Moderator
Chief Operating Officer
Halozyme
Vice President, Cell Therapy Development and Operations
AstraZeneca
SVP, Head of Technical Operations
Halozyme
Site Head, VP Norwood Drug Substance Operations
Moderna
Vice President, Preclinical Manufacturing & Process Development
Regeneron Pharmaceuticals
Next-Gen Modalities Manufacturing: How organizations are overcoming challenges in cell, gene, and mRNA therapy production
Execution in Action: Real-world strategies for aligning Manufacturing, Quality, and Supply Chain to move therapies faster to patients
Operational Resilience: Lessons learned from recent global disruptions and how teams are building more robust systems
Scaling and Capability Building: Tackling both technical and organizational hurdles to expand capacity and deliver innovative medicines
Moderator
Chief Operating Officer
Halozyme
Executive Director, Product Stewardship Lead
AstraZeneca
VP, CGT & API Global Expansion Quality
Eli Lilly
SVP & Head of Global Biologics Operating Unit
Merck
VP, Global Quality
Otsuka Pharmaceuticals
Production & Operations: What are the key challenges affecting production speed, scalability, and operational efficiency today?
Workforce & Talent: With billions invested in manufacturing, how is the workforce evolving, and what strategies ensure facilities are properly staffed with trained talent?
Technology & Innovation: Which cutting-edge technologies are having the greatest impact on modern pharmaceutical manufacturing?
Regulatory Landscape: What recent regulatory advancements have been made, and how can approvals be further streamlined?
Global Access: How can the industry enhance access to innovative medicines across global markets while balancing speed, quality, and compliance?
Chief Operating Officer
Halozyme
Amgen
VP, Head of CMC Development and Regulatory for Biologics and ATMPs
Biogen
Senior Vice President, Global Quality
Gilead Sciences
Integrating quality early into process development and operations
Using data and insights to inform faster, smarter decisions
Shifting from reactive oversight to proactive, risk-driven quality management
Vice President, Small Molecule Science and Technology
Merck
Project Farma
SVP Manufacturing Excellence Success
MasterControl
Scale Ready LLC
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.
SVP, Americas Supply Operations
AstraZeneca
Exploring the operational shifts required to support direct-to-patient distribution channels in pharma
Evaluating regulatory challenges and compliance considerations unique to patient-centric supply models
Discussing how data transparency and cold chain management impact patient safety and product integrity
VP, Head of Sustainability and Technology, R&D
Takeda
Establishing a connected, structured product knowledge model from Discovery (TCP → TPP → QTPP) through submission, tech transfer, launch, post-approval lifecycle management, and retirement
Designing the digital and business architecture required to enable an end-to-end “living” product lifecycle spine
Enabling closed-loop, contextual, and fully traceable data flow across the value stream to reduce handoffs and rework
Driving improved submission and inspection transparency, faster tech transfer and time-to-market, and sustained lifecycle state-of-control
Senior Director, Quality Strategy & Operations
Alnylam
Executive Director, Product Development & Sustainability Lead
AstraZeneca
Vice President, CMC Regulatory Affairs
AstraZeneca
Site Quality Lead
Eli Lilly
VP, Chemistry
Eli Lilly and Company
Executive Director, Head of Quality Policy & Advocacy
Gilead
Sr Director, Advanced Therapies MSAT
Johnson & Johnson
Executive Site Director
Lonza
Sr. Director, DS Network Smart Factory Lead
Moderna
Senior Director, Manufacturing Sciences and Technology
Moderna
Senior Director, Biotech Production
Regeneron
Associate Vice President, Industrial Franchise Leader, Rare Disease
Sanofi
Senior VP, Global Head of CMC Development
Sanofi
Exploring the operational shifts required to support direct-to-patient distribution channels in pharma
Evaluating regulatory challenges and compliance considerations unique to patient-centric supply models
Discussing how data transparency and cold chain management impact patient safety and product integrity
Former Chief Quality Officer, Founder & CEO
Quality Business Administration
Honeywell Life Sciences
Boehringer Ingelheim
Boston Institute of Biotechnology, LLC
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.
Former Associate Commissioner | Principal, Quality and Compliance
FDA | Canal Row Advisors
Chief Operating Officer
Halozyme
Körber Pharma Software
Chief Operating Officer
Halozyme
Group Vice President, Global API & Dry Products Manufacturing
Eli Lilly
Exploring how Lilly’s rapid capacity expansion balances growth, reliability, and operational excellence across global manufacturing networks
Identifying advanced technologies, including large-scale single-use systems and digital tools, that drive modernization and efficiency
Highlighting real-world examples of integrating innovation, quality, and compliance to build resilient, future-ready production capabilities
Vice President Cell Therapy Technical Operations
Bristol Myers Squibb
Global Vice President, Quality, Regulatory and EH&S
Thermo Fisher Scientific
Why many quality agreements fail in practice — and how to make them effective.
Moving beyond compliance to true end-to-end collaboration.
SVP, Head of Product Development & Clinical Supply
Alexion Pharmaceuticals
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.
Executive Director, Quality
TR1X
Executive Director, CMC Regulatory Affairs
Gilead Sciences
VP, CGT & API Global Expansion Quality
Eli Lilly
Fabriq
Looking at the benefits of prioritizing R&D to develop GMP-ready technologies for biologics and cell & gene therapies.
Strategies to adopt advanced, cost-intensive equipment and processes.
Discussing opportunities to improve collaboration, data sharing, and process standardization across the industry.
Driving faster, more cost-efficient development through innovation and strategic investment.
Life Sciences Supply Chain & Operations, Americas Lead
Accenture
In this session we explore how discovery, development, quality, and manufacturing can operate as one connected lifecycle. Moving beyond siloed “futures,” this workshop examines how intelligent technologies enable seamless collaboration from lab to line—and back again—to accelerate delivery, scale innovation and drive competitive advantage.
Vice President, Technical Operations Science & Innovation
AstraZeneca
Executive Director, Intercompany Operations, (GLS) (GSC) (GPS)
Bristol Myers Squibb
Director, Enterprise Quality Training & Documentation
CSL (Seqirus)
Director of Quality Assurance
Eli Lilly and Company
Sr. Director, Corporate QA Audit Program and Inspection Management
Gilead
Director, Biotherapeutics Site & External Planning
Johnson & Johnson
Sr Director, Supplier & Vendor Quality
Johnson & Johnson
Sr. Director of DNA Operations & Manufacturing Support
Moderna
VP, Supply Chain
Moderna
Sr. Director Manufacturing Operations
Regenxbio
Global Head, CMC Product development and industrialization, mRNA Center of Excellence
Sanofi
Moderator
Chief Operating Officer
Halozyme
Senior Vice President Manufacturing Operations
Eli Lilly
Vice President, CMC
Replimune
VP, Head of Pharmaceutical Sciences Program Leadership
Takeda
Vice President and Site Head, Gene Therapy Manufacturing Facility
Ultragenyx Pharmaceuticals, Inc.
Chief Operating Officer
Halozyme
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