Fall 2023 Reflections

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

October 2023
 

Dear BBCIC Participants and Supporters, 

As always I’m looking forward to an exciting (sometimes frenetic) AMCP Nexus meeting coming up in Orlando (October 16-19) where we will convene our annual BBCIC@Nexus participant meeting. Our agenda this year is as engaging as ever as we dive into the details of some of our current research projects, and lay out our research plans for 2024. It is always a highlight to spend the afternoon with our participants, both in person and virtually and the energy of the groups is sure to be invigorating!

Some significant things have happened since our last newsletter:

• We were awarded a second grant!! The project entitled “Bridging the Gap: Using Foreign Real-World Data to Inform Interchangeable Biosimilar Approvals” was selected for funding 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 submitted our first NIH 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 an opportunity entitled “Leveraging Health Information Technology (Health IT) to Address and Reduce Health Care Disparities.”
• We received seven new research ideas from within the consortium, that were reviewed by the Science Committee and we are in the process of finalizing our 2024 research plans that include some exciting new studies that bring the patient experience much more to the forefront and allow us to expand our research expertise.

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