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11:00-11:15 (CET)
Setting the scene for future therapies
11:15-11:35 (CET)
• Why lack of regulatory harmonization can hinder adoption of personalized medicine approaches
• Assessing Infrastructure and Technical limitations and what is needed to improve personalized outcomes
• Why Healthcare Integration and Digital Health Initiatives can enhance personalized medicine implementation
Speaker: TBC
11:40-12:00 (CET)
• Learnings from the COVID-19 vaccine and translating mRNA technology to other therapy areas
• How nanoparticles are paving the way to improve vaccine efficiency
Speaker: TBC Moderna
12:05-12:25 (CET)
• Advancements in precision medicine and Oncology
• Assessing at the current challenges
• Case studies and future predictions
Speaker: Sanobar Syed, Associate Director, BeiGene
12:30-12:50 (CET)
• Understand the drivers of growth in orphan drug investment and development
• Learn how to navigate the complex development and manufacturing space of orphan drugs
• Supply chain considerations when bringing an orphan drug to the clinical and market
Speaker: TBC
12:55-13:40 (CET)
Networked care is scaling up as an effective model of care for rare diseases, with the prevention, diagnosis, care, and treatment administered locally, informed by the body of knowledge and expertise from the whole network
• How a collaborative network can bring about an effective learning process, a key element for success
• Why patient involvement is crucial to improve success in rare disease outcomes
• Assessing current tested and build practices to help improve manufacturing and development quality of drug products
Speaker: TBC
1st Nov 10:45 - 11:15 Europa Room, Hall 4.0-Keynote
1st Nov 11:20 - 11:45 Europa Room, Hall 4.0
The next generation enteric capsule enables pharmaceutical companies to develop a targeted delivery solution while simplifying their manufacturing processes. The solution offers: • An acid-protective dosage form with enteric drug release through a patient centric delivery solution; • A simple encapsulation process that allows for fast and stable preparation. This solution is supported by scientific studies, both in-vitro and in-vivo, showing that enteric protection and targeted delivery to the distal intestine are achieved in comparison to marketed references. Backed up also by performance studies, this capsule showcases excellent machineability and mechanical properties, in line with standard immediate release HPMC capsules. It is available commercially in large quantities. Join Dr. Vincent Jannin to learn more on the newly launched enteric solution.
Talk Sponsor
1st Nov 11:50 - 12:15 Europa Room, Hall 4.1
Overview of LNP as an Innovative Approach to Genomic Medicine and Vaccine Development - Insights on Core Technologies for Developing RNA-LNP Genomic Medicines and Vaccines: The Genomic Medicine Toolkit - Best practices of LNP formulation, optimization and manufacturing - Case Study Snapshots: Using the Genomic Medicine Toolkit for the development of Cell Therapies, Gene Therapies, and Vaccines
Talk Sponsor
1st Nov 12:20 - 12:45 Europa Room, Hall 4.0
Latest Development, the Application of EXCiPACT GMPs to Pharmaceutical Auxiliary Materials EXCiPACT is extending its certification scheme to PAMs and is developing a guide for manufacturers and auditors. As these materials may be in intimate contact with a material which will be administered to patients, they should be manufactured in accordance with GMP principles. Typically, PAMs are removed before use in the manufacture of a drug product or function as processing aids in the manufacture of the excipient. Although the manufacturing processes used for PAMs may not be traditional chemical manufacturing processes, applying the risk-based approach in EXCiPACT GMP means this standard can be applied to PAMs. The guide will help manufacturers apply EXCiPACT GMP to the preparation and distribution of PAMs and auditors to assess their compliance for certification purposes.
Talk Sponsor
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