All of Us Research Program Opens May 6th

The National Institutes of Health (NIH) opened national enrollment today, May 6th, for the All of Us research program. Initially branded as the “Precision Medicine Initiative Cohort Program,” All of Us is the largest health and medical research program on precision medicine, aiming to enroll 1 million or more diverse volunteers. Any adult age 18 or older may enroll. Continue reading this entry

Advancing Access to Precision Medicine Act - A Bipartisan Bill

On February 15, 2018, representatives Eric Swalwell (CA-15), John Shimkus (IL-15), Scott Peters (CA-52), Erik Paulson (MN-03), and Juan Vargas (CA-51), introduced the Advancing Access to Precision Medicine Act (H.R. 5062)(“Bill”) to “provide a study by the National Academy of Medicine on the use of genetic and genomic testing to improve health care, and for other purposes.” (Bill, page 1).  The National Academy of Medicine’s report on its study is due within 3 years from the date of enactment. Continue reading this entry

Over 30% of New Drug Approvals in 2017 were Personalized Medicines

The Personalized Medicine Coalition (PMC) recently published its “Personalized Medicine at FDA: 2017 Progress Report” (Report) that highlights drug approval developments and milestones achieved in 2017. Last year was notable for a record number of personalized medicine approvals by the FDA, and 5 “firsts” for the industry:

  1. Three gene therapies were approved;
  2. A tissue agnostic indication for cancer therapy was approved;
  3. 23andMe received approval of its direct to consumer genetic test;
  4. A personalized medicine biosimilar was approved; and
  5. A test using next-generation sequencing technology was jointly approved by FDA and CMS.

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FDA Releases Stem Cell Guidance Documents

Therapies that use autologous or allogeneic stem cells are examples of early personalized therapies. Removing cells from a patient and reintroducing them to the same or a matched patient, for example, as done in bone marrow transplants or peripheral blood stem cell transplantation, has provided benefits to many patients and are effective treatments for leukemia, lymphoma, myelodysplasia, multiple myeloma, and certain immune deficiency diseases. Continue reading this entry

FDA Approves Companion Dx for PD-1 Inhibitor

According to the American Cancer Society (“ACS”), lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women (not counting skin cancer). About 14% of all new cancers are lung cancers and 85 % of those are non-small cell lung cancers (NSCLCs). Continue reading this entry