Start of 2023
A quarterly note from BBCIC Executive Director Cate Lockhart, MS, PharmD, PhD.
Dear BBCIC Participants and Supporters,
I am THRILLED to announce that BBCIC was awarded a grant funded by the FDA to assess use of real-world data to support regulatory requirements for interchangeable biosimilars! See below for more information. We are honored to be selected to conduct this important work!
In typical form, 2023 has started with a flurry of activity at BBCIC! We are wrapping up the reports and final manuscripts marking the conclusion of our first, admittedly ambitious, comparative safety and effectiveness study of granulocyte-colony stimulation factor products (filgrastim and pegfilgrastim originators and biosimilars). We are in the middle of executing on the Switching Descriptive Analysis protocol we finalized in early 2022. We are finishing up analyses and manuscripts for three utilization analyses – insulins, bevacizumab, and trastuzumab, and making decisive progress on work related to our first federal grant!
In spite of the energetic pace we are already experiencing, I always like to take a moment at the beginning of a new year to look back to see how much we accomplished in the prior year, as a kind of inspiration and motivation leading up to the exciting work ahead. In 2022 we maintained our momentum with several projects leading to many presentations and manuscripts demonstrating our consistently high-caliber work. We submitted five manuscripts to peer-reviewed journals and presented 13 abstracts as posters and on the podium. We have another six manuscripts in preparation for submission in 2023, and another long list of planned abstracts for submission to a variety of scientific and professional meetings.
Most importantly, in May we welcomed Julia Marsh to our now-slightly-larger-but-still-mighty team, as the BBCIC Senior Manager of Projects and Operations! She is already conquering her role in keeping BBCIC organized and moving, and I already can’t imagine a time without her!
We have another slate of interesting and exciting projects underway, some continuing from 2022 and some newly beginning. Please visit www.bbcic.org for more information on what research is on tap.
As always, 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!
Cate Lockhart, MS, PharmD, PhD