Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval
Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for
IBC
How Centralized IBC Review Can Benefit Gene Therapy Research
Gene therapy research is at the forefront of a coming boom in the clinical setting. Understand the growth, risks, and regulatory requirements here.
Reporting Unexpected Incidents to the IBC
When unexpected events occur during the conduct of a clinical trial, research personnel may wonder if the event is reportable,
4 Unique Challenges of Oncology Trials
Oncology trials face unique hurdles in innovation, enrollment, and endpoints, requiring strategic planning to address complex study demands and precision needs.
Improving Study Activation Time for Gene Therapy Research
This blog explores how research sites are focusing on their institutional biosafety committee (IBC) programs as part of overall study activation time.
IBC vs. IRB: What’s the Difference?
Gene therapy research requires both IRB and IBC oversight—while IRBs protect participants, IBCs ensure community and environmental safety with local site-specific reviews.
Navigating Key Complexities in the Development of Cell and Gene Therapies
Discover how biotech organizations navigate the unique challenges of cell and gene therapies, from regulatory shifts to recruitment and market uncertainty.
Risk Assessment for use of Engineered Genetic Materials in Clinical Research
The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular
FDA Guidance Offers New Flexibility to Biotechs in Cell and Gene Therapy
The Food and Drug Administration (FDA) recently released new guidance regarding cellular and gene therapy products, one of which may
Rare and Orphan Diseases in Regulated Development
Navigating research compliance often means addressing unseen challenges. Explore strategies to identify blind spots and strengthen oversight frameworks.
Regulatory Trends in Cell and Gene Therapies
As cell and gene therapy advances, the FDA is shaping regulatory trends to streamline approvals, support innovative therapies, and enhance global harmonization.
Safe Sharps Handling When Dispensing Investigational Products
Institutional biosafety committees (IBCs) frequently receive questions about the proper methodology for preparing a syringe for transport from a drug