Latest Insights
Latest News
HHS Floats Trio of Drug Pricing Models, Some More Ambitious Than Others
AISHealth.com - February 23, 2023 Jeff Myers, Catalyst’s Senior Vice President, Market Access & Reimbursement Strategies, comments on the pricing models recently announced by CMS. Mr. Myers "says cell and gene therapy manufacturers may be skeptical [...]
Former FDA Chief Counsel Elizabeth Dickinson Hailed For Her Expertise, Warmth and Mentorship
The Pink Sheet - September 27, 2022 In an article on the legacy of retiring FDA Chief Counsel/Deputy Chief Counsel Elizabeth Dickinson, Catalyst’s Nancy Bradish Myers comments that Dickinson’s management style won her internal accolades. [...]
FDAnews Webinar: On Challenges Facing the New FDA Commissioner
During her panel for FDAnews, Nancy Myers highlighted impending challenges looming over FDA’s commissioner hopeful, Robert Califf. If confirmed, Califf would enter the FDA at a time crucial to rebuilding public trust in the Agency [...]
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 [...]
Latest Blog Posts and Op Eds
Rare Disease Week: Marking the 40th anniversary of the Orphan Drug Act
By Anne McNickle, VP - Research & Communications, Catalyst Can you believe 2023 is the 40th anniversary of the Orphan Drug Act (ODA)? That is some time lapse! In this blog, we want to highlight [...]
CMS sends roses to Sickle Cell Patients; but will the rest of Cell and Gene Therapy get the thorns?
By Jeff Myers, Senior Vice President, Reimbursement Strategy and Market Access, Catalyst. On February 14th, CMS released its answer to President Biden’s Executive Order to “do something” to lower drug prices in the public payor programs. [...]
Catalyst’s Nancy Myers Co-Moderates Alliance for a Stronger FDA Webinar Featuring FDA Deputy Commissioner Andi Fristedt
Catalyst's Nancy Myers participated in an Alliance for a Stronger FDA webinar with FDA's Deputy Commissioner for Policy, Legislation & International Affairs Andi Fristedt on Jan. 13. Ms. Myers co-moderated the session with Emily Holubowich, [...]
FDA User Fee Programs Reauthorized: FDA’s CBER Is A Clear Winner
Pharmaceutical Online/Cell & Gene/Bioprocess Online – October 6, 2022 PDUFA VII, CBER and the new gene & cell therapy Super Office: Catalyst’s Nancy Bradish Myers shares her insights on the cleanest user fee reauthorization in [...]