Physician executives as opinion leaders in biotechnology and pharmaceuticals. (Careers: Special Report).

IN THIS ARTICLE...

Take a look at some of the traits and skills a physician executive needs in order to become an advisor to biotech and pharmaceutical industries.

The last 20 years saw a boom in the biotechnology industry that supports the development of new pharmaceuticals. Companies such as Genentech and Amgen, as well as the large pharmaceutical companies like Pfizer, Merck and Johnson & Johnson, lead the biotechnology scene.

Previously, pharmaceutical firms primarily depended on chemists to help isolate the compounds with therapeutic value. The picture is changing today and biotechnology feeds innovative ideas to the pharmaceutical industry to produce products such as recombinant human insulin, growth hormone, monoclonal antibodies, granulocyte colony stimulating factors, erythropoeitin and interferon vaccines.

Physicians in clinical practice understand the impact, value and power of these newer medications and comprehend the benefits and potential side effects they have on their patients. Physician executives can play an important role, too.

With hundreds of billions of dollars pumped into these precarious, high-risk industries each year, (1) physician executive opinion leaders are needed in biotechnology and pharmaceuticals to help guide the complex research and marketing activities.

Consider these staggering facts:

* Estimates from the Pharmaceutical Research and Manufacturers of America suggest that only five out of 5,000 compounds tested perform well enough to go on to human testing.

* On average, it takes about 15 years for a new drug to move from discovery to animal testing then clinical trials before going to the Food and Drug Administration (FDA) and the marketplace.

* It takes about $250 million dollars to develop a new drug and there are thousands of companies out there competing with each other.

* In the last two decades, only about 75 biotechnology driven drugs, vaccines and diagnostic tests approved by the FDA went on to achieve success.

Physician executives can have significant impact on the success or failure of a new drug at the pre-launch stage and drug introduction stage. They are able to offer input in many areas:

* Appropriate marketing strategies that will appeal to physicians

* Advice on new markets and indications

* Acceptance by managed care

* Strategies on long-term compliance with the new medications

* Cost/benefit analysis of more clinical trials

What background is needed?

The minimum benchmark for physician executive opinion leaders should be the certified physician executive (CPE), as this ensures that they are board certified in their clinical specialty and have some clinical, business and management experience. Ideally, they will be well recognized among their peers and considered experts in their field.

The physician executives should have contributed peer-reviewed publications and have an appropriate academic title with a department of a medical school. This lends credibility, especially when it comes to peer review by colleagues. Most of all, they should be team players, have an entrepreneurial spirit and be ready to be challenged by new biotechnology frontiers.

They also must be: Passionate

* They must love what they do and believe they are doing it for the common good of advancing science and business for the benefit of patients.

* Aware of the risks

Business generally involves more risk and uncertainty compared to medicine.

* Practical and market-oriented

Useful, marketable products must be pursued. The research is not conducted just to satisfy scientific curiosity.

* Creative and innovative Obviously, any new product development requires inquisitive, creative thinking.

Markets and competition

Physician executive opinion leaders must understand markets and the competition for a product in order to advise customers appropriately. The competition could be domestic or international.

Physician executives must be able to perform analyses of strengths, weaknesses, opposition and threats of competitors. They also need to be knowledgeable about market size, segments and growth.

There are many FDA regulations that may impair taking a drug to market. Physician executives need to be aware of potential stumbling blocks, keeping in mind that the FDA is primarily concerned about safety and benefits to patients.

Biotechnology customers often ask advice of many opinion leaders and decide what direction they will take after carefully considering the different views. Frequently, opinion leaders sit on scientific advisory boards, adding value and direction to companies.

What types of customers seek opinions from physician executives?

* Physician executive opinion leaders can help banks and financial institutions with investment decisions by identifying pharmaceutical and biotech companies with strong potential products and good management principles.

* They can help venture capitalists evaluate a start-up biotechnology firm.

* Pharmaceutical and biotechnology companies may, in themselves, be seeking directions in product development and capital investment. At times, these companies want physician executives to introduce a new product to physician peers.

* State and local governments may seek advice on how to lure biotech or pharmaceutical companies to their area.

Examples

A physician executive opinion leader in Alzheimer's disease was given an idea by a major pharmaceutical firm to advise on the opportunity of introducing an acetylcholine esterase inhibitor into the long-term care market.

Previously, the product's market was principally the ambulatory setting. The long-term care market was untapped and had a potential of 30 percent of the total market share.

The physician executive offered advice on the drug's chances of success in the market, suggested ways to get the product to contract pharmacies and conducted educational programs for representatives and health care .providers.

In the end, the consultant helped the company develop a new business plan for a previously untapped market.

In another example, a foreign venture capitalist approached a physician executive opinion leader on the feasibility of a biotechnology firm producing hepatitis vaccine in an overseas country where the disease was endemic.

He also wanted advice on possibly exporting the vaccine to the United States. The physician executive did some research and was able to come up with possible benefits based on demand and also examined the educational efforts required so that providers would use this new vaccine. He also helped the client find legal assistance regarding the export market.

It takes many years of experience to become a successful physician executive opinion leader to industry. Large biotechnology and pharmaceutical companies sometimes hire physician executive opinion leaders full time as medical directors, vice presidents and medical liaisons. The rapid growth in biotechnology applications to pharmaceutical products will require more of these individuals.

References

(1.) Duane, J. Successful Biotech Investing. Roseville, calif. Prima Publishing,

(2.) Bottles, K. "A Revolution in Genetics: changing Medicine, changing Lives." The Physician Executive, March-April, 2001.

Robert S. Tan, MD, MBA, CPE isan opinion leader in aging and men'is health issues and medical director of Garden Terrace Alzheimer's Center in Houston, Texas. He is also associate professor at the University of Texas Health Sciences Center co-director of the geriatric medicine fellowship program and President of AMRED consulting LLC. He can be reached by e-mail at [e-mail]