Adcom Survival Guide: Prep, Practice and Get to the Point
By Jennifer Boggs
CHICAGO – Getting through an FDA advisory committee is an oft-dreaded rite of passage for developers of novel drug candidates, and stories of disastrous adcoms have a tendency to circulate around the biopharma industry like urban myths.
For instance, there's the "tale of two adcoms," as Russo Partners' David Schull referred to the two adcom meetings prior to FDA approval of Arena Pharmaceuticals Inc.'s obesity drug Belviq (lorcaserin). Schull, who moderated a Monday afternoon session at the BIO 2013 International Convention on how to survive – even thrive – during adcoms, led off with a recap of the two Arena adcoms, the first of which gave the product a thumbs-down, sending the company's stock into a tailspin and prompted a drastic restructuring, while members of the second adcom voted to recommend approval. (See BioWorld Today, Sept. 17, 2010, March 30, 2011, and May 11, 2012.)
The negative vote by the first panel stemmed from carcinogenicity data in preclinical studies, data that had not previously been considered a serious concern. The problem was that none of the experts comprising the adcom had preclinical carcinogenicity expertise, and clearly were leery about recommending a product that had any carcinogenic links. (See BioWorld Today, Sept. 20, 2010.)
"The FDA absolutely fell down on this product," said Jim DiBiasi, partner at 3D Communications, who assists companies in prepping for adcom meetings.
But the good news, he added, is that the "Arena case is an outlier." Most of the mistakes during an adcom come from sponsors who either didn't listen closely to the agency's advice – "the FDA will tell you what they want 99 out of 100 times," DiBiasi said – or who showed up to the adcom ill prepared.
DiBiasi and other panelists offered some advice for presenting at an adcom. The first tip: Be prepared.
That means having all the data ready at hand and an organized staff member capable of pulling up the right slide at the right time, avoiding long, uncomfortable silences. And it means having analyses prepared to answer any anticipated question members of the adcom might pose.
Also, be concise. "Give the conclusion first and facts as background," DiBiasi said, even though that seems a counterintuitive approach for most scientists, who tend to prefer the explanation first before reaching a conclusion. Get to the point, be direct and present data honestly, even the not-so-stellar data.
A poor presentation might not translate into a negative adcom vote, but it doesn't win companies any points, with either the committee members or the media.
Thanks to the webcast and the up-to-the-minute media streams such as Twitter, news travels fast. And in those first few postings, "opinions start to coalesce," said Russo Partners' chairman and CEO, Tony Russo.
He also urged companies to have a plan in place for notifying the press. Have three releases – "good, bad and indifferent" – ready to go, so they can hit the news wires as soon as the adcom concludes.
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