A: SUCH CHALLENGES INCLUDE an uncertain regulatory environment causing companies to be cautious about engaging with patients throughout the R&D process, and the stark differences in cultures among industry and patient advocacy organizations. Some solutions to creating an environment where sustainable patient-driven drug development can be successful include:
- engaging patients in clinical trial design to better understand the disease burden and what patients value most
- utilizing Patient Reported Outcome (PRO) measures to better measure patient benefit – beyond clinical and functional outcomes
- partnering with scientific patient-centered organizations (e.g., AACR, ASCO, ESMO, FOCR) to help accelerate and bring treatment options to patients more quickly
- encouraging regulatory authorities to incorporate patient voices and support a patient-driven drug development environment (e.g., the 21st Century Cures Act)
CHANDRA RAMANATHAN, PH.D.
Chandra is the VP and head of the Bayer-AG’s U.S. east coast innovation center. His 20 years of industry experience include positions at Bayer, Pfizer, and Bristol-Myers Squibb.