sponsor Innovation

Advarra

Christine Senn, Ph.D., is Senior Vice President of Site-Sponsor Innovation at Advarra, an industry leader in regulatory reviews and clinical research technology. Senn began her clinical trial career at the University of Vermont College of Medicine while pursuing her doctorate in psychology. She then spent 16 years in various leadership positions, including Chief Operations Officer at the site network IACT Health, which later became Centricity Research. Senn was also the 2023 Chair of the Association of Clinical Research Professionals (ACRP), is an ACRP Fellow (FACRP), and is double-certified as a Certified Clinical Research Coordinator (CCRC) and Certified Principal Investigator (CPI).

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