Send us a text

Discover the intricate world of pharmacovigilance as Colleen Walsh, the Vice President of Global Patient Safety Operations at Alnylam, unveils her personal journey through the ever-evolving landscape of patient safety. In this enthralling episode of Innovation and the Future of Pharmacovigilance, I sit down with Colleen to unravel the complexities she's encountered, from the pivotal Tysabri incident at BioGen to leading R&D compliance at Alexion. Her story is a testament to the resilience required in the face of regulatory upheavals and the innovative spirit needed to navigate from clinical trials to post-market safety.

In a field where the stakes are as high as the patients' lives, Colleen sheds light on the arduous task of merging companies within the rare disease sector, specifically the AstraZeneca acquisition of Alexion. Through her insights, we gain an understanding of the delicate balance between patient support programs and the scrutiny of global pharmacovigilance regulations. Colleen's expertise reveals the pressing need to bridge the gap between regulatory intent and its real-world application, ensuring that patient safety remains paramount while fostering a culture of innovation.

Our discussion veers into the future of pharmacovigilance technology, examining how AI could revolutionize the industry yet poses unique challenges for both behemoths and fledgling companies in the pharmaceutical world. Colleen proposes an intriguing shift in perspective, advocating for pharmacovigilance to transition from a cost burden to a revenue generator by incorporating safety measures early in drug development. Join us on this episode as we probe into a future where pharmacovigilance not only safeguards patients but also drives value and progress in the realm of medicine.