Regulatory Strategies for the Analytical Development of New Biological Entities and Biosimilars

The pharmaceutical industry has experienced a trend in the number of accelerated approval designations for drugs (e.g. orphan drugs, breakthrough therapies, accelerated approvals, and FDA priority reviews) being developed. These designations are given shortened timelines for product development, product assessment and commercial scale-up (typically between 3-5 years) and come with several development and manufacturing challenges. In this webinar, you will hear from industry experts on overcoming scale-up challenges and fit-for-purpose manufacturing strategies.

The science of medicine has allowed us to make incredible advances in diagnosing and treating diseases. But the complexity of human biology is staggering. Every person is unique and in many ways, so are diseases. Yet the digital revolution in healthcare provides new ways to both collect high-quality data from each patient and connect it to data from large pools of other patients for analysis. This enables us to arrive at a deeper understanding of how to treat an individual. Only then can we see what distinguishes each of us as individuals, and translate that into personalized and thus improved care for every person. Real-world evidence, molecular information generated from next-generation sequencing, data from wearable devices and mobile apps and novel clinical trials are transforming the future of care.

The clinical development marketplace continues to become more complex and competitive, with stricter regulatory standards and trial oversight—all the while demanding patient-centric drug development. These, and other factors, contribute to unsustainable costs and longer timelines before much-needed therapies reach the market.

The focus on accelerated development of new modalities for advanced therapies and challenges with complex drug candidates has driven the adoption of novel concepts and technologies in pharmaceutical development and manufacturing.