The elaborate multi-phase process of developing new medications in the United States generally only includes patient input late in development when an FDA Advisory Committee convenes. Dr. Leen Kawas firmly believes it’s time for the biopharmaceutical industry to break with traditional practices and incorporate patient voices much earlier and through more phases of research.
As CEO of Athira Pharma, Dr. Kawas pioneered efforts to keep patient priorities front and center at every step. Now, as managing general partner at venture capital firm Propel Bio Partners, she coaches biotech entrepreneurs on embracing patient-focused drug development.
The five key stages of the existing drug development cycle begin with discovery and preclinical testing before proceeding through three phases of human clinical trials. Data is then presented to the FDA for safety and efficacy review to grant market approval potentially. Historically, patients have not contributed perspectives during the lengthy research process before the FDA Advisory Committee.
The FDA has recently established its Patient-Focused Drug Development initiative, specifying four areas where patient input can strengthen therapies: optimizing clinical trial experience, communicating treatment considerations, eliciting benefit/risk preferences, and structuring feedback mechanisms. Dr. Kawas strongly supports integrating patient voices per this paradigm shift. Her hands-on experiences have shown her the critical difference it makes.
While CEO of Athira, Dr. Kawas was involved in shaping more patient-friendly Alzheimer’s clinical trials, which helped increase retention. She catered to participants’ needs by providing meals. Centering trials around patient priorities and comfort ultimately collect better data to inform treatment development. Beyond clinical trials, today’s tech-empowered patients actively educate themselves about medical conditions and exchange insights on social media and through advocacy groups. Dr. Kawas advocates pharmaceutical companies working closely with patient organizations throughout the R&D process to address patient-identified barriers around recruitment, comprehension of protocols, scheduling, transportation, and more.
Modern patient groups help close the loop between pharma companies and patients for mutually beneficial collaboration. Dr. Kawas guides Propel Bio Partners‘ partner companies to truly hear patients’ voices, not just give superficial lip service. As developers balance business decisions, she reminds them success lies in serving patient populations. Therapies that transform patients’ lives will drive company valuation organically. Dr. Kawas plans to leverage her position to push more patient-centricity industry-wide over time through steadfast incremental progress, Kawas empowering the patient perspective.