CASSS Sharing Science Solutions US Manufacturing Virtual Summit 2026

Pharmaceutical Manufacturing • CMC • Regulatory Affairs • Supply Chain • Facility Strategy

May 7, 2026 | Virtual Summit

Explore the strategic, technical, workforce, quality, and regulatory challenges involved in expanding pharmaceutical manufacturing capacity in the United States with CASSS Sharing Science Solutions US Manufacturing Virtual Summit 2026.

Officially presented by CASSS – Sharing Science Solutions as the Virtual Summit on Manufacturing, this one-day virtual program was held on May 7, 2026 under the central theme:

Opportunities and Challenges of Expanding US-based Pharmaceutical Manufacturing

CASSS designed the summit to bring together thought leaders from industry, academia, and regulatory agencies to examine the changing U.S. pharmaceutical manufacturing environment and the practical requirements for expanding domestic production capacity. The program consisted of four sessions featuring speaker presentations and panel discussions, delivered through a live virtual format.

Major educational themes included:

• U.S. pharmaceutical manufacturing onshoring
• Lessons from European manufacturing models
• Biopharmaceutical facility design and construction
• Rapid operational scale-up
• Manufacturing operating-model transformation
• Workforce capacity
• Technical training
• Biomanufacturing talent pipelines
• Supply-chain resilience
• FDA inspections
• Inspection readiness
• FDA PreCheck
• Regulatory predictability
• Post-approval changes
• Manufacturing-site transfers
• Lifecycle management
• Commercial manufacturing
• Clinical manufacturing
• CMC regulatory strategy

The summit addressed a key challenge facing the pharmaceutical industry:

Building more manufacturing capacity in the United States requires more than constructing new facilities—it requires regulatory alignment, skilled personnel, resilient supply chains, effective quality systems, operational transformation, and lifecycle strategies capable of supporting manufacturing changes after approval.

Course Details

• Product: CASSS Sharing Science Solutions US Manufacturing Virtual Summit 2026
• Official Event: Virtual Summit on Manufacturing
• Organization: CASSS – Sharing Science Solutions
• Year: 2026
• Date: May 7, 2026
• Format: Virtual / Live-Streamed
• Duration: One-Day Summit
• Number of Main Sessions: 4
• Program Format: Speaker Presentations + Panel Discussions
• Official Theme: Opportunities and Challenges of Expanding US-based Pharmaceutical Manufacturing
• Primary Field: Biopharmaceutical Manufacturing
• Related Fields: CMC, Regulatory Affairs, Quality, Supply Chain, Facility Engineering, Workforce Development
• Primary Focus: Expansion and Resilience of U.S.-Based Pharmaceutical Manufacturing
• Virtual Platform: CASSS live virtual event with audience Q&A

CASSS states that virtual participants were able to submit questions directly during the speaker presentations and panel discussions, reinforcing the summit’s interactive format.

Who Was the Original Program Designed For?

The summit is particularly relevant for professionals responsible for building, operating, regulating, or expanding pharmaceutical and biopharmaceutical manufacturing systems.

The strongest professional audience includes:

• Manufacturing Engineers
• Bioprocess Engineers
• Facility Engineers
• Manufacturing Leaders
• CMC Professionals
• Regulatory Affairs Specialists
• Quality Assurance Professionals
• Quality Control Professionals
• Pharmaceutical Operations Leaders
• Supply Chain Leaders
• Technical Operations Professionals
• Manufacturing Science and Technology – MSAT Professionals
• Facility Design Professionals
• Validation Professionals
• Inspection Readiness Teams
• Regulatory CMC Specialists
• Workforce Development Leaders
• Pharmaceutical Executives

It is also relevant for:

• Pharmaceutical Physicians
• Clinical Pharmacologists
• Medical Toxicologists
• Pharmaceutical Development Professionals

The strongest original audience remains:

Manufacturing + CMC + Regulatory Affairs + Quality + Supply Chain

Learning Objectives

Upon completion of this program, participants should be better able to:

• Evaluate insights and innovative approaches for U.S. manufacturing onshoring in comparison with European manufacturing landscapes.
• Analyze strategies for building state-of-the-art manufacturing facilities and executing operational playbook changes at an unprecedented pace.
• Design capability architectures to develop future workforce capacity and enhance supply chain resilience for the emerging U.S. biomanufacturing wave.
• Understand regulatory compliance, inspection-readiness approaches, and informational frameworks surrounding the FDA PreCheck Program.
• Navigate the complexities of post-approval changes and develop compliant, efficient solutions across commercial and clinical manufacturing operations.

These objectives align closely with the six presentations officially archived by CASSS for the 2026 Manufacturing Virtual Summit.

U.S. PHARMACEUTICAL MANUFACTURING EXPANSION

The central issue addressed by the summit is the expansion of pharmaceutical manufacturing capacity within the United States.

This involves much more than selecting a location and constructing a factory.

A sustainable manufacturing strategy requires alignment across:

• Facility design
• Regulatory strategy
• CMC
• Manufacturing technology
• Workforce
• Quality systems
• Supply chain
• Operational readiness
• Inspection readiness
• Commercial lifecycle management

The overall pathway can be summarized as:

Manufacturing Strategy → Facility Design → Construction → Workforce → Qualification → Regulatory Readiness → Inspection → Approval → Commercial Operation → Lifecycle Management

U.S. Manufacturing Onshoring

One of the confirmed summit presentations was:

Accelerating US Manufacturing Onshoring: EU Landscape Insights and Innovative Approaches

presented by:

Karim Kacimi – Novo Nordisk Inc.

The presentation places U.S. manufacturing expansion within an international context rather than treating onshoring as an isolated domestic issue.

Key strategic questions include:

• What lessons can U.S. manufacturers draw from mature European manufacturing networks?
• How can manufacturing expansion occur without unnecessarily fragmenting global supply?
• Which regulatory and operational approaches can accelerate domestic capacity?
• How should global manufacturing networks adapt when new U.S. sites are introduced?

Onshoring vs. Global Manufacturing Networks

Onshoring does not necessarily mean eliminating international manufacturing.

A more resilient strategy may involve:

Domestic Capacity + Global Redundancy + Regional Flexibility

rather than:

Domestic Production Only

This distinction is important because pharmaceutical supply chains frequently span:

• APIs
• Drug substance
• Drug product
• Packaging
• Testing
• Distribution

across multiple regions.

U.S. Manufacturing & Global Supply

A related WCBP 2026 workshop examining U.S. manufacturing expansion emphasized that adding U.S. production does not necessarily mean removing manufacturing from existing global sites. It also highlighted the importance of site transfers, post-approval changes, advanced manufacturing technologies, ICH Q12, and the FDA PreCheck program in facilitating manufacturing expansion.

The strategic objective can therefore be expressed as:

Expand U.S. Capacity Without Destabilizing Global Supply

Manufacturing Resilience

A resilient manufacturing network should be able to withstand disruptions involving:

• Raw materials
• Equipment
• Logistics
• Regional events
• Workforce shortages
• Supplier failures
• Regulatory delays
• Quality events

The course’s onshoring focus therefore connects domestic manufacturing policy with broader supply-chain resilience.

FACILITY DEVELOPMENT

One confirmed summit presentation was:

Building It Is the Easy Part. Changing the Playbook Is Harder

presented by:

Julia Edwards – Eli Lilly and Company.

The title captures one of the summit’s central messages:

A new facility alone does not create new manufacturing capability.

Organizations must also redesign:

• Decision-making
• Staffing
• Processes
• Governance
• Training
• Technology deployment
• Qualification strategies
• Operational systems

to match accelerated construction timelines.

Facility Construction vs. Operational Readiness

A manufacturing facility may be physically complete yet still not be ready to produce commercial medicines.

True operational readiness may require:

• Equipment qualification
• Utilities qualification
• Cleaning systems
• Automation
• Computerized systems
• Quality systems
• Procedures
• Training
• Maintenance systems
• Material flows
• Personnel flows
• Documentation
• Regulatory readiness

The practical distinction is:

Building Complete ≠ Manufacturing Ready

State-of-the-Art Manufacturing Facilities

Modern facilities increasingly incorporate:

• Automation
• Digital manufacturing
• Modular design
• Flexible manufacturing spaces
• Advanced process monitoring
• Integrated data systems
• Rapid-changeover concepts

The goal is to build manufacturing systems that can respond to changing:

• Product portfolios
• Demand
• technology
• supply-chain requirements

without requiring complete redesign.

Accelerated Facility Development

The U.S. manufacturing push creates pressure to shorten the traditional timeline from:

Site Selection → Construction → Qualification → Regulatory Approval → Commercial Production

The challenge is to accelerate this sequence without sacrificing:

• GMP compliance
• Quality
• Validation
• Inspection readiness
• Process robustness

Modular & Prefabricated Manufacturing

FDA’s current PreCheck selection framework specifically recognizes innovative approaches such as:

• Modular construction
• Prefabricated construction
• Advanced automation
• Digital integration

as potential methods for accelerating domestic manufacturing expansion.

This reflects the broader movement toward facilities that can be:

• Built faster
• Replicated more easily
• Expanded more efficiently
• Standardized across networks

Manufacturing Playbook Transformation

Traditional manufacturing organizations often rely on established sequences of:

• Design
• Review
• Construction
• Qualification
• Validation
• Launch

Rapid domestic expansion may require teams to redesign how these activities are coordinated.

The operating model may need to support more parallel work across:

• Engineering
• Quality
• Regulatory
• Manufacturing
• Automation
• Supply Chain
• IT
• Validation

WORKFORCE CAPACITY

Another confirmed presentation was:

Workforce Capacity & Training: Building the Pipeline for the US Biomanufacturing Wave

presented by:

Jared Auclair – Northeastern University.

Manufacturing expansion cannot occur without a sufficiently trained workforce.

Physical manufacturing capacity must therefore be matched by:

Human Capability

Biomanufacturing Workforce

Potential workforce needs may include:

• Bioprocess operators
• Manufacturing technicians
• Process engineers
• Automation engineers
• Validation specialists
• Quality professionals
• Analytical scientists
• Maintenance technicians
• Regulatory specialists
• Supply chain professionals

A manufacturing facility without adequate talent may become a bottleneck regardless of the quality of its equipment.

Workforce Pipeline

The summit emphasizes building the future workforce before manufacturing demand exceeds available expertise.

A useful workforce-development pathway is:

Education → Technical Training → Hands-On Experience → GMP Qualification → Continued Capability Development

Academic & Industry Collaboration

Universities and technical-training organizations can support biomanufacturing capacity by developing programs aligned with real industry needs.

Collaboration may involve:

• Industry-designed curricula
• Internship programs
• Apprenticeships
• Manufacturing simulation
• Hands-on bioprocess training
• Quality-system education
• Continuing professional development

Capability Architecture

The learning objectives emphasize development of capability architectures.

This means organizations should not think only about individual job roles.

Instead, they should identify:

• Which capabilities are needed
• Where they are needed
• How many qualified people are required
• Which competencies are difficult to hire
• Which skills can be trained internally
• Which capabilities should be externalized

The framework is:

Future Manufacturing Demand → Required Capabilities → Workforce Plan → Training Pipeline

Workforce & Supply Chain Resilience

Human-capital planning directly affects supply reliability.

A facility cannot maintain consistent production when there are major shortages in:

• Operators
• engineers
• maintenance specialists
• quality personnel
• technical leaders

Workforce resilience is therefore part of supply-chain resilience, not a separate HR issue.

SUPPLY CHAIN RESILIENCE

A major strategic rationale for expanding U.S. pharmaceutical manufacturing is reducing vulnerability within supply networks.

Supply-chain resilience may depend on:

• Geographic diversification
• Multiple qualified suppliers
• Domestic production capacity
• Inventory strategies
• Contract manufacturing
• Raw material sourcing
• Manufacturing redundancy

Domestic Supply Security

FDA identifies supply-chain resilience as one of the primary goals of the PreCheck program and broader domestic-manufacturing initiatives.

This includes both:

• Drug products
• Biological products

and can involve strengthening availability of critical medicines.

API & Drug Product Manufacturing

Domestic pharmaceutical manufacturing can involve several different manufacturing layers:

API / Drug Substance

Manufacturing the active ingredient or biological drug substance.

Finished Dosage Form / Drug Product

Converting drug substance into the final clinical or commercial product.

Packaging & Distribution

Preparing finished product for the healthcare market.

A resilient domestic strategy may require attention to all three.

FDA PRECHECK PROGRAM

One of the most important regulatory topics in the summit was:

Regulatory Aspects Introduction – Informational Slides on FDA PreCheck Program

presented by:

Cyrus Agarabi – CDER, FDA.

CASSS’s archived FDA presentation describes PreCheck as a program intended to:

• Support early facility readiness
• Streamline inspection and approval processes
• Strengthen domestic pharmaceutical supply-chain resilience

What Is FDA PreCheck?

FDA launched the PreCheck Pilot Program in 2026 to facilitate development of new U.S. pharmaceutical manufacturing facilities through earlier regulatory engagement and a more predictable facility-review process.

The program is specifically intended to support:

• New U.S. pharmaceutical facilities
• Finished dosage-form manufacturing
• Drug substance / API manufacturing
• Biological products
• Critical medicines
• Supply-chain resilience

FDA PreCheck – Two-Phase Model

The FDA PreCheck Pilot Program uses two major phases.

Phase 1 – Facility Readiness

This phase includes:

• Early FDA engagement
• Pre-Operational Reviews
• Facility design discussion
• Equipment design and qualification
• Pharmaceutical Quality System design
• Facility-specific Type V Drug Master File development

Phase 2 – Application Submission

This phase includes:

• Pre-submission interactions
• Product-application alignment
• Facility evaluation
• Inspection planning
• More efficient resolution of manufacturing issues

Pre-Operational Review

The Pre-Operational Review – POR creates an opportunity for manufacturers to interact with FDA before the site becomes fully operational.

FDA may provide feedback relating to:

• Facility design
• Construction
• Equipment qualification
• Pharmaceutical Quality Systems

with the aim of identifying potential problems before they become expensive late-stage changes.

Regulatory Predictability

One major advantage of early regulatory engagement is improved predictability.

Instead of:

Build Facility → Finish Facility → Wait for Inspection → Discover Major Problems

the PreCheck concept supports:

Design → Early FDA Engagement → Correct Issues Earlier → Prepare for Inspection → Submit

INSPECTION READINESS

Another confirmed presentation was:

Ensuring Inspection Success

presented by:

Mary E. Farbman – Merck & Co., Inc.

Inspection readiness is essential for both:

• New manufacturing facilities
• Existing commercial manufacturing operations

Successful Regulatory Inspections

Inspection success depends on more than preparing the facility immediately before inspectors arrive.

A robust organization aims for:

Continuous Inspection Readiness

This requires:

• Effective quality systems
• Accurate documentation
• Trained personnel
• Controlled procedures
• Deviation management
• CAPA
• Change control
• Equipment qualification
• Data integrity
• Clear governance

Quality Systems

Manufacturing quality systems may include:

• Deviation management
• CAPA
• Change control
• Training
• Document control
• Supplier quality
• Validation
• Complaint systems
• Quality review

A strong inspection-readiness culture ensures these systems operate continuously rather than being activated only before an inspection.

Data Integrity

Inspectors may evaluate whether manufacturing and analytical records demonstrate:

• Accuracy
• Completeness
• Traceability
• Timeliness
• Appropriate review

A technically advanced facility can still encounter regulatory problems if its data governance is weak.

Inspection Communication

Inspection success may also depend on how effectively an organization:

• Retrieves records
• Responds to questions
• Provides SMEs
• Explains processes
• Escalates issues
• Documents commitments

Inspection readiness therefore requires both technical compliance and organizational coordination.

REGULATORY COMPLIANCE

The manufacturing expansion discussed throughout the summit must occur within established regulatory requirements.

Relevant regulatory domains may include:

• cGMP
• CMC
• facility qualification
• process validation
• quality systems
• site transfers
• supplements
• inspections
• post-approval change management

The key principle is:

Speed Cannot Replace Compliance

POST-APPROVAL CHANGES

A confirmed presentation was:

Post-Approval Changes: Navigating Complexity, Delivering Solutions

presented by:

Nina Cauchon – Amgen Inc.

Post-approval changes are especially important when companies:

• Add new manufacturing sites
• Transfer processes
• Increase capacity
• Introduce new equipment
• Change analytical methods
• Modify facilities
• Implement new technologies

Why Post-Approval Changes Matter

An approved medicine is associated with a defined:

• Manufacturing process
• Control strategy
• Site
• analytical approach
• regulatory dossier

Manufacturing expansion may therefore trigger regulatory obligations.

The lifecycle pathway becomes:

Approved Product → Manufacturing Change → Assess Risk → Generate Supporting Data → Submit / Notify → Implement Change

Site Transfers

Moving a manufacturing process from one facility to another may require:

• Technology transfer
• Comparability
• qualification
• validation
• regulatory submissions
• inspection readiness

The WCBP U.S. manufacturing workshop similarly identified site transfers and post-approval changes as major issues that must be addressed when expanding domestic manufacturing.

Technology Transfer

A successful site transfer may require transfer of:

• Process knowledge
• Equipment requirements
• Analytical methods
• Raw-material controls
• quality systems
• operator knowledge
• process parameters

The objective is:

Different Site → Comparable Product Quality

Lifecycle Management

Post-approval change management is part of a product’s lifecycle rather than an exception.

Manufacturers must be able to evolve:

• Sites
• Equipment
• processes
• technology
• analytical methods

without compromising product quality or regulatory compliance.

ICH Q12

The broader 2026 CASSS discussion of U.S. manufacturing expansion identified ICH Q12 as one regulatory framework that may help facilitate lifecycle management and manufacturing changes.

ICH Q12 focuses on:

• Pharmaceutical product lifecycle management
• Established conditions
• post-approval changes
• regulatory predictability

COMMERCIAL MANUFACTURING

Commercial manufacturing adds requirements beyond clinical-scale development.

A commercial site must consistently manage:

• Demand
• inventory
• product release
• quality systems
• equipment maintenance
• supplier performance
• deviations
• regulatory commitments

while maintaining uninterrupted supply.

CLINICAL MANUFACTURING

Clinical manufacturing may require greater flexibility because:

• Processes are still evolving
• Product knowledge is increasing
• batch numbers may be smaller
• timelines are aggressive

However, clinical manufacturing must still maintain appropriate:

• GMP controls
• traceability
• documentation
• quality oversight

The summit’s lifecycle perspective is relevant across both clinical and commercial operations.

Manufacturing Network Strategy

Large biopharmaceutical companies may operate across:

• Internal sites
• CMOs
• CDMOs
• international facilities
• U.S. sites

Expanding domestic capacity therefore requires network-level decision-making rather than isolated facility decisions.

CONTRACT MANUFACTURING

Contract manufacturing organizations can contribute to domestic capacity without requiring every sponsor to construct a dedicated plant.

Potential strategies include:

• CDMO partnerships
• contract production
• shared manufacturing platforms
• external testing
• specialized fill-finish capacity

These approaches can complement direct company investment.

Onshoring Beyond New Construction

CASSS’s broader U.S. manufacturing discussion also emphasizes that onshoring does not have to rely exclusively on construction of entirely new sites.

Potential alternatives include:

• Site expansion
• Process transfers
• additional manufacturing lines
• CDMO capacity
• advanced manufacturing
• network optimization

ADVANCED MANUFACTURING TECHNOLOGY

Advanced manufacturing technologies may support more rapid and flexible domestic expansion.

Examples may include:

• Continuous manufacturing
• advanced automation
• real-time monitoring
• digital integration
• modular manufacturing

FDA’s PreCheck framework explicitly identifies modern manufacturing technologies, automation, and digital integration as factors that may accelerate facility development and improve manufacturing efficiency.

Automation

Automation can help improve:

• repeatability
• process control
• data capture
• manufacturing efficiency
• operator consistency

but also creates new requirements involving:

• validation
• cybersecurity
• computerized-system governance
• technical expertise

Digital Integration

A modern facility may integrate:

• MES
• laboratory systems
• process data
• equipment data
• quality systems
• inventory systems

to improve manufacturing visibility.

Digitalization therefore becomes part of facility architecture rather than an optional add-on.

SUPPLY NETWORK FLEXIBILITY

Manufacturing resilience depends on an organization’s ability to respond when a site or supplier becomes unavailable.

Potential resilience strategies include:

• Multiple sites
• dual sourcing
• strategic inventories
• domestic capacity
• contract manufacturing
• flexible facilities

The course places U.S. manufacturing investment within this broader resilience framework.

Regulatory & Commercial Speed

The summit examines how manufacturers can move faster without compromising:

• product quality
• patient safety
• regulatory compliance

A practical framework is:

Accelerate What Can Be Accelerated → Preserve Controls That Protect Product Quality

Pharmaceutical Quality Systems

FDA PreCheck specifically incorporates Pharmaceutical Quality System design into early facility-readiness discussions.

Quality-system architecture should therefore begin during facility development rather than being added only after construction is complete.

Facility Readiness

True facility readiness requires alignment across:

Physical

• Building
• utilities
• equipment

Technical

• process
• automation
• qualification

Human

• workforce
• training
• leadership

Quality

• PQS
• documentation
• procedures

Regulatory

• submissions
• inspection readiness
• FDA engagement

The complete model is:

Facility + People + Process + Quality + Regulatory Strategy = Manufacturing Readiness

Program Faculty & Confirmed Presentations

CASSS’s official 2026 archive confirms the following presentations:

Karim Kacimi – Novo Nordisk Inc.

Accelerating US Manufacturing Onshoring: EU Landscape Insights and Innovative Approaches

Julia Edwards – Eli Lilly and Company

Building It Is the Easy Part. Changing the Playbook Is Harder

Jared Auclair – Northeastern University

Workforce Capacity & Training: Building the Pipeline for the US Biomanufacturing Wave

Mary E. Farbman – Merck & Co., Inc.

Ensuring Inspection Success

Cyrus Agarabi – CDER, FDA

Regulatory Aspects Introduction – Informational Slides on FDA PreCheck Program

Nina Cauchon – Amgen Inc.

Post-Approval Changes: Navigating Complexity, Delivering Solutions

CASSS also archived the Virtual Summit Manufacturing 2026 Scientific Program and Summary Infographic as official resources.

Major Topics Covered

• Pharmaceutical Manufacturing
• Biopharmaceutical Manufacturing
• U.S. Manufacturing
• Domestic Manufacturing
• Manufacturing Onshoring
• Reshoring
• European Manufacturing Landscape
• Global Manufacturing Networks
• Supply Chain
• Supply Chain Resilience
• Pharmaceutical Supply Security
• Facility Design
• Facility Construction
• Facility Expansion
• Operational Readiness
• Manufacturing Operations
• Manufacturing Playbooks
• Manufacturing Transformation
• Modular Manufacturing
• Prefabricated Facilities
• Advanced Manufacturing Technology
• Automation
• Digital Manufacturing
• Bioprocessing
• Workforce Capacity
• Workforce Development
• Technical Training
• Biomanufacturing Workforce
• Talent Pipeline
• Capability Architecture
• Manufacturing Engineers
• Facility Engineers
• Process Engineers
• Quality Systems
• Pharmaceutical Quality System
• PQS
• GMP
• cGMP
• Inspection Readiness
• FDA Inspections
• Inspection Success
• Data Integrity
• Validation
• Qualification
• FDA PreCheck
• Facility Readiness
• Pre-Operational Review
• Type V Drug Master File
• CMC
• Regulatory Affairs
• Regulatory Predictability
• Clinical Manufacturing
• Commercial Manufacturing
• Post-Approval Changes
• Site Transfers
• Technology Transfer
• Lifecycle Management
• ICH Q12
• CDMO
• CMO
• Domestic Supply
• API Manufacturing
• Drug Substance
• Drug Product
• Finished Dosage Forms
• Regulatory Compliance

Who Should Take This Course?

CASSS Sharing Science Solutions US Manufacturing Virtual Summit 2026 is particularly relevant for:

• Pharmaceutical Manufacturing Professionals
• Biopharmaceutical Manufacturing Leaders
• Manufacturing Engineers
• Facility Engineers
• Bioprocess Engineers
• Process Development Professionals
• CMC Professionals
• Regulatory Affairs Specialists
• Quality Assurance Professionals
• Quality Control Professionals
• MSAT Professionals
• Validation Specialists
• Inspection Readiness Teams
• Supply Chain Professionals
• Technical Operations Leaders
• Workforce Development Leaders
• CDMO / CMO Professionals
• Pharmaceutical Executives
• Pharmaceutical Physicians
• Clinical Pharmacologists
• Medical Toxicologists

The strongest professional audience remains:

Pharmaceutical Manufacturing + CMC + Regulatory Affairs + Quality + Supply Chain

Why This Course Is Useful

The CASSS US Manufacturing Virtual Summit 2026 examines the practical requirements for expanding domestic pharmaceutical production from multiple perspectives.

Manufacturing Strategy

• U.S. onshoring
• European manufacturing insights
• domestic capacity
• global network strategy

Facilities

• construction
• accelerated build
• modular design
• operational readiness

Workforce

• capability planning
• technical education
• manufacturing workforce pipelines

Quality & Inspection

• cGMP
• quality systems
• inspection readiness
• inspection success

Regulatory Strategy

• FDA PreCheck
• early FDA engagement
• facility readiness
• regulatory predictability

Lifecycle Management

• post-approval changes
• site transfers
• technology transfer
• ICH Q12

Supply Chain

• resilience
• manufacturing redundancy
• U.S. capacity
• global supply continuity

The overall manufacturing-expansion pathway can be summarized as:

Plan Capacity → Design Facility → Build Workforce → Establish Quality Systems → Engage Regulators Early → Qualify & Validate → Pass Inspection → Launch Manufacturing → Manage Post-Approval Changes → Strengthen Supply Resilience

Original CASSS Event Information

The official CASSS event was:

• Virtual Summit on Manufacturing
• Date: May 7, 2026
• Format: One-Day Virtual Program
• Number of Sessions: Four
• Format of Sessions: Speaker Presentations + Panel Discussions
• Theme: Opportunities and Challenges of Expanding US-based Pharmaceutical Manufacturing

CASSS also provided the program through its virtual platform and subsequently listed US Manufacturing Virtual Summit among the archived CASSS On Demand collections.

The publicly accessible CASSS event information reviewed for this product does not list an AMA PRA Category 1 Credit™ physician CME designation for this manufacturing summit.

An independently distributed MedicalAmboss package should therefore not automatically be represented as providing:

• Physician CME Credit
• AMA PRA Category 1 Credits™
• CASSS Continuing Education Credit
• Official CASSS Certificate
• Official CASSS Registration
• Official CASSS Membership
• Live CASSS Q&A Access
• CASSS On Demand Membership Access

unless those specific benefits are separately documented and explicitly included.

Product Summary

• Product: CASSS Sharing Science Solutions US Manufacturing Virtual Summit 2026
• Official Event: Virtual Summit on Manufacturing
• Organization: CASSS – Sharing Science Solutions
• Year: 2026
• Date: May 7, 2026
• Format: Virtual
• Duration: One Day
• Official Theme: Opportunities and Challenges of Expanding US-based Pharmaceutical Manufacturing
• Number of Sessions: 4
• Educational Formats: Speaker Presentations + Panel Discussions
• Primary Field: Pharmaceutical Manufacturing
• Related Fields: CMC, Regulatory Affairs, Quality, Supply Chain, Facility Engineering
• Major Areas: U.S. Onshoring, Facility Development, Workforce, FDA PreCheck, Inspection Readiness, Post-Approval Changes
• Primary Audience: Biopharmaceutical Manufacturing, CMC, Regulatory, Quality, and Supply Chain Professionals
• Additional Audience: Pharmaceutical Physicians, Clinical Pharmacologists, Medical Toxicologists

Short Description

CASSS Sharing Science Solutions US Manufacturing Virtual Summit 2026 is a specialized one-day virtual program held May 7, 2026 focused on the opportunities and challenges of expanding U.S.-based pharmaceutical manufacturing.

The program covers manufacturing onshoring, European manufacturing insights, accelerated facility development, operating-model transformation, biomanufacturing workforce capacity, supply-chain resilience, FDA inspections, FDA PreCheck, facility readiness, regulatory compliance, site transfers, and post-approval manufacturing changes.

Topics

The official CASSS archive confirms the following major presentations:

Accelerating US Manufacturing Onshoring: EU Landscape Insights and Innovative Approaches

Karim Kacimi – Novo Nordisk Inc.

Major educational focus:

• U.S. pharmaceutical manufacturing expansion
• Onshoring strategy
• European manufacturing perspective
• Global manufacturing networks
• Innovative approaches to domestic capacity
• Manufacturing resilience

Building It Is the Easy Part. Changing the Playbook Is Harder

Julia Edwards – Eli Lilly and Company

Major educational focus:

• Rapid facility development
• Manufacturing operational readiness
• Changing established manufacturing processes
• New operating models
• Organizational transformation
• Building manufacturing capability beyond physical infrastructure

Workforce Capacity & Training: Building the Pipeline for the US Biomanufacturing Wave

Jared Auclair – Northeastern University

Major educational focus:

• Workforce capacity
• Technical training
• Biomanufacturing talent development
• Academic-industry collaboration
• Workforce pipeline development
• Future manufacturing capabilities

Ensuring Inspection Success

Mary E. Farbman – Merck & Co., Inc.

Major educational focus:

• Inspection readiness
• Regulatory inspections
• Quality systems
• GMP compliance
• Manufacturing documentation
• Inspection-management strategy

Regulatory Aspects Introduction – Informational Slides on FDA PreCheck Program

Cyrus Agarabi – CDER, FDA

Major educational focus:

• FDA PreCheck
• U.S. facility expansion
• Facility readiness
• Early FDA engagement
• Regulatory predictability
• Inspection planning
• Domestic manufacturing resilience

FDA describes PreCheck as a two-phase program involving Facility Readiness and Application Submission, with early technical interaction intended to reduce downstream regulatory risk for new domestic manufacturing facilities.

Post-Approval Changes: Navigating Complexity, Delivering Solutions

Nina Cauchon – Amgen Inc.

Major educational focus:

• Post-approval manufacturing changes
• Lifecycle management
• Site changes
• Regulatory change management
• Commercial manufacturing
• Efficient implementation of compliant solutions

Related Strategic Themes

Across the summit, the confirmed presentations collectively address:

• U.S. manufacturing onshoring
• Global manufacturing strategy
• Facility expansion
• Modern manufacturing infrastructure
• Operational transformation
• Workforce readiness
• Talent development
• Supply-chain resilience
• Inspection readiness
• FDA PreCheck
• Regulatory engagement
• Post-approval changes
• Commercial lifecycle management

CASSS characterizes the entire summit as a program designed to help attendees navigate the dynamic U.S. manufacturing environment and understand the latest developments and future considerations surrounding domestic pharmaceutical manufacturing.

Topics

• Accelerating US Manufacturing Onshoring: EU Landscape Insights and Innovative Approaches

• Building It Is the Easy Part, Changing the Playbook Is Harder

• Capability Architecture: Engineering the Future Workforce for Supply Chain Resilience

• CASSS Welcome: Virtual Summit US Manufacturing 2026 Introduction

• Delivering State-of-the-Art Manufacturing Facilities at an Unprecedented Pace

• Ensuring Inspection Success

• Post-Approval Changes: Navigating Complexity, Delivering Solutions

• Regulatory Aspects Introduction: Informational Slides on FDA PreCheck Program

• Session I: Infrastructure and Building (including Panel Discussion)

• Session II: Regulatory Aspects (including Welcome, Summary, and Concluding Remarks)

• Virtual Summit Manufacturing 2026 Scientific Program and Summary Infographic

• Workforce Capacity & Training: Building the Pipeline for the US Biomanufacturing Wave