Tag Archives: Q&A

FDA’s New Breakthrough Designation Process: A Patient Perspective

With the FDA holding its first patient-focused drug development meeting in October of last year, regulators are starting to take notice of the impact disease-based organizations can have in improving drug trial design for new therapies—particularly for rare diseases. According to Teresa Barnes, Vice President of Patient Outreach & Program Support for the Coalition for […]
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On the Record: Colleen McHorney’s Next Step Agenda on Medication Adherence

PharmExec sat down with Colleen A. McHorney, PhD, former Senior Scientist at Merck’s U.S. Outcomes Research to review her long record of scientific research on adherence in advance of her retirement last month. McHorney highlights the cyclical nature of engagement on adherence programs, technology’s inherent inadequacies, the need to study the provider as well as […]
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