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American Biomanufacturing Summit 2024 - Program (1.0 MiB)
April 10, 2024
* JOIN US FOR THE PRE-EVENT HAPPY HOUR ON APRIL 9TH, 2024 FROM 6:00 PM – 7:00 PM
Registration and Networking Breakfast
Chair's Welcome and Opening Remarks
Manufacturing and Technology
Andrew Wirths
SVP, Supply Americas
AstraZeneca
Quality and Compliance
Jackie Elbonne
Chief Quality Officer and SVP, Global Quality
Amgen
Supply Chain and Logistics
Robert Bottome
VP, Global Supply Chain
BioMarin Pharmaceuticals
Cell and Gene Therapy
Chris Holt
VP and Site Head, Cell Therapy Manufacturing
Bristol Myers Squibb
Keynote
Pam Cheng
EVP, Global Operations and IT, Chief Sustainability Officer
AstraZeneca
OPTIMIZING BIOMANUFACTURING: STRENGTHENING SUPPLY CHAIN RESILIENCY THROUGH INNOVATING, COLLABORATING, AND ADAPTING
- Navigating the evolving VUCA landscape and its impact on supply chain resilience for biomanufacturing
- Ensuring supply chain resiliency in the development and delivery of new modalities, such as cell therapy products
- Lessons learned :Reducing vulnerabilities and disruptions within your supply chain
- Exploring how industry partnerships and global alliances bolster supply chain resilience
- Examining sustainable practices and the critical role they play in ensuring long-term supply chain resiliency
Plenary
Thomas Potgieter, Ph.D.
SVP, Cell Therapy Development and Operations
Bristol Myers Squibb
Revolutionizing Cell Therapy Manufacturing: Innovating, Scaling, and Optimizing
- Exploring methods for increasing cell therapy production rates while maintaining quality and consistency
- Implementing efficient, end-to-end processes to reduce manufacturing bottlenecks and minimize production costs
- Leveraging cutting-edge technology for real-time monitoring and quality assurance in cell therapy manufacturing
- Adopting strategies to flexibly scale production to meet fluctuating market demands and regulatory requirements
- Harnessing the power of automation and robotics to improve the reliability and repeatability of cell therapy manufacturing
- Discovering best practices and case studies for continual optimization of biomanufacturing processes in the cell therapy industry
Plenary
Greg Gara
SVP
ProjectFarmaAdam Pfeiffer
VP
ProjectFarmaAntinea Chair
VP, Technical Operations
CellaresThomas Potgieter, Ph.D.
SVP, Cell Therapy Development and Operations
Bristol Myers Squibb
Redefining Technical Operations For Transformative Medicines
- Discuss opportunities and innovations in technical operations to optimize manufacturing
- Gain insights into best-in-class practices for facility planning, operational readiness and startup
- Learn strategies for commissioning and qualification, quality, automation & engineering
Refreshments, Networking, and Pre-Arranged 1-2-1 Meetings
Sessions
Manufacturing and Technology
Andrew Skibo
Chief Manufacturing Officer
FluGen Inc.
Career Growth and Development in Biomanufacturing
- How to get a head start on the job market
- Navigating career changes, challenges, and curve balls
- Understanding your skills and value for new roles or stretch assignments
- Designing a career path that leads to advancement and leadership
- To stay, or go: Knowing when you're ready to take next steps in your career
- What I've learned along the way: Leadership lessons and insight from the top
- Finding resources for connecting with mentors or working groups in the field
Quality and Compliance
Peter Marks, Ph.D.
Director, Center for Biologics Evaluation and Research
FDA
Accelerating Innovative Biomanufacturing Growth Through the FDA’s Insights and Trend Analysis
- How the FDA-CBER regulates and oversees biomanufacturing processes, ensuring adherence to stringent quality standards, safety measures, and ethical guidelines for the benefit of patients and global health
- Advancing biomanufacturing practice and driving innovative technologies with cutting-edge therapies and treatments
- Embracing current biomanufacturing trends, from cell and gene therapies to bioprocessing advancements, fostering a transformative landscape for personalized medicine
Supply Chain and Logistics
Kevin Brower, Ph.d.
Global Head, Purification Development, Mammalian Platform
Sanofi
Streamlining The Industry’s Manufacturing Future: Highlights from A Process Intensification Journey
- Defining process intensification, with a focus on purification
- Intensified processing for streamlined process validation
- Engineering principles and their relevance for filing continuous processes
- Flexible modular manufacturing for an intensified, simplified network
Cell and Gene Therapy
Dominique De Jaeger
VP, CAR-T Supply Chain
Johnson & Johnson
The art and science of scaling a commercial CAR-T therapy
- How is Johnson and Johnson supporting the development and growth of its portfolio of personalized medicines?
- Identifying weak links and critical dependencies in current supply chains to mitigate distributions
- Navigating the evolving regulatory landscapes and compliance requirements to enable quick commercialization of CAR-T therapies
- Case study: Lessons learned from managing supply operations of Carvykti
Workshops
Room 1
David Shenberger
VP, Strategic Development
CAI
The Importance of Early Planning in Speed to Patient
- What all needs to be done? Making the list
- When does it need to be done? Building an integrated schedule
- Who needs to do it? Aligning all the stakeholders
- How do we plan for it? Taking time for workshops
- Why early planning is the key to speed to market
ROOM 2
Julie Pacheco
VP, Service
Integrant
Bishoy Labib
Senior Architect
Integrant
Data-Driven Biotech Manufacturing: Building a Comprehensive Platform
- How effective data management and planning can lay the foundation for streamlined biotech manufacturing operations
- The importance of governance and design in ensuring data integrity and usability throughout the manufacturing process
- Leveraging analytics to drive insights and optimize production efficiency in real-time
- Strategies for scaling data platforms to accommodate growth and technological advancements in the biotech industry
- Preparing for the integration of AI and advanced analytics to stay ahead in the rapidly evolving biotech landscape
ROOM 3
Bob Lenich
Business Director, Process and Knowledge Management
Emerson
Getting the Most from Digital Recipe Management Lifecycle Transformation
- Reviewing the current state of typical enterprise recipe management and tech transfer business processes
- Discussing a vision for transforming paper and people based manufacturing recipe management
- Providing project examples of what can be achieved with digital recipe management transformation
- Proposing a methodology for where to start in order to get there
Room 4
Sara Miller
Associate Director, Cell Therapy Business
FUJIFILM Diosynth Biotechnologies
An Allogeneic Commercial Journey
- Discussing the path of preparing a GMP cell therapy manufacturing facility to become a full service commercial CDMO
- Focusing on the journey taken to support the first approval of an allogeneic T- cell immunotherapy from inception through its PAI inspections and commercial approval as well as advancing other cell therapy programs
- Introducing pre-IND programs to devising flexible systems to support programs at all phases to the acquisition by FUJIFILM Diosynth Biotechnologies
- Allogeneic cell therapy as the next breakthrough in making cell therapy available to larger groups of patients who need it
Lunch & Learn Roundtables and Open Seating Lunch
Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required, and attendance for moderated roundtables on Day 1 is limited to attendees and speakers. Choose from:
Shawn Olsen, Ph.d.
Director, North American Sales
Rapid Micro
Removing Manufacturing Barriers to Batch Release with Rapid QC Product Testing
William Hermans
Senior Director and General Manager, Large Molecule Development
Curia
Biomanufacturing Beyond Boundaries: Exploring New Horizons in Bioprocessing
Jason Jakob
Chief Software Architect
Adlib
Conquering the Process Hurdle: Automate Labor-intensive document process
Jaya Tikhe
Senior Offer Marketing Manager
Biovia
AI-Powered Biopharma Quality Management Harnessing Virtual Twins for a Comprehensive End-to -End Solution
Mary Lee Schiesz
Senior Director, CMO Sales
Samsung Biologics
Driving Success in Biomanufacturing: Exploring Global Portfolio Expansion for Accelerated Excellence
David Frank
VP, Client Development
Azzur Group
Navigating Your Manufacturing Journey From Discovery to Delivery™
Dustin Lafferty
Senior Pharmaceutical Scientist
Singota Solutions
Navigating Early-Phase Analytical Validation
Indraneel Sanyal
Senior Director and Head of the Biologics Development
Aragen
Exploring Case-Specific Applications of Process Intensification in Biologics Manufacturing: Advantages and Challenges
Ross Turmell
Principal Scientist
Cytiva
Innovating Processing capabilities for enhanced yield and quality
Giacomo M. Di Mauro, Ph.d.
Scientist II, Large Molecules Division
BA Sciences
Ensuring Ethical and Transparent Practices in the Biomanufacturing Supply Chain
Pete Genest
Director, Business Development
Smart Labs
Identifying the right cGMP manufacturing solution for novel therapies
Pat Yang, Ph.d.
Executive Vice Chairman and Co-Founder
Resilience
Dwight Baker
Chief Innovation Officer
Resilience
Accelerating Cell Therapies to the Clinic while Assuring Commercial Success – Is There a Solution?
sessions
Manufacturing and Technology
Thomas Spitznagel, Ph.d.
SVP, Technical Operations
MacroGenics Inc.
Strategies in Biomanufacturing to Build Resilient and Robust Operations
- Leveraging platform processes to accelerate tech transfer and time to production
- Supply chain approaches to ensure availability of raw materials
- Designing facilities to ensure flexibility in scale, operations, and capacity
- Utilizing partnerships to keep capacity full
Quality and Compliance
Scott Goodberlet
VP and Head, Quality Americas Region and Device Quality
AstraZeneca
Advancing Proactive Quality Operations and Nurturing a Culture of Excellence
- What does proactive quality culture and excellence look like at AstraZeneca?
- How to inspire teams to prioritize quality, fostering a culture of excellence
- Discovering strategies for seamlessly integrating quality standards into manufacturing processes
- Utilizing effective monitoring and control measures that uphold quality standards
- Exploring methods to empower your workforce to take ownership of quality control
- Discussing sustainable practices for continuous quality improvement
- Examining the role of collaboration in building a robust quality culture
- Understanding how to adapt to industry changes while maintaining a strong quality culture
Supply Chain and Logistics
Lee Spach
VP, Cell Therapy Global Supply Chain
Bristol Myers Squibb
Unveiling the Future: Revolutionizing Pharmaceutical Supply Chains for Cell Therapy Success
- Focus on achieving end-to-end transparency in pharmaceutical supply chains to improve decision making, responsiveness, and network optimization
- Utilize digital planning to maximize capacity and scalability, allowing for the treatment of a larger number of patients
- Prioritize patient operations to ensure highly responsive service throughout the supply chain
- Emphasize the critical role of reliable transport services in delivering a consistent and positive patient experience
- Acknowledge the need for unconventional talent in the future workforce to navigate the complexities of the industry
Cell and Gene Therapy
Phillip Ramsey
SVP, Technical Operations
Sangamo Therapeutics, Inc.
The Evolving and Emerging CAR-T Therapy Supply Chain: Current Challenges and Developments
- Analyzing the unique supply chain challenges posed by personalized cell therapies
- Adapting current supply chain models to prioritize patient access and safety
- Strategies for managing hand-off points and improving shipping conditions
- Building stronger industry partnerships and establishing crisis-ready contingency plans
Workshops
ROOM 1
Josh Russell
VP, Sales and Marketing
AST
A Case Study in Flexibility: Modular, Automated Fill-Finish Solutions
- Maximizing machine uptime for multiformat operations
- Harnessing comprehensive vision and sensor checks for quality control
- Utilizing modular setups to optimize operational requirements
- Implementing best practices for fill-finish, small batch production in an automated setting, including strategies for Annex 1 compliance
ROOM 2
Erik Nordwald
Associate Director, Process Technology and Innovation
KBI Biopharma
Fast, cheap drug development with PUREcoli
- E. coli, a workhorse for protein expression
- Bacterial vs mammalian expression modalities
- PUREcoli, redefining microbial expression
ROOM 3
Kunal Bargotra
Product Manager
Adlib
The New Way: Modernizing Document Management for More Efficient Operations
- Don’t get left behind with outdated document management strategy and processes
- Understanding how the new way helps ensure adherence to regulatory compliance
- Exploring how new technologies are disrupting industry-specific automation in document management
ROOM 4
Jesse Cugliotta
Global Industry Lead, Healthcare and Life Sciences
Snowflake
A UNIFIED DATA PLATFORM WITH BUILT-IN AI: SNOWFLAKE'S SOLUTION FOR LIFE SCIENCES SUPPLY CHAINS
- Demonstrating Snowflake's transformative Generative AI capabilities for optimizing supply chain operations within the life sciences sector
- Leveraging LLM's and real-time data from both internal and third party sources to provide analytics around visibility, efficiency, and collaboration across the entire supply chain
- Addressing the unique challenges of biomanufacturing, such as regulatory compliance and sensitive product handling
- Ensuring more resilient, agile, and real-time supply chain management
Happy Hour, Networking and Pre-Arranged 1-2-1 Meetings
Panel Discussion
Aine Hanly
EVP and Chief Technology Officer
Vir BiotechnologyKatharine Miller
VP and Global Head, Biologics Development Analytics and Quality
BayerDafni Bika
SVP, Global Head Pharmaceutical Technology and Development
AstraZenecaEvelyn Marchany García
SVP and Chief Quality Officer
BioMarin PharmaceuticalsKara Renai King
VP and Site Lead
Pfizer
Women in Leadership
- What's one leadership lesson you've learned in your career?
- What has been the most significant barrier in your career as a leader?
- How do you and your organization empower the next generation of skilled professionals?
- What is the best piece of advice you've received from leadership?
- What advice would you give to the next generation of leaders?
plenary
Dan Dernbach
SVP, Global Operations, Azzur Cleanrooms on Demand™
Azzur Group
FROM DISCOVERY TO DELIVERY™ : AN INTEGRATED MODEL FOR ACCELERATION OF ATMP DEVELOPMENT
- Addressing the 5 Pillars of GMP manufacturing
- Strategies to ease transition from R&D and pre-clinical to early-phase GxP clinical production
- Mitigating hurdles impacting the ability to achieve, mature, and maintain GxP compliance
- Improving delivery capabilities to ensure a safe and expeditious time to market
- Integrating critical systems, processes to maintain optimal facilities and operations
Panel Discussion
Lauren Smith
Chief Quality Officer
Orca BioScott Bradley
VP, PSS Platform Strategy and Delivery
NovartisCenk Ündey, Ph.d.
VP, and Global Head, PTD Data and Digital
RocheJim Fries
CEO
Rx-360Katharine Miller
VP, Head, Biologics Analytical Development and Quality - Global
BayerDave Watrous
VP, Sales, Customer Success, and Marketing
IDBS
Defining and Supporting Digital Maturity in Biomanufacturing Operations
- What does digitization look like in today's manufacturing, quality and supply chain operations?
- Utilizing predictive analytics to prevent disruptions and enable proactive operational management
- Equipping sites to support better human-machine collaboration
- Assessing how digital network services helps sites navigate the highly globalized development landscape whilst optimizing quality