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Phase II drug development decisions: From clinical success to commercial readiness
Discover how to expertly navigate the transition from an early-stage clinical formulation to a scalable, patient-centric commercial product—a pivotal milestone in the drug development journey.
For orphan drugs, precision medicines, and other therapies where active pharmaceutical ingredients (APIs) are scarce or costly, every drug development decision matters—especially the early decisions that can make or break the long-term success of a program. This on-demand webinar explores how to design a fit-for-purpose Phase I formulation that enables rapid clinical entry while minimizing unnecessary development, API consumption, and technical risk.
Why do Phase II drug development decisions matter for commercial readiness downstream?
In this webinar, discover how to navigate the transition from an early clinical formulation to a scalable, patient-centric commercial product. Explore key considerations for selecting the right dosage form, container and delivery system, and manufacturing strategy—while balancing technical, regulatory, and supply chain requirements.
Learn how informed decisions during Phase II can help minimize costly late-stage changes, streamline tech transfer and scale-up, and lay the foundation for commercialization.
What you'll learn:
- Why Phase II is a strategic decision point in the drug development journey
- What commercial readiness really means, and which decisions matter most
- How to choose between vials, prefilled syringes (PFS), and autoinjectors
- How to proactively align manufacturing, packaging, and delivery requirements
- How to prepare for technology transfer, scale-up, and commercialization
Speaker:
Alessandro Chreim
Global SME, Sterile Drug Products
Pharma Services, Thermo Fisher Scientific
Alessandro Chreim provides subject matter expertise to the global Sales and Business Development team, offering technical support, developing strategies, and supporting new business opportunities for Thermo Fisher’s sterile manufacturing business.
Alessandro holds a master of science degree in chemistry and pharmaceutical technology from the University of Milan and has more than 10 years of experience in the pharmaceutical industry, with a primary focus on technology transfer, product development, and manufacturing in sterile fill-and-finish operations. He has been involved in various stages of the pharmaceutical product lifecycle, from early-stage development to commercial manufacturing.
Previously, Alessandro held various technical roles with increasing levels of responsibility at Corden Pharma, Adienne Pharma & Biotech, Novartis, and Thermo Fisher’s Monza site.