ISPE aims to build bridges to biotech

Next week, the International Society for Pharmaceutical Engineering (ISPE) meets on the Gold Coast for its 2005 Australasian Conference. Maybe you haven't heard of the ISPE, or its conference -- but if that's true, it's possibly the most important conference of which you've never heard.

The ISPE is a global, not-for-profit organisation that provides education, training and technical publications to professionals across the spectrum of pharmaceutical manufacturing. Its membership is necessarily broad, drawing from a base of industry, government and academia, and linking those elements into a quite unique whole.

"The ISPE likes to see itself as a facilitator for communication between government, industry, individuals and academics," says the society's Australasian affiliate president, Mark Donohoo, a local exec at pharma AstraZeneca. "It brings together all those elements within the conference - that's what distinguishes the ISPE from other groups.

"We have a very large membership base on which to draw -- some very highly recognised experts. Through that membership base, we can bring to Australia some very high-calibre people."

Locally, the ISPE is well developed, with three affiliate chapters in Australia and one in New Zealand, a factor Donohoo partly attributes to the society's active training program. Courses have led to a 25 per cent increase in membership over the past 18 months.

Relevance

But a brief acquaintance with ISPE's charter gives another clue as to its growing membership -- its core activities in regulatory affairs give it a hard edge of relevance.

Donohoo says that when he first entered the pharmaceutical industry, he was surprised to discover high levels of cooperation, on some levels, between companies which were openly competing for market share -- cooperation driven by the high levels of regulation to which the industry has to adhere.

The infamous Pan Pharmaceuticals episode of a couple of years ago, Donohoo says, led to a more stringent regulatory environment for the local pharmaceutical industry -- and helped to make the ISPE even more relevant.

"I think we have a good story with the regulators," Donohoo says. "We work very closely with the US Food and Drug Administration, and we have a good relationship with the Therapeutic Goods Administration in Australia.

"We're able to produce standards that are recognised and upheld by regulatory bodies. The guidelines we produce are referred to in regulatory documents. It's a reflection of ISPE's standards."

Biotech's turn

Another phenomenon that has changed the pharma landscape is the increasing importance of biotechnology -- which means a new responsibility for the ISPE. A large part of the program at the Australasian conference will be devoted to discussing the ISPE's new biopharmaceutical guidelines -- an FDA-reviewed publication, which was five years in the drafting.

Donohoo says the ISPE is now actively reaching out to the biotechnology sector -- "it's not an area with which we have had much contact," he says. "We expect the Australasian conference to attract non-ISPE members, especially in biopharma and biotech. People may not appreciate that if they are coming up with a product concept, they're getting into a regulated area in which they may not have the background experience.

"There are a number of hurdles with taking it to the next step -- it's more than simply being a smart scientist. You've got to have a good understanding of these things."

An industry rolls up its sleeves

A glance at the ISPE Australasia Conference program reveals a snapshot of an industry rolling up its sleeves and getting down to business.

Its plenary session sets the tone: addressing society's increased expectations for safe, effective, cheaper therapies, and the extra pressure faced by the pharmaceutical industry and its regulators as they meet those expectations. It describes important changes in regulatory requirements (both local and international), in market development and in industry/government collaboration, including the changing regulatory environment globally and, closer to home, Australian and NZ perspectives on a trans-Tasman therapeutic product agency.

The conference is split into three broad streams: biopharmaceuticals, manufacturing excellence and efficiency, and improving compliance through validation.

The centrepiece of the first stream is the discussion of the ISPE's just-published Biopharmaceutical Manufacturing Facilities Baseline Guide -- and delegates will be privileged to catch the guide's main architect, Jan Gustafsson, the senior principal scientist at Novo Nordisk, who will lead the discussion.

Gustafsson will be joined by Andrzej Wozniak of Australia's TGA, and patent specialist Robert Wulff, of lawyers Griffith Hack. The rationale behind the guide -- and the biopharma stream at the conference -- is the ever-increasing rate of development of biotechnology and the pharma industry's need to keep abreast of technical challenges involved in biotech processes.

This stream is a must-attend for local biotechs - it's designed to provide information for companies that are involved in, or looking at, making the transition from an R&D activity to manufacture and supply to the regulated marketplace.

The second stream will highlight opportunities for enhancing business performance through the whole manufacturing cycle.

The ISPE Australasia Conference will be held on April 14-15 on the Gold Coast. For more details, visit www.ispe.org/australia.