Keeping patients at the center of the drug design process can be a formidable challenge. However, it is important to optimizing development outcomes.
Outsourcing-Pharma (OSP) recently spoke with Tim McLeroy (TM), executive director of marketing and patient services at Noble, an Aptar Pharma company, about his scheduled CPhI Festival of Pharma keynote address, “Future of Drug Delivery” (with co-presenters Nicholas Brooke, executive director of The Synergist; and Anne-Lise Ducournau Lichtenberg, pharmacist and independent expert). McLeroy offered a preview of his presentation and advice on increasing patient-centricity along the way.
OSP: What do we mean when we talk about “patient-focused” drug design?
TM: My interpretation of the patient-focused drug design would be starting the design process already firmly grounded in an understanding of the patient experience, patient population, and environment in which the patient or caregiver is using your product….or in essence, start with the end in mind. These insights can make significant changes to a product, especially if you understand the limitations of a patient demographic and what challenges they face.
An easy example is when a product is being developed for patients with arthritis, but not understanding the dexterity or hand impairment issues that they face. How do you make the product and its support materials useful and easy to use? Design for it.
OSP: How do pharma firms and their development partners usually tackle patient input?
TM: Usually patient insights are gathered through market research, human factors studies, or work with advocacy groups when possible. It’s best to gain these insights as early as possible to prevent going down a path with a solution where there might not be a problem, or the where the perceived solution may not work for the intended population.
OSP: Please feel free to share your perspective on current approaches to engaging patients, and any faults with those approaches.
TM: Direct engagement is always best, say through ethnographies or discussions with advocacy groups. Social listening is now a tool that is being used to understand what is being bantered around in the digital space.
It is good to get both qualitative and quantitative date when possible, although I like to always take it back to an N:1. I like to get to know patients well enough that I can put myself in their shoes and look at what I am working on from that perspective.
OSP: At what stages of drug development should pharma and research professionals engage patients, and how?
TM: There has been a push lately to even get patients input into clinical trial design. As patients have greater access to information than they ever have had, it is now believed that their level of engagement and retention will be higher if they are active participants in the treatment protocols; this is especially true in the rare disease space as patient populations are smaller and more specialized in their care.
OSP: What methods work best for patient engagement?
TM: The best thing for patient engagement is so simple but is easily overlooked: listening is still the best method. Not rushing in with a preconceived idea that you want validated by someone, but actually listening to the need and tailoring a solution to meet that need. Sounds too easy, but it’s harder than it looks.
OSP: I understand you plan on discussing which methods and strategies have been most effective in advancing design/development—can you give a preview of your thoughts?
TM: At Noble, we have built our business on helping companies with their patient engagements once they were close to bringing a product to market or optimizing adherence strategies post marketing. What we are doing now is moving earlier in that development process by engaging in human factors work that will give us greater insights into patient interactions with products; this way our prelaunch planning and patient onboarding strategies can be further rooted in understanding of patients and what needs they have when it comes to new products.
McLeroy’s keynote, Future of Drug Delivery, is scheduled October 5, 11-12 CET, during the virtual CPhI Festival of Pharma event is scheduled October 5-9 and October 12-16. For more information about the sessions, exhibits and other programming, visit bit.ly/345ksGE.