The FDA set another record in 2018 with the approval of 25 personalized medicines, - 42% of the 59 approved New Molecular Entities (NMEs). Many of these targeted therapeutics are following expedited regulatory approval pathways. More than ever before, there is a critical need for speed - for the patient, healthcare system, and innovator. Speed, small batch sizes, low material losses and economics are all major concerns for companies attempting to accelerate their molecule through early development.
Topics for discussion:
- Fast, flexible options for mammalian cell line development and process development
- Advantages of Integrated Drug Substance, Drug Product and Clinical Trial Logistics solutions
- Developing the right dosage form for the First-in-Human (FIH) trial while minimizing rework in later phases
- Benefits of having the right-sized filling lines that are appropriate for early development
- Special Packaging, labelling and cold chain supply management considerations for biologics
Please join us for an informative discussion on how to accelerate the path to early trials while maintaining safety, product quality and maximizing savings with the unique advantage of manufacturing solutions.