Kicking off day one of the BIO CEO & Investor Conference in New York City, panelists in the ‘How Industry Rates Interactions with the FDA’ session brought attendees good news – communication with the FDA has improved overall.
“The improvements we have seen in increased communications between FDA and sponsors is based on a continuous dialogue that has been established over the past several years in which BIO has been at the forefront,” said Jonathan Leff, Partner, Deerfield Management.
Leff pointed to the establishment of the breakthrough therapy designation as one key example of a streamlined, expedited regulatory process through improved communication.
Cartier Esham, PhD, Executive Vice President of Emerging Companies Section at BIO, shared initial findings of a BIO survey on patterns in FDA reviews and approvals by product division. Approximately half of the 228 participants said that communication with the FDA is very beneficial for the review and approval process.
Michael Narachi, President and CEO of Orexigen Therapeutics, asserted that more input from patients is critical and encouraged reviewers to be open to their perspectives to help guide decision making on benefit and risk.
Paul Hastings, Chairman and CEO of OncoMed Pharmaceuticals, chimed in that defining patient engagement is a priority for the industry. “Personally, I encourage advocacy groups to step up and participate in advisory panel meetings to share information on what they want and what they will accept,” said Hastings.
Leff wrapped up the panel by pointing out that there is a positive trajectory toward increased and improved communication with the FDA although there is still a long way to go.
The BIO real-time survey tool on FDA/Sponsor Interactions During Drug Development can be accessed at www.bio.org/FDAsurvey.