When patient centricity is applied only once a product comes to market, subtler influencers of adherence could be missed, say William Hind of Alpharmaxim and Lisa Campbell of SSI Strategy
For drug development to be truly patient focused, patient considerations need to be incorporated right from the earliest stages of drug discovery and development.
These considerations will be critical to the take-up of novel treatments like cell and gene therapies, where the change in mindset required to accept a significantly new approach to treatment is significant. So it is no coincidence that momentum behind behavioral science’s role is growing, in determining exactly what patients are looking for in a new product – beyond quality, safety, and efficacy – from the earliest stages of conception and design.
Last year Astellas Pharma established a dedicated behavioral science consortium to help understand the importance of human behavior for patient outcomes and the benefits of using behavioral science to improve them. Health organizations, too, are developing a keen interest in the science. The World Health Organization (WHO) recently appealed for experts in the field to join its global Technical Advisory Group on Behavioural Sciences, as part of research into the potential global impact of behaviourally-informed health interventions.
The factors influencing new drug take-up can be relatively subtle, surrounding how a treatment is administered, which is where behavioral science can help – in distilling those less obvious priorities or, conversely, inhibitors to change.
For decades the accepted approach to treating severe epilepsy in children was to administer a muscle relaxant, via suppository, within the first 10 minutes of a seizure – introducing social sensitivities should convulsions happen at school, requiring staff-initiated intervention. So when a drug company (ViroPharma, at the time) introduced an equivalent product (Buccolam) that could be given orally, via a syringe, this was a potential game-changer. While this offered only a marginal improvement over existing treatments, the more socially-acceptable mode of delivery offered attractive differentiation. It followed that identifying and communicating this effectively would be the key to maximizing the new product’s take-up.
Shaping clinical development planning & design
Taking a more holistic view of a proposed new drug or repurposed product from the outset is part of the premise of patient-focused drug development (PFDD). Behavioral science has a role to play here, helping both established drugs companies and younger biotechs identify right from day one – in a science-backed way – considerations (and associated commercial opportunities) that might otherwise be missed.
In the case of novel therapies, which lack historic precedence and can feel like a step into the unknown, harnessing behavioral science to uncover wider patient priorities can help inform relevant early research and narrative creation (e.g. a higher quality of life as more intrusive treatments are discontinued).
One barrier with cell and gene therapies is patients’ fear of putting something into the body that could be there for 15 years or more, with long-term effects which are hard to predict for now. Seeing this reflected in early data offers the biopharma industry a powerful opportunity to address those fears head on, using behavioral science to identify (supported by strong data) what would make a new therapy more acceptable.
Bolstering the commercial case
Where patient priorities are researched from the outset, it follows that better-informed messaging can be presented to financial backers and board members from day one too, maximizing the commercial opportunity.
Returning to routes of administration as one differentiator, as the potential of GLP-1 agonists (originally used to treat type 2 diabetes) for lowering obesity is recognized, new consideration must now be given to whether clinically overweight populations will tolerate regular injection. Building such considerations into clinical studies would help to cover such additional angles from the start.
William Hind
William Hind founded Alpharmaxim in 2001 and has worked in sales, marketing and business development in the pharmaceutical industry, including roles at Merck and a number of communications agencies for 35 years. Alpharmaxim helps cross-functional biopharma teams communicate effectively with clinicians about new medicines or alternative treatment regimens and their potential to improve the patient experience, supported by relevant scientific evidence. William can be reached at [email protected].
Lisa Campbell
Lisa Campbell, senior director at SSI Strategy Global Life Sciences Consultancy, served as a medic (working in obstetrics and gynecology in the U.K. NHS for 13 years), and then for the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) for a decade in its clinical trials unit. SSI Strategy is a boutique management consulting company with particular expertise in cell and gene therapies.
