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Sue Sutter

Senior Editor

Washington, D.C.
Sue is a senior editor with Pink Sheet, where she writes primarily about drug, biologic and biosimilar regulation, FDA advisory committees and product approvals.  She has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the umbrella of Informa Business Information, including Pink Sheet, “The Pink Sheet” DAILY, “The Tan Sheet” and Scrip.  Previously she worked as an editor for Mealey’s Litigation Reports (now part of Lexis-Nexis), writing about asbestos, toxic tort and fen-phen litigation.

Latest From Sue Sutter

After EUA, US Will Ship Only Half Of Doses For Pfizer, Moderna COVID-19 Vaccines

Operation Warp Speed will hold back initial shipments to ensure two-dose regimens can be completed; 15 December is ‘chalk’ target date for emergency authorization of Pfizer vaccine, OWS’ Gustave Perna says, calling it only a projection that does not impinge on FDA authority. Sending only half shipments also eases burden on cold shortage capacity at state and local level, he says.

Coronavirus COVID-19 Vaccines

COVID-19 Vaccines: ACIP’s Allocation Proposal Prioritizes Long-Term Care Residents, Essential Workers

First group to receive vaccine would comprise health care personnel and residents of long-term care facilities; next in line are non-health care essential workers, who would take priority over adults with high-risk medical conditions and those ages 65 years and older, according to the CDC advisory committee’s proposed allocation framework.

Advisory Committees Coronavirus COVID-19

COVID-19 Vaccines: Placebo Crossover May Depend Upon Number Of Doses, Allocation Strategy

Although US FDA wants sponsors to maintain blinded Phase III follow-up as long as possible after emergency use authorization or licensure, vaccine researcher Larry Corey says it will become ‘untenable’ to keep individuals in placebo arm once they qualify for vaccine access under the allocation framework.

Advisory Committees Coronavirus COVID-19

Reducing Clinical Trial Burdens Brings Greater Participant Diversity – PhRMA

Industry principles for enhancing diversity in clinical trials call for use of digital data collection tools and flexible scheduling of study site visits to reduce barriers to enrollment, as well as greater involvement of under-represented communities in the trial design planning process and recruitment of investigators with diverse ethnic and racial backrounds.

Clinical Trials Guidance Documents

Biogen’s Aducanumab: Why Accelerated Approval Might, And Might Not, Be An Option For US FDA

Use of expedited pathway based on drug’s effect on brain amyloid would be problematic given advisory committee’s views of a disconnect between biomarker data and clinical efficacy results; however, one FDA expert sees potential for agency to grant accelerated approval on basis of an intermediate clinical endpoint – the same endpoint on which Biogen seeks regular approval.

Advisory Committees Drug Review

Pandemic-Affected Trials Will Need Same Exploratory Analyses That US FDA Used To Save Aducanumab

Use of exploratory methods to understand as much as possible from the two Alzheimer’s disease drug trials that were terminated early for futility is the same type of ‘innovative thinking’ that will be needed to salvage information from neuroscience trials interrupted by the COVID-19, US FDA Office of Neuroscience director Billy Dunn says.

Advisory Committees Drug Review
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