Conference Edition
| June 7, 2019
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The 11th annual Dealmakers’ Intentions Study uncovers what biopharma dealmakers need to know about supply and demand in the next 12 months.
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Editor's Note
Jim Greenwood, CEO of the Biotechnology Innovation Organization, set a weighty tone at the trade group's annual conference this week, characterizing both biotech's scientific advances and the threats from Washington as unprecedented.
BIO 2019 timestamps a moment of an industry at a crossroads. Optimism surrounding a new era of cell and gene therapies has been tempered with the challenges created by the industry's abysmal public reputation and an outcry over exorbitant drug prices. The trend may be further intensified as therapies come to market with sky-high list prices — sometimes in the millions of dollars.
Drugmakers, however, have been quick to defend their practices. At BIO, Merck's CEO argued the broad principles that underpin American business, like capitalism and free trade, also help facilitate development of new drugs.
Against this backdrop, BioPharma Dive traveled to Philadelphia to hear industry and regulators ponder these big questions. We interviewed leaders of not just drug companies, but payers, the FDA and other groups that make up the life sciences ecosystem.
Overall, the BIO conference showed how rapidly changing the drug industry is, and how much work it still has to do.
Andrew Dunn
Associate Editor, BioPharma Dive
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Overheard at the show
"People say they want placebo-controlled trials, but I always ask them would you be willing to die to give a p-value?"
– FDA CDER head Janet Woodcock, on criticism of accelerated approvals
Event coverage
Deep Dive
With multiple gene therapies nearing market, the U.S. systems of reimbursement, regulation and research are being put to the test.
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"Science has become a bad name, and a worse name is biopharma," said Regeneron's George Yancopoulos, speaking at BIO on the urgency of recruiting talented people to the industry.
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More than 1/3 of dealmakers view orphan drugs as key elements in their dealmaking strategy.
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In a wide-ranging interview, CDER chief Janet Woodcock pushed back against concerns the agency is clearing new drugs too quickly.
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"Our business has a noble purpose, but the capital markets don't go to church on Sunday, and they don't go to synagogue on Saturday," said Ken Frazier.
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Still, the acting agency chief warned clinical trial expense won't cut it as an excuse for relying on unorthodox data sources.
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Parting thought
Despite a broad focus for the conference, BIO 2019 felt dominated by gene therapy. How long will that enthusiasm last?
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