DIA Adds More History to Boston

August 1, 2008

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-08-01-2008, Volume 0, Issue 0

Highlights and insights from DIA's 44th Annual Meeting.

Impressive. That's one way to describe DIA's 44th Annual Meeting held inside the Boston Convention & Exhibition Center from June 22–26. In a time when most folks are keeping their purse strings tight and travel to a minimum, DIA managed to pull off its most well-attended U.S. annual meeting to date. In total, 8900 professionals from 56 different countries were in attendance, with some traveling from as far as Singapore and Taiwan. But for all its international flare, this year's meeting definitely showcased the city that served as its backdrop.

CDER Director Janet Woodcock, MD, (mid) who received DIA's Distinguished Career Award, along with keynote speakers Kathy Giusti, MBA, and Dennis Ausiello, MD.

Case in point: the plenary keynote speakers, who both have ties to the Boston area. First to address the packed session was Dennis Ausiello, MD, Jackson professor of clinical medicine at Harvard Medical School and chief of medicine at Massachusetts General Hospital. Dr. Ausiello expounded on the need for industry and academic collaboration to improve today's highly expensive and productivity-deficient R&D paradigm. What academia can bring to the table, says Ausiello, is a scientific nimbleness and an innovative environment where unsuccessful R&D fails fast. But forming a collaborative enterprise between both parties requires changing the cultural mindset that understanding disease is an academic pursuit and curing disease is a business. That's the "biggest challenge we face in bringing both together," said Ausiello.

Perhaps no one better understands the value of collaborative R&D than second keynote presenter and Harvard Business School alumnae Kathy Giusti, MBA. Collaboration and fund raising are the cornerstones of the business model she employs as founder and chief executive officer of the Multiple Myeloma Research Foundation and the Multiple Myeloma Research Consortium. The effort for a cure involves patients, who populate the indispensable tissue bank, databanks, and clinical trials; academic research centers; and biotech and pharma companies. Funding, which Giusti described as continuous, is filtered into three areas: basic science (20%), validation (30%), and trials (50%). It's a concerted effort that's tracked with an eagle eye all along the R&D continuum and one that's produced four FDA approved drugs so far. Giusti credits this success to the group's clear understanding of all the entities that work in drug development. "[It's] a 360-degree, high-standard, very focused business model," noted DIA's Worldwide Executive Director Linda McGoldrick. "We should all look at it and say 'hmm,' and certainly learn from it."

An additional multitrack plenary provided an update on the Food and Drug Administration Amendments Act (FDAAA) to promote drug safety. In terms of progress, CDER's Sandra Kweder, MD, Rear Admiral, U.S. Public Health Deputy Director, Office of New Drugs, compared FDAAA to a big ship that's trying to turn. Adding to the challenge is the fact that steering the ship is an understaffed crew who, although have more authority as a result of the Act, find themselves in unclear waters. In particular, uncertainty surrounds postmarketing surveillance efforts regarding study requirements and timelines. And it will be awhile, according to Dr. Kweder, before clear standards are in place for Risk Evaluation & Mitigation Strategies.

One thing FDA is certain of is that improved drug safety in the United States is contingent upon good postmarketing data collection and surveillance. To that end, explained panelist Mark McClellan, MD, PhD, chair of the Regan-Udall Foundation, FDA is moving toward a more life-cycle approach to drug management. Said McClellan, "It's simply not possible to design any premarket study to answer some safety questions."

Amidst the hustle and bustle of this year's Meeting, DIA's McGoldrick remained mindful of why so many industry professionals, exhibitors (850), and speakers (1100) gathered in Boston. It was to make a difference in patients lives. As she put it, "that's all that matters at the end of the day."—Kerri Nelen

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