News & Analysis as of

Precision Medicine Initiative (PMI)

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's...

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Lynnsey and Matthew are joined by Neal Goodwin and Pawel Krysiak of Jaya Bio, a preclinical life sciences company developing gene therapies for genetically defined neurodegenerative diseases. They share how their team is...more

Foley & Lardner LLP

NIH Funded Research Centers Support Precision Medicine Research

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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...more

Foley & Lardner LLP

White House Report Identifies Precision Medicine for Future R & D Investment

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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...more

Foley & Lardner LLP

USPTO Extends Patents 4 Patients Program

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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...more

McDermott Will & Schulte

[Webinar] Possibilities and Pitfalls: Reimbursement and Regulatory Issues - July 21st, 12:30 pm - 1:30 pm EDT

Through the groundbreaking creation and rapid development of cutting-edge diagnostic and treatments solutions that significantly improve patient outcomes for cancer and other conditions, precision medicine has, and will...more

McDermott Will & Schulte

[Ongoing Program] Precision Health: Trends And Future Potential - Exploring Consumer Engagement with Precision Medicine - July...

Precision health has the potential to dramatically transform the healthcare landscape by developing cutting-edge solutions that significantly improve patient outcomes. Now, following its contributions to the groundbreaking...more

McDermott Will & Schulte

[Ongoing Program] Precision Health: Trends And Future Potential - Possibilities and Pitfalls: Reimbursement and Regulatory Issues...

Precision health has the potential to dramatically transform the healthcare landscape by developing cutting-edge solutions that significantly improve patient outcomes. Now, following its contributions to the groundbreaking...more

McDermott Will & Schulte

[Ongoing Program] Precision Health: Trends And Future Potential - Provider Perspectives on Precision Partnering - June 29th, 12:30...

Precision health has the potential to dramatically transform the healthcare landscape by developing cutting-edge solutions that significantly improve patient outcomes. Now, following its contributions to the groundbreaking...more

Foley & Lardner LLP

Can AI Transform Precision Medicine?

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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. Recognizing...more

Holland & Knight LLP

Sequence of Events: Genetic Testing Offers Significant Promise, But Coverage and Access Limited

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In the world of rare diseases, patient testimonies about the extreme difficulties of receiving an accurate diagnosis for an illness are numerous. For instance, one woman, sick for most of her young life, was not properly...more

Foley & Lardner LLP

PMC Releases "A Consumers Guide to Genetic Health Testing"

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The Personalized Medicine Coalition, or the “PMC” is an organization of over 250 members that seeks to promote the understanding and adoption of personalized or precision medicine concepts, services, and products by health...more

White and Williams LLP

Digital Twin Technology in Healthcare

White and Williams LLP on

Imagine a future where personalized healthcare will provide every individual with the right treatment at the right time. Advances in precision medicine have already led to powerful new discoveries and treatments that are...more

Foley & Lardner LLP

Advancing Access to Precision Medicine Act - A Bipartisan Bill

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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....more

Foley & Lardner LLP

Precision Medicine - Obama’s Health Care Legacy

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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...more

Knobbe Martens

The Passage of the 21st Century Cures Act by Congress will produce Sweeping Changes to the Biotech, Medical Device,...

Knobbe Martens on

The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more

Epstein Becker & Green

Next-Generation Sequencing: FDA Issues New Guidance for Genetic Tests

Epstein Becker & Green on

On July 6, 2016, the U.S. Food and Drug Administration (“FDA” or “Agency”) released the following two draft guidance documents on the oversight of next-generation sequencing (“NGS”) tests...more

Mintz

FDA Comes Through on Promise to Release NGS Device Draft Guidelines Expeditiously

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Building on last year’s public workshops related to Next-Generation Sequencing (NGS) and expanding its efforts to advance the Obama Administration’s Precision Medicine Initiative, the FDA late last week released two draft...more

Cozen O'Connor

Data Security Plays a Key Role in the Adoption and Success of Precision Medicine

Cozen O'Connor on

The White House recently released a guidance document for those in the precision medicine community to help ensure that participants’ data and resources remain secure. The document, titled “Precision Medicine Initiative:...more

King & Spalding

White House Finalizes Data Security Framework For Precision Medicine Initiative

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On May 25, 2016, the White House unveiled the final data security framework for its Precision Medicine Initiative (“PMI”). One of the main goals of PMI is to develop a research cohort for collecting health data from...more

Winstead PC

HHS Releases HIPAA Privacy and Security Audit Guidelines as it Starts its Second Round of Audits and Continues Enforcement Efforts

Winstead PC on

During April 2016 the Department of Health and Human Services (“HHS”) posted lengthy audit guidelines for HIPAA Privacy and Security on its website (over 400 pages). As HHS starts its audits of health care providers, health...more

Foley & Lardner LLP

Despite Barriers, Community Speciality Clinics are Eager to Adopt Precision Medicine Tools

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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...more

Mintz - ML Strategies

Senate HELP Committee Convenes Third and Final Cures Markup

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On April 6, 2016 the Senate Committee on Health, Education, Labor, and Pensions (HELP) will hold its third and final markup for its biomedical innovations package. This package is a compliment to the House-passed 21st Century...more

WilmerHale

M&A: The Last Refuge for Biotechs Seeking Funding

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These are tough times in the biotech and pharmaceutical industries: Funding is drying up, investors are fleeing the space, the IPO door is pretty firmly shut, valuations are dropping, activists are lurking and the headlines...more

Foley & Lardner LLP

Capitalizing on Collaboration – The President’s Precision Medicine Initiative

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Last week President Obama marked the one year anniversary of his Precision Medicine Initiative (“PMI”) by holding a web-accessible panel discussion where he and interested stakeholders discussed his PMI initiative, its...more

Mintz

Israel Connect - Legal Insight for Success in the US Market

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We are excited to present you with the second issue of Israel Connect — our quarterly newsletter focused on forging new connections and strengthening existing bonds between Israeli businesses and the US market. In our second...more

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