AGENDA AT A GLANCE

BioManufacturing

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
VIEW DAY 1
VIEW DAY 2

Day 1

17 February 2026

GO TO DAY 2

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

TBC

Ingo Gorr, Head of Therapeutics Virus Development, Boehringer Ingelheim

14:20

Case Study: Supply Chain Diversification Implementation

14:45

Networking Break

15:30

Roundtable Discussions: Process Intensification & Energy Optimisation

  • Analytical advances in manufacturing
Mark Hilliard, Principal Scientist MSAT, Pfizer, Ireland
  • Next-Gen Biomanufacturing: Implementing Process Intensification to Boost Yields and Reduce Timelines
  • Securing the Supply: Optimising Raw Material Sourcing and Vendor Partnerships in Biopharma
  • Strategies to Reduce Energy Costs Without Compromising GMP Quality
Daniel Walsh, Energy Engineer, Astellas Pharma, Ireland
  • TBC
Warren Roche, Senior Statistical Expert, Sanofi, 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
  • Lessons Learned from Deploying AI Tools in Regulated Settings: Change Management, Training, and Cross-Functional Collaboration
Alette Ramos Hunt, Global Director, Digital Innovation and AI, Global Drug Development, Novartis, Ireland

16:30

Key Takeaways

16:45

END OF DAY 1

Want to Speak at This Event?

Join the roster of esteemed colleagues to discuss what you or your company are bringing to the biopharmaceutical industry.

Apply to Speak

Day 2

18 February 2026

GO TO DAY 1

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

11:30

Extractables and Leachable: Management Strategies

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 Farra, CSO, Vazarii and 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

15:05

Closing Panel Discussion

15:50

Chairman's Closing Remarks

16:00

END OF CONFERENCE

Get Your Ticket
View the 2025 Post-Event Report