Innovation thrives at the intersection of regulatory flexibility and robust oversight, especially within the dynamic field of first-in-class drugs. Today, we delve into this critical topic with Ivan Kairatov, a seasoned biopharma expert with extensive experience in research and development. With a
The medical landscape has been witnessing a groundbreaking shift with the advent of novel therapies aimed at tackling some of the most challenging conditions. One such development is the Phase 1/2 clinical trial of Cabaletta Bio's CAR T-cell therapy, rese-cel (resecabtagene autoleucel),
The world of personalized cancer treatment has seen groundbreaking advancements with the introduction of combination immunotherapy, particularly in the realm of metastatic gastrointestinal (GI) cancers. Researchers at the National Cancer Institute (NCI) have developed a transformative approach that
The recent resignation of Peter Marks as the head of the FDA's Center for Biologics Evaluation and Research (CBER) marks a significant moment for the cell and gene therapy industry. His departure has sparked widespread discussion about the future direction of the regulatory landscape and its
In an era where technology is constantly evolving the healthcare landscape, the recent partnership between the New Jersey Innovation Institute (NJII) and Cognome holds significant promise. This alliance is poised to make substantial strides in improving patient care through the integration of
Retinitis pigmentosa, an inherited retinal disease, is characterized by progressive vision loss over time, ultimately leading to severe visual impairment. The disease affects the retinal photoreceptor cells, where the degeneration results in the gradual loss of night vision, peripheral vision, and
