Voices from the Front Line

Biotech Tech

biotechtechby Allen Weiner

September 2002 – The voices from the front line of life sciences leadership are strong and focused. These voices are excited and visionary while also exacting and practical. The voices are of leaders who lead by example and choose their supporting teams as if they were going to war or attempting to win the Super Bowl. They are the voices of men and women who possess a rare blend of understanding of science, business, finance and evolving marketplaces. The voices from the front line might not always make the headlines, but they are heroes in their companies and with their investors.

The goal of creating this special section was to examine the personalities driving some of the cutting edge life sciences companies in today’s marketplace. Not only did the interviews yield some valuable personal insights, they raised a solid handful of guiding points that could be worthy of consideration to any entrepreneur in any marketplace. Here are five of the more notable take-aways from our visionaries:

  1. Is there a problem to be solved? In examining your area of interest or expertise, can you easily identify an issue that needs to be resolved? Is it a problem that is causing pain throughout an organization or in one small segment? Can you monetize your solution to that problem?
  2. It is important to seize an opportunity when you find one. The drawing board has its purpose, as does a solid business plan, but when an opportunity is staring you in the face, seize it.
  3. Do not stray from your strength. Many companies are not satisfied to focus on an area of core competency and exploit that opportunity for all it’s worth. Shortly after early success, too many companies want to become the be all and end all to their customers. Such a diffusion of focus is the downfall of many companies.
  4. Always look to the total solution. As you are developing a product or service, it is always wise to look at how your product or service can fit into each and every area of your client’s business. If it’s a communications tool, for example, it would be prudent to identify all the areas of a client’s business that could become more efficient with a cohesive communications solution.
  5. Seek the advice of others. No individual possesses all the product, marketing and financial knowledge to take a company from zero to infinity. The smart thing is to seek the counsel of smart people in various walks of life. Seek out mentors and surround yourself with capable teammates whose skills complement one another to build a force that is greater than the sum of its parts.

Our voices from the front line come from the worlds of hardware, software and services. Their stories and their companies are worth telling and repeating.

Health Decisions

Dr. Michael Rosenberg, M.D. MPH President and CEO

There is always a better way of doing things.

“Our approach from the beginning has been different,” says Health Decisions CEO Michael Rosenberg. “Adding technology does not address the bottom line. If you cannot trim time or money, what the hell good is it?”

Rosenberg is founder of Health Decisions, based in Chapel Hill, N.C., a clinical research organization (CRO) that conducts clinical trials for pharmaceutical companies, non-profits and governmental bodies. The company has distinguished itself in a highly competitive field of more than 1,000 CROs, consistently delivering results substantially superior to those of its competitors or large multinational pharmaceutical sponsors. The company has achieved these results through a strategy of combining technology and thought to examine and reinvent basic research processes, and tightly integrating all stages of the development process. It is the only company, including clinical research organizations and pharmaceutical companies, that both develops and uses comprehensive software packages to perform clinical evaluations of drugs, culminating in marketing applications to regulatory bodies.

Heath Decisions Clinical Management System is a fully integrated system for bringing in data (through a variety of options), validating and managing discrepancies for incoming data, real-time reporting based on database calls, a Web-based system of managing data discrepancies directly with sites that collect data, and seamless connection with a regulatory submissions system for preparation of regulatory submissions. This system has been fully operational since the fall of 1997.

In the development of Health Decisions, Rosenberg says the prime area of his focus was businesses processes, and not ones necessarily steeped in life sciences. Rosenberg’s vision started with a simple concept: “In order to do anything in life, you need three elements: collect information quickly, share that information quickly and make decisions and implement those decisions quickly.”

Rosenberg looked to Japanese auto manufacturers and how they made things go faster. He began to realize that technology alone does not succeed in “making things go faster.” “You must have the business processes to go along with it,” he says.

One of the initial ideas Rosenberg brought to the market was a change in the way data was collected in clinical trials which helped improve speed and accuracy of data. The change was in moving away from pencil and paper notations of data to the “bubble system” which is familiar to anyone who has taken a standardized test that requires one to fill in a box/square/bubble. Feeding data sheets into an optical reader not only increased accuracy but sped up the data process immeasurably.

Part of the challenge in effecting change is to gain acceptance. Change requires a realignment of thinking, Rosenberg says. For example, in the Health Decisions system, the process requires those involved in clinical trials to log into a system after hours to examine data and check for errors. The end result, however, is a drastic reduction in the number of query errors in the clinical trial process. That implemented cause and effect of change helps create acceptance of this new process.

For Dr. Rosenberg, applying his principles of “lean” production to the clinical evaluation of drugs, supported by internally-developed IT systems, has helped one client company shave the costly and lengthy process of bringing new drugs to market by as much as 30 – 50 percent. A study completed for an Alzheimer’s drug was completed a year and a half faster than expected, saved $30 million in direct costs, and was written up in Forbes magazine.

Rosenberg’s lean style of business operations is evident in the fact that Health Decisions has about 65 people on staff, with 15 of those based in England. He started the company out of his house, with what he called “a core group of one.” The company was self funded and is profitable with three times the industry average in income per employee. Practicing what they preach, Health Decisions employs a combination of technology, people and processes to get their work done. “We have no secretaries here,” says Rosenberg. “We expect people to do their own work using technology. An M.D. who writes longhand would have a challenge working here.”

Looking to the future in life sciences, Rosenberg believes that changing processes using technology will be what separates the successful from the also-rans. He emphasizes the belief, though, that technology is only a tool to enable a company to work better. The execution of a technology plan is far more important.

“Our measure of success will be our ability to catalyze change in this industry,” comments Rosenberg.

Reprinted from Biotech Tech, 2002


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