Katrina Rice, Chief Delivery Officer, Biometrics, eClinical Solutions
The biopharma industry has made efforts to address underrepresentation and diversity in clinical trials, but with slow progress. These included Congress passing legislation in 2022 requiring companies to give the FDA plans for trial diversity and the June 2024 update calling on sponsors to define Diversity Action Plan progress through measurement and monitoring. However, findings from the Government Accountability Office over the past few years showed continued underrepresentation across trial populations, highlighting diversity gaps.
However, regardless of the regulatory landscape, the focus must shift to making material advances in clinical trial diversity as the only path toward scientific accuracy and sound efficacy of medicines. The industry must reexamine how to address this challenge by supporting ‘techquity,’ embracing technology and data infrastructure to operationalize equity across the trial life cycle. Used correctly, and only when placing patients’ experience first, digital health tools can be enablers in connecting data silos, improving patient participation, and building trust within underrepresented communities.
Advancing health equity requires thoughtful embedding of tech and data-enabled approaches within trial strategies and operations. In doing so, the industry will be equipped to achieve the trial diversity objectives, drive equitable research, and ultimately, improve access to care and health outcomes for all.
Karen Rowland Yeo, Ph.D., Senior Vice President, Client & Regulatory Strategy, Certara
Diversity and representation in clinical research is a huge factor in addressing global health inequities. Model-informed drug development (MIDD) is one way the pharmaceutical industry is making studies more inclusive, by using in silico models and biosimulation to optimize dosing in special populations.
One such population is pregnant and lactating individuals, who have historically been prevented from taking many medications because of potential safety issues associated with how the drug could interact with the fetus or impact breast milk. This especially becomes an issue in areas like southern and central Africa where diseases such as malaria are prevalent, and women are faced with the choice between taking the antimalarial or breastfeeding.
An increasing number of clinical lactation studies are now being conducted by the pharmaceutical industry; the information can be used to collectively understand how differences in lactation schedules, makeup of the milk, and diet can affect the exposure of a maternal drug in breast milk. Physiologically based pharmacokinetic (PBPK) modelling has the potential to support lactation studies by running ‘what if’ scenarios through a computational model built on existing clinical data. By using models to determine how drugs will impact special populations, we can ensure more equitable access to lifesaving therapies.
David King, Senior Director of Drug Product, Samsung Biologics
Health inequity challenges from the heavily regulated biopharmaceutical industry need to be addressed collaboratively. This means all industry stakeholders — biotechnology and pharmaceutical companies, contract development and manufacturing organizations (CDMOs), raw material suppliers, and academic institutions — must work together. CDMOs, as intermediaries that bridge the gap between biopharma companies and patients, are responsible for providing essential leverage — regulatory expertise, manufacturing optimization, and quality — to those at the forefront of addressing disparities in global healthcare.
As a global CDMO, Samsung Biologics has a proven regulatory track record, navigating major authorities, such as the FDA, PMDA, and EMA, to guide clients towards approval and to expedite their long-term goals of making high-quality biomedicines accessible in underserved regions.
Samsung Biologics is also continuously optimizing its operations to ensure flexibility in manufacturing and minimize costs across all aspects. The company has been managing the raw material expenses, accelerating manufacturing timelines through efficient use of labor and equipment, and refining processes to reduce waste.
Quality is the most important leverage through which Samsung Biologics continues to excel, with a 99% batch success rate — well above the industry average of 90%. This means not only greater consistency, but also up to 10% more medicine availability per batch without additional expenditure. Building on this proven track record, Samsung Biologics has further advanced its strategies to expedite the manufacturing of unique, complex molecules.
Lastly, speed to market is critical in enabling timely access to vital medicines for patients in need. Samsung Biologics’ reliable end-to-end services, covering from early-stage development to full drug product manufacturing, help accelerate time to market. By minimizing delays associated with product transfers, release testing, storage capacity, or transportation constraints, we can save months of valuable time — making a meaningful difference in reaching patients sooner rather than later.
Chris Chen, Ph.D., Chief Executive Officer, WuXi Biologics
Equity demands that no patient be left behind. Rare diseases affect a small percentage of the population, making the development of treatments economically challenging due to limited market size. Despite each rare disease affecting few patients, over 7,000 types collectively represent a significant patient population.
Historically, the high costs and low success rates of drug development have hindered the advancement of the rare disease therapies. However, increasing regulatory incentives are prompting more pharmaceutical and biotech companies to pursue orphan drug development.
Collaborations among biotechs, academia, governments, non-profit organizations, and patient groups are essential for leveraging collective expertise and resources to address R&D challenges effectively. These partnerships facilitate knowledge sharing, cost reduction, and accelerated development of treatment for rare diseases. WuXi Biologics exemplifies this approach by providing integrated technology platforms and end-to-end service solutions that streamline drug development from discovery to commercialization. By leveraging our expertise, companies engaged in rare disease R&D can focus on innovation and clinical trials while we function as an extension of their teams, providing seamless support and services.
As of December 31, 2024, there are 21 ongoing rare disease client projects on our platform. We have enabled the commercialization of three products for rare diseases, including treatments for Pompe disease and Gaucher disease. We collaborate with our global partners to expedite high-quality novel treatments for rare disease patients.
Austin Duffy, MB, BCh, MRCPI, DMed, Director of Research, START Dublin; Consultant Medical Oncologist, Mater Misericordiae University Hospital; and Associate Professor of Translational Oncology, University College Dublin
Ireland has a major problem providing timely access to new and emerging cancer drugs. According to a recent report, we rank among the bottom of Western European countries. For example, of the 56 oncology medicines which were granted an EMA license since 2020, only 25% are currently available in Ireland. What’s worrying is that the situation seems only to be getting worse right at the moment when major progress is being seen in drug development.
There is so much excitement around the new RAS inhibitors, for example. Irish patients will read about these breakthroughs in the newspaper but won’t be able to access them when they or their family members need them. Our contribution, by partnering with START to open Ireland's first phase I center here in Dublin, is not intended as a definitive solution to this complex problem — that would require governmental action — but at least it provides an opportunity for patients with advanced cancer to access cutting-edge drugs. To be clear, these are experimental drugs, not yet approved, but for the most part represent improved versions of what went before and when done at scale, as we hope to do, can at least ameliorate some of that awful stress so familiar to Irish oncologists, the knowledge that there is a better treatment for your patient that you cannot give them.
Boro Dropulić, Ph.D., MBA, Co-Founder and Executive Director, Caring Cross, and Chief Executive Officer, Vector BioMed
To achieve an equitable access model, the industry should support more long-term technology transfer and local innovation in low- and middle-income countries (LMICs). Expanding licensing, increasing transparency in pricing, and including underserved populations in R&D planning are key steps. Equitable access must be built into business models and platform offerings, not treated as an afterthought. More industry players should focus on building global infrastructure to improve patient access; partnering with governments and civil society can help ensure that innovation reaches those who need it most.
From the perspective of a service and/or solution provider, it is imperative that the next phase of cell and gene therapy (CGT) includes a few guiding principles. 1) A renewed focus on cost of goods (COGS) en route to a marketable therapeutic. 2) Leveraging partner expertise and flexibility. 3) Commercial-friendly should replace commercially viable as it relates to CMC and pricing and licensing terms.
In CGT specifically, advancements in design, optimization, and manufacturing will move the needle on process efficiencies and product quality. Thus, keeping costs down and keeping modularity and simplicity at the forefront for global applications. Specialized solution providers should take the brunt of development complexities to streamline a path to market. Lastly, commercial-friendly takes the reshaped form of affordable, custom, and off-the-shelf solutions that bridge, not hinder, innovation to cure.
Equitable access means building bridges and facilitating real solutions for patients in need. It requires calculated reach. And it certainly requires service providers to work directly with global governments, ministries of health, and charitable organizations — so that the integrated ecosystems built can continue to provide therapeutics to underserved populations.
Innovation should be challenged with affordability at each step during therapeutic development. This requires partners and innovators to work in lockstep very early on in development to pull science forward (to market) — so that it has a maximum impact.
It all boils down to building accessibility and affordability into therapeutic goals — and coming up with ready solutions that overcome logistical barriers. So, the future lies more in operational excellence than it does in burdened, industrialized innovation. In the CGT space, for example, there are institutions and communities leading the way for equitable treatment methods. It's precisely these societies that need the right support so that they can provide sustained, equitable access to medicines.
