Antoinette F. Konski

Antoinette F. Konski

Foley & Lardner LLP

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Latest Posts › Personalized Medicine


Navigating the Diagnostic Commercialization Process

Guest Post By: Perry Dimas, Senior Vice President and General Manager for Premier Source, part of AmerisourceBergen The 2015 Business of Personalized Medicine Summit was an inspiring day with talented professionals. One...more

10/13/2015 - American Medical Association CLIA Clinical Laboratories Clinical Trials CMS Coding Data Collection Diagnostic Tests FDA Health Insurance Healthcare Healthcare Providers Manufacturers Personalized Medicine Physicians Reimbursements

FDA Oversight of Diagnostic Medicine – A Trap for the Unwary

Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more

9/24/2015 - 510(k) RTA Diagnostic Tests FDA FDA Approval Medical Devices Patent Infringement Patent Invalidity Patent Litigation Patents Personalized Medicine Premarket Approval Applications Proposed Regulation Regulatory Oversight USPTO

Patent Subject Matter Eligibility – Impact on Litigation and Prosecution

Personalized medicine relies on diagnostic technologies to accurately evaluate a patient’s clinical or genetic signature to guide treatment decisions. Protecting innovation by patenting the diagnostic methods and tools that...more

9/21/2015 - Algorithms AMP v Myriad CLS Bank v Alice Corp Diagnostic Method Innovation Patent Intellectual Property Protection Mayo v. Prometheus Patent Infringement Patent Litigation Patent-Eligible Subject Matter Patents Personalized Medicine SCOTUS Software USPTO

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

8/28/2015 - Device Manufacturers Diagnostic Tests FDA Health Insurance Healthcare Healthcare Providers Medical Devices Patients Personalized Medicine Pharmaceutical Manufacturers Prescription Drugs Reimbursements

Will Personalized Medicine Survive Alternative Payment Models?

There is no doubt that health care costs in the United States are rising. According to a recent study published by the U.S. Department of Health and Human Services, personal health care expenditures in the United States...more

6/22/2015 - ACOs Affordable Care Act Alternative Payment Models (APM) Bundled Payments Cost-Containment Department of Health and Human Services Healthcare Healthcare Costs Healthcare Providers Patient Centered Medical Homes Personalized Medicine

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...more

4/28/2015 - Health Care Providers Healthcare Jerry Brown P3s Personalized Medicine Public-Private Partnerships

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...more

3/31/2015 - Barack Obama Federal Budget Healthcare Medical Research Personalized Medicine Regulatory Standards Research Funding

Details Emerge for President’s Precision Medicine Initiative

Personalized medicine has a friend in high places. President Obama recently announced an initiative to support “precision” or personalized medicine. In very general terms, the President stated during his 2015 State of the...more

2/4/2015 - Barack Obama Complete Genomics FDA Federal Funding Healthcare NIH ONC Personalized Medicine State of the Union Technology

President Obama Revisits Interest in Personalized Medicine

President Obama announced during his 2015 State of the Union Address that he is launching a new “precision” or personalized medicine initiative to advance personalized, effective therapies for the American public. As reported...more

1/27/2015 - Barack Obama Genetic Markers Healthcare Personalized Medicine Proposed Legislation

Another Patent Challenge for Personalized Medicine

The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles...more

12/9/2014 - Diagnostic Tests Genetic Materials Healthcare Patent Litigation Patent-Eligible Subject Matter Patents Personalized Medicine

Unlocking the Promise of Personalized Medicine: Reimbursement, Coverage, and Clinical Utility

AmerisourceBergen, in connection with the Business of Personalized Medicine Summit, released “Unlocking the Promise of Personalized Medicine: Perspectives on Reimbursement, Coverage, and Clinical Utility” (“Report“). The...more

9/16/2014 - Healthcare Personalized Medicine

Considering Sex-Specific Variation for Personalized Medicine

Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more

9/3/2014 - 510(k) RTA FDA Healthcare Medical Devices Personalized Medicine Premarket Approval Applications

Managing IP Risk in the Age of Personalized Medicine

As discussed on Foley’s Health Care Law Today blog, personalized medicine treatment trends and innovations are leading diagnostic and therapeutic companies to form complex arrangements and partnerships with the ultimate goal...more

8/8/2014 - Confidential Information Healthcare Patents Personalized Medicine Trade Secrets

Personalized Medicine Today: PMC Issues Fourth State of the Industry Report

Personalized medicine is changing the paradigm of the research, development and delivery of health care. The Personalized Medicine Coalition (PMC), a consortium of interested stakeholders that seeks to promote the...more

7/8/2014 - CMS FDA Healthcare Personalized Medicine

Is Next Generation Sequencing Ready for Personalized Medicine?

Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more

5/20/2014 - Clinical Laboratories Diagnostic Tests FDA Genetic Materials Healthcare Laboratories Personalized Medicine

Six Hot Opportunities in Genomic Medicine

Advances in DNA sequencing technology and the interpretation of the acquired data have fueled advances in genomics and its application in the delivery of personalized healthcare. Illumina recently announced a new milestone...more

1/28/2014 - Birth Defects Cancer DNA Genetic Markers Genetic Services Genetic Testing Healthcare Personalized Medicine

FDA Reaffirms Commitment to Personalized Medicine

In a report released on October 29, 2013, the U.S. Food and Drug Administration (FDA) announced its continued commitment to advancing personalized medicine. “Paving the Way for Personalized Medicine: FDA’s Role in a New Era...more

10/30/2013 - FDA Healthcare Personalized Medicine

Study Advances Personalized Medicine for Newborns

Earlier this year, the American Academy of Pediatrics (AAP) and the American College of Medical Genetics and Genomics (ACMG) issued recommendations and proposed best practices for genetic testing and screening of infants and...more

9/13/2013 - American Academy of Pediatrics Genetic Testing Healthcare Medical Research Personalized Medicine

From Personal Computers to Personalized Medicine

Personalized medicine offers something for everyone. Dell Corporation, most notably known for producing computers has recently become deeply involved in the health industry....more

8/22/2013 - Biotechnology Healthcare Personalized Medicine Technology

Clinical Progress in Regenerative Medicine

Two separate clinical initiatives were recently announced that support the therapeutic use of regenerative medicine. The first utilzing induced pluripotent stem cells and the second, a state-wide network in support of...more

8/7/2013 - Healthcare Medical Research Personalized Medicine Stem cells

Expanding Access to, and Development of, Personalized Medicine

In a July 8th, 2013 letter to the Centers for Medicare & Medicaid Services (CMS), the Personalized Medicine Coalition (PMC) advised that proposed reimbursement schedules for diagnostic medicine will threaten the development...more

7/24/2013 - CMS Diagnostic Method Healthcare Medical Reimbursement Patients Personalized Medicine

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more

2/25/2013 - CMS Diagnostic Tests FDA Labeling Laboratory Developed Tests Marketing Personalized Medicine Pharmaceutical

Personalized Medicine Patenting Update

Patenting diagnostic methods is more challenging in the wake of the U.S. Supreme Courts Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (Prometheus) and the USPTO’s application of the...more

1/14/2013 - Diagnostic Method Mayo v. Prometheus Patents Personalized Medicine SCOTUS USPTO

Personalized Medicine: An Industry Report

Increasingly, the development of new pharmaceuticals utilize genetic information to stratify patient subpopulations and/or predict efficacy and adverse events – the development paradigm of personalized medicine....more

12/31/2012 - Genetic Markers Personalized Medicine Pharmaceutical

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