Incorporating behavioral science: A new approach to patient-focused drug development?

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Is it time to incorporate behavioral science into early drug design and development, in pursuit of a truly patient-focused approach from day one?

Last year, Astellas Pharma established a behavioral science consortium to perform research aimed at better understanding what matters to patients and their carers, findings that will be channeled into drug development. Health organizations are developing a keen interest in behavioral science too. The World Health Organization (WHO) recently appealed for experts to join its global Technical Advisory Group on Behavioral Sciences, as part of research into the global impact of behaviorally-informed health interventions. 

To dig deeper into the science, OSP’s senior editor Liza Laws (LL) spoke to William Hind (WH), founder and CEO of Alpharmaxim, and Lisa Campbell (LC), a former regulator and now senior director at SSI Strategy Global Life Sciences Consultancy. The interview provides new insight into behavioral science’s scope in pharma, shaping drug discovery and development and optimally positioning medicinal breakthroughs for patients.

LL: Thanks so much for talking to us about this important topic, could you say a bit more about yourselves and why behavioral science has become a focus for you?

WH: I’ve spent my career in sales, marketing, and business development in the pharmaceutical industry, including roles at Merck and various communications agencies. I founded Alpharmaxim to help biopharma teams communicate more effectively about new medicines or alternative treatment regimens and their potential to improve the patient experience, supported by relevant scientific evidence. I believe in the science of behavioral change and its potential to transform the way we build new narratives about emerging treatments.

LC: I worked as a medic in obstetrics and gynecology in the UK NHS for 13 years, then spent a decade with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in its clinical trials unit. SSI Strategy is a specialist management consulting company with expertise in cell and gene therapies. I am fascinated by the scope for behavioral science to inform patient centricity and by the moves now being made by regulators to make this a proactive focus.

LL: Lisa, based on your experience in clinical practice and regulatory affairs, how do you see the integration of patient-focused drug development (PFDD) impacting the overall success of treatments in the pharmaceutical industry?

LC: Taking a holistic view of a new or repurposed product is part of PFDD, which strives to bring the rounder patient experience to the fore from early in a treatment’s design and development. Simple factors like the way a treatment is administered or fears around trying something new can impact uptake. Understanding barriers via early research helps developers account for these factors from day one.

LL: Will, how might behavioral science be integrated into biopharma product profiling and marketing strategies to enhance patient-centricity?

WH: The goal is to conduct scientifically-robust research into patient priorities from the earliest stages of drug design and use the data to support product decision-making and communications. Some companies do the research but don’t leverage it; others focus too heavily on clinical efficacy and ignore patient factors or sensitivities until later. PFDD is particularly valuable in the rare disease space, where patients define the most relevant endpoints for clinical trials.

LL: Lisa, how can the pharmaceutical industry leverage patient priorities and insights from behavioral science to drive innovation in drug development?

LC: A major barrier to uptake of new therapies is patients’ fear of the unknown. Addressing these fears head-on in product design and messaging, supported by early patient evidence, offers a powerful opportunity to improve patient outcomes. For example, a new treatment ending a lifelong regimen can be a huge win for patients and provide significant resource savings for health providers.

LL: Will, how can investors benefit from understanding the patient acceptability of new treatments through behavioral science research?

WH: Beyond traditional measures of success, understanding patient priorities is crucial, especially with high-cost therapies for limited populations. Behavioral science insights help design early research and create narratives that transform patient experiences, maximizing market success.

LL: Lisa, can you share an example where behavioral science in drug development improved patient outcomes or treatment adherence?

LC: Behavioral science played a significant role in the UK’s COVID-19 vaccination program. Insights helped address vaccine hesitancy and improve public engagement, leading to increased vaccination uptake. This was achieved by understanding the beliefs, attitudes, and behaviors of health and social care workers towards COVID-19 vaccination.

LL: Will, how do you perceive the evolving role of behavioral science in helping pharmaceutical companies identify untapped opportunities in early product development?

WH: A data-driven approach to understanding what matters to patients is essential. For example, the delivery mode of drugs can be critical. Gathering data around patient factors at the discovery stage can significantly impact product success.

LL: Lisa, how do you see the regulatory landscape evolving to incorporate patient priorities and behavioral science insights in the approval process for new treatments?

LC: Regulatory bodies like the EMA are focusing more on Patient Experience Data (PED) in drug development and approval. We’ll see greater collaboration between regulators, patient organizations, healthcare professionals, and the pharmaceutical industry to ensure patient perspectives are considered. The regulatory process may also become more adaptive, allowing for modifications based on real-world evidence and patient feedback post-approval.

LL: Will, what advice would you give to biopharma companies looking to enhance their patient-centric approach through behavioral science?

WH: Beyond understanding the importance of this approach, companies should embed behavioral science in drug design and capture data about drivers and barriers to new drug uptake. Objective research is crucial to truly understand patient needs.