Catalyst Insight 2018-04-20T20:44:16+00:00

NEWLatest News


  • Executive Insights. Insider's view. Nancy Bradish Myers

The Digital Health Tsunami Is Here. How Is FDA Gearing Up?

April 20th, 2018|Comments Off on The Digital Health Tsunami Is Here. How Is FDA Gearing Up?

Med Device Online – In this “Insider’s View” column, Catalyst President Nancy Bradish Myers examines the coming wave of digital health, what FDA is signaling through its recent moves in the digital health space, and [...]

  • Shutdown

Shutdown Winds Down: Short ‘Lapse Period’ Likely Means Few Disruptions At US FDA

January 22nd, 2018|Comments Off on Shutdown Winds Down: Short ‘Lapse Period’ Likely Means Few Disruptions At US FDA

The Pink Sheet -  This article looks at the impact of the recent government shutdown on FDA and includes Catalyst’s perspectives the challenges involved; Catalyst President Nancy Myers notes that timelines for a number of FDA activities would [...]

  • Shutdown

How a government shutdown could affect drug safety, flu response, and more

January 17th, 2018|Comments Off on How a government shutdown could affect drug safety, flu response, and more

In this article, Catalyst’s Jill Hartzler Warner provides context for a potential future government shutdown, based on her experience at FDA. The article explores the potential impact of a federal government shutdown across a range of [...]

  • Biotech Showcase

New FDA Leadership Changes Priorities But Doesn’t Change Administration Regulations, Panel Discussion Says

January 10th, 2018|Comments Off on New FDA Leadership Changes Priorities But Doesn’t Change Administration Regulations, Panel Discussion Says

Biotech Investing News— Biotech Investing News reporters this week covered a panel featuring Catalyst’s President, Nancy Bradish Myers. In the panel, which took place on the first day of the JP Morgan Healthcare conference, at the [...]

NEWLatest Blog Posts


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 Health: New Law Encourages Telehealth Services For Medicare Patients

February 9th, 2018|Comments Off on Digital Health: New Law Encourages Telehealth Services For Medicare Patients

By Nancy Bradish Myers As Congress moved to keep the doors open for the federal government, it also swept in changes to advance the use of telemedicine for Medicare patients. These are exciting changes that will [...]

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 old [...]

Gene Therapy Milestones: Gilead’s Acquisition of Kite Pharma and FDA’s Novartis CAR-T Approval Signal an Advancing Gene Therapy Field; What Are Key Takeaways for Gene Therapy Companies?

September 1st, 2017|Comments Off on Gene Therapy Milestones: Gilead’s Acquisition of Kite Pharma and FDA’s Novartis CAR-T Approval Signal an Advancing Gene Therapy Field; What Are Key Takeaways for Gene Therapy Companies?

By Nancy Bradish Myers, Anne McNickle and Jill Hartzler Warner In the past week, we’ve seen significant advances in the gene therapy world. Within the span of two days, Gilead announced it will acquire Kite [...]