Implementing Expanded Access in Your Organization

We recently had the privilege of hosting an interactive Q&A, "Implementing Expanded Access in Your Organization," featuring a panel of leaders and experts in the field: Paula Singer, Dr. Dennis Brown, Dr. John Langlands, and our Executive Vice President, Matthew Rosen. We were thrilled to facilitate such a rich and interactive discussion, delving into the practicalities of operations, global execution, and compliance in expanded access.

A central theme from our panelists was the absolute necessity of early planning for expanded access. The discussion highlighted the importance of anticipating potential needs, whether for post-trial access or managing numerous requests from a single institution, in deciding between single-patient Investigational New Drug (IND) applications and more streamlined intermediate protocols.

The webinar also illuminated the significant value of real-world data gathered through expanded access programs. Our panelists discussed how such data, when collected efficiently and purposefully, can offer invaluable insights for clinical development and even lead to publications, while also strengthening relationships with the clinical community. This flexibility in treatment, often not possible within the strict parameters of clinical trials, provides a more realistic understanding of how a drug performs in the real world.

Ultimately, the consensus emphasized the crucial role of technology in efficiently managing expanded access programs. The transition from paper-based, ad-hoc systems to integrated, electronic platforms is vital for traceability, scalability, and seamless communication. At MedaSystems, we are committed to providing software solutions that enable pharmaceutical companies to navigate the complexities of expanded access, ensuring that patients receive timely access to treatments while maintaining compliance and operational excellence. We invite you to learn more about how we can support your organization's expanded access needs. You can watch the on-demand webinar here!