FDA and Global Oncology Leaders Advocate for Enhanced International Collaboration

FDA and Global Oncology Leaders Advocate for Enhanced International Collaboration

New York June 11, 2024 – The Bloomberg New Economy International Cancer Coalition concluded its annual in-person members’ meeting on the sideline of the American Society of Clinical Oncology (ASCO) on May 31st, 2024. Leaders in oncology and cancer research emphasized the critical importance of international collaboration and regulatory alignment to accelerate the development and dissemination of life-saving cancer treatments.

The Coalition meeting on the sidelines of ASCO 2024 convened prominent figures in policy, the pharmaceuticals industry and academia. Dr. Pazdur delivering an impactful key note speech.

Richard Pazdur, Director of the FDA’s Oncology Center of Excellence, highlighted the FDA’s pivotal role in fostering international cooperation with various drug regulators worldwide. Pazdur noted the strategic shift in submitting simultaneous applications to both the FDA and smaller regulatory agencies like those in Canada, Australia, and Switzerland. “From an ethical standpoint, rapid dissemination of scientific advances benefits everyone. Scientifically, it ensures that new standards are established quickly, becoming control arms for subsequent clinical trials,” Pazdur stated. He reported that over the past 5 years, this approach has resulted in more than 500 applications and 400 approvals, significantly accelerating patient access to new therapies globally.

Looking ahead, Pazdur expressed an openness for China to become a member of Project Orbis, and be a full participant in multi-regional international trials, rather than conducting China-only trials. He emphasized the importance of having robust data from diverse geographic areas to build confidence in regulatory systems worldwide. However, he noted that current interactions with China are limited due to the lack of a confidentiality agreement, which restricts the sharing of specific application details from clinical trials. Read more about the potential lifesaving impact of China joining Project Orbis here.

Julie Gralow, Chief Medical Officer of ASCO, echoed the importance of global cooperation. She described ASCO’s efforts to break down silos and enhance communication among oncologists in low- and middle-income countries. Through regional councils in Asia-Pacific, Latin America, sub-Saharan Africa, and Eastern and Central Europe, ASCO has tailored its programs to meet local needs, such as improving access to medicine, diagnostics, and tumor registries.

Kimryn Rathmell, Director of the National Cancer Institute (NCI), spoke about the shift towards greater collaboration and innovation in clinical trials. “We are moving into an era of collaboration that transcends boundaries, enabling us to achieve more together,” she said. The NCI’s Clinical Trial Innovation Unit, with significant input from the FDA, aims to make clinical trials faster and more accessible globally.

The International Cancer Coalition has been a major driving force, fostering international collaborations since its inception in 2021. By convening multiple stakeholders from both the public and private sectors in a collaborative manner, the Coalition has set an agenda to increase patient participation in cancer clinical trials through the lens of global health equity.

The Coalition focuses on establishing better access to diagnostics and enhancing patient-centric cancer clinical trials through leapfrog technologies such as liquid biopsy and remote care/telemedicine.

Alongside initiatives like the FDA’s Project Orbis and Asia Society’s Cure4Cancer, the Coalition hopes to play an important role in the broader international movement promoting more international cooperation across cancer clinical trials and has a strong focus on Asia and Global South. The Coalition has welcomed the below new members to our coalition in 2024.

About The Bloomberg New Economy International Cancer Coalition

The Coalition, established in 2021, represents a groundbreaking international multi-stakeholder private-public collaboration among academia, industry, government, patient advocacy groups, and policy think tanks. This alliance is dedicated to leveraging technology and fostering synergistic collaborations, with a core aim of enhancing patient access to clinical trials worldwide. A key focus is the harmonization of regulatory practices, driving forward the global mission of accelerating cancer cures and prevention in the post-pandemic era.

Central to its mission are the establishment of thought leadership and the commitment to addressing the most pressing challenges in clinical cancer trials. We have identified four pivotal pillars all explored through the lens of Global Health Equity:

Increase equitable access to testing by improving diagnostics infrastructure and data sharing across the patient journey
Promote patient-centricity by optimizing clinical trial protocols and implementation
Regulatory harmonization to lower barriers to patient-centric care globally
Build public awareness & patient empowerment through education

The Coalition is pioneering implementation of paradigm changing initiatives, together with generating insightful white papers and convening impactful discussions on these key areas. Our efforts are geared toward creating a comprehensive blueprint and serving as a guiding force for the industry, aimed at shaping the future landscape of cancer trials. This initiative not only reflects our commitment to innovation and excellence in healthcare but also underscores our dedication to transforming the lives of patients worldwide.