• Facilities and Equipment

    Track Directors:

    The Future of Facilities and Equipment – Innovative Designs and Cutting-Edge Solutions

    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.

    • Cell and Gene Therapy Facilities
    • Approaches for design and project delivery for breakthrough therapies
    • Consideration of reliability and sustainability impacts
    • Application of QRM to the C&Q process to ensure facilities and equipment fit for their intended purpose
    • Managing regulatory assessments of new facilities

    Communities of Practice/Special Interest Groups: API, Biotechnology, Commissioning & Qualification, Critical Utilities, GAMP®, HVAC/Sustainable Facilities, Oral Solid Dosage, Project Management, Sterile Products Processing

  • Information Systems

    Track Directors:

    Robert Dillman

    Informatics Specialist-Data Integrity
    Eli Lilly and Company

    Holistic Digitalization of the Artificial Intelligent Smart Factory – Pharma 4.0

    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.

    • Digitalization Strategies, Concepts and Case Studies
    • Practical Experiences in Data Integrity by Design and DI Inspection Readiness
    • Practical Experiences in achieving Digital Maturity
    • Clinical/R&D Systems digitalization
    • Technologies & Devices in Biotech, Cell & Gene, ATMPs
    • Smart Digital Health Devices

    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

  • Innovation in Pharmaceutical Manufacturing

    Track Director:

    Eamon P. Judge

    EMEA Global Projects Planning Leader
    Eli Lilly SA Irish Branch

    New Frontiers in Medicine – Innovative Technologies and Applications

    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

    • Adoption of Pharma 4.0 including Artificial Intelligence (AI) by Pharma and Biotech
    • New Developments in Antibiotics and Vaccines including their commercialization for emerging markets
    • Advanced Therapy Medicinal Products (ATMPs) and Cell and Gene Therapies
    • Biomanufacturing: Process improvements and advances including single-use systems and closed processing
    • Advances in robotics and convergent technologies such as 3D printing in the Pharmaceutical industry
    • Novel trends in drug and smart delivery devices
    • Innovative approaches to the sustainable supply of medicines
    • Next Generation approaches to Continuous Processing

    Communities of Practice/Special Interest Groups: All

  • Process Development & Manufacturing

    Track Directors:

    Innovations in Process Development and Manufacturing - Driving the Future State

    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.

    • Continuous Manufacturing for API and Drug Product
    • Flexible/Agile Laboratory and Manufacturing Environments
    • Manufacturing Technologies for Personalized Medicines
    • API/Drug Product Interface
    • Ensuring Process Capability/Product Robustness
    • Process Control and Integrated Data Analytics in Manufacturing
    • Technology Transfer
    • Knowledge Management

    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

  • Quality Systems & Regulatory

    Track Directors:

    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.

    • Patient Centricity – What’s the Real Risk?
    • Accelerated Development
    • Opportunities in Global Harmonization (e.g. ICH Q12 or Q14)
    • Submission Review and Efficiency - Opportunities and Necessities
    • Continuous Manufacturing
    • Advancing Pharmaceutical Quality
    • Combination Products

    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)

  • Supply Chain, Operations, & Packaging Excellence (SCOPE)

    Track Directors:

    Aaron Weinstein

    Senior Director, Validation Services
    IPS-Integrated Project Services, LLC

    Anticipating Supply Chain, Operations, and Packaging Challenges of the Future

    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.

    • Cell Therapies 
    • Gene Therapies
    • CAR-T
    • mAbs
    • ATMPs
    • Unique Drug Delivery Systems
    • 3D Printing
    • Nanotechnology
    • Cold Chain
    • Next Generation Packaging Solutions

    Communities of Practice/Special Interest Groups: Supply Chain, Operations, Packaging, Sterile Products Processing, GAMP®,