Exploring four patient-centric trends shaping today’s biopharma landscape

The concept of patient centricity, which has been a key focus in healthcare for a number of years, is gaining significant traction in the pharmaceutical industry, where it's reshaping the way drugs are developed and produced. Fueled by market pressures to develop therapies tailored to the specific needs and experiences of individual patients, pharmaceutical companies are moving away from mass-production models toward a more nuanced paradigm that prioritizes patient centricity in research, development, and manufacturing.

As a result of this shift, a few key trends have emerged that are transforming the pharma manufacturing landscape. Among the most impactful of these are 1) enhanced supply chain resiliency, 2) the rise of decentralized clinical trials, 3) the development of patient-friendly formulations, and 4) strategic collaborations between contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs). Each of these emerging trends reflects a deeper understanding of patient needs and plays a distinct role in shaping the future of drug development and manufacturing.

Supply chain resiliency

When the World Health Organization declared COVID-19 an emergency in January 2020, pharmaceutical supply chains around the globe experienced immediate and long-lasting ramifications. Because many active pharmaceutical ingredients and raw materials are produced and sourced in different countries, including China, the burgeoning pandemic severely disrupted drug development and manufacturing activities, ultimately impacting patients downstream. Disruptions in the pharmaceutical supply chain can have a direct and significant impact on medication access, which can overwhelmingly affect patients who rely on drugs to help manage chronic conditions and serious illnesses.

Almost four years later, the pharmaceutical industry has largely recovered from COVID-19, and sponsors have a better understanding of the risks and complexities associated with supply chains, emphasizing the need for more robust and resilient models. Specifically, they’re looking to partner with vendors that take proactive steps to ensure supply chain resiliency moving forward. That includes creating contingency plans powered by data-driven insights and artificial intelligence to enhance decision-making, improve performance, and respond to fluctuations in real time. By implementing strategies that prioritize supply chain resiliency and therefore safeguard medication access for patients, biopharma companies can also manage costs, reduce risks, and improve their ability to help people in need.

Decentralized clinical trials

Clinical trials help to establish the safety and efficacy of investigational new drugs, and they provide access to cutting-edge treatments and experimental therapies for individuals with serious or life-threatening conditions for which there are limited or no treatment options available. Historically, participation in clinical trials has been limited to patients who lived near or had the means to travel to trial sites. The decentralized clinical trial format can eliminate many of these geographical and logistical barriers, enabling patients to participate in studies remotely by leveraging advanced digital technologies for data collection, patient monitoring, and supply tracking and delivery.

The decentralized clinical trial model can also significantly enhance the diversity of recruitment efforts and often leads to increased flexibility and convenience for participants, which has the potential to foster higher retention rates. Both outcomes can lead to faster, more efficient clinical trials that result in more comprehensive and accurate data sets. The very nature of decentralization puts patients at the heart of research and development, and it has a positive impact on biopharma companies, as well. For instance, the self-administration of medicine and subsequent monitoring of symptoms at home can reduce the workload of clinical trial investigators who typically conduct such activities onsite.

Patient-friendly formulations

Increasingly, sponsors are looking to prioritize patients by researching, developing, and manufacturing more patient-friendly formulations, which refer to dosage forms and delivery systems that are specifically designed to enhance the patient experience of taking a drug. Examples include liquid suspensions for patients who have difficulty swallowing, chewable tablets that are palatable and easy to consume, and even transdermal patches that allow for the slow release of medication through the skin. One relevant example that’s increasingly in the news is the rise of sterile injectable devices, which offer a safer and more convenient self-injection option for patients.

In addition to the convenience factor, patient-friendly formulations can also improve treatment compliance and adherence, ultimately leading to better outcomes for patients overall. This is especially important for sponsors conducting post-market surveillance, which refers to the continuous monitoring and evaluation of medical devices, pharmaceuticals, or other healthcare products after they have been approved by the FDA and introduced to the market. Rather than considering formulation as an afterthought, drug developers should focus early-stage formulation efforts on researching and developing a final dosage form that’s not only cost-effective, but also patient-friendly.

Strategic CRO/CDMO collaborations

Many sponsors partner with contract research organizations (CROs) and/or contract development and manufacturing organizations (CDMOs) for core research, development, and manufacturing activities. While these organizations have traditionally operated independently, there is a growing trend toward integrating their offerings to provide comprehensive support throughout the drug development journey. This shift is not only inherently beneficial for biopharma companies as it simplifies collaboration with third-party vendors, but it also holds positive implications for the patients who will ultimately use the medicines they manufacture.

By forming strategic partnerships with the right intentions, CROs and CDMOs can help streamline the research, development, and manufacturing continuum, expediting patient access to life-saving treatments. Given their pivotal roles in establishing the safety and efficacy of novel drugs, close collaboration between CROs and CDMOs can effectively pinpoint and address potential issues early in the development phase before they create complications downstream. Moreover, integrated CROs and CDMOs have the capacity to optimize resource allocation and reduce development costs, which can translate into more affordable and easy-to-obtain therapies for patients.

Sponsors should embrace patient-centricity as a strategic imperative

Influenced by market pressures to develop therapies tailored to the specific needs and experiences of individual patients, pharmaceutical companies are embracing a patient-centric approach to drug research, development, and manufacturing, considering patient needs, preferences, and priorities at every stage of the drug development journey. Formerly a nice-to-have sentiment, patient-centricity is now a need-to-have strategy for sponsors looking to set themselves apart in an increasingly competitive and high-stakes landscape.

One way that sponsors can get ahead is by partnering with third-party vendors like CDMOs that prioritize patient-centricity as an end-to-end practice, taking strategic steps to improve pharmaceutical supply chain resiliency, enable the advancement of decentralized clinical trials, focus on the development of patient-friendly formulations, and strategically collaborate with their industry counterparts. By doing so, biopharma companies ultimately stand to help more patients in need.