Latest Developments and Insights

Navigating the FDA regulatory action process presents unique challenges, and unexpected setbacks can stall even the most promising development programs. FDA Type A Meetings provide sponsors with an opportunity to obtain regulatory advice and timely feedback on critical issues affecting…

Bringing a new drug to market is a long and highly regulated process designed to ensure safety, efficacy, and quality. The pharmaceutical drug development process moves through multiple stages—beginning with drug discovery, advancing through preclinical and clinical research, and ultimately…

Patients with serious or life-threatening conditions often face limited treatment options, and waiting for new therapies can take years. The Breakthrough Therapy Designation (BTD) helps accelerate this process for drugs that show strong early evidence of being more effective than…

Cell and gene therapy development has entered a transformative era, bringing unprecedented challenges and opportunities in Chemistry, Manufacturing, and Controls (CMC). As these revolutionary treatments progress from clinical trials to commercial manufacturing, the future of CMC in cell gene therapy…

Sujata Kulkarni Why did you choose a career in biopharma? Growing up, I didn’t have the option to pursue medicine due to various reasons, so I had to select a field that aligned with my interests. This is when my…

Stability studies are essential to pharmaceutical development, providing the data needed to make sure drugs remain safe and effective throughout their shelf life. These studies evaluate how environmental factors like temperature, humidity, and light impact a drug’s quality over time.…