AGENDA AT A GLANCE

DAY 1	DAY 2
Plenary Session	Biological Stability and Analytical Excellence
Upstream Process Optimisation	Expert Risk Management & Single-Use Economics
Process Innovation in Manufacturing Operations	CGT Manufacturing Case Studies
Roundtables: Process Intensification & Energy Optimisation	Bioprocessing Success Stories from Ireland
Drink Reception	End of Conference

Day 1

17 February 2026

8:30

Registration & Coffee

8:55

Chairman’s Welcome Note

Stephen Sullivan | Founder & Managing Director, Lindville Bio, UK

9:00

Opening Keynote: Ireland's Biologics Manufacturing Excellence

Cian O'Brien | Site Head, Sanofi, Ireland

9:25

Insights to Impact: Transforming Bioprocesses

Chloe Lang | Manager of Global Data Science, Sartorius, Sweden

9:50

Panel Discussion: Challenges and opportunities in integrating environmental sustainability in operations

Addressing operational sustainability challenges
Identifying opportunities for greener processes
Balancing efficiency with environmental impact

Moderator:

Timmy Carey | Director of Global Environmental Sustainability, Biomarin, Ireland

Panellists:

Bryan Mulchinock, Head of EHS, Alexion Pharmaceuticals, Inc., Ireland

Daniel Walsh, Energy Engineer, Astellas Pharma, Ireland

Darryl Ratty, Executive Director Global ESG, SK Pharmteco, Ireland

10:20

Networking Break

Upstream Process Optimisation

11:00

How to Make the Golden Batch: From Machine Learning to Agentic

Machine learning for process optimisation
Agent-based approaches for smarter control
Achieving consistent “golden batch” production

Will Fahey | Director Data Science, Pfizer, Ireland

11:25

From Variability to Reliability: Customised Raw Material Solutions for Biomanufacturing Excellence

Leonie Leinenbach | Technical Service Manager, BASF Pharma Solutions, Germany

11:50

Optical Methods for Monitoring Bioprocesses

Real-time monitoring with optical sensors
Tracking critical process parameters
Enhancing control and reproducibility

Michael Butler, Principal Investigator in Cell Technology, NIBRT, Ireland

12:15

Lunch Break

Process Innovation in Manufacturing Operations

13:55

From Discovery to Delivery: Standardized Oncolytic Virus Manufacturing

Ingo Gorr, Head of Therapeutics Virus Development, Boehringer Ingelheim

14:20

Supplier Management from a Quality Perspective

Gillian Fitzpatrick, Director - QA Operations, MSD, Ireland

14:45

Networking Break

15:30

Roundtable Discussions: Process Intensification & Energy Optimisation

Analytical Advances in Manufacturing

Mark Hilliard, Principal Scientist MSAT, Pfizer, Ireland

The Future of Technological Teams: Human Expertise vs. AI Skills

Adi Valdfogel, Senior Manager, Manufacturing Sciences, Analytical Technologies (MSAT), Chiesi Group, Israel

Strategies to Reduce Energy Costs Without Compromising GMP Quality

Daniel Walsh, Energy Engineer, Astellas Pharma, Ireland

Navigating the Evolving Regulatory Landscape: What’s Shifting and How Strategies Adapt

Declan Lowney, Director, Stability Sciences, BioTherapeutics Development Analytical Development, J&J, Ireland

From Prepared to Proactive: Redefining Inspection Readiness for Modern Biomanufacturing

Shada Warreth, Global Partnerships Implementation Senior Manager, NIBRT, Ireland

16:30

Key Takeaways

16:45

Drink Reception & End of Day 1

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Day 2

18 February 2026

8:30

Registration & Coffee

8:55

Chairman’s Welcome Note

Stephen Sullivan | Founder & Managing Director, Lindville Bio, UK

Biological Stability and Analytical Excellence

9:00

Stability considerations for the development of protein therapeutics

Protein chemical and physical stability
Formulation and storage strategies
Ensuring efficacy and regulatory compliance

Declan Lowney, Director, Stability Sciences, BioTherapeutics Development Analytical Development, J&J, Ireland

9:25

Service Provider - Potency Assay Technical Transfer Best Practice

Heather Malicki, Head of Analytical Sciences, Minaris, USA

9:50

Predicting Stability of Biologics and Vaccines

Predicting biologics and vaccine stability
Identifying degradation and risk factors
Optimizing formulation and storage

Warren Roche, Senior Statistical Expert, Sanofi, Ireland

10:15

Networking Break

Expert Risk Management & Single-Use Economics

10:45

Panel Discussion: Single-Use Technology: Implementation in Biologics -

Resiliency, Supply, Adoption & Platform
Pro's and Con’s of Stainless Steel

Moderator:

Miriam O'Sullivan | Executive Director Plant Manager, Amgen, Ireland

Panelist:

Mark Hilliard, Principal Scientist MSAT, Pfizer, Ireland

Kacey Fetcho-Phillips | AVP Site Head, MSD Ireland

Naresh Babu Sama, Director | Tech transfers and Process Validation, Wuxi Biologics, Ireland

Michael Inglis | Head of Manufacturing Sciences, Analytical Technologies, Chiesi Farmaceutici Global Rare Disease, Ireland

11:30

From Tech Transfer to Commercial Success

Naresh Babu Sama, Director | Tech transfers and Process Validation, Wuxi Biologics Ireland

11:55

Lunch Break

CGT Manufacturing Case Studies

13:15

Designing Ocular AAV Gene Therapies with Manufacture in Mind

Designing ocular AAV gene therapies
Manufacturing for scalability and quality
Balancing efficacy with production efficiency

Gwyneth Jane Farrar, Professor, Trinity College Dublin, Ireland

13:40

Guidance on Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products

Managing manufacturing changes in CGT
Ensuring comparability and product quality
Regulatory and risk-based strategies

Baerbel Grossmann | Associate Director Global Regulatory Affairs CMC Biologics, Sanofi Germany

14:05

Networking Break

Bioprocessing Success Stories from Ireland

14:45

Critical Quality Attributes for "Clinical-Grade" Induced Pluripotent Stem Cells

Stephen Sullivan | Founder & Managing Director, Lindville Bio, UK

15:10

Chairman's Closing Remarks

15:20

END OF CONFERENCE

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