Biotech – Large Molecule, Cell & Gene – ATMPs

The biotech sector, including cell and gene therapies (ATMP), has been the fastest growing market in the pharmaceutical industry for years and this is not expected to change in the next few decades. In addition to products already on the market and new products in development, the market will additionally grow in Biosimilars, Bio Better Products, Combined Products such as Antibody Drug Conjugates as well as in Cell and Gene and Tissue Engineering. We are seeking case studies focusing on Biotech – Large Molecules, Cell & Gene - ATMPs.

The case studies should include EU and international regulatory aspects.

• Innovative technologies and case studies related to biopharmaceuticals such as modular technologies, continuous manufacturing, stainless steel vs. Single-use system, sustainability, end-to-end solutions, etc.
• Innovative technologies and case studies related to ATMPs such as modular technologies, closed technologies, multi-product plant design preventing cross contamination, automation and robotics, biosecurity and implementation case studies, decentralized manufacturing facilities etc.
• Regulatory aspects and implementation such Annex 1, PIC/s GMP’s including Annex 1 and Annex 2A for ATMPs and EU EudraLex Part IV for ATMPs and all these aspects supported by Quality Risk Management ICH Q9.

Operational Readiness and Cultural Excellence

In today's fast-changing world, companies face the challenge of staying up to date with new technologies while ensuring their teams have the right skills to effectively maintain operations. Being flexible across all areas of a business is key to driving innovation. The same principle applies to learning and workforce advancement.

This track focuses on the following:

• Importance of improving processes, upgrading employee skills, and fostering innovation to guarantee operational readiness amid an evolving industry.
• How companies are improving systems to handle new challenges, with an emphasis on keeping operations agile and innovative.
• How companies are training their teams to successfully work with new systems and improved processes in order to ensure long-term success.

Digital Transformation and Innovative Technologies

We are pleased to invite proposals for presentations, workshops, and panel discussions focused on Digital Transformation and Innovative Technologies in the pharmaceutical industry. These sessions will explore the latest advancements, case studies, and applications in areas such as the following:

• Digital Business Transformation / Pharma 4.0: Strategies, and best practices for implementing digital business transformation along the pharmaceutical product lifecycle.
• Artificial Intelligence: AI-driven drug discovery, predictive analytics, machine learning applications, and AI in clinical trials.
• GAMP: Latest updates, compliance strategies, and case studies in the validation of GxP-relevant Systems.
• Digital Technology Transformation: including IT/OT/IoT, automation, and real-time data analytics
• Virtual Reality (VR) and Augmented Reality (AR): Applications of VR/AR in pharmaceutical training, simulation, and patient engagement.
• Innovative Technologies/Smart Manufacturing: Advances in smart manufacturing technologies, digital twins, and advanced process control.
• Blockchain: Blockchain applications in supply chain management, data integrity, and traceability in pharmaceuticals.
• Pharmaceutical Process Modeling: New methodologies, tools, and applications for modeling pharmaceutical processes.
• Emerging Technology Trends and Innovation
• Case-Studies in Digital Transformation

Good Engineering Practice and Efficient Investment Management

Every day there are new needs and new ideas to transform and grow the pharma industry. Sooner than later, they will become a project. The success of the project will open the door to becoming a reality. The key to opening the door is Good Engineering and Efficient Project Management. As time goes by, there is a very strong demand for faster and efficient project delivery. The term “fast track” seems obsolete. Standardization, modularization, BIM, agile project delivery, efficient investment management, etc. are no longer concepts but are needs and a reality. We are seeking proposals on Good Engineering Practice and Efficient Investment Management. This will be the space to learn from today’s engineering design trends, new digitalized engineering tools, project management, and construction management on real case studies that are shaping today’s project delivery landscape. Topics to cover include:

• Agile Project Management
• BIM
• New design trends
• Lean GMP manufacturing facilities
• Modularization 
• Project risk management
• Project governance
• Lean qualification
• Sustainability project
• Engineering design integration
• GMP Regulatory impact on project design and implementation
• Stakeholder Alignment
• Permitting requirements – when and how to involve regulatory agencies

The goal is to offer interactive sessions and provide the audience with the opportunity to ask questions and contribute to an open and relaxed atmosphere away from day-to-day project work.

Innovation in Business Processes

Patients and industry have been confronted with the following main problems for years. All three problem areas are interrelated and can influence each other. In this track, innovations in technical and related business processes are presented in cause-and-effect chains to show how these problems can be effectively addressed.

• Drug Availability: Drug shortages limit the availability of medicines on the market. This affects commodity drugs for the treatment of trivial illnesses, as well as drugs for the treatment of serious illnesses and also vaccines. In this track, innovative approaches are shown on how to effectively increase supply chain resiliency.
• Access to Medicines: Timely and effective investments in product life cycles can help to reduce manufacturing cost and thus increase the availability of medicines and access to medicines in all markets. It will be demonstrated how ICH Q12 “Pharmaceutical product lifecycle management” can be used effectively in practice.
• Time to Market: The third topic, which can have a significant influence on the first two topics mentioned, is product transfer, both from development to production and from the initial manufacturer to other production sites worldwide. The most important topic in product transfer is the transfer of knowledge, combined with training of the know-how carriers at the receiving production sites.

Regulatory Trends

We request submissions related to pharma industry regulation. Presentations may include case studies linked to implementation of GMP documents or regulatory initiatives regarding risks for the patients. Proposals may focus on one or multiple of these subjects:

• Annex 1 implementation case studies. This document is now fully enforced and additional clarification from regulators may be released before the conference. Case studies relating to ATMP’s may also be included.
• Drugs shortages prevention and supply chain resiliency are key topic for patients, industry, and regulators. There are many initiatives across Europe and the FDA, as well as Asia, to address this issue. Presentations may also include case studies on improving market supply.
• ICH Q9R1 is a current hot topic. Proposals should include case studies for the implementation and understanding of this revision.
• Additional topics may include updates on pharma GMP standards; draft Annex 15: Qualification and Validation; Annex 11; and Chapter 4 EudraLex vol. 4.

Sustainability

Sustainability is critical for the pharmaceutical industry. Europe is developing directives to improve sustainability of facilities and products. The ECHA plans restriction or bans for PFAS. The pharmaceutical industry is implementing initiatives for sustainable facilities and carbon footprint reductions, and some Member States and European countries have already implemented sustainable objectives in their regulation.

We are seeking proposals highlighting industry sharing initiatives, and managing sustainability for processes, building, and manufacturing facilities. Topics may include:

• HVAC: How to improve sustainability HVAC systems in clean air areas compliant with Annex 1?
• PFAS: Addressing the industry challenge of PFAS restrictions and bans and identifying alternatives.
• Will regulatory inspections cover sustainability?
• Challenges of reducing energy consumption in the pharmaceutical industry.

Manufacturing Facility Lifecycle: Progress, Trends and Challenges

Current Good Manufacturing Practices (cGMP) exist for a sole reason: to protect the quality and integrity of the final drug product and inevitably ensure patient safety. This purpose will never change; however, the driver for continuous improvement to uphold product quality will continue to progress.

Join us for an engaging track in exploring the key drivers behind the lifecycle of biomanufacturing facility design from the lens of progress, trends, and challenges. These factors collectively influence the design, operation, and evolution of biomanufacturing facilities, ensuring they can meet current and future production needs while maintaining high standards of quality and efficiency.

• Adopting emerging technologies to improve drug quality Facility Design & Expansion: Case Studies
• Migrating aging facilities with innovative solutions and technology
• Pharma Facility of the future
• Holistic approach to Biopharma Process Transfer
• Consideration of Risk Assessment in Pharma and Biotech Manufacturing Operation: Case Studies
• QBD for Product and Process Control Strategies: Case Studies