DIA Brings Canada's Best Together

January 1, 2008

Applied Clinical Trials

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

What better time to reminisce than at the start of a new year? So, here's a look back at a late 2007 conference: DIA's 5th Canadian Annual Meeting. Ottawa, the country's picturesque capital and home of its drug regulatory agency, Health Canada, hosted the event, which brought together 29 exhibitors and a little more than 300 attendees inside the Ottawa Congress Centre October 29th to 30th. Not including the large handful of U.S. and UK industry professionals present, those attending comprised a healthy mix of Canadian pharmaceutical and regulatory professionals (69% vs. 30%, respectively) who had a chance to catch up with each other at the meeting. DIA's Program Manager, Joanne Wallace, CMP, told Applied Clinical Trials, "[It was] a good forum for the industry people to meet with people from Health Canada [and] for everyone to realize how the industry is changing and how Heath Canada is adapting to these changes."

Keynote speaker Philip Blake [left] and Program Committee Chair Rav Kumar, PhD, of GSK Canada, pose for a picture after the plenary session.

Changes at hand

As attendees sipped coffee and tea, 25-year industry veteran Philip Blake took center stage at the opening plenary session. Blake, president and chief executive officer of Bayer Inc. Canada and board chairman of Rx&D, touched upon a number of topics during his keynote address—including Canada's 69% public approval rating of the pharmaceutical industry, increasing competition from China and India for clinical trials, and Health Canada's decrease in drug approval times—before getting to the heart of the meeting: the progressive licensing framework. "Progressive licensing is hugely exciting for our industry," Blake told the crowded room, referring to Health Canada's attempt to bring the country's current 40-year-old regulatory framework up to date (some provisions even date back to 1934) without overburdening industry or government in the process.

The modernizing effort will result in, Canada hopes, a top-notch 21st century drug regulatory framework on par with the United States' and EU's that supports ready access to promising new therapies and employs a lifecycle approach [preclinical > clinical > postmarketing] to regulating drugs. In general, it follows the concept that there is a progression in knowledge about a drug, thereby placing as much emphasis on postmarketing monitoring as preclinical and clinical. If any regulatory body is prepared to step up its real-world data collection efforts, it's Health Canada. The country's postmarket surveillance system is considered one of the best in the world, according to the Parliamentary Secretary of Health, Steven Fletcher, who wrapped up the plenary session with an emotional speech from his wheelchair—the result of a car accident 12 years ago. "We're not going to reinvent the wheel, but modernize what we already have," Fletcher said, "and this is what progressive licensing is all about." The model is moving forward, but it isn't expected to be fully implemented for at least another three years. In the meantime, discussion between government and industry will continue to play an important role in this large-scale project.

Electronic aspirations

In the sessions that followed, 12 in all as part of three separate, parallel tracks, there were a lot of links to the progressive licensing framework. One in particular, "eCTD and Its Use by Industry and Health Canada," shed light on the current state of electronic regulatory submissions in the country, which naturally must be up to date if the agency is to be modern.

So, how is the government body faring? Well, it's been slow going for Health Canada. Despite a strong start early in the decade, they're still very much paper dependent, according to one source, who claims they're not responding to the challenge at the rate the challenge needs to be responded to. There also seems to be a bit of confusion on the part of industry regarding e-practice submission A,B,Cs, which leads some to play it safe with paper. But Health Canada is optimistic and eager to make the changes necessary to step up its electronic efforts. Most people at the meeting seemed optimistic too, and ready for regulations to "catch up with modern science and technology"—as one Health Canadian official elegantly put it.

If conference coffee breaks are any indication of a group's communication skills, and good communication is key to a collaborative effort that's successful, then Canada's progressive licensing framework really is as exciting as the meeting's first speaker, Philip Blake, said it is, and poised for future success.—Kerri Nelen

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