6:00 pm - 7:00 pm

Welcome Drinks Reception

7:00 am - 7:45 am

Registration and Breakfast

7:45 am - 7:50 am

Opening Remarks and Important Announcements

7:50 am - 8:00 am

Chair’s Welcome Address

Charles L. Cooney
Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation
MIT

9:15 am - 9:50 am

Regionalization Versus Globalization: Strategies for Optimizing Pharmaceutical Supply Networks

• Introduction to the global pharmaceutical supply chain and the impact of balancing regional and global supply chains for efficiency and quality
• Showcasing advanced technologies, automation, and data analytics for optimizing supply networks
• Navigating regulatory considerations and compliance challenges in regional and global pharmaceutical supply networks
• Leveraging global strategies for enhancing affordable, quality pharmaceutical access and mitigating risks in emerging markets 
• Real world case studies demonstrating successful regional and global supply chain models

9:15 am - 9:50 am

Maximizing Quality and Compliance: A Strategic Approach for Pharmaceutical Manufacturing

• Introduction to the need for quality and compliance transformation and the impact of shifting regulatory landscapes on quality assurance and compliance
• The role of advanced technologies in enhancing quality practices, ensuring data integrity and improved product safety and efficacy 
• Strategies for supplier quality management for maintaining consistency and building a culture of quality and compliance
• Case studies highlighting quality driven practices that have led to improved transformation in enhancing quality practices
• Real world success stories in transforming quality practices for the modern pharmaceutical landscape

Valerie Brown
SVP, Global Quality Assurance
Gilead Sciences Inc.

9:15 am - 9:50 am

Leading the Strategic Planning Frontier: Enhancing Your Edge Through Investments in People, Processes, and Technology

• Outlining the increasingly evolving biopharma supply chain ecosystem with the goal of balancing resilience and risk
• Creating a roadmap for network optimization to avoid disruptions and drive cost-efficiency, agility and patient outcomes
• The critical relationship between talent, technology and processes in achieving supply chain excellence
• Explore the systems and technologies driving innovation and the supply chain of the future: IoT, AI, and Blockchain
• Provide real-life examples of successful process improvements and network optimization in the biopharma supply chain

Nkem Ogbechie
Head of Operations Strategic Planning, Risk and Analytics
Amgen

9:55 am - 11:35 am

Pre-Arranged One-to-One Meetings

• 10:00 am – 10:20 am: Meeting Slot 1/Networking
• 10:25 am – 10:45 am: Meeting Slot 2/Networking
• 10:50 am – 11:10 am: Meeting Slot 3/Networking
• 11:15 am – 11:35 am: Meeting Slot 4/Networking

11:40 am - 12:15 pm

Technical Operations Strategies for Transformative Medicines

• Discuss the shifting landscape of current trends and manufacturing strategies for next-generation medicines and their impact on technical operations
• Best in class practices for facility planning, build, operational readiness and startup
• New innovative technologies on the horizon

11:40 am - 12:15 pm

Why Your Digital Strategy May Be Incomplete: How Legacy Models Prevent End-To-End Digital Manufacturing

• Why pharma organizations must diversify their digitization strategy, looking beyond legacy models that prevent complete, end-to-end digital manufacturing
• How a light, configurable MES can remove paper from production entirely and enable any-sized pharma company to fully utilize their MES across all lines and sites
• How a modern MES can digitally connect different data sources to close offline data gaps, improve data integrity and visibility, and unlock critical business intelligence

11:40 am - 12:15 pm

Improving Visibility and Collaboration with CMOs and Direct Suppliers

• What key challenges drive supplier management leaders to digital transformation in the pharmaceutical industry?
• Achieving more agility with CMOs and direct suppliers
• Linking systems, processes, people and enterprises into a collective information network to support intelligent business execution
• Improving visibility and collaboration in supplier management operations

12:20 pm - 12:55 pm

Bioprocessing 4.0: Revolutionizing Innovative Technology in Biopharmaceutical Manufacturing

• The significance of bioprocessing within the pharmaceutical industry deep diving into interconnected systems and smart manufacturing in process optimization
• Showcasing the impact advanced technologies for optimizing production processes, bioprocessing and product quality
• A glimpse into the future of biopharmaceutical, including personalized medicine, supply chain resilience and the transformative potential of bioprocessing 4.0
• Unpack real world case studies highlighting the impact on innovative technologies addressing regulatory challenges and ensuring compliance

12:20 pm - 12:55 pm

Revolutionizing Quality Assurance: Harnessing Advanced Technologies in Pharma Manufacturing

• Exploring the evolving landscape of quality assurance and the shifting paradigm in pharmaceutical manufacturing
• Leveraging cutting edge technologies for catalyzing quality enhancement and making smarter quality decisions
• Optimizing efficiency and reducing downtime for enhance product quality and fostering a culture of excellence
• Regulatory and compliance challenges: addressing quality and compliance with advanced technologies 
• Real world success stories in quality revolution. Implementing advanced quality assurance technologies and the impact on patient safety and product efficacy

12:20 pm - 12:55 pm

Navigating the Complexities of Gene Therapy Commercialization and Manufacturing

• Scaling up gene therapy production, the challenges, solutions and real world examples exploring the next frontier of manufacturing and its significance 
• The future of external gene therapy development, meeting growing demand for advanced therapies
• The impact and transformation of advanced technologies on improving efficiency and product quality 
• Exploring strategies for collaboration and partnerships for large scale gene therapy production 
• Regulatory challenges in gene therapy manufacturing
• Case studies of successful external gene therapy commercialization and manufacturing models and discussing the future outlook of meeting the growing demand

Ryan Bartock
Head of Engineering, Technical & Digital
Spark Therapeutics

12:55 pm - 1:55 pm

Best Practices for Effectively Managing Supply Chain Complexities with External Partnerships and Manufacturing

12:55 pm - 1:55 pm

Connected Pharma R&D Planning: Clinical Trials Forecasting & Planning Management

12:55 pm - 1:55 pm

Industry Trends, Challenges, and Opportunities in Process and Technology Platforms for the Industrialization of Cell Therapy Products

12:56 pm - 1:55 pm

Navigating Quality 4.0: Initiating Your Path in Pharmaceutical Manufacturing

12:56 pm - 1:55 pm

Digital Transformation in Manufacturing: Leveraging Remote Work Technologies

12:56 pm - 1:55 pm

Supply Chain Security and Resilience: Protecting Pharma’s Critical Pathways

1:55 pm - 2:30 pm

Keynote: Strengthening our Industry: Intersection of Innovation, Customer Experience, and Proactive Resilience

• Preparing our organizations for the future of quality assurance within the digital transformation of advanced technologies 
• Mitigating risks, ensuring product integrity and adapting to regulatory changes and global challenges
• Transforming business growth through proactive resilience and fostering a culture of quality and innovation throughout the organization 
• Leveraging data analytics and innovation for continuous quality improvement and better decision making in management of change
• Adapting to regulatory changes and global challenges in the pharmaceutical manufacturing industry and future proofing quality assurance

Robin Kumoluyi
VP & Chief Quality Officer
Johnson & Johnson

2:35 pm - 3:10 pm

Build vs Buy vs Blend: Comparing Challenges and Opportunities for Early-Phase Biopharmaceutical Manufacturing Options

• Exploring and comparing various options available to the biopharma industry for the manufacturing of clinical batches
• Looking at: Internal manufacturing, outsourced manufacturing, and hybrid models
• What are the current challenges and opportunities for these options?  Discussing various considerations including economic and time

2:35 pm - 3:10 pm

Setting a Roadmap for the Future of Science with New End-to-End R&D Support

• Reinventing how therapies and medical devices are developed and brought to market 
• Employing advanced laboratory resources to enable programs of all sizes and scales to develop from discovery into clinical trials through one seamless platform
• How the results of co-locating R&D facilities with scale-out manufacturing facilitates unprecedented communication and access between all players in the biotech R&D and manufacturing space

2:35 pm - 3:10 pm

Navigating the Changing Pharmaceutical Dealmaking Landscape

• Diving into the ever-evolving landscape of dealmaking and unraveling the forces reshaping the industry’s dynamics
• Addressing healthcare challenges: Future real-world case studies and expert insights on strategies for forging strategic alliances, securing partnerships, and driving innovation
• Navigating intricacies of dealmaking and providing guidance for success in this transformative era

3:15 pm - 4:25 pm

Pre-Arranged One-to-One Meetings

• 3:15 pm – 3:35 pm: Meeting Slot 5/Networking
• 3:40 pm – 4:00 pm: Meeting Slot 6/Networking
• 4:05 pm – 4:25 pm: Meeting Slot 7/Networking

4:30 pm - 5:05 pm

Strategic Expansion Roadmap: Aseptic Filling Facilities for Global Growth

• Explore the strategies and considerations involved in building aseptic filling facilities across the global manufacturing network
• The importance if harmonization and global standards in pharmaceutical manufacturing. How are we ensuring consisteny and quality across different facilities
• Discuss the challenges and approaches in maintaining regulatory compliance when expanding aseptic filling capabilities. Strategic planning for navigating evolving regulations in different countries
• Exploring the role of innovation and technology. What cutting edge technologies are being employed to enhacne efficency and quality
• Highlighting Novo Nordisk’s success with real life examples of successful AP expansions and the impact of Novo Nordisk’s global operations

Flemming Dahl
SVP, Head of Product Supply AP Expansions
Novo Nordisk

5:05 pm - 5:40 pm

Integrating Customer Centricity and Innovative Technology into a Forward-Looking Manufacturing & Compliance Strategy

• How are biology and patient needs influencing risk-based investment and networking structure in the manufacturing space?
• Discussing route and location of administration, including MDCP considerations, components and suppliers, design standards
• Exploring flexible facilities, integrated clinical launches, and capital risk avoidance in the quest to get fast to clinical and fast to respond
• Understanding the need for early investment in platform changes. How is the emergence of ADCs, modality blurring, and market
• How do we ensure quality, risk management and compliance processes are in lock step as our technology and platforms evolve

David Maraldo
SVP Operations
Merck

Anil Sawant
SVP Global Quality Compliance
Merck

5:40 pm - 5:50 pm

Chair’s Closing Remarks

Charles L. Cooney
Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation
MIT

5:50 pm

Drinks Reception

7:30 am - 8:30 am

Registration and Breakfast

8:30 am - 8:35 am

Chair’s Welcome Remarks

Charles L. Cooney
Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation
MIT

8:35 am - 9:10 am

The Vertex Story: Serial Innovation in Manufacturing

• Sharing Vertex’s track record for serial innovation in manufacturing to create transformative medicines for people with serious diseases and high unmet medical needs
• Highlighting Vertex’s success with small molecule continuous manufacturing in Cystic Fibrosis
• Transforming manufacturing in cell and genetic therapies for Sickle Cell Disease, Beta Thalassemia, and Type 1 Diabetes
• Describing the specific technical innovations and breakthroughs that have been instrumental in Vertex’s manufacturing success
• Emphasizing the importance of cross-functional collaboration to drive manufacturing innovations and deliver transformative medicines

E. Morrey Atkinson
EVP Chief Technical Operations Officer
Vertex Pharmaceuticals

9:10 am - 9:45 am

Navigating Industry Evolution: Uniting Platform Innovation, Technology, and Manufacturing 4.0

• The industry dynamics: Staying ahead in a changing compliance landscape and recognizing the shifting pharmaceutical landscape and its implications
•  Enabling business growth through proactive resilience and preparing for unpredictable challenges  
• The digital transformation and leveraging technology for efficiency, quality and customer engagement white strategizing for regulatory adaptation 
• The proof in the pudding: Showcasing industry leaders who have thrived by embracing innovation, customer centricity and resilience

Chris Stevens
Chief Patient Supply Officer
Spark Therapeutics

9:50 am - 10:25 am

Innovations in Personalized Medicine Manufacturing: A Glimpse into the Future

• The growth of biologics and precision and personalized medicine is driving the need for new types of solutions across automation, manufacturing, and quality and compliance
• Learn how to modernize your operations and achieve manufacturing excellence using a future forward, agile, integrated, manufacturing solution that supports compliance and real-time quality management
• Take an industry standard approach to reach new levels of maturity in your digital transformation journey
• A look ahead at the expanding role of personalized medicine in pharma and overcoming hurdles in personalized medicine production and scalability

Patrick Gammell
VP, Global Manufacturing Sciences
Biogen

9:50 am - 10:25 am

Enhancing Quality Agility: Leveraging Insights from Cell and Gene Therapy for a Swift Clinical to Commercial Transition

• Exploring how the cell and gene therapy revolution is transforming the landscape of modern medicine 
• The critical role of quality assurance and navigating unique quality and compliance challenges in advanced therapies 
• Strategies for efficient scaling and market entry for the clinical to commercial transition and ensuring uninterrupted access to advanced therapies examining supply chain resilience 
• Ensuring safety and efficacy as therapies reach wider populations utilizing real time monitoring and agile adjustments 
• Showcasing real world case studies and demonstrating successful clinical to commercial transitions and their impact

Evelyn Marchany-Garcia
SVP, Chief Quality Officer, Technical Operations
BioMarin

9:50 am - 10:25 am

Harnessing Digitalization for Supply Chain Scaling in Autologous and Allogenic Cell Therapies

• Achieving a balanced investment in manufacturing capacity and how to build a strong supply chain
• Allogeneic manufacturing process, scalability considerations, and optimizing patient supply
• Approaches to manufacture autologous, allogeneic and “next generation” autologous therapies
• Donor Variability, the greatest source of variability for cell therapies. Thoughts on characterizing and accommodating this variability
• Identifying the key challenges and areas for improvement in three case studies

10:25 am - 11:15 am

Pre-Arranged One-to-One Meetings

• 10:30 am – 10:50 am: Meeting Slot 8/Networking
• 10:55 am – 11:15 am: Meeting Slot 9/Networking

11:20 am - 11:55 am

Sanofi Manufacturing Transformation: Turning Science into Reality for Patients

• Our new purpose: we chase the miracles of science to improve people’s lives
• Our race to make available breakthrough treatments & vaccines for patients supported by diverse modalities: accelerate product launches and optimize our asset performance
• Our ambition to develop a network of Factories of the Future
• Leveraging advanced digital technologies while working CMOs and adapting CMO relationships to meet changing market demands

11:20 am - 11:55 am

The Competitive Edge: How a Culture of Quality Excellence Transforms Pharmaceutical Operations

• Building a quality centric culture, exploring strategies for fostering excellence across all aspects of operations
• The link between high quality products, quality excellence and customer satisfaction
• Equipping manufacturers to stay ahead of the competition and bring high-quality, safe products faster to the market
• Prioritizing data driven decision making and leveraging insights for quality enhancement 
• Adaptability in a dynamic landscape, maintaining stringent standards and regulatory compliance

11:20 am - 11:55 am

Responding to the Challenges and Opportunities of Next-Generation Supply Chain Planning

• Addressing the complex and dynamic nature of pharmaceutical supply chains ensuring the timely and efficient delivery of life saving medication and healthcare products to patients around the world 
• Increasing customer demand for faster delivery and real time tracking, putting additional pressure on supply chain planning 
• Highlighting the intricacies of managing pharmaceutical supply chains on a global scale, emphasizing the diverse regulations, market dynamics and logistical challenges that come into play
• Exploring the role of advanced technologies, data analytics and automation in improving visibility, traceability and operational efficiency in pharmaceutical supply chain planning

12:00 pm - 12:35 pm

Three Essential Steps to Competitive Advantage

• Developing a step-by-step modular content production workflow suited to your organization, from inception to implementation
• Mapping key functions and resources for each stage of workflow including external partners
• Identifying critical enablers and challenges you may encounter at each stage and how to address them

12:00 pm - 12:35 pm

Your “Future-Proofed” Platform Is Holding You Back: Look to the Future with Connected Life Sciences

• Is the platform approach the “be-all and end-all” of software solutions?
• Facing the challenge of no “one-size-fits-all” solution for every organization
• How certain approaches to quality can disrupt other parts of the business and upheave proven working systems in order to continue platform building
• Avoiding gaps in critical applications causing inefficiencies, as well as limiting the ability to make data-driven decisions

12:00 pm - 12:35 pm

Beyond Capabilities and Capacity: What Traits Should Biopharma Companies Look for When Partnering with CDMOs

• Best traits to look for when partnering with a CDMO, besides just capabilities and capacity
• Best practices for discerning which CDMO’s are best for biopharma companies to partner with
• Key steps for helping biopharma companies navigate complex sales processes with CDMOs

12:36 pm - 1:35 pm

The Convergence of Pharmaceuticals and Digital Health: Opportunities and Challenges

12:36 pm - 1:35 pm

From Approvals to Patients— Ensuring Ongoing Inspection Readiness and Manufacturing Success

12:36 pm - 1:35 pm

Supply Chain Revolution: Prioritizing Patients in Pharmaceutical Logistics

12:37 pm - 1:35 pm

Quality by Design 2.0: Next Gen Strategies with Advanced Control Technologies

12:37 pm - 1:35 pm

Enabling Volume-Driven Growth and Staying Efficient Through Continuous Improvement and Technology Advancement

12:37 pm - 1:35 pm

Shifting Regulatory Standards in Cell and Gene Therapy

1:35 pm - 2:10 pm

Smart Manufacturing in Pharma: Implementing AI and Machine Learning for Process Optimization

• Managing the challenges: investing in infrastructure, data security and employee training to make the most of AI and ML
• The transformative role AI and ML has played in modernizing pharmaceutical manufacturing processes, improving efficiency and reducing costs
• Enhancing quality control, reduce errors and ensure strict adherence to regulatory standards, contributing to patient safety and product quality
• Optimizing R&D processes by accelerating drug development and extracting actionable insights from the vast amount of pharmaceutical data, enabling better decision making and process optimization

1:35 pm - 2:10 pm

Elevating Your Competitive Edge: The Strategic Power of Quality Investments

• Positioning quality as a strategic imperative and the importance of quality as a strategic asset that can set pharmaceutical companies apart, enhance their reputation and drive competitiveness 
• Highlighting the role of a skilled and motivated workforce in maintaining quality standards and discuss the significance of continuous training and development
• The integration of advanced technologies and the need to streamline manufacturing processes, reduce inefficiencies and minimize efficiencies and errors to lower cost and enhance product quality 
•  Discussing the direct impact of quality on patient safety, satisfaction and trust underlining the ultimate purpose of pharmaceutical manufacturing with case studies

1:35 pm - 2:10 pm

Creating Resilient Supply Chains and Robust Manufacturing Platforms: Expediting the Commercialization of Cell and Gene Therapies

• Exploring the need for global collaboration among various stakeholders to expedite the delivery of cell and gene therapies worldwide, ultimately improving healthcare outcomes
• The complexities of cell and gene therapy supply chains and the importance of building resilience to ensure consistent access for patients
• The revolutionary potential of cell and gene therapies in healthcare and the unique manufacturing challenges they present
• Leveraging advanced technologies for automation resulting in driving efficiency and consistency adhering to regulatory compliance in the commercialization of these therapies, ensuring patient safety and satisfaction

2:15 pm - 2:50 pm

Panel: Looking Backwards, Looking Forwards: Maximizing Our Impact on the Future of Medicine

• How has this changed the CMC ecosystem, and are we overbuilding capacity again?
• Avoiding the dangers of fragmentation. How should we better communicate, collaborate, and consolidate our best ideas so we all succeed?
• Discussing the reasons to set up a new company today, and imagining how our business ecosystem will continue to grow and evolve
• Debating which production platforms will best suit the newer modalities
• Exploring the next steps for existing platforms like mAbs: How do we efficiently serve giant markets such as Alzheimer’s indications, for example?
• Striking the balance between pandemic and personalized medicine as we look to the future

Carlo de Notaristefani
Former Lead, Manufacturing & Supply Chain Advisor
Operation Warp Speed

Pat Yang
Vice Chairman & Co-Founder
Resilience, Inc.

2:50 pm - 3:00 pm

Chair’s Closing Remarks

Charles L. Cooney
Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation
MIT