Virtual Adcom Vet Says In-Person Events May Be Better For Product Approval Recommendations
Executive Summary
Syndax CEO also says US FDA’s virtual meetings would benefit from having advisory committee members on camera, which may be a technology challenge.
Briggs Morrison, a veteran of in-person and now virtual US Food and Drug Administration advisory committee meetings, believes an in-person event may be better when a product’s approval is on the agenda.
Morrison is CEO of Syndax Pharmaceuticals, Inc., a clinical-stage company focused on cancer therapies, and was among the first sponsors to participate in a virtual FDA advisory committee meeting when he and colleagues presented during the 17-18 June Oncologic Drugs Advisory Committee’s pediatric subcommittee review of pediatric development plans. In a 10 July interview with the Pink Sheet, Morrison said that the virtual meeting went very well and was productive, but wondered whether a product-specific advisory committee session would be just as successful virtually.
“Those to me feel like there is a benefit to having everybody together in a room hashing it out,” he said.
FDA officials will make their first attempt at conducting an virtual advisory committee focused on application review on Tuesday when ODAC considers GlaxoSmithKline plc’s belantamab mafodotin, which is undergoing priority review for treatment of adults with relapsed/refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent. (See sidebar.)
Morrison said situations where “the tone of the room was challenging for the sponsor” may be difficult to control in a virtual setting. During in-person meetings a strong committee member sometimes “refocused the tone of the room,” he said.
“I do think there was some body language and enthusiasm and energy that you got from the comments that somebody was making to sort of change the tone of the room that I think would be hard to do in a virtual setting.”
At the same time, Morrison said there also may be advantages to the committee being separated, while together. Members will not be distracted by those around the table and audience, so the FDA and sponsor may get “more objective reads from each of the advisors because they're not influenced by the body language of somebody else in the room.”
Technological and other drawbacks may lead sponsors to wonder whether waiting for an in-person opportunity is advisable because of the interactive value of the setting. (Also see "US FDA Exploring Virtual Advisory Cmtes.; Might Sponsors Want To Wait For In-Person Meetings?" - Pink Sheet, 1 Apr, 2020.)
Put Adcom Members On Camera To See Non-Verbal Communication
Along the same lines as preferring product-specific meetings in person, Morrison also thinks advisory committee members should be on camera during virtual sessions.
Without video, sponsors, advisory committee members, and the FDA lose the ability to read body language and judge the impact of a message or discussion point.
Syndax CEO Briggs Morrison
But adding live video could create technical problems, due to varying Internet connectivity and signal quality. The FDA told the Pink Sheet that it is considering using webcams for advisory committee meetings, “but because of bandwidth and connectivity concerns we have yet to implement their use.”
The FDA also has not universally adopted video conferencing for its one-on-one meetings with sponsors. Lisa Yanoff, acting director of the Division of Diabetes, Lipid Disorders, and Obesity in the Office of New Drugs, said during a virtual session at the recent Drug Information Association Annual Meeting that her division is not using video for external meetings. Yanoff said the staff misses non-verbal cues, but decided the risk of technology failure associated with video outweighed the disadvantage of not seeing speakers.
The agency prefers WebEx for virtual meetings with sponsors; security problems prompted FDA staff to recommend against using Zoom. (Also see "US FDA Shies Away From Zoom Meetings Because Of Security Concerns" - Pink Sheet, 18 Jun, 2020.)
During an in-person meeting, a member of the sponsor team would usually stand and request an opportunity to speak. In the virtual session, Morrison said one of his staffers decided to virtually raise their hand and was recognized to make the clarification.
Tech Mastery A Focal Point, Along With Anticipating Panel Questions
Preparations for a virtual advisory committee meeting were similar to an in-person meeting, except there was substantial effort to master the teleconference software before the meeting, Morrison said.
About 90% of the preparation was to ensure Syndax’s messages were clear, all potential committee questions were answered, and back-up slides were available if needed. But Morrison also said he and staff practiced logging into and using the Adobe Connect platform and worked out problems like dropped connections. He said there was a lot of testing and retesting, such as whether connections were more reliable logged into the software directly or through a web browser.
“We made a lot of mistakes,” he said. “We learned a lot about sort of where the little glitches are in the system and how to do all this.”
Syndax’s preparations appeared to have paid off: It was the only one of the four sponsors that didn’t experience technical problems during its ODAC presentation. Overall, the meeting still appeared to run smoothly. (Also see "Going Virtual: GSK’s Multiple Myeloma Drug Belantamab Tapped For US FDA Online AdComm In July" - Pink Sheet, 19 Jun, 2020.)
Pre-Recording A Risk, Just Like A Live Presentation
Syndax chose to make its presentation to the committee live, rather than pre-recorded, a decision partially driven by the meeting’s agenda.
Morrison said that he requested the company be the first of the four sponsors on the agenda to present, but the agency put Syndax last. Chief Medical Officer Michael Meyers felt more comfortable giving the presentation live, but the choice was made easier by the running order, Morrison said.
“We decided to do it live because we wanted to watch the other three presentations,” he said. “The presentation itself we had submitted in advance, so the slides weren’t going to change, but we thought there might be some voiceover that we might want to change in the language that we presented, depending on what we heard.”
“It turned out there really wasn’t much change, but we wanted to reserve that optionality, just in case there were themes that were coming up in the other three presentations that we wanted to proactively cover in our talks,” Morrison added.
While not a major factor in the decision, Morrison also said his IT advisors determined that the prerecorded option may be open to more tech problems than a live presentation.
At the ODAC pediatric subcommittee meeting, only one of the sponsors, Salarius Pharmaceuticals, Inc., opted to prerecord their presentation. And technical problems lead to dead air when agency staff attempted to show the video.
The glitch hasn’t doomed the prerecording option. GSK is expected to prerecord its its initial presentation for the belantamab panel, and for future advisory committees, the FDA is considering releasing any prerecorded presentations in advance of the meeting to keep the live event shorter. (Also see "US FDA May Make Pre-Recorded Virtual Adcom Presentations Available Before Meeting" - Pink Sheet, 19 Jun, 2020.)
[Editor’s note: Salarius CEO Salarius David Arthur and FDA Office of New Drugs Deputy Director Khushboo Sharma will discuss their experiences with virtual FDA meetings as part of a webinar event on 21 July. Registration for the webinars, featuring executives, regulators and key opinion leaders from around the globe addressing the impacts of COVID-19, is free.]