SOUTH SAN FRANCISCO, Calif. — (BUSINESS WIRE) — Freenome, a leading artificial intelligence (AI) genomics company, announced the creation of its IMPACT Advisory Board, a group tasked with helping Freenome’s leadership team optimize the company’s short- and long-term strategies, including those for its first commercial launch.
With a focus on clinical development, regulatory approval, health economics, coverage and reimbursement, the IMPACT Advisory Board is the cornerstone of Freenome’s commitment to ensuring that as many patients as possible have access to and benefit from the first ever, blood-based, AI-genomic test available for the early detection of colorectal cancer (CRC).
Guiding regulatory strategy will be Alberto Gutierrez, Ph.D., a partner at NDA Partners LLC and a former 25-year veteran of the U.S. Food and Drug Administration (FDA), including six years as Director of the agency’s Office of In-Vitro Diagnostics (OIVD), a tenure that saw breakneck advances in the field of molecular diagnostics. Joining Dr. Gutierrez will be Louis Jacques, M.D., Chief Clinical Officer of ADVI Health and former head of the Centers for Medicare and Medicaid Services’ (CMS) Coverage and Analysis Group. He will advise on payer strategy along with Sherie Smalley, M.D., Senior Medical Director, Medical Policy, at UPMC Health Plan.
According to Dr. Jacques, “After conversations with representatives of companies during my years with CMS, I was often left with the feeling of, ‘I wish they had talked to us two, three, even four years earlier. We might have been able to give them some advice back then that would have put them in a better situation now.’ Working with Freenome is an opportunity to get it right from the very beginning.”
According to Girish Putcha, M.D., Ph.D., Freenome’s Chief Medical Officer,“With the IMPACT Advisory Board, we’re intentionally recruiting experts who represent the diversity of stakeholders in the healthcare ecosystem. This initial group has a proven track record of safeguarding patients while expediting access — not just to the latest technologies, but to those with the most significant clinical benefits.”
To advise on clinical development strategy, Freenome has retained expert gastroenterologists, such as Douglas Robertson, M.D., M.P.H., from the U.S. Multi-Society Task Force of Colorectal Cancer (MSTF). Inclusion in clinical screening guidelines from such organizations is often an essential step to achieving broadscale coverage and reimbursement from the nation’s payers.
“In today’s healthcare environment, even the most revolutionary medical technology can only be transformational if it’s widely reimbursed,” said Mike Nolan, Chief Commercial Officer of Freenome. “Beginning with that end in mind was what led us to reach out to the people who understand that reality better than anyone else.”
Freenome is an AI genomics company on a mission to empower everyone with the tools they need to detect, treat, and ultimately prevent their diseases. By applying advanced machine learning techniques to recent breakthroughs in genomic science, Freenome is developing noninvasive blood tests to detect early-stage cancer and improve precision oncology treatments for millions of patients. The company has raised $78 million from investors such as Andreessen Horowitz, Google Ventures, Polaris Partners, and Founders Fund. More information at: https://www.freenome.com/.
Lena Cheng, M.D.