Lessons on the journey to commercialisation

One of the Asia Pacific region’s best known biotech leaders, Dr Greg Collier, says successful commercialisation of a new drug or therapy takes, “discipline, a strong set of nerves and a stroke of luck.”

“Of course, a talented and wise board of directors also helps,” adds Collier, the former CEO of ChemGenex, which was sold last year to US-based pharma, Cephalon, for $225 million.

Collier, who has a PhD in biochemistry from Monash University, was part of the original group of researchers that founded Autogen in 1998, which later became ChemGenex. The company is one of the few in Australia, to apply for FDA approval for a product developed in Australia. Collier’s team played a major role in the commercialisation of a treatment for chronic myeloid leukaemia called Omapro. They took the Omapro through to the completion of Phase three clinical trial with a New Drug Application accepted by the FDA and a Marketing Authorisation Application validated by the FDA’s equivalent in Europe.

“It was an interesting and challenging journey for the team,” says Collier. “There are so many variables and considerations, some of them completely out of your control. However, the elements that you can control require careful and considered management and strategy,” added Collier.

Collier says many promising treatments and therapies never reach commercialisation because of management mistakes and misjudgement rather than weak science.

“The landscape for drug approvals seems to be constantly changing and unpredictable, but the reaction to pitfalls can be carefully managed,” says Collier. For example, he said his team learned a hard lesson from a set-back in 2010 that caused the company’s stock to plunge 62%, at one point, after a ruling from the FDA.

“Overall, the FDA review panel was very positive about the drug, but it asked for additional information. This is fairly normal. However, because we were one of the first Australian biotechs to seek FDA approval for a product, local investors panicked when they didn’t understand the typical kinds of challenges during the approval process. One of the biggest lessons we learned was the need to thoroughly educate our investors and the industry about the approval process, the expected pitfalls and also manage expectations around timelines,” says Collier.

Collier, who will be sharing stories and the learnings from his experience as CEO of ChemGenex at the upcoming AusBiotech conference in Melbourne, says: “We weren’t the only ones who learned some great lessons. I think our experience with the FDA helped to educate the entire Australian biotech community.”

Dr Anna Lavelle, AusBiotech’s CEO, agrees that many were closely watching ChemGenex. “Australia’s biotech industry has matured significantly in recent years. We now have a large number of companies entering late stage development who are looking for guidance and assistance with commercialisation,” says Lavelle. “Thankfully there have been a few trailblazers and success stories, such as ChemGenex, which have helped to both educate and inspire our industry. I’m sure Greg’s talk will be inspiring and insightful.”

Dr Lavelle says delegates to the conference will also hear stories about the path to commercialisation from executives of other companies QRx Pharma, Pharmaxis and Bionomics. The AusBiotech conference runs 30 Oct – 2 Nov in Melbourne. More info can be found at http://ausbiotechnc.org