Long-Term Follow-Up for CGT Trials: Best Practices to Operationalize

By Desmond Cabrera, Project Director, Cell and Gene Therapy With today’s cutting-edge technology, we are on the cusp of developing truly magnificent therapies using cell and gene science. However, as with any new therapy, we must always consider the patient first.   Guidelines to Ensure Patient Safety  As far back as 2001, as new cell and […]

How Technology Makes Virtual Clinical Pharmacology Phase 1 Studies Possible

With the current COVID-19 pandemic, drug developers and researchers are searching for drug development strategies that limit human contact. For certain drugs and certain types of Phase 1 studies, a “virtual” Phase 1 trial might be possible. A guidance issued by the FDA in March 2020 to address pandemic concerns states: “Since trial participants may not be […]

Journal for Clinical Studies: Combination Approaches in Immuno-Oncology Trials: New Horizons for Multiple Tumor Indications

Cancer immunotherapy has steadily been gaining momentum over the last decade, due to its proven efficacy as monotherapy in patients with various tumors, including tumors resistant to chemo- or radiotherapy. With an ever-increasing amount of clinical trials reporting significant benefits in long-term overall survival of patients with specific cancers following mono-immunotherapy, the goal has shifted […]