5:00 pm - 6:00 pm

Welcome Day Panel: Planning for Pharmaceutical Manufacturing of the Future: What are the Five Big Things We Need to Talk About?

• Is talent and workforce development in our industry changing? If so how and why?
• What are the most important new technologies in manufacturing today?
• What current factors are affecting speed of development and efficient manufacturing?
• What Regulatory progress has been made and what future opportunities exist?
• How can we improve the access of innovative medicines?

Paul Testa
EVP Supply Chain and Operations
Kyowa Kirin

Marian Gindy
Vice President, Small Molecule Science and Technology
Merck

Sandra Poole
Chief Operating Officer
Mythic Therapeutics

Alex Cooke
CEO
Phase3

Christine Sheaffer
Head of Manufacturing & Supply
Spark Therapeutics

6:00 pm - 7:00 pm

Welcome Drinks Reception

7:30 am - 8:15 am

Registration and Breakfast

8:15 am - 8:20 am

Opening Remarks and Important Announcements

8:20 am - 8:30 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

9:45 am - 10:20 am

Panel: Optimizing Technical Operations: Best Practices for Manufacturing Next-Gen Medicines

• Current trends and manufacturing strategies for next-generation medicines
• Best in class practices for facility planning, CQV, operational readiness and startup
• New innovative technologies on the horizon

Anshul Mangal
President
Project Farma

Flemming Dahl
Senior Vice President, Fill & Finish Expansions Management
Novo Nordisk

Ciaran Brady
Vice President MS&T
Vertex Therapeutics

Jason Politi
Chief Technology Officer
Verve Therapeutics

9:45 am - 10:20 am

Data Doesn’t Lie – Digital Marketing ROI

• Why digitizing production records and connecting to other systems is needed to remain competitive 
• The areas where digital systems have significant impact and how that translates to the bottom line
• How digital systems can improve the work experience for operators
• How to clearly demonstrate the ROI of a digital system

Martin Smyth
SVP Go To Market Strategy
MasterControl

9:45 am - 10:20 am

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

10:25 am - 12:05 pm

Pre-Arranged One-to-One Meetings

• 10:30 am – 10:50 am: Meeting Slot 1/Networking
• 10:55 am – 11:15 am: Meeting Slot 2/Networking
• 11:20 am – 11:40 am: Meeting Slot 3/Networking
• 11:45 am – 12:05 am: Meeting Slot 4/Networking

12:10 pm - 12:45 pm

Manufacturing as a Strategic Enabler for Serial Innovation

• 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
• 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

Ciaran Brady
Vice President, Manufacturing Science and Technology, Cell and Gene Therapy
Vertex Therapeutics

12:10 pm - 12:45 pm

Proactivity – the Future of Quality

• Using Human and Organizational Performance (HOP) in designing quality into the end to end supply processes and how to implement effectively
• Adopting risk-based approaches to identify and mitigate potential issues, maintaining a focus on critical processes and regulatory compliance
• Fostering a culture of continuous improvement, leveraging digital tools to optimize processes and enhance overall quality management
• Establish a proactive approach to regulatory compliance and production effectiveness using appropriate problem solving and conducting regular self-assessments

Anthony Mire-Sluis
SVP Head of Global Quality
AstraZeneca

12:10 pm - 12:45 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

12:45 pm - 1:45 pm

Best Practices for Integrated Business Planning in Pharma: Leveraging Connected Planning to Drive Growth

Robert Honer
PMP CPIM
Anaplan

12:45 pm - 1:45 pm

Industry Trends, Challenges, and Opportunities in Process and Technology Platforms for the Commercialization of Gene Therapy Products

Christopher Klem
Sr. Director Global Manufacturing
AskBio

12:45 pm - 1:45 pm

Knowledge Retention in a Time of High Turnover

Kari Borroel
Head of Operations Quality Learning & Development
AstraZeneca

12:46 pm - 1:45 pm

Automation Technology to Unlock the Future of Cell Therapy Manufacturing

Paul Kopesky
VP Cell Process Development
Beam Therapeutics

12:46 pm - 1:45 pm

Lessons and Opportunities in Value Stream Mapping

Alok Bhatt
Senior Director, Biologics Value Chain, Global Manufacturing & Supply
BMS

12:46 pm - 1:45 pm

Supply Chain Revolution: Prioritizing Patients in Pharmaceutical Logistics

John Glavas
AVP External Manufacturing
Merck

12:47 pm - 1:45 pm

Creating the Multi-Launch CTOs of the future: Who, How, & When?

Alex Cooke
CEO
Phase3

12:47 pm - 1:45 pm

Modernizing the Pharma Quality System. What is it and does it drive results?

Lisa Winstead
Sr. Director – Site Quality Head
Resilience

12:47 pm - 1:45 pm

Culture Transformation: from Compliance to Performance

Yana Collins
Head of Quality Culture and Transformation
Sanofi

12:48 pm - 1:45 pm

Leveraging Platform Processes for Efficient and Effective Gene Therapy Manufacturing

Christine Sheaffer
Vice President of Manufacturing & Supply
Spark Therapeutics

Rusty Shreve
Director, Manufacturing Operations
Spark Therapeutics

12:48 pm - 1:45 pm

Changing the Compliance Paradigm in Large, Global Companies

Peter Shearstone
VP Global Quality & Regulatory Affairs
Thermo Fisher Scientific

12:48 pm - 1:45 pm

1:45 pm - 2:20 pm

Driving Transformation in Quality to Meet the Needs of Our Customers

• Quality as a business driver by “Flipping the Ratio”
• Transforming business growth through Proactive Quality
• Preparing our organization for the future of Quality Assurance

Robin Kumoluyi
VP & Chief Quality Officer, J&J Innovative Medicine
Johnson & Johnson

2:25 pm - 3:00 pm

Accelerate Your Bench to Production Timeline by Collocating Research with Process Development and Pilot Scale Production

• Facilitate tech transfers between teams
• Transition from a PD lab to Pilot lab as business needs change
• Ensure quality of pharmaceutical products
• Improve your process as it evolves during optimization

Peter Genest
Head of Client Solutions
SmartLabs

2:25 pm - 3:00 pm

The Value of a Unified Life Sciences Solution in Pharma 4.0

• Manage the production process and quality in real time from order to batch release in one browser-based user interface visualizing real-time and historical data
• Streamline collaboration between manufacturing and quality people and processes to maximize throughput and accelerate batch release
• Digitize all direct batch execution (EBR) and execution related activities (Logbooks and Digital Procedures) to eliminate paper or unstructured electronic records where data is trapped
• Take advantage of configurable functionality
• Analyze and report on operational data in one place for a single source of the truth
• Achieve measurable results in cost reduction, risk mitigation, and revenue opportunities

Zillery Fortner
Industry & Business Development Director
Honeywell

April VanDenDriessche
MES Technical Solutions Consultant
Honeywell

2:25 pm - 3:00 pm

From “Impossible” to Commercialization

• Boehringer Ingelheim BioXcellence™ demonstrates how effective collaboration in contract manufacturing can expedite the delivery of innovative medicines
• Leveraging expertise in microbial development and manufacturing
• Toolbox approach for a groundbreaking cancer vaccine platform, that was honored with European Inventor Award in 2022
• Showcasing two perspectives from CMO and partner
• The session will highlight the power of collaboration and innovation in the pharmaceutical industry

Scott DeWire PhD
US Head, Business Development & Licensing
Boehringer Ingelheim

Michael Kraich PhD
Vice President of Global Project & Product Management BioXcellence
Boehringer Ingelheim

3:05 pm - 4:15 pm

Pre-Arranged One-to-One Meetings

• 3:05 pm – 3:25 pm: Meeting Slot 5/Networking
• 3:30 pm – 3:50 pm: Meeting Slot 6/Networking
• 3:55 pm – 4:15 pm: Meeting Slot 7/Networking

4:20 pm - 4:55 pm

Leading Through Transformations and Integrations – The Evolution of Global Product Development and Supply

4:55 pm - 5:30 pm

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

Daniela Ottini
SVP, Manufacturing and Supply Head of Specialty Care
Sanofi

5:30 pm - 5:35 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

5:35 pm - 6:35 pm

Drinks Reception

6:30 pm

Executive Dinner

7:30 am - 8:20 am

Registration and Breakfast

8:25 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

A Vision for the Future: Moderna’s Plans for mRNA Technology, Manufacturing and Scale

• Pivoting fearlessly: How Moderna transitioned from a pandemic to an endemic market
• Building for scale: Where the company is investing and partnering as it plans to launch up to 15 products in 5 years
• Prioritizing culture: What it took to encode the company’s mindsets and unique culture

Jerh Collins
Chief Technical Operations and Quality Officer
Moderna

9:10 am - 9:45 am

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

Anil Sawant
SVP Global Quality Compliance
Merck

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

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.

9:50 am - 10:25 am

Fireside Chat: Supply Chain Excellence: Balancing Resiliency and Efficiency to Enable Growth

• Exploring the complexity of the biopharma industry and using R&D to market authorization and global challenges
• Highlighting Amgen’s supply chain optimization and discussing strategies for efficiency and network enhancement
• Showcasing Amgen’s commitment to industry excellence while diving into it’s leading manufacturing capabilities
• Ensuring reliable access to medicines with a patient focused supply assurance

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

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

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

11:20 am - 11:55 am

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

11:20 am - 11:55 am

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

12:00 pm - 12:35 pm

Real Time Release: A Distant Dream or Reality?

• Insight into J&J’s journey to implement real time multivariate analytics, PAT, modeling and feedback control
• Achieving integrated quality objectives, reducing non-conformance, enhancing quality control, and enabling real time release
• Integration of digitalization, data, and Quality By Design to intensify processes for flexible and modular manufacturing tailored to customer requirements in quality, price, quantity, and delivery
• Exploring the lessons learnt from the real-time release journey and their alignment with J&J’s long-term vision of quality-driven progress

Olav Lyngberg
VP Innovation and Technology Deployment, Janssen Supply Chain
The Janssen Pharmaceutical Companies of Johnson & Johnson

12:00 pm - 12:35 pm

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

12:00 pm - 12:35 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

12:36 pm - 1:35 pm

CMC Considerations as We Standardize and Work Towards Commercialization

Matthew Conover
Sr. Director Cell Therapy CMC
BMS

12:36 pm - 1:35 pm

Integrating Green Chemistry Principles into Manufacturing Supply Chains

Jonathan Tripp
Principal Scientist
Gilead Sciences

Michael O’Keefe
Senior Research Scientist II/Associate Director
Gilead

12:36 pm - 1:35 pm

Navigating Quality 4.0: Initiating Your Path in Pharmaceutical Manufacturing

JR Humbert
VP Quality
INCOG BioPharma Services

12:37 pm - 1:35 pm

Keeping Pace with the Evolving Quality and Regulatory Trends in Cell Therapy

Scott Nichols
Director Quality
Kite Pharma

12:37 pm - 1:35 pm

Realtime Manufacturing While Stabilizing The Workforce

Dottie Barr
SVP Manufacturing & Technical Operations
Lantheus

12:37 pm - 1:35 pm

Achieving Speed to Market in an Evolving CGT landscape Via Laser Focus on Compliance, Systems and People

Elena Kichula
Sr. Director – Manufacturing, Science, and Technology and Process Engineering
Spark Therapeutics

Vaishal Patel
QA Site Lead
Spark Therapeutics

1:35 pm - 2:10 pm

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

2:10 pm - 2:45 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, ADC’s, mRNA: How do we efficiently serve giant markets such as Alzheimer’s indications, for example?

Joanne Beck
Chief Technology Officer
Aerium Therapeutics

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

Alex Cooke
CEO
Phase3

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

2:45 pm - 2:50 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