Breaking Ground in Medicine: Our Role in the Approval of Bivigam by ADMA Biologics
March 8, 2024Since 2004, ARG has been working in the immunology space, using our individualized approach to optimize the likelihood of successful development programs for sponsors. Our team has completed significant work in the area of IgG replacement therapy in adult and pediatric populations diagnosed with Primary Immunodeficiency Disease (PID).
ARG began working with ADMA Biologics in 2017, and since then, has thoroughly enjoyed our ongoing collaborative relationship in the PID space.
Our strong working relationship with ADMA Biologics was forged in:
- Overcoming the challenges in enrolling pediatric patients that required intravenous administration of study medication
- Securing the retention of those patients throughout the study in order to complete pharmacokinetics analysis
- Developing tools and strategies to accommodate parents and their children to make their clinical trial experience as smooth as possible
- Leveraging our team’s strong relationships with investigators and coordinators that have been established since ARG’s inception
All of the hard work and collaboration by both teams culminated in a successful study.In December of 2023, ADMA announced the FDA’s approval for Bivigam in the pediatric population of 2 years of age and older.
To learn more about ARG’s Immunology expertise, visit atlanticresearchgroup.com/expertise/immunology.
