The extensive process of developing new medications in the United States still needs to include input from the patients these drugs are meant to help; according to Dr. Leen Kawas, a managing partner at the venture capital firm Propel Bio Partners, that needs to change. With her leadership experience as the former CEO of the biotech company Athira Pharma, Dr. Kawas firmly believes the patient voice should be incorporated into multiple phases of bringing a new drug to market.
The current FDA-regulated development cycle is lengthy, taking new drug candidates through discovery, preclinical testing, three phases of clinical trials, regulatory review, and eventual approval. Patients have sometimes been invited to participate in advisory committees late in this cycle, but earlier and more extensive patient engagement is rare.
The FDA’s new Patient-Focused Drug Development (PFDD) initiative aims to solicit patient experiences, needs, and priorities much earlier to guide targeted therapy development. As the ultimate end-users of these therapies, patients have invaluable insights. The PFDD wants their input on improving clinical trial participation, communicating about treatment risks and benefits, gathering patient preferences, and structuring feedback to inform decisions.
With her patient-centric approach, Dr. Kawas is aligned with the goals of the PFDD. At Propel Bio Partners, she advises biotech entrepreneurs on running more patient-focused trials, just as she did leading drug development at Athira Pharma. Her solutions included a clinical trial design incorporating patient priorities to improve retention and ordering meals for Alzheimer’s patients and caregivers during trials.
Today’s tech-savvy patients are getting more involved in their care and drug development through online health research, social media communities closed pharma-run patient groups, and patient advocacy organizations collaborating directly with the industry. Dr. Kawas sees many opportunities to amplify the patient’s voice via these channels.
As she guides Propel’s partner companies through the intricacies of bringing new drugs to market, Dr. Kawas insists the patient remains at the center. All stakeholders must recognize that serving patients and improving lives is the number one priority. When biotech companies keep patients involved and satisfied, the industry’s shared goal of getting valuable new therapies to those in need will follow.