In conversation with Gailina Liew

As chief operating officer of GeneNews (TSX:GEN), Gailina Liew seemed destined to lead the company co-founded in 1998 by her father Choong-Chin Liew, a heralded academic. As a lawyer with science training, and while raising a family 10 years ago, Ms. Liew worked closely with her father back then, “watching out for him,” in her own words, by vetting documents and shareholders’ agreements. Last year, GeneNews launched ColonSentry in Ontario, the world’s first blood-based test for colorectal cancer screening. It is the first in what the company hopes will be a line of screening tests using its Sentinel Principle technology to facilitate personalized medicine. Ms. Liew shares her unique insights in an exclusive interview with biotuesdays.com.

What is your mandate as COO?

In 2008, my goal was to get our lead product, ColonSentry, out into the marketplace on time, which we did, and then undertake the transformation of GeneNews into a commercial enterprise from a development company.

Now, I’m focused on getting partnerships for ColonSentry in the U.S. and Europe, and continuing with the evolution of GeneNews into marketing.

Many biotechs struggle making the transition to marketing. What makes GeneNews different?

We brought Heiner Dreismann on board as lead director and interim CEO (Mr. Dreismann is a former CEO of Roche Molecular Systems, a division of multinational F. Hoffmann-La Roche, and the company that pioneered molecular diagnostics in the clinical arena). He has made a huge impact on our company. He has brought a focus on quality and that the customer is first, how you work in the marketplace, and how you communicate with doctors so people will start to use ColonSentry.

Even though we’ve come through a challenging year, what gets people charged up is that we’re all touching a technology that will improve people’s lives and make a positive difference. That’s a rare privilege.

How do you manage with an interim CEO?

Heiner is based in California but we communicate constantly. On a day-to-day basis, I’m here on the ground and people know who to turn to for ultimate direction. Heiner is a great sounding board and he’s pretty hands off. As lead director, he gets us into companies at the executive board level so we can initiate partnership discussions at a very high level.

How has GeneNews weathered the recent tough times in the biotech sector?

We’ve downsized dramatically, yet hit our milestones. So, it has really been a tremendous year of accomplishments. Part of that success came from us bringing that commercial focus on board.

But we’re still in transition. Because of the challenging times, we haven’t been able to build out the commercial side as we had intended. We don’t have a senior marketing person or a senior sales person. To conserve cash and extend the runway, we decided to hang tight and juggle. My role has been to do a little of everything because we’re still thin. We are going to add those people when we get more working capital under our belts, whether it’s through partnerships, alliances or a capital raise. We’re very opportunistic about those options.

We did a couple of small financing rounds last year and we’ve raised just over $5-million this year. And we’ve continued our R&D in low cost regions in Asia.

What makes your Sentinel Principle special?

My father’s discovery of looking in blood to see RNA gene expression was critically important because it effectively tells us what’s happening anywhere in your body. And, instead of taking a biopsy from tissue, which is an invasive procedure, we can do this with a simple blood sample.

The technology is called the Sentinel Principle because it stands guard over your health. Not only can it tell us whether you have a disease or not, but it can tell us how the body is responding to a specific treatment. It’s going to make an incredible difference in the way we practice medicine.

Earlier this month, we received the U.S. patent for the Sentinel Principle. It was a game-changing event because it protects the application of our technology across a broad spectrum of diseases.

In colorectal cancer, for example, our panel can pick up stage 1 cancer. And in this disease, the chances of survival are very good in stages 1, 2, and 3. Even in stage 3, the survival rate is over 60% after five years. It’s only when you’re in stage 4 that the chances of survival drop below 10%.

What is the current focus of the company?

It’s oncology because there is a tremendous clinical need and commercial possibilities are attractive. GeneNews is not a one-trick pony by any means and ColonSentry is just the tip of the iceberg. We have a platform technology that is applicable to any disease or condition.

The idea is to have a line of Sentry products. The one that is furthest ahead is for prostate cancer and we’re looking at a panel to distinguish between aggressive and non-aggressive forms of prostate cancer. Launching it next year depends on getting our hands on sufficient funding to finish development and validation.

Who pays for ColonSentry?

Right now, it isn’t covered by OHIP but about 50% of patient claims submitted to private insurers have been covered. We’re also pursuing a Revenue Canada ruling that ColonSentry qualifies as an eligible medical tax benefit. When we get that ruling, the Big Three insurers have told us it will be part of their extended medical health plans.

And outside of Canada, where are you headed?

We’re focused on discussions with partners in the U.S., Europe and Asia. In the U.S., we’re targeting esoteric clinical labs that have the expertise to do complex tests. The reasoning is that they will probably perform the test in their own lab rather than send it back to us. There’s also a regulatory component in the U.S. and each lab will have to take the test through its own validation process. There are no formal regulations for this type of test in Europe and Asia.

So what do you need to become profitable?

All we need is a couple of strong partners to take ColonSentry out into a larger marketplace and get some decent uptake. On the Canadian front, the ColonSentry business can be profitable within a three-year time frame.

Is a partner your major milestone next year?

Yes, we want to have at least one very strong partner in each of the U.S. and Europe. Discussions are underway, they’re going well and I’m optimistic. We’re looking for milestones, pretty decent royalties and likely minimum payments based on sales.

How do you see a role for GeneNews as medicine evolves?

I believe medicine is heading into an era where patients will take more charge of their own general health. It’s unavoidable with the Internet and the ease of access of information that brings. And as this continues, few clinicians will be able to claim to be better informed than a patient who puts his or her mind into finding out about something. What patients will want from clinicians is very expert interpretations.

With our technology, I believe we are well positioned to be able to help facilitate this change, which is already under way. The overall mission or goal of this company is to enable personalized health management. And the reason we have this vision is because we have the ability to see what goes on everywhere in the body.

Gailina J. Liew Title: Chief Operating Officer of GeneNews Ltd., Richmond Hill, Ont. Born: Dec. 25, 1965 in Toronto. Education: B.Sc. degree in Molecular Genetics and Molecular Biology, University of Toronto; LLB degree, University of Western Ontario; MBA degree, Kellogg-Schulich School, Northwestern and York universities. Career Highlights: 1994: Ontario Lead Investment Fund; 1995: Criminal Injuries Compensation Board, Ontario; 2000-2006: general counsel and progressively senior roles with ChondroGene Ltd., the predecessor company of GeneNews; 2006: senior vice president of GeneNews; 2008: acting COO of GeneNews; 2009: COO of GeneNews