Latest News

September 27, 2017

Commissioner Gottlieb, CAR T-Cells, & The Future Of Rare Disease Therapies

September 27, 2017 / 0 Comments 0 Comments
Pharmaceutical Online-  What do Commissioner Gottlieb’s recent statements on orphan drug innovation—coupled with the FDA’s first gene therapy approval this summer (for the CAR T-Cell therapy, Kymriah)—mean for the industry?… read more →
May 30, 2017

Innovation and FDA’s Regulatory Frameworks: Catalyst Co-Authors Explore How the Coming Data Shift Will Impact Medical Product Regulation in Therapeutic Innovation & Regulatory Science Article

May 30, 2017 / 0 Comments 0 Comments
Given rapid advances in technology and our understanding of disease, the future will bring a shift in how the health care system thinks about and uses data, Michael Doherty, Foundation… read more →
April 24, 2017

Former FDA Associate Commissioner Jill Hartzler Warner Joins Catalyst Team, Expanding the Firm’s Expertise in Regenerative Medicine, Rare Disease Drug Development and Combination Product Regulation

April 24, 2017 / 0 Comments 0 Comments
Press release Washington, DC – Catalyst Healthcare Consulting is pleased to announce that Jill Hartzler Warner, JD, has joined the firm as Vice President, Regulatory Policy. She will advise clients… read more →

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Latest Events

December 4, 2017

Digital Medicine: Catalyst to Speak at Digital Medicine & MedTech Showcase

December 4, 2017 / 0 Comments 0 Comments
Join us on Jan. 9 as Catalyst President Nancy Bradish Myers speaks as part of a panel entitled “Once the train has left the station, is it possible to regulate?”… read more →
August 23, 2017

The Changing Regulatory Landscape Under Gottlieb and Trump: Catalyst Featured as Part of Expert Panel Webinar Series

August 23, 2017 / 0 Comments 0 Comments
Catalyst VP-Regulatory Policy and ex-FDAer Jill Hartzler Warner, JD, will analyze the changing regulatory environment for biopharma and device companies as part of an FDANews expert panel series this Fall.… read more →
June 12, 2017

FDA User Fees, Drug Competition and Drug Pricing: Catalyst to Present on Regulatory and Legislative Vehicles for Change

June 12, 2017 / 0 Comments 0 Comments
On June 13, Catalyst President Nancy Bradish Myers will present on PDUFA and other user fee agreements, and their impact on drug competition. Ms. Myers will be a featured speaker… read more →

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