Day Two - Wednesday 4th December, 2024 - GMT (Greenwich Mean Time, GMTZ)
- Tiffany Rau - Adjunct Professor of Biochemistry & Cell Biology | Owner & Principal Consultant, University College Cork | Rau Consulting USA | Bio Pharma Technical Consulting IRE
Analyse CDMO partnership success factors. Evaluate outsourcing benefits versus in-house capabilities. Ensure scalability, consistency, and data security in CDMO collaborations. Provide access to GMP facilities for smaller companies.
- Connie Leach - Global Director Quality, Compliance & Regulatory Services, CAI, Ireland
- Rachel Harte - Associate Director Regulatory Affairs, CAI, Ireland
Jazz Pharmaceuticals employ a risk based approach to new vendor onboarding – a technical deep dive to evaluate capabilities, identify risks and opportunities and establish mitigation / improvement plans, with a cross functional team across MS&T, QC / Analytical, Facilities and Utilities Eng and Process development.
- Derek Lonergan - Director, New Product Integration MS&T, Jazz Pharmaceuticals, Ireland
Explore cloud MES benefits and challenges. Evaluate vendor offerings. Consider MES-specific cloud requirements. Anticipate future trends.
- Brian Reynolds - Digital Manufacturing Lead, Johnson & Johnson, Ireland
Enhance Ireland's CGT profile through effective marketing. Leverage Irish location for CGT advantages.
- Frank Barry - Professor of Cellular Therapy, National University of Ireland Galway and Principle Investigator, Regenerative Medicine Institute (REMEDI), Ireland
- Tiffany Rau - Adjunct Professor of Biochemistry & Cell Biology | Owner & Principal Consultant, University College Cork | Rau Consulting USA | Bio Pharma Technical Consulting IRE
Developing a skilled workforce, expanding talent pools, and leveraging government support for education are crucial to meet biomanufacturing demands.
- Shada Warreth - Global Partnerships Implementation Senior Manager, TU Dublin, NIBRT, Ireland
- Brian O'Connor - Vice President, Global Quality, Orchard Therapeutics, Ireland
- Sidney Reid - Chief Operations Officer, CASTL, Canada
- Overview of Galapagos and our innovative decentralized T cell therapy manufacturing platform and clinical programs
- Key elements enabling scalable and consistent decentralized production at global scale
- Real world experience with a decentralized CAR-T manufacturing platform supporting Phase I/II clinical trials at the point-of-care in EU
- Ruiz Astigarraga - Head of Manufacturing - Cell Therapy, Galapagos
- Lee Buckler - Senior VP of Advanced Therapies, BCA Advanced Therapies Network
- Panellists’ experiences and expertise in the space.
- Reimbursement & Market access considerations.
- How can we create links between academia, SMEs and pharma?
- Current funding landscape: VC, Angel, Grants, etc.
- Innovative funding mechanisms to balance risk and reward for investors and developers.
- Recovering from the Covid Bubble bursting
- Ensuring equitable access to advanced therapies across different economic landscapes.
- Impact of new EU Pharmaceutical Legislation – Intellectual Property Rights: How will this affect Biopharma?
- Rory Mullen - Head of BioPharma and Food, IDA Ireland, Ireland
- Eimear O'Leary - Director of Communications and Advocacy, Irish Pharmaceutical Healthcare Association, Ireland
- Eric Halioua - President & Chief Executive Officer, PDC*line Pharma
- Dr Hiro Usuda - Scouting & Transaction Lead, Business Development, Astellas Innovation Management LLC