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2027 Agenda

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May 17th

3:00 pm

Registration

3:30 pm - 4:20 pm WELCOME DAY SPECIAL CONTENT

Panel: Scaling New Modalities: What It Takes to Move from Innovation to Reliable Manufacturing

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  • How organizations are translating complex new modalities into manufacturable processes that can support consistent clinical and commercial production, despite high variability and process sensitivity
  • The operational and technical challenges of scaling cell, gene, and RNA-based therapies, including control strategy design, reproducibility, and evolving manufacturing platforms
  • How development, manufacturing, and quality functions are aligning earlier to improve tech transfer and reduce late-stage rework in highly complex therapeutic modalities
  • The role of platform approaches, modular facility design, and standardization in enabling scalability while maintaining flexibility for highly diverse therapy types
  • How companies are building the infrastructure, capabilities, and workforce models required to industrialize next-generation therapies across clinical and commercial stages
4:25 pm - 5:00 pm WELCOME DAY SPECIAL CONTENT

Workshop: Building Competitive Advantage Through Strategic Partnerships

Executive to be Announced

Accenture LLP

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  • How pharmaceutical manufacturers are leveraging strategic partnerships to access specialized capabilities, accelerate execution, and support portfolio growth
  • Best practices for building collaborative relationships that extend beyond transactional outsourcing to drive long-term operational value
  • Aligning internal and external teams around shared goals, governance structures, and performance expectations to improve outcomes across the product lifecycle
  • Lessons learned from integrating partners into manufacturing, quality, technology, and supply strategies while maintaining oversight and control
5:10 pm - 6:00 pm WELCOME DAY SPECIAL CONTENT

Panel: The Forces Reshaping Pharma Manufacturing: How Technology, Regulation, and Complexity Are Changing the Way Medicines Are Made

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  • How accelerating regulatory expectations and global variability are influencing manufacturing strategy, validation, and operational decision-making
  • The impact of AI, automation, and digital tools on how manufacturing and quality processes are executed and controlled
  • How growing portfolio complexity is reshaping capacity planning, tech transfer, and lifecycle management across products and sites
  • The trade-offs between efficiency, resilience, and speed as organizations redesign global manufacturing and supply models
  • How leaders are adapting operating models to manage increasing externalization, partner networks, and cross-functional interdependencies
6:00 pm

Drinks Reception

6:30 pm

Executive dinner

(By Invite Only)

May 18th

Stream 1 Chair

Charles Cooney

Robert T. Haslam Professor Emeritus of Chemical Engineering

MIT

Stream 2 Chair
Stream 3 Chair

Executive to be Announced

Körber Pharma Software

7:30 am - 8:15 am

registration & breakfast

8:15 am - 8:30 am

Opening Remarks, Important Announcements & Chair's Welcome Address

Charles Cooney

Robert T. Haslam Professor Emeritus of Chemical Engineering

MIT

8:30 am - 9:05 am KEYNOTE

Reimagining CMC Through AI: Accelerating Development, Tech Transfer, and Commercial Readiness

Dafni Bika

Senior Vice President, Global Head Pharmaceutical Technology and Development

AstraZeneca

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  • Applying AI and advanced analytics across CMC to improve decision-making from development through commercial manufacturing
  • Strengthening tech transfer by using digital tools to better connect process understanding, scale-up data, and manufacturing execution
  • Embedding data-driven approaches into CMC workflows to improve speed, consistency, and confidence in commercial readiness
9:10 am - 9:45 am Case Studies
Stream One - Strategic Manufacturing

From Molecule to IND: How Integrated Product, Analytical, and Process Development Shapes Speed, Cost, and Clinical Readiness

Hanne Bak

Senior Vice President Product, Analytical and Process Development

Regeneron

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  • How early product, analytical, and process development decisions collectively influence the speed, cost, and probability of success in progressing a molecule from discovery through to IND
  • Aligning product, analytical, and process development earlier in the pipeline to reduce downstream variability, late-stage rework, and technical transfer risk
  • The role of platform strategies, analytical standardization, and early scalability assessment in accelerating clinical entry while maintaining robustness across diverse modalities
  • How cross-functional integration between research, development, and manufacturing is being structured to improve decision-making speed and ensure end-to-end CMC continuity across stages
Stream Two - Quality

Embedding Quality into the Speed of the Business - Moving from Oversight to Integration

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  • Shifting from a review-and-approve model to one where quality is built into process design, development handoffs, and daily operational decisions
  • What risk-based quality integration looks like in programs moving at accelerated timelines where the traditional quality review cadence cannot keep up with the pace of the business
  • How data is changing the role of quality professionals: from document reviewers to signal interpreters who identify issues before they become deviations
  • The cultural and structural changes that make quality integration sustainable, rather than a temporary posture adopted under timeline pressure
Stream Three - Innovation

Building Platform Approaches for Advanced Therapies: Reducing Variability Across Complex Modalities

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  • How platform-based approaches are being used to bring greater consistency, repeatability, and control to the manufacturing of highly complex advanced therapies
  • Identifying where standardization across processes, analytics, and manufacturing workflows can reduce variability without limiting modality-specific innovation
  • The role of modular process design and shared manufacturing components in accelerating development and improving scalability across therapy types
  • How organizations are balancing platform consistency with the need for flexibility across diverse cell, gene, and RNA-based modalities
  • Lessons learned from applying platform thinking to reduce development timelines, improve tech transfer, and strengthen end-to-end process reliability
9:50 am - 10:25 am Workshops
STREAM 1 WORKSHOP

Panel: Industrializing Pharma Manufacturing Delivery: How Facilities, Capital Projects, and Operational Readiness Are Being Executed at Speed

Executive to be Announced

Project Farma

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  • How pharma organizations are accelerating facility delivery by integrating capital project execution, CQV, and operational readiness from the earliest design stages
  • Practical approaches to reducing time from construction completion to GMP-ready operations through improved planning, sequencing, and cross-functional coordination
  • How commissioning and qualification strategies are evolving to support faster, more predictable startup of complex manufacturing environments
  • Lessons from executing large-scale facility builds and expansions while maintaining compliance, quality standards, and operational control
STREAM 2 WORKSHOP

From Systems of Record to Systems of Action: How Quality and Manufacturing Platforms Are Evolving in GxP Environments

Executive to be Announced

MasterControl

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  • How regulated manufacturing organizations are moving from static documentation systems to connected, real-time quality and operational intelligence platforms
  • The role of integrated quality and manufacturing data in enabling faster, more informed decision-making while maintaining full GxP compliance
  • How “systems of record” are evolving into “systems of action” that actively support execution, deviation management, and continuous improvement
  • Practical approaches to building trusted data foundations that strengthen traceability, audit readiness, and operational control across complex environments
STREAM 3 WORKSHOP

Improving Performance Across Global Manufacturing Networks

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  • How manufacturers are using network-level visibility, harmonized KPIs, and shared performance platforms to drive consistent execution across sites with different systems and maturity levels
  • The technology and governance approaches that make cross-site performance improvement programs sustainable — not just successful at launch
  • Balancing global standardization with the flexibility individual sites need to respond to local regulatory, operational, and workforce realities
  • What the highest-performing global manufacturing networks have in common — the structural, cultural, and technological characteristics that drive differentiated results
10:25 am - 12:10 pm Pre-Arranged One-To-One Meetings Arrow Icon

These mutually agreed-upon conversations are arranged and facilitated by Executive Platforms staff to ensure attendees have valuable discussions about their top-of-mind questions, challenges, and opportunities.

  • 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 pm: Meeting Slot 4/Networking
12:15 pm - 12:50 pm Case Studies
Stream One - Strategic Manufacturing

External Manufacturing Strategy: Strengthening Performance Across Partner Networks

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  • How organizations are evolving external manufacturing strategies to better integrate CDMOs and partners into end-to-end operational and quality models
  • Improving visibility, governance, and performance management across increasingly complex and geographically distributed partner networks
  • Aligning expectations, data sharing, and decision-making frameworks to ensure consistent execution across internal and external manufacturing sites
  • Balancing cost, capacity flexibility, and risk management while maintaining supply reliability and product quality across outsourced operations
  • Lessons learned from strengthening collaboration models that move beyond transactional outsourcing toward long-term strategic partnerships
Stream Two - Quality

Digital Quality in Practice: Building the Systems That Enable GMP Compliance Across Amgen’s Global Network

RJ Doornbos

VP, Quality Operating Systems & Services

Amgen

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  • Embedding digital quality capabilities into core GMP systems to improve consistency, traceability, and compliance across a global manufacturing network
  • Standardizing and simplifying quality processes and systems to reduce complexity while maintaining regulatory rigor across sites and partners
  • The role of integrated quality data, workflows, and system connectivity in enabling faster decision-making and more proactive GMP oversight
  • Evolving the quality operating model to balance global standardization with local execution, strengthening inspection readiness and end-to-end system control
Stream Three - Innovation

From Disconnected Data to a Structured Product Record: Building the Foundation for Faster Submissions and Smoother Transfers

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  • How organizations are replacing fragmented, function-specific data environments with structured product knowledge models that serve development, manufacturing, regulatory, and commercial needs from a single source
  • What a connected product data architecture enables that siloed systems cannot: compressed tech transfer timelines, faster variation submissions, and real-time lifecycle state-of-control
  • The data standards, integration decisions, and governance structures that determine whether a product data program delivers durable end-to-end connectivity or just better-connected silos
  • How organizations are prioritizing their data connectivity investments when the full program is multi-year but the business needs to see value delivered along the way
12:50 pm - 1:50 pm THEMED LUNCH DISCUSSIONS

Explore this year’s themed lunch discussions led by industry leaders, where executives engage in focused conversations over a meal, discussing topics they’re passionate about alongside their peers.

AI in Manufacturing: What's Actually Working and What's Still Theoretical

Executive to be Announced

Boehringer Ingelheim Biopharmaceuticals GmbH

AI in Manufacturing: What's Actually Working and What's Still Theoretical

Mahesh Kulkarni

Head of DD&T - MBO

Takeda

What Does the Workforce Look Like When Automation Takes On More?

Aligning Quality and Development When Timelines Are Compressed

Driving Right-First-Time Outcomes in Complex Biologics Manufacturing

Getting CMC, Manufacturing, and Quality on the Same Page

Early CMC Decisions and the Manufacturing Problems They Create Later

Building Development Programs That Are Ready to Scale Before They Need to Be

1:55 pm - 2:30 pm Case Studies
Stream One - Strategic Manufacturing

Closing the Loop Between Commercial Demand and Manufacturing Decisions

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  • How leading manufacturers are building tighter connections between commercial demand signals and manufacturing capacity planning to reduce both shortages and waste across their networks
  • What integrated business planning looks like in a pharmaceutical context where regulatory constraints, long production lead times, and shelf-life limitations complicate standard IBP approaches
  • The data and system integration requirements for meaningful demand-supply alignment across multi-site, multi-modality manufacturing networks
  • Lessons from organizations that have achieved genuine commercial-manufacturing alignment — and what it cost them organizationally to get there
Stream Two - Quality

Panel: Quality in the Age of AI - Governing What You Can't Fully See, Validate, or Predict

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  • Where quality organizations are drawing the line between autonomous AI decision-making and explicit human accountability – and whether that line is holding up in practice
  • What data integrity and audit-trail control look like when AI is embedded in GxP systems that weren’t designed for it
  • How evolving FDA and EU regulatory expectations around AI are changing what readiness actually requires across development and manufacturing
  • Where the gap between deployment speed and compliance maturity is creating inspection exposure — and how quality leaders are closing it
  • What effective AI governance looks like in a quality system: oversight structures, escalation paths, and human review checkpoints that make it defensible
Stream Three - Innovation

Supply Chain Lessons from Products That Broke the Model: What High-Demand Launches Taught the Industry

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  • What the GLP-1 capacity crisis, advanced therapy logistics failures, and recent high-demand biologic launches revealed about the limits of pharmaceutical supply chain planning
  • How demand signal quality, capacity reservation practices, and CDMO relationship structures either protected or exposed organizations during periods of acute supply pressure
  • The supply chain design decisions made years before a product launches that determine whether a commercial organization can serve patients at peak demand
  • How the industry is applying those lessons prospectively — particularly for the next wave of advanced therapy and large-molecule launches where supply chain complexity is unprecedented
2:35 pm - 3:10 pm Workshops
STREAM 1 WORKSHOP

Building the Next Generation of Intelligent Manufacturing Environments: Connecting Facilities, Automation, and Operational Performance

Executive to be Announced

Honeywell Life Sciences

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  • How pharma manufacturing environments are evolving from connected facilities to more integrated, performance-driven operational ecosystems
  • The role of advanced automation, building controls, and industrial technologies in improving reliability, efficiency, and operational visibility across manufacturing sites
  • Integrating facilities, utilities, and production systems to enable more consistent performance and reduce variability in GMP operations
  • Practical approaches to modernizing existing manufacturing infrastructure while maintaining compliance, validation integrity, and operational continuity
STREAM 2 WORKSHOP

From Data to Decisions: Where Digital in Manufacturing Actually Delivers Value Today

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  • Where digital capabilities in manufacturing are delivering measurable improvements in execution, decision-making speed, and operational reliability today
  • Moving beyond data collection toward practical use cases that directly impact deviation management, throughput, and batch performance
  • How manufacturers are prioritizing digital investments based on operational bottlenecks rather than technology potential
  • The role of integrated data across manufacturing, quality, and supply chain in improving cross-functional decision-making in real time
  • Lessons from implementations that have delivered tangible value versus those that remain limited to visualization or reporting layers
STREAM 3 WORKSHOP

Strengthening Sterilization and Contamination Control Strategies Across Complex Pharma Manufacturing and Supply Networks

Executive to be Announced

Steri-tek & Prince Sterilization Services

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  • Strengthening sterilization and contamination control strategies across increasingly complex pharma manufacturing and packaging environments
  • Ensuring sterility assurance through validated processes, robust controls, and consistent execution across internal and external operations
  • The role of specialized sterilization services in supporting regulatory compliance, product integrity, and reliable manufacturing performance
  • Managing sterilization and validation requirements across diverse products, modalities, and global supply chain configurations
3:10 pm - 4:30 pm Pre-Arranged One-To-One Meetings Arrow Icon

These mutually agreed-upon conversations are arranged and facilitated by Executive Platforms staff to ensure attendees have valuable discussions about their top-of-mind questions, challenges, and opportunities.

  • 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 KEYNOTE

Leading Global Quality at Scale: Building Consistency, Trust, and Agility Across a Complex Network

Magaly Aham

Global Quality Officer

Takeda

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  • How global quality leadership is evolving from functional oversight to enterprise-wide stewardship across manufacturing, supply, and external partner networks
  • Building consistency in GMP expectations, decision-making, and compliance execution across increasingly complex and geographically distributed operations
  • Strengthening trust in quality systems and data to enable faster, more confident decisions without compromising regulatory rigor
  • Balancing standardization and local execution to maintain control while supporting speed, innovation, and operational flexibility across the enterprise
5:05 pm - 5:10 pm

Chair's Closing Remarks

5:10 pm

Drinks Reception

5:45 pm

Executive dinner

(By Invite Only)

May 19th

Stream 1 Chair

Joanne Beck

Chief Operating Officer, Hypercon

Halozyme

Stream 2 Chair
Stream 3 Chair

Executive to be Announced

Körber Pharma Software

7:50 am - 8:50 am

registration & breakfast

8:00 am - 8:35 am breakfast workshops
STREAM 1 BREAKFAST WORKSHOP

From Digital Manufacturing to Manufacturing Intelligence: Turning Connected Operations into Better Performance

Executive to be Announced

Körber Pharma Software

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  • Moving beyond digitization initiatives to create connected manufacturing environments that improve execution, visibility, and operational decision-making
  • Leveraging manufacturing, quality, and process data to identify bottlenecks, reduce variability, and drive continuous improvement across operations
  • How manufacturing intelligence platforms are enabling faster issue resolution, improved process performance, and more proactive operational management
  • Practical lessons from building the data foundations, system integrations, and governance models required to scale digital manufacturing capabilities
8:50 am - 9:00 am

Chair's Opening Remarks

Joanne Beck

Chief Operating Officer, Hypercon

Halozyme

9:00 am - 9:35 am KEYNOTE

The Future of Global Biologics Manufacturing: Building Operating Models for Speed, Resilience, and Growth

Jens Vogel

SVP & Head of Global Biologics Operating Unit

Merck

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  • How biologics manufacturing networks are evolving to support growing portfolio complexity, capacity demands, and accelerated timelines
  • Balancing flexibility, standardization, and technical rigor across global manufacturing operations
  • The operating model changes needed to improve decision-making, execution, and cross-site coordination at scale
  • Preparing manufacturing organizations for the next generation of biologics, advanced therapies, and evolving supply expectations
9:40 am - 10:15 am Case Studies
Stream One - Strategic Manufacturing

From Clinical Supply to Commercial Operations: Aligning Manufacturing and Supply for Emerging Therapies

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  • How organizations are transitioning emerging therapies from clinical supply models to stable, repeatable commercial manufacturing and distribution systems
  • Aligning manufacturing, quality, and supply functions to ensure continuity of supply, consistent execution, and regulatory compliance during commercialization
  • Key differences in planning, capacity allocation, and operational control when moving from trial-based supply to full commercial operations
  • Managing variability in demand, process maturity, and manufacturing readiness across cell, gene, RNA, and other advanced therapies
  • Lessons learned from establishing reliable end-to-end supply chains that can support both launch and long-term patient access requirements
Stream Two - Quality

Simplifying Quality Systems: Reducing Complexity Across Global Operations and External Networks

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  • Reducing fragmentation across quality systems created by growth in products, sites, and external manufacturing partners
  • Rationalizing and standardizing quality processes to eliminate duplication and improve operational efficiency
  • Improving system integration to create clearer workflows, better data flow, and fewer handoffs across quality operations
  • Balancing global standardization with local execution to reduce complexity while maintaining compliance and control
Stream Three - Innovation

Advancing Biologics from Development to Launch: Building Robust, Scalable CMC Systems for Commercial Readiness

Kartik Subramanian

Vice President, Biologics Product Development, Science and Technology

AbbVie

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  • Strengthening late-stage biologics CMC development to ensure robust, scalable processes that consistently translate from development through to commercial manufacturing
  • Integrating product, process, and analytical strategies to reduce variability and de-risk scale-up as assets move through Phase III and toward launch
  • Improving tech transfer execution between development and manufacturing to ensure speed, reproducibility, and regulatory confidence at commercial readiness
  • Building more connected CMC systems that bridge development and manufacturing, enabling smoother transition from clinical supply to reliable commercial production
10:15 am - 11:10 am Pre-Arranged One-To-One Meetings Arrow Icon

These mutually agreed-upon conversations are arranged and facilitated by Executive Platforms staff to ensure attendees have valuable discussions about their top-of-mind questions, challenges, and opportunities.

  • 10:20 am – 10:40 am: Meeting Slot 8/Networking
  • 10:45 am – 11:05 am: Meeting Slot 9/Networking
10:25 am - 11:00 am FOCUS GROUP

Executive focus groups are informal moderated discussions among peers, held during networking breaks outside the summit agenda. No sign-up is required; delegates and speakers can join any group of interest.

TOPIC one

Inside the FDA Inspection: What Regulators Really See Beyond the Documents

Sarah Miksinski

Executive Director/CMC Regulatory Affairs

Gilead

Bob Iser

VP, Quality Policy & Advocacy

Genentech

11:15 am - 11:50 am Workshops
STREAM 1 WORKSHOP

AI Beyond the Pilot: Building the Operating Model for Scaled Adoption Across Pharma Manufacturing

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  • Moving from isolated AI use cases to enterprise-wide adoption across manufacturing, quality, technical operations, and supply functions
  • Building the governance, data, and organizational foundations required to scale AI responsibly in regulated environments
  • Aligning technology investments with operational priorities to drive measurable improvements in performance, productivity, and decision-making
  • Lessons learned from integrating AI into existing workflows, operating models, and business processes without disrupting execution
STREAM 2 WORKSHOP

Building Trusted Systems for Quality, Compliance, and Operational Performance

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  • Strengthening the systems, processes, and data foundations that support consistent quality, regulatory compliance, and operational execution across manufacturing environments
  • Improving visibility, traceability, and control by connecting quality and manufacturing processes through integrated digital platforms
  • Balancing compliance requirements with operational efficiency through simplified workflows, standardized processes, and risk-based approaches
  • Building trust in data and systems to enable more proactive decision-making, stronger inspection readiness, and sustained performance improvement
STREAM 3 WORKSHOP

From Operational Excellence to Intelligence: How Leading Manufacturers Are Connecting People, Systems, and Data to Drive Consistent Performance

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  • How manufacturers are evolving from traditional operational excellence programs toward more connected, intelligence-driven operating models
  • Integrating people, processes, and systems to create real-time visibility into performance, deviations, and operational constraints across sites
  • Leveraging connected data environments to improve decision-making speed, consistency, and cross-functional alignment in daily operations
  • Moving from retrospective performance management to proactive identification of risks, bottlenecks, and improvement opportunities
  • How leading organizations are structuring governance and capability models to sustain operational intelligence at scale across global manufacturing networks
11:55 am - 12:45 pm KEYNOTE

Panel: Redesigning Pharma Manufacturing for the Next Decade: How Organizations Are Building More Connected, Resilient, and High-Performing Systems

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  • How manufacturing organizations are rethinking network design to balance flexibility, cost efficiency, and long-term resilience
  • The evolution of operating models to improve decision-making speed and alignment across manufacturing, quality, and technical functions
  • How companies are reducing fragmentation by connecting data, processes, and governance across global manufacturing systems
  • The role of internal and external manufacturing integration in creating more adaptable and scalable production capacity
  • How structural changes in leadership, capabilities, and talent models are enabling more consistent execution and long-term system performance
12:45 pm - 2:00 pm THEMED LUNCH DISCUSSIONS

Explore this year’s themed lunch discussions led by industry leaders, where executives engage in focused conversations over a meal, discussing topics they’re passionate about alongside their peers.

How Is a Changing FDA Actually Impacting How We Operate?

Talent in Technical Operations: Where Are the Next Generation of Leaders Coming From?

Honest Assessment: What Does a Good CDMO Relationship Actually Look Like?

Capacity Planning When Your Portfolio Won't Stop Growing

Turning Quality Data Into Decisions People Actually Act On

How Is Automation Changing the Relationship Between Manufacturing and Quality?

Supply Reliability in Biologics: Where Are the Real Vulnerabilities?

Digital Tools in the Plant: What's Delivering and What's Collecting Dust?