2023 Progress So Far

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

June 2023
 

Dear BBCIC Participants and Supporters, 

I always feel energized when the group of BBCIC participants get together, and that is no different after our BBCIC Annual Meeting & Workshop that was held on June 14, 2023. We had an enthusiastic mix of in-person participants who joined us at AMCP Headquarters in Alexandria, VA, and a large group of dedicated participants who joined us virtually. It was a great meeting. A full summary of events is included in this newsletter.

Some significant things have happened since our last newsletter:

  • We submitted a grant proposal entitled “Generating BETTER RWE: Strategies to Enrich Patient Diversity in Real-World Data to Enhance the Quality and Efficiency of Clinical Research and Regulatory Decision-Making” in response to a request for applications by FDA as part of their real-world data program.
  • We submitted a second grant proposal entitled “Bridging the Gap: Using Foreign Real-World Data to Inform Interchangeable Biosimilar Approvals” in response to a request for applications by the FDA as part of the BsUFA III Regulatory Sciences Program, the source of funding for our existing grant. We have partnered with colleagues from Italy and Denmark to explore how non-US data could be used for biosimilar regulatory assessments.
  • We are finalizing data analyses for several studies: Switching Descriptive Analysis in patients treated with biologics or immunomodulating therapies for rheumatoid arthritis; Trastuzumab Utilization Analysis; Effect of COVID lockdowns on treatment for patients with IBD.
  • We kicked off two new workgroups: one to participate in our existing FDA grant project in which we will emulate a switching trial, and one to launch our newest project assessing the impact of biosimilars on patient access, outcomes, and treatment patterns.

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