Carol L. Covin & Sky Blue Pharmaceuticals, LLC



It was the first time Carol had shared her 50-year plan in public. The first task on her list was: Cure Cancer. No one in the audience laughed. Afterwards, a young man came up to her and said, "My mother died of cancer when I was seven. I hope you are successful."

Carol was a software engineer who had been told by her friend, Rod, about a promising cancer treatment. Rod had used it against his inoperable stomach cancer. His 30-pound tumor was gone in six weeks. But, Rod told Carol, it was all natural, so couldn't be patented. He thought it would never go through clinical trials because no company would put up the money up to pay for it. Carol was neither a scientist nor a doctor. She thought if the science and medical problems were solved by this treatment, then this was, fundamentally, a business model problem. She put it away in her desk for 7 years.

Background with "Aha" Moment

Carol had always put herself in situations where she had no previous background. She told herself that it was because they were challenging and interesting. But, she also knew enough about herself to realize it lowered the risk of failure. No one expected an inexperienced person to be successful in a new field right away. It had happened when she studied Chinese, when her only previous language experiences were with the Latin-based languages of French and Spanish. It had happened when she was hired as a programmer with no Computer Science background. It had happened when she wrote her first book, and later opened her own publishing company. This was another case in that long line. No one would expect a software engineer to cure cancer.

Professional Challenge (Detail)

After that first public announcement that she was working on a cancer treatment, Carol continued to research the treatment in her spare time. She checked to see if the private library where Rod had found the original protocol still existed. It did. She spoke to the librarian, who remembered Rod, and asked for additional papers written by the scientist who had developed the protocol. And, she told people what she was doing. But, the key came one day when she told a friend who was a fellow volunteer at the MIT Enterprise Forum, Robbie. Robbie, also the President of Women in Bio, knew people in the biotech community, which Carol did not. Robbie said, 'There's someone you should meet.'

She introduced Carol to Freddie Ann, a pediatric oncologist who had worked at the Food and Drug Administration, the National Cancer Institute and a large pharmaceutical company. She had a consulting practice to help small pharmaceutical companies navigate the regulatory process. For Carol, this was the first independent, objective review of her project.

"Freddie Ann gave me homework assignments," says Carol. "I didn't have a lot of money to pursue this effort, and I wanted to conserve what little I had to pay for professional services like Freddie Ann's. First, she suggested I do a scientific literature survey to see what other scientists had done with this protocol. I spent 4 months in the NIH Medical Library getting copies of articles cited by the original scientist, then copies of articles they cited, 5 or 6 levels deep. It was a scientific education for me, similar to the immersion process of learning any language."

In the end, Carol wrote a 30-page abstract of what she'd been able to glean from almost 300 articles and gave it to Freddie Ann for review, along with the list of articles, to see if there was any point in pursuing this project.

Freddie Ann said, "Well, most of the articles are old, some self-published. But, the interesting thing about it is, people are using it. Go find 10 of them."

That took 14 months. As it happened, Freddie Ann had helped write the guidelines, while at FDA, for bringing promising alternative treatments through the regulatory process. Usually, they are too hard to test because they use plants which cannot be tested precisely or the active ingredients identified, or they use a combination of things so there are too many possible ways it might be working to nail down which one is causing the effect you see.

Carol's protocol was simple. The active ingredient was a simple compound. This was an excellent test of this relatively new approach for bringing alternative treatments through the regulatory process, by documenting case studies of people who had used the protocol, including what other treatments they might have followed, to find 'Best Cases'. These are necessarily anecdotal and retrospective, but, the idea is if you can show ideal cases where something seems to have worked, documented with medical records, then you might have identified something promising enough to study under controlled conditions in a clinical trial.

With her 10 case studies documented in a way that would pass FDA regulatory scrutiny, Carol gave the package to Freddie Ann for review. "3 of these cases used no other treatments except your protocol. FDA will find that interesting," was Freddie Ann's way of saying Carol had enough evidence to move forward with clinical trials. Next steps: formulation, manufacturing and fund-raising.

Carol has now interviewed 5 contract manufacturers, the companies that make the pills you use in a clinical trial. FDA requires exacting information about the manufacturing process and only a few manufacturers are willing to make the short runs needed for a clinical trial, and of those, only a few specialize in making pills. Carol is getting ready to interview chemists who will develop the formulation that is the blueprint a manufacturer needs to make the pills. Along the way, an attorney who specializes in working with small pharmaceutical companies, told her that formulations can be patented, so she is now writing a patent application for her formulation.

Since clinical trials, even the kind of small one she anticipates first, cost several million dollars, fund-raising will be a considerable challenge. The typical grant mechanisms available for pharmaceuticals are generally aimed earlier in the process, at the research stage, not the clinical trial stage.

Self-funded to date, when she could still do much of the work herself, Carol realizes signing up a manufacturer will take the commitment of someone or some organization with deeper pockets than hers. And, she needs to cut down the large funding commitment into smaller chunks, to see if there are organizations willing to underwrite some of the smaller tasks, while she builds trust and success in her approach. Her new challenges are: how to carve out milestone-oriented tasks, with small dollar requirements to interest small investors in her venture and how to identify and contact potential investors, some with the ability to fund small tasks, some with the means to underwrite a clinical trial.

Personal Challenge (Detail)

Carol knew she could not continue to hide behind the safety of being new to a professional area. Already, people were starting to ask her, 'How did you get to be so knowledgeable in this field?' A fellow entrepreneur, Sharon, who had similarly taken on a challenge in a new industry, told her, "When I started out, I could only talk for 5 minutes before someone realized this wasn't my area, then 15 minutes. Now, they don't ask me anymore."

During the seven years she let this lie in her desk, she occasionally sent a copy to people who were in the news, in the last stages of cancer. Some had even started foundations to look for a cure. The approach had been known for twenty years. Thousands had reportedly tried it. Surely, there were many people more qualified than she to pursue this. But, no one did.

There is safety in not being expected to know. But, you have to earn credibility to move ahead and that means taking responsibility for knowing the area you are discussing. In one of her early presentations, Carol made the mistake of answering a question too quickly by extrapolating what she knew to the questioner's concern. Later, more data suggested she was wrong, but, by then, she had lost all credibility with that questioner, a potential investor, as it turned out.

She needed to own her stake in this project and own the fact that, though she had come to the effort with no background, now she had assembled information about it that no one else had. In the larger world of cancer treatments, there would always be much she didn't know. She would never be a scientist or physician. And, just like many other promising treatments, there was always the possibility that she was going down a blind alley. She learned early in the process that, unlike in the software world, where you could generally work around a technical problem, in this world, every milestone ended with a go/no go decision. She could no longer use the excuse that this was not her world. Now, it is.