Even though the bio-pharmaceutical market is expected to grow significantly in the next few years, there are challenges on the horizon. Specifically,
- Labor shortages
- Sustainable sourcing
- Adoption and training on new technologies
- How to efficiently work with Regulatory authorities (To quickly get products to the patient)
- How to flexibly use or transform older facilities, i.e. mono-facilities conversions to multiproduct facilities.
The most successful companies will be able to sculpt their strategy and remain agile to take advantage of industry trends.
- Georgia Sloboda - Senior Director, CMC, Latham Biopharm Group
- Patrick Falvey - Principal Consultant, Latham Biopharm Group
• Fast-track registration pathways in China
• Special registration procedures in China
• Imported drugs for urgent clinical use & real world clinical data
• Case studies
China's drug registration process has undergone significant reforms aimed at simplifying application procedures and aligning with international standards since its membership in the ICH in 2017. This presentation explores China's accelerated pathways and pilot programs for drug registration, with a focus on urgent clinical use, rare diseases, pediatrics, breakthrough therapies, and more. It covers the definitions, procedures, requirements, and timelines associated with each pathway, accompanied by case studies highlighting successful registrations and imports. Attendees will gain valuable insights into leveraging these policies for faster market access to China.
- April Wang - Senior Regulatory Affairs Manager, Accestra Consulting
- Kenneth Bilenberg - COO and Executive Vice President, Large Scale Business Unit, FUJIFILM Diosynth Biotechnologies
Process analytical technologies are typically studied at lab scale prior to commercial manufacturing deployment. Consequently, compromises may have to be made when trying to match one set of process parameters while disregarding the other for a desired attribute. In this talk, Mohamed will discuss personnel training for data analytics, deployment and troubleshooting of errors even with automated process control similar to training pilots to take advantage of autopilot.
- Mohamed Noor, PhD - Digitalization Manager, National Institute for Bioprocessing Research and Training (NIBRT)
- Sun Chau Siu - Executive Director, Head of Technical Operations, Altruist Biologics
- Alessandro Butté - CEO, DataHow
- Marylene Zhan - Senior PV Manager, Accestra Consulting
The use of Quality by Design (QbD) and Design of Experiments (DOE) during process development is key to transparent risk management and maintaining safety, efficacy, and efficiency. An important step is identifying critical process parameters (CPPs) to ensure that a product meets defined quality goals. Regeneron will define strategies for identifying CPPs that emphasizes the relationship between studied ranges and manufacturing operating ranges.
- Rachel Erwin - Process Development Engineer, Regeneron