Listening to patients: The FDA goes from strength to strength - The Pharma Letter

Hosted by the FDA’s Office of Patient Affairs (OPA), together with the National Organization for Rare Disorders (NORD) and the Reagan-Udall Foundation, Patient Listening Sessions are small and informal conversations that bring patients/caregivers and researchers together. These sessions are aimed at complementing the FDA’s existing patient engagement initiatives.
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How to Talk to Patients Reluctant to Get a COVID-19 Vaccine - Medscape

Family physician Mitchell A. Kaminski, MD, MBA, was still awash in feelings of joy and relief at recently being vaccinated against COVID-19 when a patient's comments stopped him cold. The patient, a middle-aged man with several comorbidities, had just declined the pneumonia vaccine – and he added, without prompting, that he wouldn't be getting the COVID vaccine either. This patient had heard getting vaccinated could kill him.

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'Part of recovery is awareness': Pandemic casts harsh spotlight on industry-wide lack of diversity in clinical trials -Endpoints

Moderna emerged as an early leader in the race for a vaccine to stop Covid-19 in its tracks. The Cambridge, Massachusetts-based biotech bounded through development of one of the world’s first mRNA vaccines, but in September — when the pandemic was claiming upwards of 700 lives a day in the US — they took a step back.

The company did something not many (if any) biotechs have ever done: At the urging of the US government, they slowed Phase III enrollment to recruit more participants from minority groups.

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COVID-19 Evidence Accelerator: A parallel analysis to describe the use of Hydroxychloroquine with or without Azithromycin among hospitalized COVID-19 patients

The COVID-19 pandemic remains a significant global threat. However, despite urgent need, there remains uncertainty surrounding best practices for pharmaceutical interventions to treat COVID-19. In particular, conflicting evidence has emerged surrounding the use of hydroxychloroquine and azithromycin, alone or in combination, for COVID-19. The COVID-19 Evidence Accelerator convened by the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research, assembled experts from the health systems research, regulatory science, data science, and epidemiology to participate in a large parallel analysis of different data sets to further explore the effectiveness of these treatments.
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APhA Foundation names 2021 Jacob W. Miller Award recipient - Drug Store News

Susan Winckler, CEO of the Reagan-Udall Foundation for the Food and Drug Administration, is the American Pharmacists Association Foundation’s 2021 recipient of the Jacob W. Miller Award. The award recognizes individuals who help to advance the Foundation’s mission through their involvement and leadership in longstanding programs and new initiatives. 

Established in 2000, the award honors Jacob W. Miller who held positions in state and national pharmacy organizations and was APhA Foundation president from 1990-2000.

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