Working to find relief for chronic pain sufferers

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It’s about more than just building a successful company - it's about building a company that demonstrates a model for the 21st century.

They're pretty lofty words alluding to a pretty lofty goal, but Christopher Gallen, MD, PhD and president and CEO of Neuromed Pharmaceuticals Inc. believes he has the right formula in place to make it happen.
“My goal is not just to create a company that is a success. My goal is to build a company to last, a great company that moves from success to success to success over time, that demonstrates the model for the 21st century pharmaceutical company,” said Gallen.

Neuromed is a British Columbia based private biopharmaceutical company that is working hard to develop a brand new generation of drugs meant to treat chronic and neuropathic pain. Launched in 1998, the company has plenty of science behind it and a number of successes already.
The company’s lead drug candidate - MK-6721 (NMED-160), for pain relief, is the first orally available N-type calcium channel blocker to be tested in clinical trials.

Calcium channels affect many vital physiological functions by regulating the concentration of calcium in cells. These functions include electrical pain signaling in the nervous system, heart and muscle contractions and hormone release.

The company's focus is on two of the five types of calcium channels found in the body: N-type in the nervous system and the T-type found in both the heart and nervous system. N-type calcium channel blockers represent a new class of analgesics that are selective for calcium channels involved in pain signal transmission. The concentration of calcium entering certain nerve cells in the spinal cord is directly linked to pain signal transmission.
Neuromed is the first company to successfully bring a small molecule N-type calcium channel blocker into clinical trials, with hopes of taping into a giant market. It is estimated that in the U.S. alone, 50 million people suffer from chronic pain and effective treatment options are limited to opioids (morphine and related drugs) and non-steroidal anti-inflammatories (NSAIDs). Opioids have significant potential side effects and NSAIDs are ineffective for moderate-to-severe pain.

This past year was full of successes for Neuromed, having received the 2006 British Columbia Biotechnology Award for Life Sciences Company of the Year and being named to FierceBiotech's annual Fierce 15 list of biotech companies to watch. Undoubtedly the biggest news of the year for the company was the research collaboration and license agreement with Merck & Co. to research, develop and commercialize novel compounds for the treatment of pain and other neurological disorders. This includes Neuromed's lead compound, MK-6721. Under the terms of the agreement, Neuromed grants Merck an exclusive worldwide license to research, develop and commercialize MK-6721 and other compounds that selectively target the N-type calcium channel. Merck made an initial $25 million cash payment, with research funding to follow over the next two years, with the option to renew for an additional two years. Merck is responsible for all development costs and activities.
"As far as we can tell, this was the largest pharmaceutical partnership deal in Canadian history," said Gallen.

Gallen started with Neuromed in 2004, bringing with him an extremely extensive list of experience and knowledge. Although he had wanted to acquire Neuromed for quite sometime before that, timing just wasn't right.

"I was very familiar with Neuromed from having evaluated it when I was working in a large pharma and was very interested in acquiring Neuromed at the time. I thought that Neuromed had the best science I had ever seen in a small company and thought that this was an opportunity to create the kind of company that I knew could exist, but I felt did not exist at this time. In a sense, I've been developing the skills and the background to do exactly as I'm doing right now. This is the perfect job for me," explained Gallen.

What made it such a perfect job for Gallen was that it was able to put to use his many talents, skills and experiences that he had been gathering up to that point. Gallen comes from a varied background, training as a physician, an MD, a biochemist, a PhD, a psychiatrist, a neurologist and more. His first interaction with the biotech industry began when he started to work closely with a local neuro-imaging company, helping it to clinically develop its products and support it right through its IPO and secondary offerings. Gallen then moved to a clinical research organization.

"I was fortunate to work with a great group of people and to work on several successful drugs - five drugs that ended up getting registered and driving its clinical programs. I really learned how to execute on the conduct of clinical trials and really help them grow significantly in terms of adding a quality of science in the work we were doing," said Gallen.

This experience gave Gallen enough background to then start his own clinical research organization, along with a few other guys. It grew up over the course of the next few years to eventually become an enterprise that encompassed a couple of hundred people. Running the company gave Gallen a chance to learn the business side of clinical research, something he feels is extremely important.

Time was also spent in a big pharma company, to round out his skills even more. "The key for me in moving to the big pharma was it gave me a chance to understand fully the science of how the drugs are developed but also to understand how organizational structure, processes and technology impact the performance of an organization."

So what does he have to say about all his experience and how it's helping him today?
"I bring a thorough understanding of the science, in particular the clinical science and CMS to Neuromed. I think I bring a lot of experience and knowledge of how small and large companies successfully develop drugs, as well as where they go off the rails."

Through the years Gallen has worked at forming his own formula for success, which he has applied at Neuromed.

"The key formula for success is strong science developed in a rigorous objective data oriented way, strong management that is not driven so much by hope but by recognition that you're going to run into challenges, that ups and downs are absolutely inevitable and that you have to think through them before they happen so that you can be prepared to surmount them and succeed in the end."

Another key Gallen pushes is to look for market opportunities that are significant enough to be motivating to people and push the enormous resources it takes to develop a product forward. However, Gallen, isn't satisfied with just success alone, he wants go beyond that and build a company that lasts.

"I've spent a lot time thinking about things that I think many in biotech do not think about as much, namely, what is the culture, the values and the orientation I want the people in my company to have? How do I use the structure of the organization in order to drive products to successful execution? What kinds of processes empowered by technology can you use to be much more efficient pound for pound for your people? And finally, what is the right strategy to succeed for a given mechanism, to choose the right indications, the right trial designs, the right regulatory strategies," explained Gallen.

"From my point of view, there are three core values: intelligence; thinking things through integrity - doing work that is absolutely solid and believable and initiative - being driven to make things work, being driven to make things happen. I think that if you install those things into the DNA of the organization when it is small, then you can create something great in the long run."

In his time, Gallen has seen plenty of companies fail and is eager to share some words of wisdom with those looking to start up a biotech company. The biggest mistake he sees time and time again is people trying to push their drug to a later stage of development before they have figured out what the actual properties of the drug are and have found out for certain what the right dose of the drug is. Gallen insists it's about doing your homework and not rushing to make things happen instead.

No-one will argue that it's a tough industry to crack into right now, but Gallen sees Canada as being a "great environment" for biotech companies where the various associations, the government, the investment community and the universities are becoming more and more interactive and coordinated with each other, all pushing towards a successful result. Gallen also praises Canada as being a very "cost effective" environment to do research.

Looking ahead, Neuromed's future looks bright and Gallen wants to make sure it stays that way. "We want to have a big year in 2007 in terms of accomplishments but really set the basis for a spectacular 2008. The pharmaceutical industry is so very important to every human life on the planet and it is so troubled and under so much strain right now, I think that it is possible to do it much better than we've done in the past and Neuromed is a great place to start," said Gallen.