Antoinette F. Konski

Antoinette F. Konski

Foley & Lardner LLP

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Latest Posts › Clinical Trials


EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated...more

6/20/2016 - Clinical Trials Comment Period DNA Draft Guidance EU Genetic Markers Personalized Medicine Pharmaceutical Industry Prescription Drugs

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

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

5/23/2016 - Clinical Trials Diagnostic Tests Genetic Testing Health Care Providers Personalized Medicine Physicians Precision Medicine Initiative (PMI) Reimbursements

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 Care Providers Health Insurance Healthcare Manufacturers Personalized Medicine Physicians Reimbursements

FDA Issues Draft Guidance for Clinical Trials Using Enrichment Strategies

The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment...more

1/7/2013 - Biotechnology Clinical Trials FDA

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