As potent compounds continue to increase in prevalence, an ever-increasing number of drug developer companies are investing in outsourcing partners for the development and manufacture of potent compounds for clinical studies and commercial supply.
The CMC section of a biopharmaceutical project is typically on a time-critical path, which can prove a challenge for both the client (contract giver) and the CMO (contract acceptor). To ensure a successful collaboration and outcome, client expectations must be aligned with the contracted CMO, a factor particularly relevant in the highly potent space, where containment facilities and expertise are of paramount importance. This workshop will allow you to ‘wear the hat’ of a big pharma sponsor in a safe, educational and entertaining environment, allowing you to explore a multitude of outsourcing situations in one day, gaining expertise that would usually take years to develop. Immerse yourself in interactive, hands-on sessions covering every aspect of the outsourcing journey, including:
CMO SELECTION PROCESS
Take part in an interactive case study, giving you a handson experience in selecting CMOs in different geographies and with different experiences, to ensure a successful outsouring process.
Ensure that the key process and analytical factors are communicated and transferred effectively to external manufacturers.
EXECUTION OF CONTRACT
Learn effective vendor-management tools to create a sense of ‘co-ownership’ of the project, to facilitate a seamless contract execution and completion.
Firelli Alonso, Senior Director, Biotherapeutics & Vaccines Outsourcing, Pfizer
Jon Crate, President & Senior Chemist, FAI Testing
Kim Hejnaes, CEO, Hejnaes Consult
Development, manufacturing, and delivery of safe and high-quality pharmaceutical products require input and cooperation of multiple functions throughout the product’s life cycle within a company or an organization. This workshop will focus on identification and discussion of internal and external operational challenges that companies experience and expect to experience in changing regulatory and fast-paced development environments.
Attendees will discuss:
Patricia Weideman, President & Principal, Sakari Consultants
This workshop will improve industry consistency by defining and maintaining categorization. This session will provide a general overview of handling recommendations and basic descriptors of safe work environments based on categorization. Qualitative health-based approaches have been developed to assess and communicate the potential health hazards of these novel compounds to workers.
Attendees will discuss:
Bob Sussman, Managing Director, SafeBridge