A Remembrance: An exceptional responder

Remembering Jane Reese-Coulbourne, a fierce advocate for patients who changed medical research

Jane Reese-Coulbourne was an exceptional responder.

In 1990, faced with a diagnosis of advanced breast cancer, she enrolled in a clinical trial at the National Cancer Institute, enduring a grueling regimen of high doses of chemotherapy drugs, nightly injections of GM-CSF, and radiation. The researchers deemed the trial a failure because it didn’t help most of the women -- but it was a success for Jane.

The trial not only saved her life, it changed its course, propelling her on a path that enriched the lives of many others.

Jane abandoned a successful career as an engineer, dedicating the rest of her days to empowering patients and to pushing scientists, physicians and drug developers to understand the need to put patients at the center of medicine and medical research.

That idea, which seems obvious now, seemed absurd to most in the field when she started.

Jane co-founded the National Breast Cancer Coalition, an advocacy group for breast cancer survivors, and served as its EVP from 1991 to 1998. There, she helped create Project Lead, which gives breast cancer survivors the scientific knowledge they needed to participate in decision-making about allocation of research funds and trial designs.

The coalition recruited women for trials of Herceptin trastuzumab at a time when it looked like Genentech Inc., now part of Roche, might have to abandon the drug because it couldn’t enroll enough breast cancer patients to demonstrate its safety and efficacy. The coalition’s efforts made the development of a life-extending drug possible, and in the process demonstrated the value of integrating patients into drug development.

“Jane insisted that people living with cancer and other conditions had a place at the table.”

Mark Krueger, MK&A

Jane left the coalition in 1998 to serve as an advisor to NCI Director Richard Klausner. At NCI, she helped design studies to produce data that was more relevant to patients and reduced barriers that made it difficult for patients to participate in research.

After leaving NCI, Jane advised individual patients, patient advocates and advocacy groups. She served as board chair of the Lung Cancer Alliance from 2008 to 2010.

In 2010, FDA Commissioner Margaret Hamburg tapped Jane to become the founding executive director of the Reagan-Udall Foundation for the FDA. She brought her training as an engineer, expertise in regulatory science, and passion for patients to the job. She also had to draw on her toughness and sense of humor to stay afloat through political storms that threatened to sink the organization.

Her legacy at Reagan-Udall includes establishment of the Innovation in Medical Evidence Development and Surveillance (IMEDS) program, which applies big data methods to biomedical research.

After leaving Reagan-Udall in January 2016, Jane joined MK&A, a consulting firm, where she advised medical product developers on clinical trial designs and pre-approval access.

“Jane insisted that people living with cancer and other conditions had a place at the table and should be respected for their knowledge, experience and preferences,” said Mark Krueger, president of MK&A. She believed that “clinical trial designs should reflect patients’ experience,” and that pre-approval access should be offered when appropriate.

Jane helped shape expanded access programs for a number of drugs, including Gleevec imatinib from Novartis AG, Iressa gefitinib from AstraZeneca plc, and Velcade bortezomib from Takeda Pharmaceutical Co. Ltd. She was a member of the New York University Langone Medical Center Working Group on Compassionate Use and Pre-Approval Access.

Jane “had a huge impact on thinking about clinical trials from a patient point of view,” Arthur Caplan, head of the Division of Medical Ethics at NYU, told BioCentury. “She was a key player on the Washington scene in part because she brought personal experience battling illness, in part because she was very, very smart, and in part because she had an engineer’s ‘let’s get it done’ view of life.”

In February, Jane was named executive director of the Hearing Industries Association.

Jane Reese-Coulbourne died of cancer on April 23.

For all who knew her, and many more who benefited from her actions, she will be remembered as an exceptional responder.

Companies and Institutions Mentioned

AstraZeneca plc (NYSE:AZN; LSE:AZN), London, U.K.

Genentech Inc., South San Francisco, Calif.

Hearing Industries Association, Washington, D.C.

Lung Cancer Alliance, Washington, D.C.

National Breast Cancer Coalition, Washington, D.C.

National Cancer Institute, Bethesda, Md.

New York University, New York, N.Y.

Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland

Reagan-Udall Foundation for the FDA, Washington, D.C.

Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan

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