Federal drug review nettles biotech industry

Concern evident on eve of Boston expo

Biotech industry representatives attended the BIO International Convention in Boston yesterday, the first of four days of panels, networking, and business dealing.
Biotech industry representatives attended the BIO International Convention in Boston yesterday, the first of four days of panels, networking, and business dealing.

Federal drug regulators found themselves under the spotlight Monday as the massive Biotechnology Industry Organization’s annual convention opened in Boston.

As more than 15,000 life sciences professionals converged on the Boston Convention & Exhibition Center for four days of panels, networking, and business dealing, a Food and Drug Administration plan to make decisions on new drugs more transparent and consistent drew criticism from industry skeptics.

Drug makers have long complained about what they consider a needlessly complicated and sometimes risk-averse review process for experimental medicines. But a proposed framework for evaluating drug candidates did little to quiet their concerns.

More than 15,000 life sciences professionals converged on the Boston Convention & Exhibition Center Monday.

“They move too slowly, and this is very disappointing,” said Vladimir Shnaydman, president of Orbee Consulting, an Ashland firm that advises life sciences companies, after one panel. He likened the FDA’s proposal to “kindergarten.”

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In a separate panel, David Verbraska, vice president of drug maker Pfizer Inc., while claiming the FDA remains the “golden standard” for drug regulation, said industry leaders often grouse about “the mystery, the black box nature” of the agency’s process for reviewing and approving drug candidates.

The drug review process has been a perennial bone of contention between the industry and its regulators. Patrick J. Frey, director of planning and analysis at the FDA’s Center for Drug Evaluation and Research, said the goal of the FDA’s proposed “benefit-risk framework,” which has been in the works since 2009, is to improve the consistency of the agency’s review criteria for new drug candidates and make them easier to communicate.

Under the proposed criteria, FDA reviewers would describe a medical condition, list other therapies used to treat it, assess the effectiveness and safety of the existing treatments, and compare them with those of the experimental drug.

The framework mirrors what the FDA staff already does, but it would create a formal structured framework for the first time.


In its current reviews, Frey said, “Oftentimes, the table can be littered with benefit-risk considerations. But when you boil them down, this is what really matters.”

Critics have called on the FDA to make more “quantitative” decisions on drug candidates, using data to make the decisions less subjective. Such data-driven outcomes are common in other industries, they contend.

But not all in the industry agree that final decisions on new drugs should be based entirely on quantitative data.

“Quantification can be useful in drug development to help structure go or no-go decisions,” said Rebecca Noel, senior research scientist at Eli Lilly & Co. in Indianapolis. “But I don’t think any of us have reached the stage where we think quantification can make the decision on a regulatory review. It can help inform the decision, but not make the decision.”

Brian G. Atwood, managing director of Versant Ventures, a venture capital firm in Menlo Park, Calif., said the FDA’s review process and decision criteria should be simple enough to communicate to members of Congress and the media. Unless such outside parties “buy in” to the integrity of the process, he said, they can derail new drugs by focusing on safety problems.


“Bomb throwers and the media really hurt the industry,” Atwood said. “You need to find some way to immunize the industry. We’re doing something that’s great for society.”

‘Bomb throwers and the media really hurt the industry.’

Panels related to FDA regulation were among more than 100 scheduled at BIO, as biotech representatives from 48 states and 65 countries set up exhibits and meeting space in a cavernous hall larger than four football fields.

Strategically located at the bottom on the main escalators to the exhibition hall was the 7,700-square-foot Massachusetts pavilion, where Governor Deval Patrick, Mayor Thomas M. Menino of Boston, and state Senate President Therese Murray will be among the government officials planning to be on hand for news announcements scheduled for Tuesday and Wednesday.

Murray was set to disclose Tuesday a multinational collaboration on throat cancer research and detection, with a Massachusetts connection, as well as a US-European Union health care conference planned for Boston this fall. Patrick, meanwhile, will team up with Israel’s chief scientist, Avi Hasson, to award the first round of grants under the Massachusetts-Israel Innovation Partnership rolled out at last year’s BIO convention in Washington.

Conventioneers flocked Monday night to a dozen private parties and receptions, from Kendall Square in Cambridge to the South Boston Waterfront, where companies such as Cubist Pharmaceuticals Inc., Amgen Inc., and Bayer AG hosted visitors from around the globe. More than 70 parties and special events related to BIO will be held this week.

Robert Weisman can be reached at