Overcoming Manufacturing Challenges for Accelerated Development

The frontiers of data sciences and real-world data represent promising areas of innovation and possibility for life sciences and health-care organizations, especially within precision medicine. These areas are continuously evolving, and there are questions about how to navigate this complex and rapidly evolving set of resources, capabilities, and organizations. This webinar, in partnership with the Kraft Precision Medicine Accelerator at the Harvard Business School, aims to provide a landscape of the organizations working in real-world data and advanced analytics, including artificial intelligence and machine learning, and provide commentary on the recent changes to space. It will introduce attendees to the Kraft Precision Medicine Accelerator and teach them about real-world data analytics technologies and data assets that may help advance their research agendas, determine the subject of collaborations, or serve as an investment target.

IIdiopathic multicentric Castleman disease (iMCD) is a hematologic illness involving cytokine-induced lymphoproliferation, systemic inflammation, cytopenias and life-threatening multi-organ dysfunction.

Regulation is clear that, whenever possible, products intended to be sterile should be terminally sterilized in their final container. Only if terminal sterilization is not possible, filtration or aseptic assembly should be applied. This webinar will focus on elements to evaluate prior to selecting aseptic assembly for the manufacturing of sterile drug products.

Formulators modify the release profiles of drugs for multiple reasons: to target delivery of the API, enhance bioavailability, provide dosage convenience, improve patient adherence, and extend the patentable life cycle of an existing drug.Whether the desired profile is for immediate or modified release, formulators must overcome the development hurdles of poorly soluble APIs. Modified-release drugs may require more excipients and more complex formulations and manufacturing steps, resulting in longer, and more expensive, development processes. Proven formulation methods and careful excipient selection, however, can be employed to develop formulations for modified release drugs that offer value to the patient.