BioWorld Today Contributing Writer

Editor's note: Biotech Foundations is a new BioWorld Today column that recognizes biotech-related nonprofit organizations, as well as those founded by biotech industry luminaries. Tell us about your nonprofit at newsdesk@bioworld.com.

When Laura Shawver was president of Sugen Inc., which developed Sutent (sunitinib malate) to treat kidney and stomach cancer, she never dreamed she would one day become a cancer patient. But when Shawver was diagnosed with ovarian cancer in 2006, she quickly learned that her wealth of knowledge about the molecular pathways of cancer cells was of little value in treating her own condition.

Rather than benefiting from the advances of molecular profiling, Shawver discovered, women diagnosed with ovarian cancer were still being treated using protocols developed 40 years earlier.

At Redwood City, Calif.-based Sugen, which was acquired in 2003 by Pfizer Inc., of New York, scientists had sought to develop optimum dosing regimens for oncology drugs by targeting pharmacodynamic markers rather than relying on the traditional dose-escalation model.

"We would routinely collect blood, tumor, hair, skin and other samples from patients as part of clinical trials," Shawver told BioWorld Today. "When I was diagnosed, my first thought was, 'I'm going to get my tumor profile.' I thought that would be easy, but it wasn't."

Shawver got lucky; her cancer was discovered at stage I. Still, she learned that ovarian cancer's high recurrence rate subjected many women and their physicians to a treatment guessing game. Although multiple treatment options exist for refractory and recurrent ovarian cancer, the individual response rate is less than 10 percent, according to Shawver.

When she complained that ovarian cancer was still treated empirically, a colleague, attorney Tracy Macuga, encouraged Shawver to apply her experience as a biotech researcher and executive to change that paradigm. Recognizing that the market for ovarian cancer – which is newly diagnosed in some 21,000 women in the U.S. each year – was too small to sustain a for-profit business, Macuga suggested a foundation. She proposed the name – the Clearity Foundation – to reflect Shawver's cancer, which was the chemo-refractory clear-cell subtype. The name struck a chord with Shawver "that we were clear" about treating recurrent and refractory disease and, in 2008, she launched the foundation.

The Clearity Foundation is a 501(c)(3) not-for-profit that serves as a clearinghouse for women diagnosed with refractory and recurrent ovarian cancer. With the goal of helping women diagnosed with ovarian cancer to find the most appropriate treatment available at the time they need a decision, its website lists many of the clinical trials for ovarian cancer and provides a link to the complete list at the National Institutes of Health.

The foundation also partners with CLIA-certified diagnostic labs to offer access to immunohistochemical analyses, gene amplification and mutational analysis of tumor samples. The foundation pays for tests to be performed if they are not covered by insurance and interfaces with a patient's gynecologic oncologist, surgeon, pathologist and genetic counselor to ensure that appropriate samples for molecular profiling are obtained and results – including treatment options – are communicated to the treating physician. To date, the foundation has profiled the tumors of nearly 200 women.

"We're the only foundation in America that is focused on women who are diagnosed with cancer today and need help today," Shawver explained. "We are not about early detection, and we're not about cures for the future. Our mission is simply to help women and their physicians who are facing difficult treatment decisions."

Using that mission as a platform to raise grants and other funding requires the foundation to run a lean operation. With only one full-time and three part-time employees, plus volunteers and consultants, the organization operates almost virtually. Shawver hopes to expand the staff as more physicians and patients seek out the foundation's services.

"We want to stay up to date with the latest technologies and markers that match to drug efficacy," she explained. Today, those technologies consist of a battery of chemical markers, mutational analyses and DNA amplification tests. Tomorrow, the science might encompass circulating tumor cells or microRNA, she added.

Until recently, Shawver served as CEO of San Diego-based Phenomix Corp., which ceased operations last month. (See BioWorld Today, Oct. 28, 2010.)

As an entrepreneur-in-residence at 5AM Ventures, in Menlo Park, Calif., she's temporarily devoting additional time to Clearity.

The foundation's board members and officers also volunteer their time. Partners such as molecular diagnostics company Illumina Inc., of San Diego; advisory firms Blueprint Life Science Group, of San Francisco; and New York-based public relations firm Porter Novelli Life Sciences offer in-kind services and underwrite educational and other events.

To date, the foundation's signature achievement has been to facilitate a system to transfer ovarian cancer samples from hospital pathology labs to specialized testing facilities, Shawver said. In April, she also presented a poster at the American Association for Cancer Research's annual meeting in Washington, describing the dynamic range and expression of ovarian cancer markers that matched to drugs in a subset of patients in the foundation's database.

Long term, the Clearity Foundation hopes to improve the survival rate and quality of life for women with ovarian cancer. Shawver also wants to educate payers about the value of tumor profiling. Across all cancers, only 25 percent of patients respond to chemotherapy, so many patients "get toxicity without benefit at a cost," she said. If patients and their physicians could choose from among five therapeutic options to treat recurrent cancer, "why not pick one where there's some rationale to expect a response?" she asked.

Shawver hopes the evidence on ovarian cancer that the Clearity Foundation is gathering today will lead to an appropriate clinical trial design where the data can be tested formally.

"I chose to start a foundation because I couldn't find anything out there that was focused on recurrent patients," she said. "I knew how frustrated I was when I was trying to get my tumor profiled. If you're Jane Doe off the street, it's even more difficult to get access to the latest diagnostic tools."