When global health crises such as the COVID-19 pandemic and HIV/AIDS epidemic occur, drug developers and researchers have an opportunity to highlight the benefits of implementing international clinical development plans to make treatments available as quickly as possible for patients around the world. However, when these public crises are not a factor, organizations typically wait until a product is nearing its approval stage before planning for and developing an international strategy.
Creating a global plan during the early stages of a drug candidate’s life cycle has the potential to expedite development, enhance its ability to compete with other products and bring new products to patients faster. In all drug development and especially in the treatment of a worldwide health issue such as cancer, it can be highly advantageous to recognize the crucial role global hubs play in accelerating the delivery of groundbreaking therapeutic options to patients.
Global Hubs as Gateways to Expertise and Talent
While opportunities in remote work and new communication technologies are helping drug developers access insights from more researchers and experts, the creation of global hubs provides more direct access to professionals with diverse capabilities. The expertise and insight they bring from local academic institutions and life science companies can offer fresh approaches to complex challenges in oncology drug development and research while also contributing to economic growth in many countries.
Creating hubs across emerging and growing markets also allows drug developers to build deeper relationships with local clinical sites and with physicians who have a greater understanding of the medical care and social structures in their respective countries. These stakeholders understand the intricacies of local demographics and disease prevalence, which can enhance patient recruitment and adherence to protocol and offer valuable insights into oncological drug development strategies. They also can bring a detailed understanding of local healthcare systems and practices.
The use of global hubs can also enable companies to develop stronger connections with patient advocacy organizations and communities. These relationships can help companies better understand cultural and language considerations that can play important roles in planning successful clinical research programs. Having experts in different hubs can strengthen opportunities for cross-disciplinary collaboration and facilitate the exchange of knowledge and expertise among research professionals and advocacy leaders.
Overcoming Regulatory Challenges in Multiple Markets
The pharmaceutical industry has long grappled with complex, costly and time-consuming regulations that often impede the development of many drugs, including many therapies for diseases that have no treatments available. Global hubs can provide regulators with more insights into a company’s operations and research, and development processes, which can ensure a smoother regulatory pathway. Developing these hubs early in a product’s development journey can help avoid challenges surrounding international standards, saving companies precious time and resources.
Unfortunately, there are multiple cases of oncological products that experienced international approval delays due to unfamiliarity with foreign regulatory bodies. For example, Japan is experiencing a “drug-lag” trend that is at least partially attributed to the fact that many pharmaceutical companies do not have domestic legal entity in Japan, leading to delays in regulatory submissions. Such a lag may arise not only between Japan and Europe, but also between Japan and another country in East Asia, despite their geographic proximity.[2]
Pharmaceutical companies typically operate from strategic locations around the world where research, development, and production operations are centered to maximize efficiency. But centralized operations in turn cannot access the potential advantages of a strategy based on establishment of multiple global hubs.
Enhancing Clinical Trial Diversity
The lack of diversity, equity, and inclusion (DEI) in oncology clinical trial recruitment and participation is a complex problem that has persisted for decades despite efforts to increase enrollment from underrepresented racial and ethnic communities. For example, recent analyses of cancer therapeutic trials found that African Americans and Hispanic Americans constitute 13% and 16% of the US population, but only around 5% and 1% respectively of these populations participate in clinical trials. [1] While Asian Americans constitute 5% of the U.S population [4], a report of population and recruitment rates for prostate, lung, colorectal and ovarian screening trials shows that only 3.6% of participants were Asian American. A systemic review of the factors that influence participation of African Americans and Hispanic Americans in cancer clinical trials reported that low clinical trial awareness, barriers such as access to healthcare and transportation, and financial constraints are potential causes for lack of participation. On the other hand, many Asian-American communities were found to have low awareness of and negative attitudes towards clinical trials. In a study of Asian American cancer patients, 62% reported having no knowledge of clinical trials.[5]
While plans to increase diversity in clinical trial representation are being implemented at regional and national levels in the U.S. and Canada, global hubs can help to expedite access to underrepresented populations. Multi-hub international trials can be better positioned to attract participants from diverse ethnicities, age groups, and genetic backgrounds that supports the generalizability of study results and provides a more comprehensive understanding of a drug’s effectiveness.
Catalyst for Oncological Advancement
As the first Canadian life sciences company to establish headquarters in both Ireland and Singapore, Zymeworks is an industry leader in global expansion to harness the power of international hubs to support drug development. Earlier this year, Zymeworks launched a new Early Research and Development hub in Singapore, one of the leading biomedical and pharmaceutical hubs in the Asian Pacific region. This thriving ecosystem creates opportunities for pioneering partnerships and growth as the company expands its portfolio of antibody-drug conjugates and multi-specific antibody therapeutics in preclinical and clinical development. In June 2023, Zymeworks also announced the establishment of a new clinical and regulatory headquarters in Dublin, which will create up to 20 new roles and significantly strengthen the company’s ability to coordinate clinical trials throughout the EU.
The company also plans to develop a hub in San Francisco, California that will support early and late-stage development as well as commercialization. The area is known for having one of the largest and strongest biotechnology talent pools in the United States and aligns with a strategic company goal to partner assets when appropriate while maintaining commercialization rights in North America.
With a presence in these dynamic locations, Zymeworks is better positioned to be familiar with the regulatory requirements of different regions and recruit a larger and more diverse pool of patients in clinical studies, propelling the global drug development process forward. Importantly, by establishing a global footprint early in the drug development process, Zymeworks will be able to optimize clinical trial recruitment while building relationships with a broad range of researchers, industry professionals, and regulators in those regions. This strategy improves the ability to ensure that clinical research engages closely with underserved patient populations and aligns with the unique health structures and regulatory guidelines of each country. More broadly, drug development standards that embrace a multi-hub strategy are poised to reshape the future of oncological drug development and expedite the delivery of essential drugs to cancer patients worldwide.
References
[1] Mutale F. Inclusion of Racial and Ethnic Minorities in Cancer Clinical Trials: 30 Years After the NIH Revitalization Act, Where Are We? J Adv Pract Oncol. 2022 Nov;13(8):755-757. doi: 10.6004/jadpro.2022.13.8.2. Epub 2022 Nov 1. PMID: 36727023; PMCID: PMC9881739.
[2] Noguchi E, Yaginuma H, Fujiwara Y. Challenges in Expediting the Development of Oncology Drugs. JCO Oncol Pract. 2023 Apr;19(4):216-217. doi: 10.1200/OP.22.00705. Epub 2023 Jan 19. PMID: 36657099.
[3] Awidi M, Al Hadidi S. Participation of Black Americans in Cancer Clinical Trials: Current Challenges and Proposed Solutions. JCO Oncol Pract. 2021 May;17(5):265-271. doi: 10.1200/OP.21.00001. PMID: 33974816; PMCID: PMC8258017.
[4] Liu Y, Elliott A, Strelnick H, Aguilar-Gaxiola S, Cottler LB. Asian Americans are less willing than other racial groups to participate in health research. J Clin Transl Sci. 2019 May 28;3(2-3):90-96. doi: 10.1017/cts.2019.372. PMID: 31660231; PMCID: PMC6802418.
[5] Ma GX, Seals B, Tan Y, Wang SY, Lee R, Fang CY. Increasing Asian American participation in clinical trials by addressing community concerns. Clin Trials. 2014 Jun;11(3):328-335. doi: 10.1177/1740774514522561. PMID: 24603005; PMCID: PMC4156927
Featured image: Clinical Trials. Photo Courtesy:© 2016 – 2023 Nappy on Unsplash. Used with permission.
How to Cite
DOI: https://doi.org/10.14229/onco.2023.10.03.002
Joe Woolery, B.S., Pharm.D., BCOP 1
Think Globally, Act Globally: The Key Role Global Hubs Play in Oncological Drug Development – Onco Zine – The International Oncology Network, October 2, 2023.
DOI: 10.14229/onco.2023.10.03.002
1 Zymeworks, Inc.
