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Leen Kawas: Including the Patient Voice in the Drug Development Cycle

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The United States drug development process involves five key steps where the safety and effectiveness of a new drug candidate are rigorously evaluated. Crucially, the patient’s voice is historically not included in the first four steps of the process. Dr. Leen Kawas, an established bioscience leader and current Propel Bio Partners Managing General Partner, believes strongly that the patient perspective must be integrated into much of the drug development cycle.

Instead of deferring patient input to the last step, Dr. Kawas advocates including patient contributions in the clinical research phase. In her biotech entrepreneur work at Propel Bio, Dr. Kawas encourages the venture capital firm’s biotech partners to act on this progressive paradigm. She provides hands-on guidance to incorporate meaningful patient participation into their drug development cycles, especially clinical trials.

While serving as CEO of Athira Pharma, Dr. Kawas championed a patient-first ethos that drove the company’s clinical trial design and administration. To boost patient trial enrollment and ongoing participation, Dr. Kawas pinpointed the factors most important to patients. She relayed these preferences back to her team, spurring tailored improvements. For example, during one Alzheimer’s trial, Dr. Kawas ordered catered onsite meals for patients and their caregivers.

The FDA also recognizes that patients can provide pivotal contextual insights into treatment priorities, preferences, and risk tolerance. The FDA seeks patient input on enhanced communication, improved clinical trial experience, and structured feedback mechanisms in its Patient-Focused Drug Development initiative. Dr. Kawas strongly agrees with this forward-thinking effort to capture the patient’s voice at critical junctions systematically.

Today’s digitally engaged patients are taking more active roles in their healthcare journey and the broader drug development process. There are increasing rates of sharing condition experiences on social media and online health forums. Some pharma companies also host closed-patient community groups centered on drug development topics. Beyond information exchange, patient advocacy organizations now partner directly with pharmaceutical firms on initiatives related to the drug development cycle.

Ideally, these collaborative patient groups can help address barriers to efficient clinical trial execution. Patient advocates may provide valuable recommendations on recruitment messaging, eligibility criteria, visit schedules, and logistics. Resolving these pain points can help drive the robust trial enrollment and ongoing participation needed for regulatory approval.

As Propel Bio Partners’ leader, Dr. Leen Kawas continues advocating for greater patient inclusion across her portfolio companies’ development programs. She firmly believes systematically capturing patient experiences and preferences will lead to better therapies and improved patient outcomes over the long term. Dr. Kawas plans to leverage her decades of drug development expertise to create even more opportunities for patient voices to guide and inform the process.

Trey Rory
the authorTrey Rory