November 17, 2025

* JOIN US FOR THE PRE-EVENT HAPPY HOUR on November 16, 2025 FROM 6:00 PM – 7:00 PM EST

7:00 am – 8:00 am EST

DELEGATE REGISTRATION AND NETWORKING BREAKFAST

8:00 am – 8:10 am EST

CHAIR'S WELCOME AND OPENING REMARKS

Manufacturing

Becca Ford

VP, Project Delivery, Global Fill and Finish Expansions
Novo Nordisk

Outsourcing

Luiz Alberto Barberini

Head, External Manufacturing, Latin America
Bayer

Supply Chain

Kevin Luft

Senior Director, Global Supply Chain
Bristol Myers Squibb

Quality

Joseph Horvath

Head, Quality Risk Management
Takeda

8:10 am – 8:40 am EST

OPENING KEYNOTE

Embracing Industry 5.0 for Digital Transformation in Pharmaceutical Manufacturing and Outsourcing

  • Exploring the integration of Industry 5.0 principles, combining human expertise with advanced technologies for smarter, more connected operations
  • Discussing the impact of manufacturing digitization on enhancing efficiency, agility, and sustainability in pharmaceutical production processes
  • Addressing challenges and opportunities in adopting Industry 5.0 principles, including workforce reskilling, data security, and interoperability of digital systems
  • Collaborating on strategies for leveraging emerging technologies such as AI, IoT, and blockchain to drive Industry 5.0 initiatives in pharmaceutical manufacturing and outsourcing
  • Showcasing case studies of successful implementations of Industry 5.0 in pharmaceutical manufacturing, demonstrating improved productivity and quality outcomes
8:10 am – 8:40 am EST

Keynote

Daniel VonDielingen

SVP, Global Parenteral Network Expansion
Eli Lilly

The Future is Now: Scaling Manufacturing in a Global Network

  • Expanding manufacturing capacity to meet evolving global demand
  • Enhancing production effectiveness and efficiency through automation and digital transformation
  • Cultivating culture as the enabling foundation
8:40 am – 9:10 am EST

Plenary

  • Koustuv Chatterjee

    SVP and Head, External Manufacturing and Supply
    Sanofi

Driving Resilient Growth Through Strategic External Manufacturing and Global Supply Network Integration

  • Strengthening external partnerships to ensure flexibility and supply continuity across global markets
  • Streamlining operational governance to improve oversight, quality, and speed at contract manufacturing sites
  • Leveraging digital tools for real-time visibility and decision-making in outsourced production models
  • Building proactive risk management frameworks to anticipate disruption and accelerate response readiness
9:10 am – 9:40 am EST

Plenary

Speaker TBA


TraceLink

Empowering Resilient Supply Chains Through Technology and Collaboration

  • Enhancing visibility and collaboration through real-time data integration across supply networks
  • Connecting enterprise systems with suppliers and partners for efficient digital supply chain management
  • Utilizing real-time data to optimize decision-making with AI and machine learning
  • Strengthening supply chain resilience to protect revenue and mitigate risks effectively
  • Modernizing supply chains with digital tools suitable for businesses of any size or capability
  • Integrating technology into supply chain operations to achieve strategic business goals seamlessly
9:45 am – 11:25 am EST

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

10:45 am – 11:15 am EST

Stream Sessions

Manufacturing

Advancing CMC: Innovating and Integrating for Excellence

  • Incorporating novel formulation technologies and manufacturing processes to enhance product quality and accelerate time-to-market.
  • Integrating regulatory expertise early in the CMC lifecycle to streamline approvals and ensure compliance with evolving guidelines.
  • Leveraging advanced analytics and predictive modeling for data-driven decision-making and optimization of CMC strategies.
  • Collaborating with CMOs to leverage specialized capabilities and resources, fostering innovation and efficiency in CMC development.
  • Navigating complex supply chain dynamics and global regulatory landscapes to mitigate risks and ensure robust CMC strategies.

Outsourcing

Optimizing Supply Chains: Enhancing Efficiency and Reliability

  • Exploring strategies for effective forecasting, planning, and management of supplies to ensure timely and accurate delivery.
  • Discussing best practices for mitigating risks and overcoming challenges in supply chain management, including temperature control and global logistics.
  • Sharing insights on how to leverage technology and data analytics to optimize inventory management and streamline supply chain operations.
  • Addressing regulatory requirements and compliance considerations for supply chain management, including labeling, packaging, and distribution.
  • Providing case studies and real-world examples to illustrate successful approaches to supply chain optimization and management.

Quality

Strengthening Quality-Supply Chain Link: Driving Performance Through Collaboration

  • Integrating quality standards into supplier selection and management processes to ensure consistency and compliance across the supply chain.
  • Establishing clear communication channels and collaboration frameworks to address quality issues promptly and effectively.
  • Implementing risk-based approaches to identify and mitigate quality-related risks throughout the supply chain.
  • Leveraging technology for real-time monitoring and transparency, enhancing visibility and traceability of quality metrics across the supply chain.
  • Fostering a culture of quality throughout the supply chain through training, audits, and shared accountability for product integrity.
11:30 am – 12:00 pm EST

Sessions

Manufacturing

Lori Canzanese

Executive Director, Digital Manufacturing Operations
Merck

Advancing Global Digital Manufacturing to Enhance Operational Speed, Quality, and Decision-Making

  • Integrating site automation and IT to boost speed and consistency in production
  • Building scalable digital systems to support analytics and AI in manufacturing
  • Driving real-time visibility using connected equipment, sensors, and controls
  • Improving global collaboration by standardizing data, platforms, and workflows
  • Strengthening infrastructure to protect data integrity and process continuity

Outsourcing

Luiz Alberto Barberini

Head, External Manufacturing, Latin America
Bayer

Strengthening Supplier Relationships and Embracing Digital Transformation in External Manufacturing

  • Building strong partnerships with suppliers for long-term success
  • Developing suppliers to drive innovation and growth
  • Connecting procurement, logistics, planning, and production to optimize external manufacturing
  • Using AI and technology to improve supplier management and procurement

Supply Chain

Imara Charles, Ph.D.

VP, Process and Digital Excellence, Global Supply Chain
Bristol Myers Squibb

Command Center Capabilities: Data-Driven Decision Making

  • Establishing a command center for real-time data monitoring and analysis
  • Leveraging data to drive strategic supply chain decisions
  • Building digital capabilities for enhanced data integration and accessibility
  • Ensuring data accuracy and quality for informed decision making
  • Implementing best practices for digital literacy and data sharing

Quality

Joseph Horvath

Head, Quality Risk Management
Takeda

Developments in Quality Risk Management

  • Navigating the evolving QRM landscape in modern pharma manufacturing
  • Addressing new areas of focus: formality, subjectivity, and validity
  • Implementing software-enabled workflows for risk assessment and reporting
  • Assessing A.I. model risk in GxP environments
12:05 pm – 12:35 pm EST

Workshops

Room 1

  • Jacob Greenwood

    VP, Strategy
    ProjectFarma

  • Daniel VonDielingen

    SVP, Global Parenteral Network Expansion
    Eli Lilly

  • Becca Ford

    VP, Project Delivery, Global Fill and Finish Expansions
    Novo Nordisk

  • Kevin Kerls

    Executive Site Director
    Lonza

  • Yolanda McLean

    Senior Director, Quality Strategy and Operations of Quality
    Alnylam Pharmaceuticals

Optimizing Facility Planning, Construction and Start Up for Next-Generation Medicines

  • Analyzing current trends and strategies shaping technical operations in life sciences
  • Leveraging advanced technologies and innovations to streamline facility operations
  • Implementing best practices for facility planning, project controls, and CQV processes

Room 2

Aaaron Dely

VP, Research and Development
PLD Pharma Services

Strategies & Solutions for Launching OTC and Rx Gummies

  • Exploring how the $10.6 billion gummy vitamin market has tremendous potential for the use of gummies as a drug delivery system
  • Overcoming challenges in dosage accuracy, production, and taste for gummy medications
  • Tapping into 20+ years of gummy manufacturing experience and world-class GDUFA facilities
  • Utilizing starchless manufacturing to create superior, compliant gummy products
  • Navigating CFR 211 and CFR 111 requirements with advanced manufacturing practices

Room 3

Bob Lenich

Business Director, Life Sciences
Emerson

Accelerate Tech Transfer with Standards and Seamless Integration

  • Understanding the value opportunities in digitizing the tech transfer processes
  • Recognizing how digitally transforming the tech transfer process enables speed and flexibility
  • Establishing re-usable process specification and recipe standards provides expanding benefits
  • Showcasing the tangible benefits of standards and seamless integration
12:40 pm – 1:40 pm EST

Lunch & Learn Roundtable Discussions

Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required, and attendance is limited. Choose from:

Jared McDonald

VP, Formulation Development
Coating Place

From Complexity to Commercialization: Partnering for Breakthrough Results

Sean McCarthy

Senior Regulatory Manager
ECI

Navigating Regulatory Pathways for Drug-Device Combination Products

Rhonda Bronenberg

VP, Manufacturing Services
Process Alliance

The Essential Operational Readiness Milestones

Jun Takada

Senior Marketing Director
Bushu Pharmaceuticals

Unlocking 25+ Years of Expertise: Innovative Perspectives on Contract Manufacturing in Japan

Souroush Honary

Co-CEO
System Loco.

How To Build Systematic Control Across the End‑to‑End Pharma Supply Chain through IoT & Integrations

Speaker TBA


SysTechCorp Inc

Securing the Digital Supply Chain: Protecting Product Integrity from Factory to Patient

Speaker TBA


TraceLink

Intelligent Orchestration of Your End-to-End Supply Chain

Speaker TBA


Interchem Corp

Advancing biopharma pipelines from IND to market through an integrated CMC approach in drug development

1:45 pm – 2:15 pm EST

Sessions

Manufacturing

Amlan Dutta

Head, Quality, Rare Disease, Oncology, and Immunology
Sanofi

Seamless Scale-Up from Development to Commercial Manufacturing Across Therapeutic Platforms

  • Building an integrated quality framework to support the scale-up of product from clinical supply through commercial launch
  • Strengthening global manufacturing oversight and tech transfer execution across internal sites and contract manufacturing partners
  • Optimizing CMC readiness for inspections with risk registers, story boards and simulated Pre-Approval Inspections
  • Modernizing legacy processes and systems with digital upgrades

Outsourcing

Gil Roth

Founder and President
Pharma & Biopharma Outsourcing Association

Navigating Challenges and Capturing Opportunities in a Dynamic CDMO Landscape

  • Understanding the factors shaping the growth and evolution of the CDMO sector
  • Strategies for navigating changing global regulations and their operational implications
  • Examining key legislative trends and policies impacting CDMOs and their clients
  • Assessing the impact of shifting manufacturing strategies on CDMO operations
  • Rethinking supply chains to enhance robustness and mitigate risks in a volatile environment

Supply Chain

Jagy Patel

VP, Americas Supply Chain Planning
Johnson & Johnson Innovative Medicine

Next-Generation Supply Chain Planning: Accelerating Performance Through Digital Transformation

  • Enabling real-time decision-making through digital twin technology and advanced planning tools
  • Building a digitally integrated ecosystem: connecting manufacturing, logistics, and commercial teams
  • Leveraging AI and machine learning for demand forecasting and scenario planning
  • Creating a unified, end-to-end view of the supply network to drive performance and risk mitigation
  • Lessons learned and key success factors in scaling digital capabilities across a global enterprise

Quality

Colin Baker

SVP, Quality Assurance
Bimeda

Preparing for FDA Inspections: Best Practices for Global Quality and Compliance Leaders

  • Ensuring FDA inspection readiness across multiple global sites
  • Streamlining quality management systems to enhance inspection outcomes
  • Implementing lean quality processes to reduce risk and increase compliance
  • Building strong cross-functional teams to support FDA audit preparation
  • Leveraging automation and data to optimize testing and batch release strategies
2:20 pm – 2:50 pm EST

Workshops

Room 1

Speaker TBA


TraceLink

Unlocking Real-Time Intelligence in External Manufacturing Networks to Improve Supply Chain Efficiency

  • How Business-to-Network integration improves collaboration with all contract manufacturers
  • Exploring external manufacturing transactions that enhance supply chain resilience and inventory control
  • Streamlining inventory management to reduce operational costs effectively
  • Digitalizing external manufacturing to optimize supply network configurations
  • Establishing your IT roadmap for external manufacturing

Room 2

Jonathan De Keukelaere

Head of Network Collaboration & Transformation Practice USA
Bluecrux

Anouk Schoenmakers

Managing Director Consulting Operations
Bluecrux

Building a Stronger Value Chain - Transforming Outsourcing Success Through Network Collaboration

  • Why pharma companies must embrace AI to drive agility, resilience, and smarter decision-making
  • How stronger supplier networks reduce risks, accelerate launches, and improve patient outcomes
  • Introducing the Bluecrux blueprint: Our proven framework for building collaboration across the pharma ecosystem
  • The four key elements to enable visibility, trust, agility, and innovation across your value chain
  • Identifying gaps and opportunities with a structured, rapid assessment of your supplier network collaboration

Room 4

Speaker TBA


Genesis AEC

Designing Facilities of the Future for Efficient and Compliant Pharmaceutical Production

  • Integrating architecture, engineering, and construction to streamline small-molecule facility delivery
  • Optimizing layouts, workflows, and systems to enhance operational efficiency and compliance
  • Advancing sustainability practices to reduce energy, water use, and environmental impact
  • Ensuring readiness through commissioning, qualification, and validation for seamless production operations
2:55 pm – 4:15 pm EST

Happy Hour, networking and pre-arranged 1-2-1 meetings

4:20 pm – 4:50 pm EST

Plenary

Dave Miller, Ph.D.

Chief Scientific Officer
AustinPx

Cutting Drug Costs Without Cutting Corners: A CDMO’s Role in Smarter Manufacturing

  • Exploring how CDMOs improve drug affordability through smarter, simplified manufacturing processes
  • Quantifying savings from eliminating solvents, reducing energy use, and simplifying drying steps
  • Examining cost benefits of scalable, solvent-free tech from development to commercialization
  • Highlighting how CDMOs deliver both innovation and cost-efficiency without compromise
  • Case Study: Comparing KinetiSol® vs. spray drying - equivalent bioavailability with lower cost, complexity, and environmental impact
4:50 pm – 5:20 pm EST

Plenary

  • Rachel Mandel

    VP, Specialty Strategy, Global Supply Chain
    GSK

Building Resilient Supply Chains and Strategic Partnerships

  • Core principles for designing and executing a resilient, adaptive supply chain strategy
  • The importance of aligning manufacturing and supply chain strategies for successful product development
  • How strategic partnerships and collaborations with CDOs drive growth and innovation
  • Approaches to managing large investments and ensuring the efficient delivery of products across global markets
5:20 pm – 6:05 pm EST

PANEL DISCUSSION

  • Karin Shanahan

    EVP, Global Product Development and Supply
    Bristol Myers Squibb

  • Priya Durvasula, Ph.D.

    VP, Global Supply Chain, Quality Digital and Tech
    GSK

  • Vaishali Shukla, Ph.D.

    VP, CGT and API Global Expansion
    Eli Lilly

  • Mark Hill

    Chief Digital Information Officer
    CSL

  • Jack Prior

    Head, MSAT Process Monitoring and Data/AI Strategy
    Sanofi

The Innovation Imperative: Driving Change with Digital Tools and AI

  • Leveraging digital twins and real-time data for smarter, faster manufacturing decisions
  • Integrating AI and machine learning to drive predictive quality and process optimization
  • Applying generative AI to accelerate process design, documentation, and knowledge sharing across global teams
  • Accelerating automation adoption to streamline operations and minimize manual intervention
  • Scaling flexible, tech-enabled manufacturing systems to support product diversity and rapid changeovers
  • Enhancing supply chain resilience through data-driven outsourcing strategies and smart vendor management
6:05 pm – 6:15 pm EST

Chair's closing remarks

Manufacturing

Becca Ford

VP, Project Delivery, Global Fill and Finish Expansions
Novo Nordisk

Outsourcing

Luiz Alberto Barberini

Head, External Manufacturing, Latin America
Bayer

Supply Chain

Kevin Luft

Senior Director, Global Supply Chain
Bristol Myers Squibb

Quality

Joseph Horvath

Head, Quality Risk Management
Takeda

6:20 pm – 7:20 pm EST

Networking Drinks Reception

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