Industry Council

On October 23, 2024, OCRA convened an Industry Council discussion among approximately 35 ovarian and gynecological cancer stakeholders providing a forum to engage multi-stakeholder discussion about advances in development and use of liquid biopsy in oncology, with a lens on opportunities and challenges for diagnosis, prognosis, and treatment of ovarian and gynecologic cancers. The meeting featured Andrew Berchuck of Duke University, MD, Eric Klein, MD of GRAIL, Faraz Salmasi, PharmD of Natera, and Dawn Mattoon, PhD of Mercy BioAnalytics, who shared their perspectives on current diagnostic options and those in development, acknowledging the exciting, yet complex road ahead. The meeting also featured two OCRA Advocate Leaders, who shared insights around current experiences and hopes for future uses of liquid biopsy in ovarian and gynecologic cancers.

On August 1, 2024, OCRA convened an Industry Council discussion among approximately 60 ovarian and gynecological cancer stakeholders providing a forum to engage multi-stakeholder discussion about regimen optimization and how future trial designs can provide more insights around the impact phase of each treatment. The meeting featured a presentation from Dr. Stephanie Wethington of the FDA’s Oncology Center of Excellence about trial designs for treatment regimens with multiple phases, with a goal of fostering robust discussion around opportunities and challenges for therapy development in gynecologic cancers. Dr. Carol Aghajanian of Memorial Sloan Kettering Cancer Center and Dr. Kathleen Moore of the University of Oklahoma also presented on the topic, with a lens on ovarian cancer and endometrial cancer therapy development. The meeting also featured the perspectives of two patient advocates and their experiences as treatment paradigms evolve.

Previous Ovarian Cancer Industry Council meeting topics and goals:

On April 16, 2024, OCRA convened an Industry Council meeting among approximately 35 ovarian and gynecological cancer stakeholders to discuss the opportunities and challenges of focusing on all gynecologic cancers as a proactive strategy to better serve patients. The group considered various perspectives including the clinical rationale, patient views, and potential for progress in therapy development for ovarian and related cancers. This meeting featured Dr. Sarah Adams and Dr. Emily Ko, patient advocates, and industry partner GSK, all of whom shared their perspectives on the changing landscape and possible ways forward.

This discussion focused on the policy landscape for gynecologic cancers, specifically the Inflation Reduction Act (IRA) and its potential impact on patient access to innovative new therapies. The meeting featured speakers from The Haystack Project, Merck, and AstraZeneca. Approximately 50 ovarian and gynecological cancer stakeholders attended.

Initiatives to streamline clinical trial design for the gynecologic cancer community were discussed. Friends of Cancer Research presented their work on Lung-MAP, a first-of-its-kind model with multiple arms to match patients with clinical studies based on their unique tumor profiles. FDA presented on Project Pragmatica, which promotes the use of pragmatic trial design to streamline and increase access to clinical trials. OCRA’s scientific leadership, industry partners, and regulatory officials discussed the impact of these projects on cancer therapy development. Approximately 45 ovarian cancer stakeholders attended.

This roundtable conversation looked at current industry-sponsored activities and the resulting impact of these projects on ovarian cancer therapy development. Dr. Sarah Adams and Dr. Amanda Nickles-Fader also provided an overview of the SGO BRIDGES program, which aims to bridge the gap between different practice types, integrate translational research into clinical trials, and prioritize study designs that increase access to clinical trials and overcome disparities in participation. Approximately 55 ovarian and gynecologic cancer stakeholders attended.

A recent FDA initiative relating to accelerated approval of novel therapies and FDA draft guidance relating to the use of external control data in clinical trials was the topic of this discussion. The goal of the meeting was to facilitate open dialogue about initiatives to transform clinical trial design, in particular the potential for therapy access in an earlier clinical setting for advanced or metastatic cancer. Approximately 40 ovarian cancer stakeholders attended.

OCRA’s scientific leadership and approximately 40 stakeholders across the biopharmaceutical and diagnostic industries discussed their shared goal of increased collaboration. Dr. Beth Y. Karlan, Dr. Kunle Odunsi and Dr. Anil K. Sood shared some of the unmet needs in ovarian cancer therapy development and how increased collaboration with industry can address these needs. Dr. Ronald Alvarez shared an overview of OCRA’s research grants, highlighting the promising science in the pipeline. Attendees also shared their personal and professional perspectives on gynecologic oncology, from what inspired them to work in the field to internal challenges within their respective companies. The meeting helped spur partnerships between expert clinicians and industry leaders to collaboratively address challenges in patient-centric therapy development.

Innovation in clinical trials and ways to accelerate development and accessibility was the topic of this meeting. Speakers from Cancer Research Institute (CRI) and Global Coalition for Adaptive Research (GCAR) discussed their work in adaptive platform trials in oncology. BioAtla provided an industry perspective on the role of innovation in ovarian cancer clinical trials, emphasizing the importance of strong relationships between sponsors, investigators, and patients to advance trials that can move the needle in patient outcomes. Approximately 50 ovarian cancer stakeholders attended.

This discussion about dosing, safety, and tolerability aspects of therapies for ovarian cancer had a specific focus on the perspectives of ovarian cancer patients. Dr. Vishal Bhatnagar, FDA OCE, described efforts at FDA to capture and disseminate patient-generated information about the patient experience with oncology drugs in development through Project Patient Voice. Dr. Mirat Shah, FDA OCE, described Project Optimus, an initiative to reform the dose optimization and dose selection paradigm in oncology drug development. Approximately 30 ovarian cancer stakeholders attended.

A biobank/data commons project for ovarian cancer in the U.S. was the topic of this discussion. Stakeholders from global academic institutions, government regulatory bodies, the pharmaceutical industry, and patient advocates provided input to OCRA about the need and potential structure for an ovarian cancer biobank or biospecimen/data-sharing mechanism to facilitate research collaborations and advance the development of new therapies. Approximately 30 ovarian cancer stakeholders attended.

At this meeting, opportunities and challenges in precision medicine and biomarker development for ovarian cancer were evaluated. Lessons learned and current gaps to be addressed in research and clinical trials specific to biomarkers, including assay development, clinical trial design, and regulatory processes, were discussed.

This meeting evaluated barriers to ovarian cancer clinical trial accrual and diversity within ovarian cancer clinical trials. Multi-stakeholder solutions to enhance accrual and expand diversity in ovarian cancer clinical trials were identified.

Findings of a patient survey on barriers to care, conducted by OCRA, were discussed at this meeting. Access issues and solutions in reducing barriers to care were also evaluated.