Patrick Beyrer, Research Associate on Global Public Health at the Asia Society Policy Institute’s Center for China Analysis

May 15, 2024

• Introduction
• Biotech Competition between U.S. and China
• U.S. Response to China’s Biotech Ambitions
• The BIOSECURE Act and Pharmaceutical Firms
• Overseas Investment in Chinese Biotech
• Conclusion
• Acknowledgements

Introduction

Since the U.S.-China trade and technology relationship took center stage during the Trump administration’s trade war, observers have sought to identify specific industries that could exacerbate tensions between Washington and Beijing. The Chinese biotech sector might be that next, risky frontier. Although long heralded as the new “national security obsession” and “next battleground” for U.S.-China technology decoupling in Beijing and Washington alike, past U.S. policymaking and official enforcement actions on the sector were precise and limited. But this reality is quickly unfurling.

Starting in earnest in late 2022, U.S. officials have continued to ratchet up their rhetoric and actions in a campaign to ensure U.S. leadership in global biotech competition and rulemaking. This flurry of regulation has not limited itself to the water’s edge of diplomacy and statecraft, as entrepreneurs, scientists, and major commercial entities are starting to feel the results of this sea change in policy. The U.S. House Select Committee on Strategic Competition between the United States and the Chinese Communist Party (CCP Select Committee) has spearheaded efforts among U.S. lawmakers to draw up a new playbook for this challenge. Rep. Mike Gallagher, former CCP Select Committee chairman, described new enforcement efforts in biotech as a “moral and ethical battle” to establish technical standards.

Other lawmakers and experts have asserted that biotech competition holds equally critical stakes for innovation and statecraft. In the wrong hands, biotechnologies – which can be used to manipulate DNA, surveil and identify individuals, augment advanced materials and chemical manufacturing, improve energy efficiency, and enable agricultural resilience and abundance – can be used for nefarious and even weaponized ends.

Biotech Competition between U.S. and China

The United States is not the only one seeking to fortify its research and manufacturing base. China’s own internal rhetoric has at times inflamed biotech competition in similarly nationalistic and even existential terms. Since biotech’s identification as a critical emerging technology for independent innovation in the Made in China 2025 policy, CCP attitudes appear fixed; nearly every application of biotech is invaluable to China’s conception of itself as a rising world power.

In April 2022, President Xi Jinping encouraged Chinese scientists to break through “bottlenecks” in key technologies and aspire for major breakthroughs in life sciences research, including biological macromolecules and genetics. Around the same time, he declared food security—an application of agricultural biotech—“an issue of utmost national importance,” describing arable land as the “lifeblood” of the Chinese nation. At provincial, city, and company levels (both state-owned and private), officials have connected the concept of “red genes” in party-building activities to upskilling talent in the biomedical industry. Within the latest State Council work report, both biomanufacturing and life sciences are highlighted as industries primed under the “new productive forces” campaign for China to “build new growth engines” and “open new tracks” for development. These speeches and signals are not simply political theater. Beijing touts major Chinese biotech companies as instrumental to the construction of its civil-military governance model: the “party-army-state.” Biotech corporations’ cooperation with researchers from the People’s Liberation Army (PLA) only reifies this trend.

U.S. Response to China’s Biotech Ambitions

The Biden administration has recognized the challenges posed by China’s biotech ambitions. In September 2022, the White House issued a biotechnology executive order (EO), which accelerates a “whole-of-government approach” to respond to Chinese biotech competition. The administration has delegated various departments to enhance targeted enforcement measures while working with Congress to ratchet up pressure on industry stakeholders to avoid Chinese partnerships of concern.

The Bureau of Industry and Security (BIS) within the Department of Commerce (DOC) has played the largest role in these countermeasures. By scrutinizing the end uses of Chinese biotech companies’ products, especially those relating to unethical biometric surveillance and research ties with military programs, the BIS has steadily added Chinese biotech companies and institutions to its Entity List: 34 in December 2021, 33 in February 2022, and 28 in March 2023. These include both sister companies and affiliates of firms WuXi AppTec and BGI Group, who have both been singled out by lawmakers for their partnerships with the PLA, and in the case of WuXi AppTec, have allegedly transferred U.S. client data without consent, according to intelligence officials.

The Department of the Treasury (USDT) and the Department of Homeland Security (DHS) have followed the DOC’s lead to similar effect. In the same salvo as the 2021 BIS Entity List adjudication, the USDT concurrently instituted sanctions on Chinese biotech companies involved in the illicit drug trade and imposed a set of follow-up sanctions in October 2023. For its part, the DHS has brought enforcement actions against Chinese agricultural and chemical biotech companies under the Uyghur Forced Labor Prevention Act for their ties to forced labor, with the most recent sanctioned companies announced in August and October 2023.

Interagency efforts scrutinizing Chinese biotech across genetics, illicit pharmaceuticals, chemical manufacturing, and biometric technologies have further consolidated departmental efforts with even more significant implications. In a first-ever directive defining additional national security factors for the Committee on Foreign Investment in the United States (CFIUS), a September 2022 EO listed “biotechnology, biomanufacturing and elements of the agricultural industrial base” as areas of fundamental interest for CFIUS review. An additional February 2024 EO proposed measures that would block the high-volume export of U.S. genomic data, health data, and biometric data to China, with Biden administration officials going as far as identifying genomic data export as the most acute threat of the data categories to U.S. national security and commercial interests.

If the administration has orchestrated forceful efforts, then Congress has taken even more direct steps. Although the CCP Select Committee lacks a legislative mandate, its leadership and senior members have found common cause with fellow lawmakers to fast-track legislation that promotes the decoupling of the U.S.-China biotech sectors in sensitive areas. In the Senate, Sen. Marco Rubio reintroduced the GENE Act in June 2023 to require CFIUS reviews of genetic transfers and increase corresponding congressional oversight—a set of measures former chairman Gallagher previously signaled interest in. In July 2023, Gallagher partnered with Rep. Dan Newhouse to propose expanding CFIUS jurisdiction to assess Chinese land purchases near U.S. military sites and consider food security via biotech acquisition as a factor in national security reviews.

These efforts also take on a bipartisan sheen. In February, Rubio teamed up with Senate Intelligence Committee chair Mark Warner to urge the DOC and the USDT to develop a more “robust export control regime” that blunts Chinese biotech influence in the United States. Gallagher and CCP Select Committee ranking member Raja Krishnamoorthi proposed the BIOSECURE Act, which would ensure that “foreign adversary biotech companies,” including BGI Group and WuXi AppTec, are blocked from future U.S. federal contracting and government technology procurement. Gallagher and Krishnamoorthi have also forcefully written to the USDT, the DOC, and the Department of Defense to suggest the addition of BGI, WuXi AppTec, and its sister company, WuXi Biologics, to various entity and sanction lists.

Congressional interest in Chinese biotech’s national security implications has taken other notable forms. Announced in March 2022, the National Security Commission on Emerging Biotechnology (NSCEB) has supported the policy behind the BIOSECURE Act by recommending a federal procurement ban of BGI Group products. Additionally, NCSEB vice chair Michelle Rozo offered testimony at a February hearing of the U.S.-China Economic and Security Review Commission that reaffirmed China’s commitment to achieving food security, securing military advantages, and maintaining genetic resources access through biotech research and applications.

The CCP Select Committee has been equally active in publicly spreading this message. In a field visit to Boston, Gallagher and Krishnamoorthi led a group of lawmakers to meet with U.S. biotech executives to discuss challenges posed by China’s biotech sector, including pharmaceutical dependencies. In the months prior, the CCP Select Committee’s policy recommendations described U.S. dependence on Chinese pharmaceutical supply chains as a “distinct national security risk” and recommended the establishment of corresponding controls on Chinese biotech, including investment restrictions. Another CCP Select Committee report investigated U.S. venture capital firms’ investments in emerging Chinese technology and their ties to biometric surveillance, among other biotech advancements, enabling state control.

Although most of the legislation focused on Chinese biotech has yet to be approved, a combination of public pressure and congressional actions have both directly caused and coincided with major impacts across the Chinese biotech sector. WuXi AppTec’s and WuXi Biologics’ share values have declined nearly 40% and 50%, respectively, in the first several months of 2024, largely due to the announcement of the BIOSECURE Act and the CCP Select Committee’s letters to various federal executive departments and the Pentagon. BGI has since been dumped as a client by major Washington lobbying firms that previously advocated for the company’s U.S. market access. The Biotechnology Innovation Organization similarly cut ties with WuXi AppTec and affirmed biotech as a “national security imperative” after being called out by Gallagher for lobbying against the BIOSECURE Act on behalf of WuXi.

The BIOSECURE Act and Pharmaceutical Firms

Pharmaceutical firms are already responding to the BIOSECURE Act and related tensions through potential supply chain adjustments and contingency plans with an eye on the long term. According to the Financial Times, 23 different U.S. biotech companies have warned of their dependency on the WuXi companies in annual reports since March, with at least five such companies informing investors they will seek alternative manufacturing partners. Analysts additionally expect U.S. firms’ drug development costs to skyrocket in the absence of WuXi and BGI, as WuXi AppTec has been described as a “research superstore” for its U.S. partners and WuXi Biologics stands as the second largest biologic outsourcer in the world. In one recent survey of pharma executives, over 90% of respondents indicated that the BIOSECURE Act’s passage would set back their drug pipelines, with 53% stating it would be extremely difficult to replace Chinese contract development and manufacturing organizations like WuXi.

Overseas Investment in Chinese Biotech

U.S. investors in Chinese biotech have been similarly affected. Last September, the Wall Street Journal reported that the value of Chinese biotech venture deals including U.S. investors in 2022 was $102.6 million—a far cry from the $1.01 billion recorded a year earlier. Firms mentioned in the CCP Select Committee’s venture capital funding report have since attempted to sell off their stakes in different Chinese tech startups.

Downward pressure over the last year on Chinese biotech partnerships and investments has precipitated divestments at the corporate and academic levels, too. In February, German agri-tech giant BASF revealed it would exit from two of its joint venture chemical plants in Xinjiang, while U.S. biotech giant Thermo Fisher Scientific announced it would halt sales of DNA collection kits in Tibet. Notably, both regions are where Chinese biometric surveillance is purportedly used en masse, sometimes via American equipment.

On the academic side, in March 2023, France’s Pasteur Institute ended a partnership with the Chinese Academy of Sciences in Beijing and ceased another research operation in Shanghai. In February 2024, reports emerged that the academic journal Molecular Genetics and Genomic Medicine would retract eighteen genetics papers from China due to concerns over data “inconsistencies” on how human genetic samples were collected from vulnerable populations. Finally, as the long-term renewal of the U.S.-China Science and Technology Agreement continues to hang in the balance, state-to-state-level partnerships on crop gene sequencing and infectious diseases, in addition to other biotech-enabled projects, are liable to cancellation.

To this end, experts have suggested that the large financial impacts stemming from recent enforcement actions show that academics, investors, and corporates are not prepared for an expedited biotech decoupling. During the CCP Select Committee’s biotech hearing, NCSEB chair and Gingko Bioworks CEO Jason Kelly stated that industry conversations on national security have been “surprising” for many biotech entrepreneurs, who must avoid “putting our heads in the sand” on strategic biotech competition with China in the future. As one China biotech scholar has remarked, “the geopolitics and trade and investment parts of the U.S.-China relationship are on totally different planes.” This dynamic could not be more apparent as several key pharma executives traveled to Beijing in March, praising China’s biopharma innovation while announcing a series of expansion initiatives.

Looking forward, renewed congressional focus and public pressure campaigns are poised to further tighten the screws on the Chinese biotech sector, as CCP Select Committee leadership hopes to bring a “big China bill” to the House floor this year and human rights groups raise awareness of Chinese biotech’s more draconian applications. Krishnamoorthi has expressed his dedication to moving the BIOSECURE Act forward for a spring markup session in the House of Representatives, even in the absence of Gallagher.

Conclusion

Regardless of whether pending legislation passes through Congress, U.S.-China biotech decoupling is likely to continue, especially in areas of sensitive research and investment. As studies show that China leads the United States in four of seven major emerging biotech categories, the scramble between Washington and Beijing to lead, apply, and control emerging technology within the biotech sector appears to have only just begun. Speaking to the stakes of this new arena of U.S.-China tensions, Rep. Krishnamoorthi remarked during the CCP Select Committee’s hearing in March that “the competition with the CCP in biotech is make or break… so we must, and we will, win.”

In entering this competitive phase of potential U.S.-China biotech decoupling, Americans outside of the industry or the scientific community are not adequately prepared for its consequences in their daily lives. In addition to China representing the largest and most cost-effective exporter of active pharmaceutical ingredients to the U.S. market, jointly developed drugs, agricultural technologies, and other biotech-enabled solutions have improved countless American lives. As the New York Times has reported, the elimination of companies like WuXi from U.S. supply chains would impact developments in treatments for critical medical conditions, including hearing loss, cystic fibrosis, and leukemia. U.S.-China gene editing research collaborations have created disease-resistant crops while improving their yields. Research published in the Harvard Business Review has shown that China’s integration into a full U.S.-led international regulatory harmonization of cancer clinical trials could save 1 to 2 million lives annually through expediting critical reviews of breakthrough medicines. The collapse of U.S.-China biotech partnerships would spell the end of such jointly developed innovations that harbor the potential to deliver sorely needed global public goods, including saving American lives suffering from diseases such as cancer.

Corporations and academia are not ready for a full U.S.-China biotech decoupling, nor do they seek it. As enforcement from Washington grows broader and more restrictive, U.S. biotech firms, institutions, and researchers will face difficult choices when evaluating relationships with Chinese partners. Although changes are certainly necessary within the United States’ posture toward biotech cooperation with China, if decoupling is pursued to its fullest extent, the impacts on the U.S. economy and innovation ecosystem may prove severe. With U.S.-China competition likely to persist, remaining avenues for scientific cooperation, including in biotech, will likely have far-reaching consequences for the rest of the world.

Acknowledgements

The author would like to acknowledge the members of the Cure4Cancer team, as well as other contributors from the Center for China Analysis (CCA), Asia Society Policy Institute (ASPI), for their review and input on the article.

ENHANCING CLINICAL TRIALS ACCESS AND COOPERATION TO SAVE MILLIONS OF LIVES FROM CANCER

• Introduction
• Global Health Equity
• Clinical Trials and the Fight Against Cancer
• Benefits of China’s Participation
• Obstacles, Skepticism and Responses
• Authors
• Acknowledgements
• References

Introduction

Cancer accounts for approximately 10 million deaths globally each year. Too many of these 10 million lives lost to cancer could be saved through enhanced international cooperation.

According to a study by the Bloomberg New Economy International Cancer Coalition, global regulatory harmonization for clinical trials and cancer therapy approvals could reduce global cancer-related deaths by an estimated 10% to 20%, or 1 to 2 million lives per year.

However, studies have shown that the current patient participation in oncology clinical trials is fewer than 5% globally with significant disparities among communities, even though more than 70% of the same patients are either inclined or very willing to participate in such trials

This first Cure4Cancer report of a policy series underscores the potential impact of international regulatory harmonization, with a case study of China joining Project Orbis. Such cooperative initiatives could greatly streamline international regulatory processes and bolster global health equity by expanding access to clinical trials and precision oncology worldwide. 

Download the report here

Global Health Equity

Health equity is defined as the absence of avoidable differences based on sex, gender identity, race, ethnicity, disability, sexual orientation, or other factors that affect access to care and health outcomes.

Achieving global health equity requires the identification and elimination of factors that create inequities in health outcomes in living conditions; education; socioeconomic status; geography; access to quality, culturally competent, and affordable health care; and so on.  

The significance of equity in oncology R&D cannot be overstated. Before the Covid-19 pandemic, an estimated $50 billion was spent annually on oncology R&D by the biopharmaceutical industry; the cost of clinical trials, which often last many years, is exorbitant, amounting to tens or hundreds of millions of dollars for each trial. Today, oncology R&D is estimated to cost the industry $80 billion per year according to the recent analysis. 

Advancing global health equity, therefore, is not only a prerequisite for the sustainable development of global public health but also a strategic business decision. Developing international clinical trials could prove essential for advancing global public health equity. International clinical trials stand to increase patient access in global communities, diversify participants, accelerate R&D timelines, reduce cost, and increase the worldwide impact of scientific results. 

Increasing the percentage of patients from diverse backgrounds who have access to clinical trials (from the current fewer than 5% through international collaboration), could accelerate accrual and shorten the drug approval timeline from the traditional 10–15 years to a 2–3 year process. This would save millions of patients waiting for treatments, lower the costs associated with clinical trials, open new markets and revenue streams for pharmaceutical companies: these have the potential to contribute significantly to global health equity. 

What are the barriers to global health equity?

China, a country with the world’s largest cancer burden, has not been sufficiently included or integrated into the international R&D and regulatory approval framework in terms of relevant data and cases over time.  

This also epitomizes the situation of many low- and middle-income countries with large cancer patient populations lacking representation in the international regulatory landscape. 

As the global cancer burden is expected to continue to rise, the importance of equity in oncology R&D is gaining increasing recognition in both industry and academia. To integrate equity more deeply into oncology R&D, therefore, is not only a moral imperative but also a sound policy and business strategy that can lead to significant advances in cancer care. 

Clinical Trials and the Fight against Cancer

Clinical trials are research studies to test and evaluate how innovative cancer drugs, vaccines, and technologies perform for patients.    

Continued human progress in cancer treatments and prevention is deeply reliant on access to clinical trials. By testing innovative therapies, these clinical trials have the potential to both save the lives of trial participants and expedite regulatory approvals of new cancer treatments that can help millions more patients battle the disease. 

The clinical trial development process is constantly changing in a number of ways. For example:

• The technology for matching clinical trial patients to interventions based on AI algorithms is evolving. 
• Regulatory agencies such as the U.S. FDA and the European Medicines Agency (EMA) have created novel and accelerated regulatory pathways to increase the flexibility of clinical trials design and execution. 
• Remote monitoring and clinical trial participation technology have the potential to decentralize the distribution of clinical trial patients away from major academic centers.

In sharp contrast to the breakthroughs and innovations in clinical trial development, there is also growing attention to the barriers that impede the advancement of cancer treatments research and development. Among these barriers, first and foremost is the lack of patient access to clinical trials. 

The main barrier to finding lifesaving new cancer treatments or preventions is the time it takes to conduct clinical trials. 

Many factors contribute to this problem, but inadequate international regulatory coordination and cooperation is one of the more prominent ones: bureaucratic red tape, gaps in regulatory systems, less standardized institutional review boards with delays in clinical trial activation, and a lack of policy coordination between government regulatory agencies in different countries substantially limit clinical trial progress by resulting in delays in regulatory review and approvals, the cancellation of international cooperative regulatory projects, and grants and funding expirations while waiting for regulatory approvals.  

Better international standardization of clinical trials and their approvals can shorten the time needed to roll out a new cancer treatment from the traditional 10–15 year process to a 2–3 year timeline, accelerating biological discovery and having a positive impact on future funding and investments in more clinical trials. 

It can also lead to more affordable cancer treatments for more patients globally, more international academic collaboration and research output, and reduced R&D costs for all stakeholders. Conversely, if we continue with the current status quo of fewer than 5% clinical trial access with an expensive and lengthy R&D timeline, it is safe to say that the Cure4Cancer or the eradication of cancer as a major cause of death will not be achieved. 

REGULATORY FRAMEWORKS SUPPORTING GLOBAL COOPERATION AGAINST CANCER: CANCER MOONSHOT WITH A CASE STUDY ON PROJECT ORBIS AND CHINA

Cancer Moonshot, launched in 2016 and reignited in 2022, is a signature project of U.S. President Joe Biden that is led by the White House, in collaboration with the National Cancer Institute of the National Institutes of Health (NIH) and other federal agencies. The White House Cancer Moonshot aims to “end cancer as we know it,” specifically reducing the cancer death rate in the United States by at least half by 2047. Cancer Moonshot currently supports more than 70 programs and more than 250 research projects housed at the NIH. 

The FDA Oncology Center of Excellence (OCE) has already made progress toward this goal with the 2019 launch of Project Orbis, an initiative to set up an international regulatory infrastructure for simultaneous submission, review, regulatory action, and approvals of clinically significant new cancer treatments in multiple countries, instead of separate sequential applications in each country, thus avoiding duplicity and shortening the time needed for patients to access innovative cancer medicines. Current Project Orbis Partners (POPs) include the regulatory health authorities of Canada, Australia, Switzerland, Singapore, Brazil, the UK, and Israel.    

Since its inception, Project Orbis has led to the multinational approval of 75 oncology drugs for patients across the world. Major oncology disease categories were represented in the Orbis submissions, including solid tumor and hematologic malignancy indications.

However, the effectiveness of the project needs to be further developed from several aspects, including the limitation of the number of member countries and the limitation of the amount of corresponding data. Its current member countries account for only 21.64% of new cancer cases worldwide in 2020 – hardly representative of the vast global cancer population, leaving shortcomings in the timeliness, diversity, and equity of the programs it supports for approval.

Cancer experts and regulatory agency leaders from the United States and China have been discussing a potential agreement to collaborate in the fight against cancer through regulatory harmonization in multiregional clinical trials and the possibility of China joining Project Orbis. So far, China, with the world’s highest cancer patient population and potentially the most impactful partner in this effort, remains absent from the initiative.

The United States and China share a common international regulatory background and have a history of cooperation: both are members of the International Council for Harmonisation (ICH) and have adopted international standards per ICH guidance documents, and each country has issued several guidance documents to further clarify respective regulatory requirements; thus, the bilateral review process would build on existing regulatory requirements and drive greater harmonization in regulatory decision-making.

China’s participation in clinical trials would yield manifold benefits for promoting public health equity, but it also faces obstacles and challenges. 

Benefits of China’s Participation

POPULATION AND DATA: If China were to join Project Orbis, the number of new cancer cases in 2020 represented by the POPs would rise from 21.64% to 46.88%. Accounting for nearly 40% of the global annual cancer deaths, the prospect of the United States and China working together with other countries to fight the common enemy of humanity offers significant opportunity for success.

STANDARD SETTING: With the patient population and size of the China market, the global community is better served by including China’s regulatory agencies, cancer researchers, doctors, and industry leaders in the international standard-setting regulatory process. Simultaneous regulatory reviews allow global cancer breakthroughs to enter the China market earlier and impact more lives. Likewise, Chinese cancer breakthroughs through multiregional clinical trials could also greatly benefit patients in all POP countries.

URGENCY: China is the world’s No. 1 cancer hotspot, with more than 4.8 million new cancer cases and 3.2 million deaths annually. The United States follows as No.2 in cancer burden, with about 1.9 million cases and more than 600,000 deaths annually. This makes the people of the two countries the largest number of cancer patients and natural collaborators as epicenters for cancer research and clinical trials, as well as humanitarian need, to fight against cancer, their common enemy.

REDUCING COSTS FOR ALL: The bilateral review process has the potential to eliminate or reduce delays in regulatory approval of innovative drugs in either market, thereby enabling patients in both countries to gain earlier access to therapies with reduced time costs and less costly expenses. One of the core measurable benefits of Project Orbis is a minimization in the lag times between FDA approval and approval in POPs.

More data and lower regulatory hurdles translate directly into faster clinical trials and could lower costs for R&D. This has the potential to significantly improve the affordability of approved treatments for U.S. and global cancer patients and insurers, hence saving more lives.

IMPACT ON THE INDUSTRY: The more diverse infrastructure of approval frameworks and the faster approval timelines among participating countries, if achieved by China’s involvement in Project Orbis, can significantly improve the “return on” and the impact of clinical trials, which indicates substantial investment opportunities across the industry.

RECIPROCITY: The FDA has specific requirements for data quality and applicability through multiregional clinical trials, and these standards will be upheld and strengthened through Project Orbis, applying to all its members. Shorter approval timelines will benefit patients in both China and the United States, not to mention the rest of the world. And since the majority of the U.S. and international biopharmaceutical companies operate in both the United States and China, reducing the lag time for drug approvals in China and facilitating faster entry into the China market would benefit all such companies.

GLOBAL MULTILATERAL LEADERSHIP AND INNOVATION: China’s participation would provide a very strong incentive for other countries to join Project Orbis, further advancing the harmonization of international regulations, speeding up clinical trials, and saving more lives. This has the potential to firmly demonstrate U.S. global leadership and the ability to serve concrete global public goods. China has the same incentive.  

STABILIZE U.S.-CHINA RELATIONSHIP AND PROMOTE WORLD PEACE: Genuine cooperation could help stabilize the U.S-China bilateral relationship, but unfortunately such opportunities are rare. But both countries have a strong national interest in reducing cancer’s death toll, and so Project Orbis could present one such chance for cooperation. 

Obstacles, Skepticism and Responses

BIOSECURITY AND HUMAN GENETICS: Biosecurity around international clinical trials are of particular concern to U.S. citizens. However, the nature of Project Orbis is inherently secure, with only trial data (and no biological material) passing across international borders. Data sharing is key to the success of international clinical trials, and the sharing of cancer genetics has been routinely done in a secure, anonymous fashion for over two decades (see the publicly available Cancer Genome Atlas as a result of this). Continual compliance with existing regulations on human genetics will ensure no unnecessary delays to international clinical trials and breakthroughs.

INTELLECTUAL PROPERTY PROTECTIONS: There are no concerns about Intellectual property (IP) protections within Project Orbis.  International clinical trials are highly regulated and transparent. Secondly, clinical trials are intended to transfer scientific breakthroughs for which IP has already been patented and published, and to turn the IP into medical treatments that can then be made commercially available. 

Authors

Bob T. Li,MD, PhD, MPH, Physician Ambassador to China and Asia-Pacific, Memorial Sloan Kettering Cancer Center; Associate Professor of Medicine, Weill Cornell Medicine, Cornell University; Senior Fellow on Global Public Health, Center for China Analysis, Asia Society Policy Institute

Jing Qian, Co-Founder and Managing Director, Center for China Analysis, Asia Society Policy Institute; Advisory Board Member, Bloomberg New Economy

Greg Simon, Distinguished Fellow, Global Public Health, Center for China Analysis, Asia Society Policy Institute; Former President, Biden Cancer Initiative

Justin Finnegan, Founding Managing Director, Bloomberg New Economy, Senior Fellow on Global Public Health, Center for China Analysis, Asia Society Policy Institute

John Oyler, Co-Founder and CEO, BeiGene

David Fredrickson, Executive Vice President, Oncology Business, AstraZeneca

Chitkala Kalidas, PhD, Vice President, Global Head of Oncology Regulatory Affairs, Bayer AG

Shaalan Beg, MD, Vice President, Oncology, Science 37; Adjunct Associate Professor, University of Texas Southwestern Medical Center

Si-Yang Liu, MD, Visiting Investigator, Memorial Sloan Kettering Cancer Center; Attending Thoracic Surgeon, Guangdong Lung Cancer Institute and Guangdong Provincial People’s Hospital, Chinese Thoracic Oncology Group

Dorrance Smith, Media Advisor on Global Public Health, Center for China Analysis, Asia Society Policy Institute

Morgan Speece, Director of Operations, Asia Society Policy Institute; Project Manager, Center for China Analysis

Yi Qin, Junior Fellow on Chinese Society and Public Health, Center for China Analysis, Asia Society Policy Institute

Sepideh Shokrpour, Coalitions Manager, Bloomberg New Economy

Mary Gospodarowicz, MD, FRCPC, FRCR(Hon), Princess Margaret Cancer Center, University of Toronto

Olufunmilayo I. Olopade, MBBS, FACP, OON, Walter L. Palmer Distinguished Service Professor of Medicine and Human Genetics, Center for Global Health, University of Chicago

Otis W. Brawley, MD, Bloomberg Distinguished Professor of Oncology and Epidemiology, Johns Hopkins University

Bobby Daly, MD, MBA, Assistant Attending in Thoracic Oncology, Memorial Sloan Kettering Cancer Center 

Acknowledgements

• Asia Society Policy Institute
• Memorial Sloan Kettering Cancer Center (MSK)
• Chinese Thoracic Oncology Group (CTONG)
• Bloomberg New Economy International Cancer Coalition 
• Forbes China
• Thoracic Oncology Group of Australasia (TOGA)
• AstraZeneca
• Bloomberg New Economy International Cancer Coalition 

His Excellency the Honorable Dr. Kevin Rudd, former Asia Society Global President and CEO, Stefan Oelrich, president of Bayer Pharmaceuticals. 

We also acknowledge the work of countless others who helped in the creation of this report, including Gary Rieschel, Lulu Wang, Orville Schell, Shane Williams-Ness, Duncan Clark, Peter Jakes, as well as Susan Galbraith, Shira Gerver, and Megan Yuan from AstraZeneca and Shreya Jani and Mark Lanasa from BeiGene. Colleagues at Asia Society include Debra Eisenman, Kevin Hogan, Danny Russel, Rorry Daniels, Susie Jakes, Alexandra Zenoff, Linda Benson, Anisa Chugthai, as well as Bates Gill, Nathan Levine, Wendy Ma, Inger Marie Rossing, Johanna Costigan, and Patrick Beyrer at the Center for China Analysis, Asia Society Policy Institute.

References

1  “What Are Clinical Trials?” National Cancer Institute. Accessed May 1, 2023. https://www.cancer.gov/about-cancer/ treatment/clinical-trials/what-are-trials#:~:text=Through%20clinical%20trials%2C%20doctors%20determine,people%20 during%20and%20after%20treatment.
 
2  Daly, B., Finnegan, J., Li, B. T., and Qian, J. “We Need a Global System for Testing and Approving Cancer Treatments.” Harvard Business Review, October 18, 2022. https://hbr.org/2022/10/weneed-a-global-system-for-testing-and-approving- cancer-treatments.
 
3  Sung, H., Ferlay, J., Siegel, R.L., et al. “Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.” CA: A Cancer Journal for Clinicians 71, 209-249 (2021). https://doi.org/10.3322/ caac.21660.
 
4  Li, B. T., Daly, B., Gospodarowicz, M. et al. “Reimagining Patient-Centric Cancer Clinical Trials: A Multi-Stakeholder International Coalition.” Nat Med 28, 620–626 (2022). https://doi.org/10.1038/s41591-022-01775-6.
 
5  “Health Equity.” World Health Organization. Accessed May 4, 2023. https://www.who.int/health-topics/health- equity#tab=tab_1.
 
6  “Increasing Access for Clinical Trials.” Data from Bloomberg New Economy International Cancer Coalition. Est. publication in 2023.

7  “Clinical Trials.” World Health Organization. Accessed April 15, 2023. https://www.who.int/news-room/questions-and- answers/item/clinical-trials#:~:text=What%20is%20a%20clinical%20trial,referred%20to%20as%20interventional%20trials.

8  “Diversity and Inclusion in Clinical Trials.” National Institute on Minority Health and Health Disparities. Accessed June 28, 2023.

9  Flannery, R. “U.S.-China Collaboration Could Cut Development Time, Cost for New Cancer Treatments.” Forbes, March 27, 2023. https://www.forbes.com/sites/forbeschina/2023/03/22/us-china-collaboration-could-cut-development-time-cost-for- new-cancer-treatments/.

10  “Global Cancer Data by Country: World Cancer Research Fund International.” WCRF International, April 21, 2022. https:// www.wcrf.org/cancer-trends/global-cancer-data-by-country/#:~:text=Globally%2C%2018%2C094%2C716%20million%20 cases%20of,women%20(178.1%20per%20100%2C000).

11  “Definition of a Clinical Trial.” University of California–San Francisco Clinical Research Resource HUB. Accessed August 18, 2023. https://hub.ucsf.edu/clinicaltrialsgov-definition-clinical-trial.

12  “Notice of Revised NIH Definition of ‘Clinical Trial.’” Notice Number: NOT-OD-15-015. Release Date: October 23, 2014. NOT- MH-20-105. Issued by National Institutes of Health (NIH). https://hub.ucsf.edu/clinicaltrialsgov-definition-clinical-trial.

13  “Project Orbis: A Framework for Concurrent Submission and Review of Oncology Products.” U.S. Food and Drug Administration. Accessed March 3, 2023. https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis.

14  “Project Orbis Approvals.” Oncology Center of Excellence, U.S. Food & Drug Administration. Accessed July 7, 2023. https:// www.fda.gov/media/169691/download?attachment.

15  R. Angelo de Claro, Dianne Spillman, Lauren Tesh Hotaki, et al., “Project Orbis: Global Collaborative Review Program,” Clinical Cancer Research 26, 6412–6416 (2020). https://doi.org/10.1158/1078-0432.ccr-20-3292.

16  Masson, G. “FDA’s Oncology Center of Excellence Slowed Launch of New Projects in 2022 to Focus on Trial Modernization.” Fierce Biotech, February 7, 2023. https://www.fiercebiotech.com/biotech/fdas-oncology-center-excellence-slowed-launch- new-projects-2022-focus-4-specific-programs.

17  Ferlay, J., Ervik, M., Lam, F. et al. Global Cancer Observatory: Cancer Today. Indonesia Fact Sheet. Lyon, France: International Agency for Research on Cancer; 2020. Accessed July 10, 2021. https://gco.iarc.fr/today/data/factsheets/populations/360- indonesia-fact-sheets.pdf  

18  Puspitaningtyas H, Espressivo A, Hutajulu SH, et al. “Mapping and Visualization of Cancer Research in Indonesia: A Scientometric Analysis.” Cancer control : journal of the Moffitt Cancer Centervol 28, 10732748211053464 (2021). https://doi. org/10.117710732748211053464.

19  Howlett, J. IAEA Department of Technical Cooperation and Gil, L. IAEA Office of Public Information and Communication. “Indonesia Plans to Increase Access to Cancer Control.” International Atomic Energy Agency. February 6, 2018. https://www. iaea.org/newscenter/news/indonesia-plans-to-increase-access-to-cancer-control. 

We’re Putting Man on the Moon Again: Why Don’t You Know About it?

“Last year, Jill and I re-ignited the Cancer Moonshot that President Obama asked me to lead in our administration,” President Biden said at the 2023 State of the Union. “Our goal is to cut the cancer death rate by at least 50% over the next 25 years.” 

This ambitious goal is a reference to the Biden administration’s Cancer Moonshot. The project is under the management of the National Institutes of Health’s (NIH) National Cancer Institute and aims to accelerate the development of cancer treatments. 

The good-faith intentions of this project should not be doubted. President Biden’s son Beau died of brain cancer in 2015, and after he left the Vice Presidency, Biden launched a private, albeit short-lived, cancer research philanthropy. Still, a central question remains: the president of the United States is trying to cure cancer, yet you probably haven’t heard about it. Why? 

Clinical Trials: A Possible Catalyst?

Public awareness is not just critical to mobilize efforts around cancer prevention, inequity, and advocacy. It is also crucial for the development of cancer treatments, which are often discovered through clinical trials. Studies have shown that fewer than 5% of U.S. cancer patients participate in clinical trials despite the fact that over 70% of the same patients are either inclined or very willing to participate in the trials. By testing innovative therapies, these trials have the potential to both save participants’ lives and expedite official approvals of new cancer treatments that can help thousands more patients battle the disease.

Raising public awareness of the availability of clinical trials, through direct recruitment and media engagement, have proven effective. As Cancer Moonshot called for further research on clinical trial networks through the 21st Century Cares Act five years ago, the project presents ample opportunity to both increase patient participation in clinical trials and reimagine their delivery. In the post-pandemic world, experts have suggested that clinical trials can be transformed to optimize patient experience through remote consent, monitoring, and ready-to-ship therapies patients can take from their own homes. 

Cancer Moonshot could help mobilize the public and the government toward what President Biden has called a “truly American moment that rallies the country and the world together and proves that we can do big things.” The project’s progress and potential deserve more attention. But one major roadblock might be standing in the way of raising awareness about Cancer Moonshot: funding.

Cost of the Cure

Progress on Cancer Moonshot has stalled since then-Vice President Biden unveiled the project in 2016, and the project was effectively sidelined in the waning days of the Obama Administration. Meanwhile, only $400 million in funding remains available over the next year from Congress’s original $1.8 billion budget; no proposal for additional funding is currently on the House floor. 

The funding gap remains one of the scientific community’s principal concerns. Presently, Cancer Moonshot supports over 70 programs and more than 250 research projects housed at the NIH. Without additional financial support, many of the administration’s cutting-edge efforts, such as the Cancer Moonshot Biobank—a key effort in centralizing relevant genetic data and expanding the scope of research collaborations—may be canceled before they can deliver meaningful results for scientists.

“We don’t want to see reallocation of existing dollars at NIH to pay for this initiative,” Jon Retzlaff, Chief Policy Officer of the American Association for Cancer Research, told Science in 2016. 

Today, the sentiment remains the same. Scientists have suggested a “scaled-up, redoubled, and accelerated” approach to Cancer Moonshot that has the potential to deliver on the project’s stated goals. President Biden has continued to urge Congress to reauthorize the 1971 National Cancer Act, which established the National Cancer Institute and would “lock in” further funding. But this approach is still pending on the legislative side.

Organization and Outreach

Cancer Moonshot’s 2022 reboot aims to incorporate the perspectives of all stakeholders, from bureaucrats to patients. 

On the administrative side, Cancer Moonshot has called for improvements on inter-government cooperation through a ‘Cancer Cabinet’ spearheaded by recently-appointed project coordinator Dr. Danielle Carnival. The ‘Cancer Cabinet’ aims to improve interagency cooperation between representatives, taking a “whole-of-government process” touted from President Biden’s personal commitment down to the grassroots. 

Interagency cooperation not only fast-tracks cooperative efforts and cuts administrative red tape, but also allows the 2022 Moonshot reboot to expand its scope beyond scientific research. As a White House fact sheet explained, beyond “ending cancer as we know it,” Cancer Moonshot seeks to improve services for cancer-afflicted patients and families, detect diseases faster, and address health inequities present at the core of cancer treatment. As Dr. Carnival told POLITICO in February, “We’re going to have to reach more people with the tools we already have and those we develop along the way. The purview is much broader than research.”

The broadened scope on interagency involvement and comprehensive cancer care has achieved promising results in its early stages––expanding both the administration’s reach to contend with challenges associated with cancer and its efficacy in treating the disease itself. 

In September, the Department of Health and Human Services announced that it would expand partnerships with 11 community health centers nationwide to provide underserved populations with cancer screening and early detection services in support of Cancer Moonshot’s goals. In February 2023, the Environmental Protection Agency, with funding from the Inflation Reduction Act, accelerated plans to clean up hazardous landfills, mines, and other infrastructure, protecting Americans from further cancer risk. The Department of Veterans Affairs’ PACT Act has enlarged the suite of medical services available to veterans previously exposed to toxic substances, including streamlining cancer benefits claims. Most recently, the Department of Energy shared its progress in mobilizing its own resources to improve drug manufacturing and developing therapies to treat rare cancers.

Outside of these measures, President Biden has declared that improving academic research sharing is a further goal of Cancer Moonshot. Through the Office of Science and Technology Policy, Biden has called for academic journals to immediately provide public access for public-funded research programs by 2026. In an attempt to expedite this policy, under the guidance of the National Cancer Institute, Cancer Moonshot has mandated that all of its grantees submit plans to make their research public as soon as possible.

These initiatives, among many others, have been highlighted by Dr. Carnival herself as critical components of the Biden Administration’s commitment to addressing cancer at a variety of levels and through complementary methods––attempting to enact cultural change within community health, bureaucratic practice, and even academia. As Carnival said of Cancer Moonshot’s comprehensive working scope this February, “we are just getting started.”

Spreading the Word

The most critical challenge Cancer Moonshot faces is a lack of public awareness. The project was mentioned in 2016, 2022, and 2023 State of the Union Addresses (and this year, President Biden spent more time speaking about cancer than China), but its significance to Biden has been largely underreported.

Over 10 national and international outlets covered the speech from the angle of fraying U.S.-China relations, while fewer than five even substantively mentioned Cancer Moonshot as a part of President Biden’s “Unity Agenda.” As these stories continually emphasize external threats to America rather than how we can solve issues at home, Cancer Moonshot’s message is drowned out by other domestic priorities and geopolitical tensions.

Due in part to the gap in the program during the Trump years, the White House has encountered challenges in sustaining the would-be bipartisan message that eliminating cancer is a national priority. In the meantime, other issues have arguably surpassed cancer research within public health discourse, including the opioid crisis, the human costs of climate change, and new medicare provisions embedded in the Inflation Reduction Act. In the process, an issue that could be highly bipartisan—popular with the 1.8 million Americans who are affected by cancer every year—has instead gone largely unnoticed. 

Still, the White House has not given up on making its call to action heard. The Biden Administration has reminded the public of Cancer Moonshot through seasonal messaging during National Colorectal Cancer Awareness Month and provides updates on the initiative’s progress. Additionally, First Lady Jill Biden has delivered remarks at national forums like the American Cancer Society and traveled to various research centers nationwide to spread the word.  

A Limitless Future

Cancer Moonshot has the potential to change thousands of lives. It has the potential to be a forum to address health inequality and an incubator for cutting-edge research; it could be a centerpiece of community engagement and a catalyst for American industrial renewal. The project could reignite an American “national purpose,” paving the way for the U.S. to one day work internationally on comprehensive cancer care.

In his February 2022 speech reigniting Cancer Moonshot, President Biden said, “I promise you we can do this. For all those we lost, for all those we miss, we can end cancer as we know it.” If Americans can rally around Cancer Moonshot, the proper funding, resources, and implementation may just follow to make this goal a reality.

Harvard Business Review, October 18, 2022

Author: Bobby Daly, Justin Finnegan, Bob T. Li, and Jing Qian

The lack of a standardized international system for approving new cancer therapies undergoing clinical trials has led to the loss of approximately 2 million lives each year. The authors propose that by establishing harmonized regulations for oncology therapies’ approvals globally, the number of annual cancer-related deaths could be reduced by 10% to 20%, saving 1 to 2 million lives. They highlight the success of the U.S.’s Project Orbis, an initiative by the FDA Oncology Center of Excellence, in streamlining the approval process for new cancer treatments and suggest expanding this framework internationally. Standardizing criteria across participating nations would expedite drug approvals, making treatments accessible to patients sooner, consequently extending the lives of those in critical need.

The article delves into the potential impact of concurrent international regulatory approvals by examining specific case studies of two drugs – pembrolizumab and enzalutamide. The FDA approved pembrolizumab for metastatic non-small cell lung cancer (NSCLC) in 2016, significantly prolonging the lives of patients. However, delays in approvals in other countries have prevented patients from benefiting from this life-saving drug. Similarly, enzalutamide, approved by the FDA in 2012 for late-stage prostate cancer, faced delays in global approvals, particularly in China. The authors estimate that hundreds of thousands of patient life-years could have been saved if these drugs had been approved globally simultaneously with the U.S.

To establish a global system, the authors propose several key steps, including strengthening regulatory bodies, defining requirements for ethnicity-specific trials, standardizing manufacturing inspections, planning for approvals in secondary markets, and reforming insurance coverage for life-prolonging treatments. These measures aim to streamline the drug approval process, accelerate patient access to innovative treatments, and ultimately reduce the staggering number of cancer-related deaths worldwide. The authors acknowledge the challenges in implementing these changes but emphasize the urgent need to address the significant loss of lives to cancer each year, making the effort worthwhile and crucial.

Read the full article in the Harvard Business Review.