John Hood, CEO, Endeavor BioMedicines discusses a potential timeline on availability of ENV-101 for patients with IPF and further validation of the treatment's safety profile.

Regulatory agencies are open to changes within the review process which means the uptake of CAR T-cell therapy will change the landscape itself. This is especially true with large-scale ...

The panelists provide their closing thoughts on CAR T-cell therapies and what they look forward to as these therapies become popular beyond cancer, extending to autoimmune diseases as well. There is ...

Site selection for CAR T-cell clinical trials is a complex process that requires the right expertise, capability, and facility. Infrastructure is another major factor to consider as patients will ...

Panelists set up for addressing the clinical trial landscape, key challenges, regulations, and the future of cell and gene therapy. In this exclusive Pharmaceutical Executive Roundtable video series, ...

Huestis discusses the ways that quantum simulation and quantum systems can be used in areas such as drug discovery and the creation and protection of intellectual property in the life sciences ...

The regulatory landscape for CAR T-cell therapies is constantly evolving with the FDA establishing their own guidelines needed for approval. Often, the approval can be long and difficult to obtain.

Clinical trials involve a lot of moving parts which require a good relationship between a sponsor, CRO, and site. Having logistical and study coordinators are one tool to better ensure everything is ...

Approval was based on results from the Phase III CheckMate-67T trial, which demonstrated non-inferior pharmacokinetics compared to intravenous Opvido. The FDA has approved Bristol Myers Squibb’s (BMS) ...

The panelists explain how they hope CAR T-cell clinical trials will improve over time. Tactics like developing scalable manufacturing techniques, having adaptive manufacturing, streamlining regulatory ...

Patient selection is a key component to the success of a clinical trial. A CAR T-cell study protocol is critical in outlining the site, the desired patient diagnosis, biomarkers of the tumor, and ...

In this Pharmaceutical Executive video interview, Dr. Lawrence B. Werlin, MD, FACOG of HRC Fertility (@md.lawrence.werlin on TikTok), discusses making advanced fertility treatments more accessible and ...