Ashfield Pharmacovigilance held a complimentary seminar in November at the North Carolina Biotechnology Center in Durham, USA, designed to enhance the knowledge of pharmaceutical and biotech professionals on the differences in pharmacovigilance requirements when transitioning from clinical to approval stage in a product’s lifecycle or when launching newly acquired products.
There are numerous challenges surrounding product launch. Many of these challenges are planned for and expected, yet pharmacovigilance, an integral part of the post market arena, is often met with much confusion. This seminar brought the biotechnology and pharmaceutical community together to increase awareness of their pharmacovigilance needs.
The full day event featured several speakers covering a full spectrum of pharmacovigilance considerations for product launch. Subject matter experts and thought leaders shared their experiences and offer their advice for a successful product launch.
Keynote speaker Cindy Whitehead, Chief Executive Officer of Sprout Pharmaceuticals began the day by sharing her own experiences with product launch and the numerous challenges they faced, including their latest FDA requirement for enhanced pharmacovigilance. “The science was too good to be abandoned, and the need was too great.” Cindy Whitehead says about the Addyi story.
Dr. Elizabeth Garrard set the stage by presenting a post-market approval preparation checklist outlining regulatory shift that occurs when the product enters the post market phase of its lifecycle. She also discussed the people, process and technology needs when transitioning out of clinical development.
Sharon Donatucci of Ashfield Pharmacovigilance outlined the varying adverse event report sources from clinical to post market approval while Glen Martin, also of Ashfield Pharmacovigilance stressed the importance of training all company employees on adverse event reporting requirements. “Adverse Events are a safeguard for patients to ensure we’re in a safer environment while taking products.” Glen Martin tells the audience.
Marisa Law of Ashfield Pharmacovigilance discussed the post market reporting requirements in other countries and Dr. Hemang Maisuria of Foresight Group AG spoke about the implications when transitioning from a clinical to a safety database.
After a luncheon at the North Carolina Biotechnology Center, the conference venue, attendees gather into the auditorium for the second session of the day. The afternoon session was comprised of presentations on the differences in clinical and post market medical review, and a framework for PV due diligence, perhaps more appropriately titled ‘how to check for skeletons in the pharmacovigilance closet’ given by Margaret McCulloch, co-founder of Alba BioPharm Advisors and Mary Ellen Turner, President of Mary Ellen Turner Consulting respectively. “Businesses are now realizing it’s important to get a pharmacovigilance perspective during due diligence” states Mary Ellen Turner.
The end of the day took a shift toward commercialization with Clint Burrus, of Ashfield Market Access discussing Market Access Due Diligence, while ending key note speaker, Jarrett Disbrow of Chief Operating Officer of Aytu BioScience closed the day by bridging the gap between clinical and commercial also opening the door for future topics surrounding product launch.