2nd PD2M Future Pharmaceutical Manufacturing Conference Technical Program

Schedule Time BST/IST (GMT+1:00)

Monday, May 17th, 2021: Pre-recorded Videos Released

Day 1 – Tuesday, May 18th, 2021

1:15 PM - 3:20 PM

Session 1: Modular Supply Including Supply Chain

Session Chairs: Andrew Rutter (Rutter Design), Marcus O'Mahony (PMTC/UL)

1:15 PM-1:20 PM

Invited Speaker: Jag Srai (Centre for International Manufacturing)

Supply Chain Economics and Future perspectives

Invited Speaker: Luke Rogers (On Demand Pharmaceuticals Inc)

From COVID to Canals: Cautionary tales of Centralized Pharmaceutical Manufacturing.

Invited Speaker: Patrick T. O’Sullivan and Olav Lyngberg (The Janssen Pharmaceutical Companies of Johnson & Johnson)

The Impact of Technology to a Manufacturing Supply Chain

Invited Speaker: Larry Lee (FDA)

FDA’s Journey in Advanced Manufacturing

3:30 PM - 5:45 PM

Session 2: Pharma 4.0 - Industry 4.0, AI, Digitisation of Therapeutic Manufacturing

Session Chairs: Stephen Goldrick (UCL), Barry Heavey (Accenture)

Invited Speaker: Stephen Goldrick (UCL)

The current and future digital trends within the biopharmaceutical sector

Invited Speaker: Mark Barrett (APC)

Digitization of CMC: The Future for Regulatory Submissions

Invited Speaker: David Lovett (Perceptive Engineering)

What is the vision for AI in pharmaceutical manufacturing?

Invited Speaker: Oisin Daly (HPRA)

Data analytics in pharmaceutical manufacturing – regulatory considerations

Day 2 – Wednesday, May 19th, 2021

Session 3: Future of Biopharmaceutical & Vaccine Manufacturing

Session Chairs: Ioscani Jimenez-del Val (UCD/SSPC), Chloe Coveney (BioMarin)

Invited Speaker: David Sullivan (Pfizer)

Supplying COVID 19 Vaccine at Unprecedented Pace and Scale

Invited Speaker: Massimo Morbidelli (ETH/Politecnico di Milano), Michael Sokolov (DataHow AG), Alessandro Butte (DataHow AG)

The potential of hybrid process modeling and digital twins to master the goals of industry 4.0 in bioprocessing

Invited Speaker: Jonathan Bones (NIBRT)

Online Mass Spectrometry for Monitoring Process Parameters and Product Quality Attributes

Invited Speaker: Steffen Gross (PEI)

A snapshot of current possibilities allowing flexible manufacturing – a regulators view

Session 4: Manufacturing and Supply of Advanced Therapeutic Medicinal Products (ATMP)

Session Chairs: Niall Barron (NIBRT/UCD), Mary Martin (Avectas)

Invited Speaker: Ilona Reischl (AGES/EMA CAT)

Regulatory Aspects of ATMPs

Invited Speaker: Mark Lowdell (UCL)

Current and near-future challenges in ATMP manufacture

Invited Speaker: Shirley O’ Dea (Avectas)

Non-viral engineering technologies for manufacture of next-generation cell therapies

Invited Speaker: Robert Baffi (Biomarin)

Challenges and Opportunities for Manufacturing Advanced Therapeutics

Panel Discussion and Q&A: Shirley O’ Dea (Avectas), Mark Lowdell (UCL), Robert Baffi (Biomarin), Niall Barron (NIBRT/UCD), Mary Martin (Avectas), Ilona Reischl (AGES/EMA CAT)

Day 3 – Thursday, May 20th, 2021

Session 5: New Technologies and Strategies in Pharmaceutical Development and Manufacturing

Session Chairs: Sharon Bourke (Lilly), Moiz Diwan (AbbVie)

Invited Speaker: Jason Hein (UBC)

The Next Evolution of Flexible Automation Through Machine Vision 

Invited Speaker: Moussa Boukerche (AbbVie)

Making Co-processed API using mesoporous carriers

Invited Speaker: Sarah Hudson, Steven Ferguson (SSPC)

Next generation manufacturing platforms for Synthetically derived APIs

Invited Speaker: Tom O'Connor (FDA)

Novel Characterization Methods to Support the Development and Manufacturing of Complex Product

Closing Remarks Conference Chair AICHE PD2M (Dr. Carla Luciani, Vertex)

Closing Remarks: Steven Ferguson (SSPC)

Networking Session (multiple break-out rooms)

1. "Hybrid Models and Digitalization for Everyone" [sponsored by Scale-up Systems] [Moderator: Steve Cropper, Scale-up Systems]

2. SSPC1

3. SSPC2