November 19, 2026

* JOIN US FOR THE PRE-EVENT HAPPY HOUR on November 18, 2026 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

Mayor's Welcome Address

8:10 am – 8:20 am EST

CHAIR'S WELCOME AND OPENING REMARKS

Manufacturing

Aaron Bazal

Chief Executive Officer and Founder
Vibraclean

Outsourcing

Goldi Kaul, Ph.D.

VP and Head, External Alternative Chemistry, Manufacturing and Controls Development
Boehringer Ingelheim

SUPPLY CHAIN

Shonna Scalfani

SVP, Chemistry, Manufacturing and Controls and External Manufacturing
Amylyx Pharmaceuticals Corp.

Quality

Vaishali Shukla, Ph.D.

VP, Cell Gene Therapy and Active Pharmaceutical Ingredients, Global Expansion
Eli Lilly

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
8:20 am – 8:50 am EST

Keynote

Cedric Dubois

SVP, Head of Global External Manufacturing
Teva Pharmaceuticals

Designing and Executing a High-Performing Global External Manufacturing Network: From Strategic Architecture to CMO Excellence

  • Elevating external manufacturing from a reactive capacity provider to a core driver of strategic competitive advantage
  • Balancing internal capabilities and external partner strengths to build an agile, cost-effective, and supply-resilient network
  • Transitioning from transactional CMO relationships to strategic partnerships aligned around shared long-term objectives
  • Establishing scalable governance, risk management, and operational accountability across a diverse global footprint
  • Aligning external capacity and technical capabilities with product launches, lifecycle shifts, and commercial demand fluctuations
  • Driving productivity, continuous improvement, and network simplification to maintain long-term reliability
8:50 am – 9:20 am EST

Plenary

  • Shashank Shukla

    VP, Site Head, API, Drug Product Manufacturing
    Bayer

Driving Production Site Excellence: A Transformation Plan in Operations and Performance

  • Strengthening operational performance through structured transformation plans that align people, processes, and technology across production sites
  • Leveraging operational excellence frameworks to improve efficiency, reliability, and performance consistency in manufacturing environments
  • Building a culture of continuous improvement by empowering frontline teams and leaders to identify and solve performance challenges
  • Applying data-driven insights and digital tools to enhance decision-making, productivity, and real-time operational visibility
  • Aligning cross-functional teams around shared performance goals to accelerate execution and sustain long-term improvements
  • Developing scalable transformation roadmaps that support growth, innovation, and operational resilience across global manufacturing networks
9:20 am – 9:50 am EST

Plenary

Rob Livada

VP, Supply Chain ABP Business Process Architects
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
9:55 am – 11:35 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.
11:40 am – 12:10 pm EST

Sessions

Manufacturing

Roshy Pakdaman

VP, Global Product Development
AstraZeneca

Advancing New Technologies to Transform Biopharmaceutical Development, Manufacturing, and Supply

  • Accelerating product introduction by integrating development, manufacturing, and cross-functional expertise early
  • Scaling innovative manufacturing technologies across modalities to support efficient product development
  • Leveraging AI and advanced analytics to improve development decisions and execution
  • Integrating formulation, process, analytical, device, and digital capabilities across development programs
  • Building high-performing scientific teams that advance innovation, quality, and operational excellence
  • Enabling scalable technology transfer and manufacturing readiness across diverse therapeutic modalities

Outsourcing

Goldi Kaul, Ph.D.

VP and Head, External Alternative Chemistry, Manufacturing and Controls Development
Boehringer Ingelheim

Accelerating Pharma Development Through External CMC Innovation

  • Evolving the CMC model from transactional outsourcing to strategic external innovation
  • Building global partnerships that enable speed, scalability, and quality by design
  • Integrating emerging technologies with external development to streamline tech transfer and scale-up
  • Managing regulatory alignment and risk across diverse external ecosystems
  • Operational excellence strategies that support agility while maintaining compliance
  • Case perspectives: when to innovate internally vs. externally for maximum impact

Supply Chain

Sev Sislian

VP, Procurement Operations
AbbVie

Bridging R&D and Operations Sourcing to Accelerate Commercialization and Resilience

  • Aligning procurement strategies with R&D and manufacturing timelines to ensure seamless commercialization
  • Integrating capital construction and facility sourcing to support rapid capacity expansion projects
  • Mitigating global supply risks through robust category management and diversified sourcing frameworks
  • Driving cost optimization while maintaining quality standards across complex external manufacturing networks

Quality

Frank Seibel

VP and Site Head, Quality
Roche

Enhancing Quality Culture and GMP Compliance through Lean GMP and Quality Oversight

  • Implementing Lean GMP methodologies to streamline biomanufacturing processes and improve efficiency
  • Enhancing quality oversight to ensure consistent compliance with cGMP standards
  • Building a robust quality culture through accountability and continuous improvement practices
  • Utilizing risk-based approaches to Quality Management Systems (QMS) for better compliance and operational performance
  • Leveraging CAPA and change control strategies to drive ongoing improvements in quality assurance
12:15 pm – 12:45 pm EST

Workshops

Room 1

Rhonda Bronenberg

VP, Manufacturing Services
Process Alliance

Building the Future Together: Partnering to Develop the Next Generation of Scientists and Engineers

  • Creating meaningful career pathways through hands-on, project-based learning, mentoring, and exposure to real-world manufacturing challenges
  • Developing both technical excellence and the leadership, collaboration, business acumen, and problem-solving skills required in modern pharmaceutical operations
  • Preparing adaptable, innovation-focused talent for emerging technologies, advanced therapeutics, digital manufacturing, and increasingly complex operating environments
  • Building cultures and early-career experiences that inspire, engage, and retain top talent while enabling meaningful contributions from the start

Room 2

Jonathan De Keukelare

Head, Supply Chain Operations Practice US
BlueCrux

Cedric Dubois

SVP, Head of Global External Manufacturing
Teva Pharmaceuticals

From Vision to Value: How a Renewed Supplier Collaboration Framework Became a Strategic Transformation Initiative for Teva

  • Discover how Teva is translating its supplier collaboration vision into a practical transformation plan
  • Explore how clear priorities and alignment across processes, technology, data, and people shape an actionable roadmap
  • Hear Teva’s perspective on the beginning of the journey, including the first considerations and decisions
  • Learn how pharma organizations can accelerate value realization and build a scalable foundation for stronger external supplier collaboration

Room 3

Speaker TBA


Katalyze AI

Building the Data Foundation for Smarter, More Connected Pharmaceutical Manufacturing 

  • Unifying fragmented manufacturing data to create a trusted foundation for faster operational decision-making
  • Connecting production records, specifications, SOPs, and batch data across complex manufacturing environments
  • Transforming unstructured operational information into standardized, accessible data for manufacturing teams
  • Establishing traceable data relationships to strengthen visibility, compliance, and confidence in manufacturing decisions
  • Accelerating digital transformation by integrating existing systems without lengthy implementation timelines
  • Enabling scientists and engineers to spend less time gathering data and more time solving problems

Room 4

Speaker TBA


Delpharm

Navigating Complex Tech Transfers to Ensure Seamless Commercial Scale-Up and Launch

  • Implementing robust technology transfer protocols to mitigate risks during large scale manufacturing
  • Leveraging extensive multi-site capabilities to provide global supply security for diverse portfolios
  • Optimizing formulation development strategies to accelerate speed to market for innovative medicines
  • Ensuring rigorous quality standards across global networks to maintain high regulatory compliance
12:50 pm – 1:50 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:

Speaker TBA


Arcwood Enviromental

Building a Circular Pharma Ecosystem: Integrating Sustainable Waste Management and Environmental Remediation into Manufacturing Strategy

Jamie Iserloth

VP, Quality
Coating Place Inc

Strengthening CDMO Performance Through Better System and Workflow Decisions

Nicole Olivieri

Product Marketing Manager
BA Sciences

Smarter Outsourcing: Leveraging Specialized Analytical Expertise Across Drug Development

Speaker TBA


Enhanced Compliance Inc

Navigating the Total Product Life Cycle: Strategic Compliance and Quality for Seamless Pharma Outsourcing

Speaker TBA


Bushu Pharmaceuticals

Mastering the Gateway to Asia: Strategic CDMO Partnerships for Seamless Global Pharmaceutical Outsourcing

Alexander Srbulj

Director, Business Development
Interchem

Optimizing the Global API Supply Chain: Strategic Sourcing and Compliance for Pharmaceutical Outsourcing

Taylor Chartier

Chief Executive Officer
Modicus Prime

Managing AI Suppliers: Ensuring Control Across Pharma AI Systems

Maxence Jeunesse

Chief Data AI Digital Officer
Efor Group

The Future of CQV: Combining Human Expertise and AI

Ashley Switalski

Automation and CSV Program Manager
Process Alliance

Optimizing Operational Readiness and Tech Transfer for Complex Pharmaceutical Capital Projects

Gilberto Jimenez

Senior Director, Solutions Engineering
SQA Services

Optimizing External Pharmaceutical Manufacturing Compliance Through Advanced Supplier Quality Audit Programs

Richard Richieri

Chief Operations Officer
Avid Bioservices

Mid-Phase Tech Transfer: Onshoring Strategies, Operational Pitfalls, and Lessons Learned

Jeremy Tanner

Senior Director, Sales, MODA
STARLIMS

Leveraging AI and Automation in QA/QC to Boost Efficiency and Simplify Compliance

Kushal Suri

President, International Growth
Morepen Laboratories Ltd

Optimizing Global Active Pharmaceutical Ingredient Supply Chains Through Strategic Manufacturing Partnerships

Emilee Liston

Executive RPO Recruiting Partner
PrincetonOne

Optimizing Pharmaceutical Manufacturing Growth Through Strategic Talent Acquisition and Workforce Scalability

1:55 pm – 2:25 pm EST

Sessions

Manufacturing

Serafino Fabiano

AVP, Site Head
Eli Lilly

Optimizing Capital Project Delivery and Operational Readiness for Sterile Manufacturing Sites

  • Designing flexible facility footprints to accommodate evolving parenteral and device technology portfolios
  • Accelerating operational readiness through integrated commissioning, qualification, and validation execution strategies
  • Aligning capital investment roadmaps with long-term global capacity planning and network strategy
  • Leading cross-functional teams to ensure compliance and asset reliability during complex startups

Outsourcing

Seshu Tummala

VP, Drug Substance Process Development and Manufacturing
Uniquity Bio, Inc.

Navigating Complex CMC Technical Decisions to Streamline Advanced Therapeutic Program Roadmaps

  • Definition of important components and roles/responsibilities of CMC team
  • Understanding critical inputs from overall organization to drive effective decision making by the CMC team
  • Translation of critical inputs and process capability into a phase appropriate manufacturing strategy including CDMO selection
  • Development of a phase appropriate drug product presentation strategy to facilitate clinical trial flexibility while delivering on commercial launch requirements
  • Integration of Quality By Design approaches to enable an efficient regulatory filing pathway for therapeutic licensure

Supply Chain

Imara Charles, Ph.D.,

VP, Global Supply Chain
Immunovant

Optimizing Global Biopharmaceutical Supply Networks Through Predictive Analytics and Digital Excellence

  • Integrating advanced artificial intelligence models to optimize global supply chain network operations
  • Harmonizing enterprise resource planning architectures to eliminate biopharmaceutical production process friction
  • Deploying comprehensive supply chain master data frameworks to accelerate commercialization timelines
  • Utilizing predictive analytics platforms to mitigate operational risk across decentralized networks
  • Scaling automated serialization platforms to ensure seamless asset delivery across global markets

Quality

Karin Ann Payne

VP, Regulatory Compliance
Johnson & Johnson

Operationalizing Ethical Artificial Intelligence Governance Frameworks Across Enterprise Regulatory Compliance Networks

  • Establishing ethical oversight frameworks for deploying artificial intelligence across quality and compliance systems
  • Ensuring algorithmic transparency and data integrity during automated regulatory decision-making processes
  • Mitigating algorithmic bias and compliance risks within predictive quality risk assessment tools
  • Aligning AI validation protocols with evolving global health authority regulatory expectations
  • Safeguarding patient data privacy and ethics across AI-integrated global supply network operation
2:30 pm – 3:00 pm EST

Workshops

Room 1

Speaker TBA


AgileOne

Optimizing Contingent Workforce Visibility Through Integrated Managed Services Program Digital Platforms

  • Deploying unified MSP data analytics to ensure real-time contingent workforce traceability.
  • Automating specialized talent segment tracking to mitigate compliance risks and churn.
  • Integrating RPO sourcing with onboarding workflows to accelerate talent deployment cycles.
  • Utilizing predictive talent analytics to prevent labor shortages and optimize pipeline.
  • Streamlining regulatory compliance through automated payroll audit trails and electronic documentation.

Room 2

Carter Lloyds

Chief Marketing Officer
Indeavor

Your Supervisor Is Your Scheduling Integration Layer. Is That a State of Control?

  • The four-number smoke test (available, demanded, scheduled and paid hours): can your site pull all four for last week in one morning?
  • Reading the gaps between the four numbers: where capacity falls short, where coverage has holes, and where paid hours are leaking away from planned work
  • Systems: why your supervisor became the integration layer between the LMS and the roster, a single point of human error that goes home at the end of every shift
  • Compliance: turning “adequate number of qualified personnel” into a control you can measure shift by shift, with qualification checked at the point of scheduling and provable on demand
  • Efficiency: why reactive overtime, late backfills and stopped runs are symptoms of the same uncontrolled decision, and how planned coverage protects capacity and the run
  • One root cause, multiple returns: bringing staffing into a state of control reduces deviation risk, reactive overtime and supervisor firefighting at the same time

Room 3

Brijesh Ramakrishnan

Agentic Architect
Tracelink

Building the Foundation for Agentic AI: Transforming Life Sciences Operations through Intelligent Network Orchestration

  • Transitioning from traditional linear supply chains to an autonomous, intelligent network capable of self-orchestration
  • Leveraging high-fidelity serialization data to feed AI models for predictive risk mitigation and inventory optimization
  • Overcoming data silos through multienterprise orchestration to enable real-time visibility across CMOs, 3PLs, and wholesale partners
  • Exploring the role of Agentic AI in automating complex decision-making processes within the pharmaceutical value chain
  • Enhancing service excellence by reducing lead times and waste through automated, network-wide collaboration

Room 4

Massimo Crudeli

Director, Client Solutions
Staedean

Future-Proofing Life Sciences Operations: Leveraging AI-Enabled ERP for Global Growth and Compliance

  • Understanding the value of purpose-built ERP software embedded within Microsoft Dynamics 365 to drive operational excellence in life sciences
  • Exploring how AI-enabled systems and multi-agent AI can drive growth and confidence in complex pharma and medtech manufacturing
  • Modernizing legacy ERP systems to improve cross-functional collaboration, transparency, and shared ownership across global networks
  • Implementing no-code data management solutions to integrate, govern, and secure critical manufacturing and supply chain data
  • Strengthening global supply chain visibility and performance through automated document exchange and intelligent data orchestration
  • Examining a case study on modernizing ERP frameworks to navigate the last mile of functionality and regulatory requirements
3:05 pm – 4:25 pm EST

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

4:30 pm – 5:00 pm EST

Sessions

Manufacturing

Luiz Alberto Barberini

Head, External Manufacturing, Latin America
Bayer Consumer Care

Advancing Digital Supplier Collaboration to Unlock Agility, Visibility, and Performance in External Manufacturing

  • Integrating digital platforms to enable end-to-end visibility across external manufacturing partners
  • Applying predictive analytics and AI to anticipate supply risk and improve decision speed
  • Enhancing collaboration by connecting procurement, quality, and planning data streams in real time
  • Driving supplier performance and innovation through transparent metrics and digital engagement
  • Building adaptable governance models that strengthen accountability and business continuity
  • Fostering a data-driven culture to maximize the value of external manufacturing networks

Outsourcing

Celeste Frankenfeld Lamm

Senior Director, Global Quality and Regulatory CMC Policy and Advocacy
Merck

Advancing Pharmaceutical Innovation Through Smarter CMC Policy and Regulatory Collaboration

  • Driving global regulatory alignment and policy development to enable faster adoption of advanced pharmaceutical manufacturing technologies
  • Strengthening collaboration between industry, regulators, and standards organizations to remove barriers to innovation in CMC and quality frameworks
  • Leveraging digital technologies, advanced manufacturing, and data-driven regulatory approaches to modernize pharmaceutical development and oversight
  • Using cross-industry advocacy to address regulatory challenges that impact supply chain resilience and product quality
  • Aligning regulatory policy, manufacturing innovation, and quality systems to accelerate patient access to safe and reliable medicines

Supply Chain

Sudha Vippagunta

Senior Director, CMC Leader
Bristol Myers Squibb

Optimizing CMC Strategies to Accelerate Biologics and Small Molecule Clinical Supply

  • Driving integrated drug product development from early compound nomination through commercial launch
  • Aligning cross-functional analytical development and drug substance operations for complex biologics
  • Managing global drug supply logistics and clinical manufacturing capabilities through strategic alliances
  • Applying risk-balanced development approaches to ensure scientific rigor and regulatory submission success

Quality

Arjun Channi

Senior Director and Global Lead, Regulatory
Takeda

Aligning Manufacturing Strategy with Regulatory Compliance: Ensuring Inspection Readiness Across Global Operations

  • Integrating regulatory requirements into manufacturing processes to ensure consistent global compliance
  • Translating evolving health authority expectations into actionable manufacturing and quality strategies
  • Strengthening collaboration between Regulatory, Manufacturing, and Quality teams to align on submission and inspection readiness
  • Embedding compliance considerations into technology transfer, scale-up, and commercial manufacturing activities
  • Leveraging real-world evidence and data to support regulatory submissions and lifecycle management
  • Driving proactive risk management to anticipate regulatory challenges and ensure successful approvals
5:05 pm – 5:35 pm EST

Plenary

Aaron Dely

VP, Research and Development
PLD Pharma Services

Accelerating Speed-to-Market for OTC Products: Technical, Regulatory and Cost Considerations

  • Rethinking traditional tech transfer approaches to identify faster, smarter paths to commercialization
  • Leveraging existing CDMO ANDAs to reduce timelines, costs, and regulatory complexity
  • Navigating tech transfer challenges and avoiding common assumptions around bioequivalence requirements
  • Evaluating CBE-30, Prior Approval Supplements, and BE studies across different formulations
  • Assessing delayed-release and controlled-release products to determine appropriate regulatory pathways
  • Engaging technical and regulatory stakeholders early to strengthen outsourcing and commercialization decisions
5:35 pm – 6:20 pm EST

Panel Discussion

  • Serafino Fabiano

    AVP, Site Head
    Eli Lilly

  • Bharath Sundararaman

    Senior Director
    Pfizer

  • Zaher Shabani

    Senior Director, Global Regulatory Affairs CMC
    Incyte

  • Deborah Soto-Ortega, Ph.D.

    Executive Director, Site Head
    Moderna

  • Laks Pernenkil, PH.D.

    Principal, Life Sciences Product, Supply, & Manufacturing Operations Practice Leader
    Deloitte

  • Colin Baker

    SVP, Quality Assurance
    Bimeda

Accelerating Performance and Agility through Intelligent Operations and Technology

  • What does the future hold for pharmaceutical manufacturing and outsourcing?
  • Leveraging digital twins for real-time decision-making in manufacturing processes
  • Scaling flexible manufacturing to meet diverse product demands and market needs
  • Mitigating risks by diversifying outsourcing partnerships and ensuring supply chain resilience
  • Harnessing AI and machine learning for predictive quality and process improvements
  • Establishing a continuous digital thread across manufacturing and outsourcing networks to enhance visibility and collaboration
6:20 pm – 6:30 pm EST

Chair's closing remarks

Manufacturing

Aaron Bazal

Chief Executive Officer and Founder
Vibraclean

Outsourcing

Goldi Kaul, Ph.D.

VP and Head, External Alternative Chemistry, Manufacturing and Controls Development
Boehringer Ingelheim

Supply Chain

Shonna Scalfani

SVP, Chemistry, Manufacturing and Controls and External Manufacturing
Amylyx Pharmaceuticals Corp.

Quality

Vaishali Shukla, Ph.D.

VP, Cell Gene Therapy and Active Pharmaceutical Ingredients, Global Expansion
Eli Lilly

6:35 pm – 7:35 pm EST

Networking Drinks Reception

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