April 14, 2026

* JOIN US FOR THE PRE-EVENT HAPPY HOUR ON APRIL 13, 2026 FROM 6:00 PM – 7:00 PM

7:00 am – 8:00 am PST

Registration and Networking Breakfast

8:00 am – 8:10 am PST

Chair's Welcome and Opening Remarks

Manufacturing and Technology

Kara Renai King

VP, Platform Leader Americas and China and Head, Global Manufacturing Learning and Development
Zoetis

Quality and Compliance

Paul Houri

SVP and Chief Quality Officer
Bristol Myers Squibb

Supply Chain and Logistics

Laura Alquist

SVP and Global Head, Technical Operations
Kite Pharma

Cell and Gene Therapy

Blair McNeill, Ph.D.

SVP and Head, Cell Therapy
Sumitomo Pharma

8:10 am – 8:40 am PST

Keynote

Rao Mantri

Chief Manufacturing Officer
Astellas Pharma

Fraiser Kansteiner

Editor
Fierce Pharma

SYNCHRONIZING MULTI-MODALITY DEVELOPMENT AND MANUFACTURING EXCELLENCE: AN INTEGRATED END-TO-END APPROACH

  • Integrated Process Architecture: Harmonizing early-stage product development with commercial manufacturing to ensure seamless end-to-end scalability across product lifecycle
  • Multi -Modality Operational Frameworks: Engineering flexible manufacturing infrastructures and network to manage diverse modalities and complex portfolios including strategic “Make” versus “Buy” decision-making
  • Balancing Quality and Agility: Leveraging an agile operating model to accelerate development-to-launch timelines while maintaining rigorous quality standards and regulatory compliance
  • Leadership Journey and talent development: Sharing insights from the path to Chief Manufacturing Officer and cultivating the next generation of leaders to build a high-performance culture
8:40 am – 9:10 am PST

Plenary

  • Paul Houri

    SVP and Chief Quality Officer
    Bristol Myers Squibb

From Compliance to Competitive Advantage: Evolving Quality Culture in a Global Organization

  • Building and strengthening a culture of quality and continuous improvement
  • Ensuring accountability and ownership of quality practices at all levels
  • Partnering with the business to deliver quality as a strategic value driver
  • Enhancing agility by leveraging innovation and risk-based quality management approaches, while maintaining global regulatory compliance
9:10 am – 9:40 am PST

Plenary

  • Adam Pfeiffer

    Senior Vice President
    ProjectFarma

  • Sarah Hinchin

    Associate Director, Project Management - Corporate Engineering and Facilities
    Gilead

  • Oliver Hesse

    VP of CMC Digital Transformation and Data Science
    Bayer

  • Jim Watson

    Chief Solutions Officer
    Project Farma

Optimizing Facility Strategy in a Volatile Market: A Practical Approach

  • Building agility into facility design and planning to meet evolving capacity needs
  • Making informed decisions on internal vs. external manufacturing for complex modalities
  • Best practices for de-risking capital investments in a fast-changing regulatory and commercial environment
  • Leveraging modular and single-use technologies to accelerate timelines and reduce cost
9:45 am – 11:25 am PST

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

11:30 am – 12:00 pm PST

Sessions

Manufacturing and Technology

Judy Chou, Ph.D.

President and CEO
AltruBio, Inc.

Managing Development Strategy and Scale as a Clinical-Stage Biotech

  • Designing a development strategy for Phase 2 and beyond
  • Strengthening the link between clinical progress and CMC readiness
  • Leveraging partnerships and CDMOs for clinical-stage manufacturing
  • Anticipating regulatory needs while remaining agile
  • Building a scalable platform without overextending resources

Quality and Compliance

Stelios Tsinontides

VP, QMS, Transformation and External Advocacy
Merck & Co., Inc

Bridging the Gap: Aligning Quality Management Systems with Evolving FDA Manufacturing Assessments for Successful PAIs/PLIs, Approvals & Commercialization

  • Translating regulatory expectations into actionable QMS strategies to de-risk commercial manufacturing assessments
  • Transforming legacy quality systems to enable advanced biotechnologies and accelerate product lifecycle management
  • Leveraging external advocacy and industry collaborations to influence and adapt to emerging Regulatory tools and compliance standards
  • Selecting facilities and implementing control and oversight strategies with regulatory assessment criteria to ensure rapid approval

Supply Chain and Logistics

Thomas Spitznagel

SVP, Technical Operatons
MacroGenics Inc.

Building a Reliable Supply Chain for ADCs: Strategies for a Complex Modality

  • Partnering for success: Selecting and managing CDMOs with ADC capabilities
  • Mitigating risk in sourcing high-potency payloads and linker chemistries
  • Coordinating upstream biologics and small molecule manufacturing timelines
  • Ensuring compliance and safety in handling and transport of cytotoxic components
  • Aligning supply strategy with clinical and commercial goals for ADC programs

Cell and Gene Therapy

Harish Santhanam

VP, Cell Therapy Technical Operations
Bristol Myers Squibb

Autologous Cell Therapy Manufacturing: How to Make Manufacturing a Core Competency and drive up reliability, reduce COGM and TAT

  • Autologous Cell Therapy Manufacturing – Current and Future
  • Using Cell biology to drive adaptive manufacturing
  • Automation for both Process and QC
  • Vector Manufacturing
  • Operations and TAT
12:05 pm – 12:35 pm PST

Workshops

Room 1

Krystyna Riley

CEO
Havior

Kim Huggins

Managing Director
Havior

Beyond Fatigue: Why Manufacturing Transformations Stall and How Top Performers Break Through

  • The Four Failure Patterns that compound to create systematic execution breakdown in 70-80% of organizations
  • The Behavioral Architecture that explains why initiatives fail despite capable people and sound strategies
  • A practical Diagnostic Framework leaders can use immediately to pinpoint barriers and design targeted, high-impact interventions

ROOM 2

Mark Raimondo

Senior CQV Project Manager
Jacobs

Streamlining Commissioning and Qualification to Accelerate Time-to-Market

  • Execution speed improves when continuity replaces handoffs, keeping the same team from startup through C&Q to reduce rework and delays
  • MC readiness—not paperwork—must be the true gate to qualification, ensuring systems, utilities, and vendors are genuinely prepared
  • Early integration of startup, QA, and suppliers enables parallel execution, minimizing late‑stage surprises and deviations
  • A risk‑based, streamlined C&Q model delivers predictable outcomes, cutting startup‑to‑qualification timelines by 20–40% while lowering costs
  • Modular facilities combined with integrated C&Q create a scalable advantage, accelerating regulatory readiness and reducing capital and site risk

ROOM 3

Scott Barnard

Managing Director, NA
Bluecrux

Stefanie Leysen

Head of Solution,Binocs
BlueCrux

From Lab to Patient: Scaling Biotech Planning Across R&D, Manufacturing, and Commercial Operations

  • Biotech organizations are under increasing pressure to scale.
  • Yet many remain stuck in siloed planning, making it difficult to scale across lab, manufacturing, and commercial operations.
  • What works in early-stage development often breaks down as volumes increase, modalities diversify, and patient-centric models become the norm.
  • This session explores why scaling planning in biotech is uniquely complex, starting in the lab and extending all the way to the patient.
  • We will dive into common planning challenges across biotech operations, including fragmented data, manual processes, and disconnected systems that limit visibility and agility.
  • We will also look at concrete use cases in areas such as Cell and Gene Therapies and other vein to vein models, where planning must account for single-patient batches, strict chain-of-custody requirements, and extreme sensitivity to delays.

Room 4

Hovsep Kirikian

VP, Strategy & Operations
USDM Life Sciences

INTELLIGENT QUALITY MANAGEMENT: ARCHITECTING AI-DRIVEN OVERSIGHT IN MODERN BIOMANUFACTURING

  • Transitioning from static, manual quality workflows to AI-enabled, continuously learning systems embedded across GMP operations
  • Deploying agentic and autonomous AI to monitor risk, interpret complex quality signals, and orchestrate cross-functional workflows in real time
  • Accelerating deviation resolution, batch review, and inspection readiness while improving transparency, consistency, and operational scalability
  • Establishing governance, validation, and control frameworks to deploy AI responsibly within regulated environments and strengthen compliance resilience
12:40 pm – 1:40 pm PST

Lunch & Learn Roundtables and Open Seating Lunch

Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required, and attendance for moderated roundtables on Day 1 is limited to attendees and speakers. Choose from:

Simon Trigg

Senior Director, Supply Chain
Rentschler BioPharma Inc.

How is AI being embedded into your daily Supply Chain decision‑making and operations?

Michael Dunn

Chief Commerical Officer
Afton Scientific

Flexible Aseptic Fill‑Finish for Biologics & Small Molecules

Ross Turmell

Principal Scientist
Cytiva

Reduce/Remove PUPSIT requirements from Annex 1

Gord Adamson, Ph.D.

Senior Directory of Technical Operations
Resilience

Accelerating Therapies to the Clinic While Assuring Commercial Success – Is There a Solution?

Joe Petrosky

SVP, Global Sales
PBS Biotech Inc

Cell Therapy from Start to Scale: How to Stay on the Leading Edge without Ending Up on the Bleeding Edge

Speaker TBA


Bionova Scientific

Accelerating Biologics Development and Manufacturing: From Cell Line to Commercial Success

Dustin Lafferty

Senior Pharmaceutical Scientist, Process and Product Development Supervisor, Analytical Development and Validation Supervisor
Singota Solutions

Early phase analytical validation

Jon C Best

Director, Business Development
AbbVie

Building supply chain resiliency to mitigate risk for complex biologics (ie ADCs)

Richard Richieri

Chief Operations Officer
Avid Bioservices

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

Beth Simmons

Director, Technical Excellence
OXB

Taking Viral Vectors from Clinic to Commercial: Strategic Choices that Define Biomanufacturing Success

Speaker TBA


Novartis

Integrating Biologics, Small Molecule, and Cell & Gene CDMO Capabilities in a Unified Platform

Devan Howlett

Business Development Manager, Industrial
Honeywell

Implementing Smart Automation & MES for cGMP Biomanufacturing Control and Compliance

Relly Brandman

Moonshot Lead
A-Life - A Google X Moonshot

From Cells to Products: Leveraging AI for Efficient Biomanufacturing

Vishal Prasad

Co-Founder, Chief Product Officer
Mareana

Knowledge Graph as the CPV and VSM Multiplier!

Mayank Gupta

Principal
ZS

Steve Yu

Principal
ZS Associates

Enabling faster, smarter manufacturing and quality operations augmented with agentic AI

Reza Farahani

Co-Founder and CEO
Katalyze AI

Shreyas Becker

Co-Founder and COO
Katalyze AI

Leveraging AI Agents to Reduce RCA Investigation Time by Over 60% and Accelerate CAPA Execution in cGMP Manufacturing

Roy Lind, Ph.D

Chief Technology Officer
Boston Insititute of Biotechnology

How can we Achieve Cost-Effective Biologic Manufacturing at Ultra-Large Scale Without Compromising Quality or Speed?

Coming soon

1:45 pm – 2:15 pm PST

sessions

Manufacturing and Technology

Sumitra Angepat

VP, Global Biologic Drug Substance
Bayer

Transforming Biomanufacturing: The Power of Agile Teams and End to End Flexibility

  • Bayer's transformation journey embraces agility and flexibility, accelerating therapy delivery to patients
  • CMC transformation uses end-to-end expertise and Dynamic Shared Ownership to manage dynamic portfolios
  • Global teams in Europe and the US boost efficiency using time zones and talent
  • An integration case study demonstrates agile product shifting across development and clinical manufacturing sites

Quality and Compliance

Farah Fawaz

SVP, Quality and Compliance
Allogene Therapeutics

Ensuring End-to-End Product Excellence: Integrating Quality Attributes Across the Cell Therapy Lifecycle

  • Designing and implementing quality strategies spanning early development through commercial launch
  • Defining and monitoring critical quality attributes at each stage of the cell therapy lifecycle
  • Streamlining processes ensuring regulatory compliance while maintaining product integrity and consistency
  • Leveraging cross-functional collaboration to embed quality and compliance into development and manufacturing

Supply Chain and Logistics

Sheena Behn

VP, Vaccine and Immune Therapy and Oncology Global Supply
AstraZeneca

Scaling Supply Chains for Advanced Therapies to Meet Global Patient Needs

  • Reimagining supply chains to prepare for the delivery of new modalities to patients
  • Integrating clinical and commercial supply strategies for seamless product scale-up and delivery
  • Enhancing intelligent supply chain resilience with AI-enabled forecasting while maintaining compliance and quality outcomes
  • Building a future-ready, digitally empowered workforce through AI upskilling

Cell and Gene Therapy

Andy Lin

VP and Global Head, Individualized and Cell Therapy Development, Pharma Technical
Genentech

Bridging Chemistry, Manufacturing, and Controls (CMC) Management and Commercial Strategy in Cell and Gene Therapy

  • Integrating CMC, clinical, and regulatory strategies to accelerate early-to-mid stage development
  • Building frameworks to enable scalability across diverse cell and gene therapy modalities
  • Overcoming end-to-end value chain complexities in patient-specific material acquisition and processing
  • Case study: Operationalizing personalized therapy at Genentech’s Hillsboro Individualized Therapies (HIT) facility
  • Preparing technical operations for the next 5 years of CGT innovation and commercialization
2:20 pm – 2:50 pm PST

Workshops

ROOM 1

Shahzad Khan

Global Solution Consultant
Yokogawa

Michiya Kanzaki

Senior Advisor
Yokogawa Electric Corporation

Smart Bioprocessing Starts Here: Yokogawa’s Platform for Predictive, Connected, and Autonomous Manufacturing

  • Autonomous workflows that simplify scale‑up and tech transfer
  • End-to-end connectivity across sensors, PAT, equipment
  • Embedding predictive analytics into routine operations
  • Closing the loop between monitoring, modeling, and control
  • Roadmap for companies beginning digital transformation

ROOM 2

Drew Parker

Senior Field Application Scientist, North America
Rapid Micro Biosystems

Building a Paperless, Digital QC Process with Automated Rapid Microbial Testing

  • Reducing errors through automation and simplified workflows
  • Enhance data integrity and inspection readiness with digital documentation and traceability
  • Accelerated microbial contamination detection enabling earlier data-driven decision making
  • Shorten time-to-release through automated data approvals

ROOM 3

LEANING INTO KOJOX™ VISION BY BUILDING A FLEXIBLE SUPPLY CHAIN FUELED BY INNOVATION

  • Investing billions in global cell culture capacity expansion to drive industry transformation
  • Enabling seamless clinical-to-commercial scale-up and scale-out with the KojoX™ strategy
  • Standardizing, modularizing, and optimizing facilities for speed, flexibility, and efficiency
  • Implementing a uniform operating philosophy to enhance supply chain agility across all sites

ROOM 4

Imroz Ghangas

VP, Commerical Sales
Asimov

Model-driven Genetic Design and Bioprocess Optimization Across Modalities

  • Addressing the limitations of traditional biopharmaceutical production
  • Presenting a vision for biopharmaceutical development using AI-driven, mechanistic, and hybrid models for genetic systems, cell lines, and bioprocesses
  • Case Studies: Demonstrating the power of our approach across multiple modalities, including monoclonal antibodies and viral vectors
2:55 pm – 4:15 pm PST

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

4:20 pm – 4:50 pm PST

plenary

  • Brid Rooney

    Vice President of Quality Assurance & Quality Control
    Rentschler

The Role of Quality as a Client Partner: From the Quality Assurance Agreement to Ways of Working on a Routine Basis

  • QAAs define GxP responsibilities between client and CMO, aligned with business contracts
  • Use secure extranets and structured document hierarchies to manage collaboration and file sharing
  • Clearly define document scope, review requirements, approvals, and deliverables within QAAs
  • Project Leaders streamline cross-functional communication by joining meetings or accessing decisions
  • Establish clear timelines, turnaround expectations, and defined limits for document review processes
  • Track and review performance metrics regularly to ensure accountability and continuous improvement
  • Maintain strong partnerships through clear communication, regular meetings, and collaborative engagement
4:50 pm – 5:35 pm PST

Panel Discussion

  • Laura Alquist

    SVP and Global Head, Technical Operations
    Kite Pharma

  • Maria Brown

    VP, Manufacturing Science and Technology
    Bristol Myers Squibb

  • Ben Beneski

    Chief Technology Officer
    Allogene Therapeutics

  • Andy Ramelmeier, Ph.D.

    Chief Technology Officer
    Adverum Biotechnologies, A wholly-owned subsidiary of Eli Lilly and Company.

  • Karin Ann Payne

    VP, Head of Regulatory Compliance
    Johnson & Johnson

From Innovation to Execution: Enabling Scalable Agile and Tech Forward Biomanufacturing

  • How are organizations aligning early stage innovation with long term manufacturing scalability
  • Balancing flexibility and standardization as the next generation of biomanufacturing infrastructure evolves
  • Integrating digital tools such as AI, digital twins, and MES for accelerated tech transfer and process optimization
  • The role of CDMO partnerships in ensuring agility and execution at scale
  • Addressing talent gaps by building digitally fluent cross functional teams to support modern biomanufacturing
  • Key risks and success factors when moving from clinical to commercial scale production in emerging modalities
5:40 pm – 5:50 pm PST

Chair's closing remarks

Manufacturing and Technology

Kara Renai King

VP, Platform Leader Americas and China and Head, Global Manufacturing Learning and Development
Zoetis

Quality and Compliance

Paul Houri

SVP and Chief Quality Officer
Bristol Myers Squibb

Supply Chain and Logistics

Laura Alquist

SVP and Global Head, Technical Operations
Kite Pharma

Cell and Gene Therapy

Blair McNeill, Ph.D.

SVP and Head, Cell Therapy
Sumitomo Pharma

5:55 pm – 6:55 pm PST

Networking drinks reception

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