Navigating the Future of Gene Therapy In January 2024, the FDA issued a guidance document, outlining critical considerations in the clinical development of CRISPR/CAS9 drug candidates. This guidance addresses the nuanced challenges associated with the development of human gene-edited (GE) products, placing particular emphasis on mitigating risks linked to both the gene therapy product itself and the gene editing process. Key Read more
Türkiye’s Emerging Role in Clinical Research: Regulatory Updates and Simplified Processes With a population exceeding 85 million and a robust, comprehensive healthcare infrastructure, Türkiye has quietly established itself as an undiscovered treasure in the field of clinical research. With a relatively low per capita number of clinical trials and a substantial pool of treatment-naive patients, Türkiye is witnessing a surge in engagement from biotech and pharma Read more
J.P. Morgan’s Healthcare Conference: A Glimpse into the Optimistic Pulse of 2024 The annual J.P. Morgan Conference in San Francisco, typically accompanied by rain, saw milder weather this year—was this a symbolic shift hinting at a brighter forecast for 2024? The biopharmaceutical industry, emerged from 2023’s continued downturn in finance deals and mergers and acquisitions (M&A) and showcased resilience and determination at the 2024 JPMorgan Conference. Notable Read more
Pragmatic Clinical Trials in 2024 Pragmatic clinical trials (PCTs) stand as a transformative approach in the biotech and pharmaceutical industries, providing crucial real-world insights into treatment effectiveness within the contexts where they are expected to be applied. Unlike explanatory trials that focus on controlled and specific biological outcomes, PCTs delve into the applicability and generalizability of interventions across diverse clinical Read more
