Somatic mosaicisms are post-conception changes to cellular DNA that lead to genetic variation among cells in an organism. These changes can account for variation among individuals’ health or disease progression. Therefore, an understanding of their implication in disease response could
Personalized Medicine Bulletin
The Personalized Medicine Bulletin, published by Foley & Lardner LLP, focuses on legal and regulatory developments related to precision and personalized medicine. It covers topics such as FDA approvals of personalized therapies, gene and cell-based treatments, diagnostic testing systems, and emerging technologies in biomanufacturing and gene editing. The bulletin also addresses government initiatives and funding programs supporting precision medicine research, including NIH and White House efforts. Additionally, it discusses intellectual property issues like patent programs for cancer immunotherapy and regulatory guidance impacting the development and commercialization of personalized medical products.
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Cancer Moonshot Initiative Adds Precision Surgery Effort
The White House recently announced the Precision Surgery Initiative (PSI) as a “first-of-its kind Advanced Research Projects Agency for Health (ARPA-H) program to develop novel technologies” to more precisely excise cancerous growths to improve outcomes for cancer patients. July 27…
White House Report Identifies Precision Medicine for Future R & D Investment
Precision medicine was identified by a recent White House Office of Science and Technology Policy Report (“Report”) as a research and development priority for the United States over the next 20 years. The Report highlighted goals to advance…
Personalized Medicine at FDA: The Scope & Significance of Progress in 2022
The Personalized Medicine Coalition (PMC) recently released its annual report on the progress of precision medicine as measured by precision medicine FDA approvals in 2022 (“Report”). As summarized in the Report, 2022 milestones include progress in diagnostics, therapeutics…
USPTO Extends Patents 4 Patients Program
Precision or personalized medicine seeks to find the right treatment for each patient at the right time based on the patient’s genes, proteins and other personal characteristics. The approach has been successfully used to treat cancer. Indeed, many of the…
Impact of Current 101 Jurisprudence on Precision Medicine Innovation
The USPTO recently released a Report to Congress (“Report”) detailing the results of its call for public comments regarding the impact of U.S. jurisprudence on patent subject matter eligibility. The Report is responsive to requests from Senators Thom Tillis (R-NC),…
Personalized Medicine: 2021 FDA Guideposts for Progress – Focus On Diagnostics
Last week I reported on The Personalized Medicine Coalition’s (PMC) recently released PERSONALIZED MEDICINE AT FDA: The Scope & Significance of Progress in 2021 (2021 Report) that surveyed U.S. Food and Drug Administration (FDA)-approved personalized therapies. In addition to personalized…
Personalized Medicine: 2021 FDA Guideposts for Progress
The Personalized Medicine Coalition (PMC) released PERSONALIZED MEDICINE AT FDA: The Scope & Significance of Progress in 2021 (2021 Report), its recent survey of U.S. Food and Drug Administration (FDA)-approved personalized therapies and diagnostic tests that enable those therapies. The…
Can AI Transform Precision Medicine?
Artificial Intelligence (AI) has changed our lives. Improvements in data mining, personal and automotive navigation, cybersecurity, personal entertainment and healthcare are several examples of the impact of AI.[1] Recognizing that technological process can be measured by a review of the…
Does Payer Coverage Drive Genomic Test Utilization in the United States?
Does payer coverage of genomic testing drive utilization? That is the question The Personalized Medicine Coalition (“PMC”) asked and answered in its recent report “Understanding Genomic Testing Utilization and Coverage in the US” (“Study”). PMC’s Study, conducted in…