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Accelerated Approval Standards: Application to Gene Therapy

September 25th, 2021|Comments Off on Accelerated Approval Standards: Application to Gene Therapy

At the ASGCT Policy Summit 2021, Nancy Bradish Myers shared these slides to help participants understand FDA’s accelerated approval standards and how they specifically apply to gene therapies.  In addition, she highlighted the ongoing debate [...]

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Ruling Blocks Okla. MCO Program, But Fight May Not Be Over

June 25th, 2021|Comments Off on Ruling Blocks Okla. MCO Program, But Fight May Not Be Over

AISHealth.com — June 25, 2021 Jeff Myers, Catalyst’s Senior Vice President, Market Access & Reimbursement Strategies, discusses the legal technicalities which tripped up Oklahoma as the health providers win their lawsuit against Republican Gov. Kevin [...]

Wall Street Sees Woodcock Commissionership As Positive for Aducanumab, But Eyes Should Be On Cavazzoni

February 1st, 2021|Comments Off on Wall Street Sees Woodcock Commissionership As Positive for Aducanumab, But Eyes Should Be On Cavazzoni

Pink Sheet: Informa Pharma Intelligence – January 29, 2021 Nancy Bradish Myers shares views with Sarah Karlin-Smith that approval watchers’ eyes should more appropriately be on what CDER’s Cavazzoni is thinking around the aducanumab Alzheimer’s [...]

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RWE at the Tipping Point: From Registries to Artificial Intelligence, RWE is Poised to Accelerate Medical Product Development

May 24th, 2018|Comments Off on RWE at the Tipping Point: From Registries to Artificial Intelligence, RWE is Poised to Accelerate Medical Product Development

By Anne McNickle This is an exciting time for those of us interested in RWE development. Digital technologies and advanced computing capabilities are enabling the generation of RWE continuously, and from sources that have traditionally [...]

Artificial Intelligence (AI): Coming to a Policymaker Near You

April 2nd, 2018|Comments Off on Artificial Intelligence (AI): Coming to a Policymaker Near You

By Nancy Bradish Myers It’s as if Artificial Intelligence just reached the DC area and policy makers need to think about it. Software companies, academic institutions and innovative companies hoping to develop and harness the [...]

Digital Medicine is Here: Why the Combination of Abilify and Proteus’ Ingestible Sensor is “Sweet”!

November 14th, 2017|Comments Off on Digital Medicine is Here: Why the Combination of Abilify and Proteus’ Ingestible Sensor is “Sweet”!

By Nancy Bradish Myers Yahooooo! What a thrill it is to finally have the first digital medicine approved by the FDA: Abilify Mycite (aripiprazole + Ingestible Event Marker). When I visualize it, it’s like the [...]