She’s an innovator because…as president and CEO of Cooke Pharma, she introduced HeartBar™—a science-based bar product fortified by L-arginine—as a medical food.

The Background:

Darlene Walley, Ph.D., president and CEO, Cooke Pharma, Belmont, CA, joined the company in September 1997 as a consultant. She was appointed president in April 1998 and CEO in January 1999. She helped Cooke Pharma raise over $20 million including venture capital funding to grow Cooke Pharma to become a leader in the nutraceutical category. Cooke Pharma was acquired by United Therapeutics at the end of 2000.

Dr. Walley brings to Cooke Pharma over 15 years of experience in product development and operations in major consumer health product companies and over six years working with start-up companies. She worked in R&D at Procter & Gamble, then was senior director of product development at Church and Dwight (Arm & Hammer Division), where she was responsible for new products including the successful entries into the personal care and dental areas. She was then vice president, research & development of Oral-B Laboratories at Gillette, where she was responsible for worldwide R&D including clinical, regulatory, packaging and claim support as well as product development. She was then recruited as executive vice president and chief operating officer of Hill Top Research, Inc. and president of DRW Consulting Corporation, serving OTC and Rx start-up companies in technology development, business plans and marketing strategies. Dr. Walley holds 12 patents, largely dealing with consumer health products, and over 15 publications.

Words of Wisdom:

What has been the biggest challenge you’ve faced thus far?

“Creating awareness for our product. Even with healthy funding—$20 million initially plus a reasonable operating budget now that we’ve been acquired—it takes an incredible amount of money to create awareness.”

What should be the measure of success in our industry?

“Product sales and profit are obviously important, but we are also changing people’s lives. This has been a re­warding experience and we feel good about what we’re doing, but our shareholders are looking for a return on their investment. Hopefully by changing lives, we can spread the word and bring us to profitability.”

Where would you like to see your company/your work/your industry in five years?

“A $100 million brand. That’s reasonable in five years; we’ve added more products and changed our business model to a direct marketing model with doctors and ‘peer counselors.’ We’ve also introduced a new line of bars and drinks and we’re optimistic about our future growth.”

Are we making a difference?

“We’re making a huge difference. We are dealing with people who were in severe pain and couldn’t walk and now can do what they want to do.”

If you could change one thing, on an industry-wide scale, that would open up new opportunities for all industry, what would it be?

“I would bring more credibility to the category. Consumers are skeptical; we need to do clinical trials, put safety first and maintain efficacy in products.”