Pioneering Leader’s Visionary Research Underpins Two Flagship Personalized Medicine Products That Revolutionized Cancer Care
WASHINGTON (June 19, 2019)
In recognition of visionary scientific research underpinning two flagship personalized medicine products — a therapy and a diagnostic — that have revolutionized cancer care, the Personalized Medicine Coalition (PMC) is pleased to announce that it has selected Dr. Steven Shak, Co-Founder, Chief Scientific Officer, Genomic Health, as the recipient of the 15th Annual Leadership in Personalized Medicine Award.
Dr. Shak demonstrated his talent for groundbreaking scientific discoveries soon after he earned his M.D. from New York University (NYU). After beginning his career as an assistant professor at NYU, Dr. Shak discovered and cloned the human DNase I gene during the first half of his 14-year tenure at Genentech. This discovery provided the foundation for Genentech’s development of dornase alfa (Pulmozyme), the first treatment for cystic fibrosis. The therapy helped extend the life expectancy of cystic fibrosis patients significantly.
Dr. Shak turned his attention to personalized medicine while leading development of Genentech’s trastuzumab (Herceptin), a targeted therapy that is designed to inhibit the function of genes over-expressed by breast cancer cells. Dr. Shak spearheaded the first regulatory approval of a personalized medicine in the U.S. by shepherding trastuzumab through the Food and Drug Administration (FDA) on the heels of rigorous clinical trials in 1998, five years before scientists spurred the development of additional personalized therapies by finishing the first complete sequence of a human genome.
Trastuzumab is now part of the standard of care for the 20 – 30 percent of breast cancer patients whose tumors over-express HER2 genes.
Following his tenure at Genentech, Dr. Shak co-founded Genomic Health, where he led the development of the Oncotype IQ® portfolio of diagnostic tests and services, which analyzes the genomic characteristics of cancer cells to predict how aggressively the cancer might spread, thereby sparing patients and the health system from unnecessary side effects and costs. The tests, which were among the first to demonstrate that personalized medicine can improve patient care and make health systems more efficient, have already been used to guide treatment decision-making for more than 1 million cancer patients and have saved health care systems more than $5 billion.
Following the release of long-term study results last year, the American Society of Clinical Oncology (ASCO) has published new guidelines that support the use of Oncotype testing based on its ability to identify which node-negative, early-stage breast cancer patients can safely avoid chemotherapy treatment.
Kim Popovits, Chairman of the Board, CEO, President, Genomic Health, said Dr. Shak is now focused on unlocking an era of personalized medicine enabled by real-world evidence. “Steve is truly a pioneer in personalized medicine who continues to blaze new frontiers,” Popovits said. “He constantly challenges all of us to innovate so that we continue to answer the most critical clinical and scientific questions.”
PMC will present Dr. Shak with the Leadership in Personalized Medicine Award during The 15th Annual Personalized Medicine Conference at Harvard Medical School. After accepting the award, Dr. Shak will share his vision for the future of the field with conference attendees.
Christopher J. Wells
About the Personalized Medicine Coalition:
The Personalized Medicine Coalition, representing innovators, scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system.
About the Leadership in Personalized Medicine Award:
PMC’s Leadership in Personalized Medicine Award recognizes an individual whose contributions in science, business, and/or policy have helped advance the frontiers of personalized medicine.
About The Annual Personalized Medicine Conference:
PMC's Annual Personalized Medicine Conference convenes the world’s leading researchers, investors, industry executives, policy experts, payers, clinicians, and patient advocates to define the landscape and outlook for personalized medicine in science, business, and policy. For more information about the conference, visit www.personalizedmedicineconference.org.