Tailoring Treatments to the Individual

Carrie Wolinetz PhD Associate Director for Science Policy and Chief of Staff for NIH Director Dr. Francis Collins www.nih.gov, speaking at the “The Regulatory Pathway for Personalized Medicine” event held in D.C on September 18th told the attendees, “To fight cancer, it is essential to find the right treatment, for the right person, at the right time”.

According to Dr. Wolinetz, “One size does not fit all. Each individual is different since our individuality creates a variation in disease and how we will react to medications. The fact is that treatments must be tailored to individuals, be precise, safe, and effective.”

Advances in EHRs, new technologies, genomics revolution, the evolution of data science, and the ability to merge data has enabled precision medicine to advance. As Dr. Wolinetz explained, “NIH’s “All of Us” Research Program https://allofus.nih.gov is the cornerstone of the precision medicine initiation.

The program is a new model of research based on collaboration among researchers to enable them to gather data over time from more than one million people living in the U.S. The goal is to use the data from the program for studies on a variety of health conditions, and to learn more about the impact of individual differences in lifestyle, environment, and biological makeup. The data types includes data from surveys, EHRs, physical measurements, biosamples, and from mobile and wearable technology.

Dr. Wolinetz explained, “The program will provide data on an ongoing basis to enable participants being studied to learn more about their own health indicators. The data infrastructure will be a rich data resource that will empower research and create a catalyst for innovative research programs and policies.”

The established program infrastructure will include data and research centers, biobanks, participant centers, community groups, a technology system center, healthcare provider organizations, plus communications and engagement partners. The right information will be collected to provide the right therapies for specific individuals.

“We want this program to reflect the rich diversity of our country,” said Eric Dishman, Director of the “All of Us” Research Program. Expanding our national network of healthcare provider organizations enhances our ability to reach communities that are underrepresented in medical research.”

Last July, awards were made as part of the program for $13.8 million and went to the Southern All of Us Network, SouthEast Enrollment Center, and to All of Us Wisconsin.” In addition, four community partners received awards totaling $1.7 million to begin building a national network to motivate diverse communities to join the research program and be part of the precision medicine initiative.

These awards went to FiftyForward, National Alliance for Hispanic Health, Delta Research and Educational Foundation, and to the San Francisco General Hospital Foundation.