Category Archives: Precision Medicine Initiative

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USPTO Extends Cancer Immunotherapy Pilot Program

On June 29th, 2016, the USPTO announced the Cancer Immunotherapy Pilot Program to allow expedited examination of patent applications that pertain to cancer immunotherapy. Under the Program and after proper petition, the USPTO has examined qualifying applications out of turn thereby expediting examination. The Program was implemented to support the National Cancer Moonshot and was … Continue reading this entry

Precision Medicine - Obama’s Health Care Legacy

As we come to the end of President Obama’s administration, it is time to look back on the past eight years and the administration’s impact on the delivery of the nation’s health care. While the Affordable Care Act (signed into law early in the President’s administration on March 23rd, 2010) is a significant achievement in … Continue reading this entry

Personalized Medicine: Insights Into Current Legal Issues

Guest Post by:  Nate Beaver, Esq.; Gary Koch, Esq.; Antoinette Konski, Esq.; and Judy Waltz, Esq., Foley & Lardner, LLP. In his January 20, 2015 State of the Union address, President Obama brought to the nation’s attention the promise of personalized medicine when he announced the Precision Medicine Initiative (the “PMI”). In announcing this initiative during … Continue reading this entry

FDA Issues Guidance on Use of Public Human Genetic Variant Databases and Their Use in Personalized Medicine

Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development of personalized or precision medicine. Analysis of whole genomes is providing insight into the diagnosis, prediction and treatment of disease, and will continue to do so as more genetic information is collected and … Continue reading this entry

FDA Issues Draft Guidance To Streamline Regulatory Oversight Of NGS-Based Tests For Diagnosing Germline Diseases

Personalized or Precision Medicine needs reliable and accurate diagnostic tests to guide clinical intervention and treatment decisions. Traditional testing of germline variants is site-specific and therefore only provides information on one or at most, several variants at a time. Advances in DNA sequencing technology, notably Next Generation Sequencing (NGS), permit the analysis of millions of variants … Continue reading this entry

DESPITE BARRIERS, COMMUNITY SPECIALTY CLINICIANS ARE EAGER TO ADOPT PRECISION MEDICINE TOOLS

GUEST POST BY Vicki Albrecht, Ph.D., Senior Vice President and General Manager of ION Solutions Fueled by technological advances, scientific breakthroughs and significant financial investments, precision medicine (PM) has emerged as a promising approach to disease prevention and treatment. A multi-faceted solution to patient care, PM can improve patient outcomes and increase the effectiveness of … Continue reading this entry

Data Transmission, Personalized Medicine, and Privacy

Health care analytics make use of patient data to inform treatment decisions and is increasingly moving front and center in personalized medicine. For example, the President’s Precision Medicine Initiative (see post of January 26, 2016) has rolled out a program to collect health data from one million volunteers to inform and guide future research. Consumers … Continue reading this entry

The President’s Precision Medicine Initiative – The First Annual Check-Up

Watching President Obama’s recent 2016 State of the Union Address reminded me that one year has passed since the President announced a new “precision” or personalized medicine initiative to advance personalized, effective therapies for the American public. It was during his 2015 State of the Union Address that the President stated:[1] “[T]onight, I’m launching a … Continue reading this entry

California’s Bet on Precision Medicine

California sees opportunities in personalized medicine. Earlier this month, Governor Brown announced the creation of a two year initiative – California Initiative to Advance Precision Medicine to “begin building infrastructure and assembling resources necessary to advance precision medicine-orientated data, tools and applications.” See California Launches Initiative to Advance Precision Medicine.… Continue reading this entry

Perspectives on the President’s Precision Medicine Initiative

President Obama’s “precision medicine initiative” earmarked over $200 million from his proposed 2016 budget to “bring us closer to curing diseases like cancer and diabetes – and to give all of us access to the personalized information we need to keep ourselves and our families healthier.”[1] The National Institutes of Health (“NIH”) and the National … Continue reading this entry