Program

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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

7:00 am – 8:00 am PST

Registration and Networking Breakfast

8:00 am – 8:10 am PST

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

8:10 am – 8:40 am PST

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
8:40 am – 9:10 am PST

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
9:10 am – 9:40 am PST

Plenary

  • Greg Gara

    SVP
    ProjectFarma

  • Adam Pfeiffer

    VP
    ProjectFarma

  • Antinea Chair

    VP, Technical Operations
    Cellares

  • Thomas 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
9:45 am – 11:25 am PST

Refreshments, Networking, and Pre-Arranged 1-2-1 Meetings

11:30 am – 12:00 pm PST

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
12:05 pm – 12:40 pm PST

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
12:45 pm – 1:45 pm PST

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?

1:50 pm – 2:20 pm PST

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
2:25 pm – 3:00 pm PST

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
3:05 pm – 4:25 pm PST

Happy Hour, Networking and Pre-Arranged 1-2-1 Meetings

4:30 pm – 5:15 pm PST

Panel Discussion

  • Aine Hanly

    EVP and Chief Technology Officer
    Vir Biotechnology

  • Katharine Miller

    VP and Global Head, Biologics Development Analytics and Quality
    Bayer

  • Dafni Bika

    SVP, Global Head Pharmaceutical Technology and Development
    AstraZeneca

  • Evelyn Marchany García

    SVP and Chief Quality Officer
    BioMarin Pharmaceuticals

  • Kara 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?
5:15 pm – 5:45 pm PST

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
5:45 pm – 6:30 pm PST

Panel Discussion

  • Lauren Smith

    Chief Quality Officer
    Orca Bio

  • Scott Bradley

    VP, PSS Platform Strategy and Delivery
    Novartis

  • Cenk Ündey, Ph.d.

    VP, and Global Head, PTD Data and Digital
    Roche

  • Jim Fries

    CEO
    Rx-360

  • Katharine Miller

    VP, Head, Biologics Analytical Development and Quality - Global
    Bayer

  • Dave 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
6:30 pm – 6:40 pm PST

Chair's closing remarks

6:40 pm – 7:40 pm PST

Networking drinks reception