This track is designed to inform attendees on options to design, build and qualify modern and efficient facilities and equipment used to support the development, manufacturing, testing, storage and distribution of therapeutic products today and into the future. As speed to market and breakthrough therapies continue to reshape the landscape, there is even more need to apply a harmonized approach to innovative design solutions and project delivery strategies. Each product component and the product itself create unique challenges for facility design, equipment selection and overall project execution. How these challenges are addressed will ensure that quality therapeutic products are brought to market in an efficient manner in order to improve patient health. The emphasis of the topics presented by the F&E Track has been arranged to provide Owners/ Users/ Designers – whose experiences, wants and needs are invaluable – with modern-day examples of how to modernize, harmonize, and transform the facilities and products of the future.
Communities of Practice/Special Interest Groups: API, Biotechnology, Commissioning & Qualification, Critical Utilities, GAMP®, HVAC/Sustainable Facilities, Oral Solid Dosage, Project Management, Sterile Products Processing
The digitalization and the management of big data and its analytics enables not only the control, but also the prediction and optimization of all related business processes. This disruptive change from retrospective control to predictive control is enabled by big data management and the data integrity by design approach. The Digitalization of the pharmaceutical industry coming with the ISPE Pharma 4.0 Operating Model and the Smart Manufacturing approach results in disruptive changes in Information Systems (IS) design and lifecycle management. The new digital ICH Q10 Pharmaceutical Quality Systems / PQS enablers Digital Maturity and Data Integrity by Design need new design concepts, enabling inspection readiness. The PQS Digitalization Element Information Systems has a key role in the Digitalization of the AI Smart Factory. This includes the end-to-end ICH based pharmaceutical lifecycle management from Development, Clinical, Tech Transfer, Scale Up to Commercial Manufacturing streamlining the manufacturing supply chain.
Communities of Practice/Special Interest Groups: GAMP®, Pharma 4.0, Oral Solid Dosage, Supply Chain, Operations, & Packaging, Data Integrity, Blockchain, AI, MES, PAT & Lifecycle Control Strategy
The innovation forum will focus on emerging and evolving technologies that are helping drive a revolution in medicinal therapies, analytical techniques, manufacturing paradigms, medical devices including novel methods to deliver the next generation of drugs to patients. The intent of this track is to highlight the global Pharmaceutical industry’s challenges, recent innovations, opportunities and success stories relative to the discovery and adoption of emerging technologies for pharmaceutical applications. This forum seeks to highlight innovations in small molecule, biopharmaceutical (large molecule) as well as whole cell and tissue engineering. The focus is on the full lifecycle of therapeutic production : early drug substance production to final drug product and the patient experience. Regulatory perspectives on the key challenges and opportunities for the adoption of these technologies will also be in scope for the innovation forum sessions. Novel approaches that will improve the sustainability / global social responsibility of the sector are welcome as are operational excellence examples that improve efficiency. Bioprinting
Communities of Practice/Special Interest Groups: All
Novel therapies are leading us to reassess the way we develop and manufacture drug substances and drug products. The track will explore the business strategies and technology aspects associated with the future state of manufacturing. This includes transition to continuous processing to streamline process development, minimize manufacturing footprint and provide supply flexibility. Utilizing plug and play equipment for an agile approach to process development and manufacturing. Integration of data analytics and process control to define process capability and robustness. If you are involved in any aspect of drug substance and drug product development and manufacturing (Quality, Regulatory, Technical, Project Management, Equipment, EHS or Supply Chain) you should plan to attend this session to share best practices and benchmark solutions which will enable the future state of process development and manufacturing.
Communities of Practice/Special Interest Groups: Regulatory, Information Systems, Knowledge Management, Sterile Products Processing, Containment, Biotechnology, Oral Solid Dosage, PAT and Lifecycle Control Strategy, Process/Product Development
Patient Centricity Amidst Global Complexity
This year’s focus will be on global harmonization as an enabler for patient centricity in the regulatory and quality landscape. Track sessions will explore current challenges in both patient centricity and global convergence, while identifying opportunities and ideas that support both concepts. Areas of specific focus include accelerated development, advancing pharmaceutical quality, continuous manufacturing, combination products, and initiatives that may support submission and review efficiency throughout the product lifecycle.
Communities of Practice/Special Interest Groups: Advancing Pharmaceutical Quality Team (APQ), Product Quality Lifecycle Implementation (PQLI), Regulatory Quality Harmonization Committee (RQHC), Quality Metrics, Continuous Manufacturing, North American Focus Group (NAFG)
The Supply Chain, Operations, and Packaging Excellence (SCOPE) track will focus on the operational, supply chain and packaging challenges that have arisen during a period of intense technological advances. We intend to take a unique “campfire” approach to knowledge sharing during our sessions. Attendees will have the opportunity to interact with subject matter experts and each other to shed light on paths forward to address unexpected and newly emerging challenges with next generation therapies. Rising technologies and process innovations hold promise for companies faced with meeting new supply chain, operations, and packaging demands.
Communities of Practice/Special Interest Groups: Supply Chain, Operations, Packaging, Sterile Products Processing, GAMP®,