The White House, February 2, 2022

President Joe Biden has reinvigorated the Cancer Moonshot initiative, initially launched during his time as Vice President in 2016, with a renewed focus on accelerating progress against cancer. The administration aims to reduce the death rate from cancer by at least 50% over the next 25 years while enhancing the experience of individuals living with and surviving cancer. This effort builds upon recent advancements in cancer therapeutics, diagnostics, and patient care, coupled with lessons from the COVID-19 pandemic, to set ambitious goals for combating cancer.

The Biden-Harris Administration is committed to addressing cancer disparities, improving access to cancer screenings that were postponed due to the pandemic, and advancing cancer research and treatments. The administration emphasizes the importance of early detection, prevention strategies, and equitable access to cutting-edge cancer diagnostics and therapies across all communities. By leveraging public-private partnerships and bipartisan support, significant progress has been made in cancer research and treatment, with a focus on personalized medicine, targeted therapies, and innovative approaches such as immunotherapies and cancer vaccines.

To achieve the newly set national goals for the Cancer Moonshot, President Biden’s administration seeks to mobilize the entire government through White House leadership and the formation of a Cancer Cabinet comprising various departments and agencies. A strong emphasis is placed on promoting cancer screening and early detection to reduce missed screenings during the pandemic and improve access to preventive measures. By fostering collaboration among stakeholders, including government entities, private sector partners, healthcare providers, and the research community, the administration aims to drive forward initiatives that will significantly impact cancer outcomes and patient experiences in the years to come.

To read the full article, visit The White House website.

Russell Flannery, Forbes, August 28, 2021

Former Australia Prime Minister Kevin Rudd, who is currently the CEO of the Asia Society, suggested that a joint effort between the U.S. and China in fighting cancer could be akin to the historic ping-pong diplomacy that helped thaw bilateral relations in the 1970s. Rudd expressed optimism about leveraging cancer collaboration to bridge gaps between the two nations amidst other challenges in the relationship.

The 2021 Forbes China Healthcare Summit centered on advancing the global fight against cancer with a focus on achieving progress in the post-pandemic era. Amid the ongoing COVID-19 pandemic, which has claimed millions of lives worldwide, the summit highlighted the critical importance of addressing cancer, a disease projected to cause close to 10 million deaths this year. The vulnerability of cancer patients to COVID-19 was emphasized, underlining the urgency of heightened collaboration and research in cancer treatment.

Participants at the summit included key figures from the healthcare and oncology sectors, discussing strategies to combat cancer at a global level. The event also touched on the bipartisan nature of cancer research and treatment efforts in the U.S., transcending political boundaries. Notable figures like Joe Biden’s previous involvement in promoting cancer research, and the potential for international collaboration in this realm, were highlighted as avenues for significant progress in the fight against cancer. The summit aimed to foster dialogue and cooperation among stakeholders to make strides in cancer treatment and drug research on a global scale.

To read the full article, visit Forbes.com

U.S. Food and Drug Administration, March 4, 2023

Project Orbis, initiated by the FDA Oncology Center of Excellence (OCE) in May 2019, aims to facilitate concurrent submission and review of oncology products among international partners. The collaboration among global regulators under Project Orbis enables patients with cancer to access treatments earlier in countries where regulatory delays are significant, regardless of FDA approval status. This framework is particularly beneficial for oncology drug development as pivotal clinical trials are often conducted globally, emphasizing the importance of establishing consistent global standards for effective trial design.

Since its establishment, Project Orbis has processed numerous oncology marketing applications and successfully approved several oncology drugs for patients worldwide. By enhancing international cooperation and streamlining the review process, Project Orbis has played a pivotal role in accelerating patient access to innovative cancer therapies. The success of Project Orbis has been attributed to the collaboration with international regulatory counterparts such as Australia, Canada, and other countries that have joined as Project Orbis Partners (POP) to enhance the efficiency of oncology product reviews.

The core team behind Project Orbis comprises dedicated professionals like R. Angelo de Claro, Dianne Spillman, Lauren Tesh Hotaki, Yinghua Wang, and Tina MacAulay, each bringing unique expertise and experience to drive the initiative forward. These team members play integral roles in managing applications, facilitating international communication, and overseeing the review process with foreign regulatory counterparts. As Project Orbis continues to evolve and expand its reach, the framework is expected to further streamline oncology product reviews and promote faster access to life-saving therapies for patients around the globe.

To read more about Project Orbis, visit the FDA site.

ICH Official Website

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) was established to address the need for harmonization in the evaluation and regulation of medicinal products. The realization of the importance of independent product evaluation emerged at different times globally and was often driven by tragic incidents like the thalidomide case in Europe in the 1960s. As the industry expanded internationally, varying technical requirements in different countries led to duplicative and costly procedures to market products globally. This highlighted the urgent need for rationalizing and harmonizing regulations to reduce healthcare costs, streamline R&D expenses, and meet public demands for timely access to safe treatments.

The initiation of ICH in the 1980s by the European Commission set the stage for harmonization efforts. Discussions among Europe, Japan, and the US on regulatory harmonization led to the formation of ICH at the World Health Organization Conference of Drug Regulatory Authorities in 1989. The collaboration between regulatory authorities and industry stakeholders culminated in ICH’s establishment in 1990 to focus on harmonizing safety, quality, and efficacy standards for new medicines. Over the years, ICH has evolved, developing guidelines on various topics, such as MedDRA and the Common Technical Document, to streamline regulatory processes across regions.

As ICH enters its fourth decade, the focus has shifted to extending harmonization benefits globally. Organizational reforms in 2015 aimed to increase international outreach, enhance governance structures, and disseminate information to a wider stakeholder audience. These changes have solidified ICH as a legal entity, fostering stable operations and enabling greater industry and regulatory participation. The establishment of the ICH Association with an Assembly as the governing body underscores the commitment to advancing global pharmaceutical regulatory harmonization efforts in a collaborative environment.

Find out more about the ICH on their website.

International Council for Harmonisation Assembly

The International Council for Harmonisation (ICH) Assembly met in Montreal, Canada, making significant decisions and progress in the field of medicines for children and clinical trials. The Assembly approved the China Food and Drug Administration (CFDA) as a new Regulatory Member, expanding the collaboration to improve healthcare standards. Additionally, the Assembly agreed to work on developing a new international harmonized guideline on extrapolation for pediatric medicines. This initiative aims to enhance the utilization of pediatric extrapolation to expedite access to new drugs for children, a crucial step in improving pediatric healthcare.

Furthermore, the ICH Assembly decided to revise the 1997 ICH E8 guideline on general considerations for clinical trials, as part of the strategic ‘GCP renovation’ announced in Osaka in November 2016. This revision will focus on enhancing study design, planning, and conduct by identifying critical factors for quality. By improving clinical trials, the aim is to provide better evidence for regulatory decision-making, reduce the need for repeat trials, and enhance participant safety, ultimately contributing to the advancement of public health.

The Assembly also finalized important guidelines, including the M7(R1) addendum on the Assessment and Control of DNA Reactive Impurities in Pharmaceuticals and the update of Questions and Answers on the guideline E2B(R3) for Electronic Transmission of Individual Case Safety Reports. In an effort to streamline operations and accommodate a growing number of members and observers, the Assembly made revisions to the Articles of Association and rules of procedure. The goal is to ensure that Expert Working Groups remain manageable in size and to engage with relevant global organizations effectively, showcasing ICH’s commitment to agile growth and harmonization. The ICH Assembly’s efforts demonstrate a proactive approach to improving healthcare standards and advancing regulatory practices in the pharmaceutical industry.

To read the full history of the ICH, visit their website.

Forbes China, May 22, 2023

Dr. Bob Li from Memorial Sloan Kettering Cancer Center emphasized the importance of U.S.-China collaboration in fighting cancer, despite tensions between the two countries. The collaboration is crucial due to the high number of cancer-related deaths in both nations. Memorial Sloan Kettering Cancer Center, a pioneer in cancer treatment, has been at the forefront of innovative treatments like immunotherapy, which has saved many lives. International cooperation in clinical trials is vital for translating scientific discoveries into life-saving treatments.

Dr. Li highlighted the lengthy and expensive process of drug development, with clinical trials taking 10 to 15 years to complete without global collaboration. With only about 5% of cancer patients participating in new treatment trials, there is a need to streamline processes and make treatments more accessible. Precision medicine, which tailors treatments to individual patients, further emphasizes the need for international collaboration to reach more patients and accelerate the development timeline.

Successful collaborations between the U.S. and China, like the development of the EGFR inhibitor for lung cancer, demonstrate the potential benefits of working together. Looking ahead, Dr. Li stressed the need to rethink the current ecosystem of oncology research and make it more patient-centric. He called for every cancer patient to have access to clinical trials and emphasized the importance of reinventing the rules to accelerate progress and save lives. Collaborative efforts can help bridge gaps in clinical trial accrual, diversify patient populations, and bring treatments to those in need.

Read the original article on Forbes.com.