Start of 2024

A quarterly note from BBCIC Executive Director Cate Lockhart, MS, PharmD, PhD. 

April 2024
 

Dear BBCIC Participants and Supporters, 

Spring is here! Kind of. Depending on the day. And where you live. As the buds pop out on the trees, and the pollen fills the air, we are coming up to full speed on our new research projects! We have several protocols in development for both new projects, and new phases in ongoing projects. Here are a few highlights:

  • FDA Grant #1 - (1 U01FD007757-01): We are finalizing the protocol to emulate a switching study using real-world data to demonstrate how it may be used for biosimilar and interchangeable biosimilar regulatory decisions. The research team has chosen pegfilgrastim use in patients with breast cancer as the test case to evaluate data quality and fitness for use in three US data sources.
  • FDA Grant #2 - (1 U01FD008042-01): In collaboration with our partners in Italy and Denmark, we are preparing a protocol to emulate two biosimilar switching studies to demonstrate how FDA may use data from non-US sources to answer biosimilar and interchangeable biosimilar regulatory questions.
  • Biosimilar Access and Utilization Study: Our colleagues at Carelon are leading this study in which we are exploring the impact of biosimilar availability on treatment patterns, utilization, and outcomes in patients treated with bevacizumab or trastuzumab. This protocol is nearly finalized and will be conducted using Carelon data and in parallel using our PearlDiver data asset.
  • Bone Anti-Resorptive Therapy: To begin laying the foundation for this new-to-us disease area, we are conducting a literature review and landscape analysis of real-world research assessing denosumab for bone health, in anticipation of the two new biosimilars that were recently approved.

As always, we have a lot going on, and I have to say CONGRATULATIONS to all of BBCIC for your ongoing support, enthusiasm, and perseverance to continue to produce high-quality, important research. And I have to say THANK YOU for all those same reasons. We are tiny but mighty!

It takes a village to raise a consortium, and we are grateful for your continued support and engagement!

Kind Regards, 
Cate Lockhart, MS, PharmD, PhD