Latest Developments and Insights

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…

Developing the manufacturing process can be one of the most time- and resource-intensive aspects of pharmaceutical development. Staying competitive requires leveraging cutting-edge tools that enhance efficiency, reduce costs, and improve overall process performance. One such tool is Computational Fluid Dynamics…

In the ever-evolving landscape of cancer treatment, timely access to effective therapies is crucial. The FDA’s Real-Time Oncology Review (RTOR) program is a groundbreaking initiative designed to expedite the review process for oncology drugs and biologics ensuring that patients receive…

In the first instalment of our multi-part series, the key differences between biologic drugs and traditional small molecule drugs such as active pharmaceutical ingredient source, molecular size, structural complexity and immunogenicity were introduced.  In this second instalment, we explore the…

In the dynamic landscape of biopharmaceutical development, adherence to evolving international standards is crucial. The recent updates from International Council for Harmonisation (ICH) Q2 “Validation of Analytical Procedures” from Revision 1 to Revision 2, coupled with the introduction of ICH…

Authorized by the 21st Century Cures Act , Food and Drug Administration’s (FDA) Oncology Center for Excellence (OCE) was established in January 2017. OCE was established to facilitate the development and clinical review of oncology products by uniting scientific experts…