Conference Schedule

Monday, 30 September 2013

08.45 – 09.00 Introduction
Honorary Chair: Gert Mølgaard
Vice President (VP), Strategy Development
NNE Pharmaplan, Past Chair for ISPE, Denmark
Chair: Thomas Zimmer, Former SVP EHS & Sustainability of Boehringer Ingelheim, CEO of ZS.CTIS Consulting GmbH, Germany
Co-chair: Robert J E Bowen, Director, Facilities Integration Ltd, UK
09.00 – 09.40 The Road Ahead... Trends, Implications and Strategy for Pharma Manufacturing and Supply Organisations
Louis Schmukler, President, Global Manufacturing and Supply, Bristol-Myers Squibb, USA
09.40 – 10.20 Responsiveness of Facilities How to Create More Agility?
Dr. Gabriele Schönberger, Director, Boehringer Ingelheim, Germany
10.20 – 10.50 Networking Break
10.50 – 11.30 New EMA Drafts: GMP Guideline Chapters 3 and 5 Guideline on Setting Health-Based Exposure Limits
Dr. Andreas Flückiger, Chief Occupational Health Officer, F.Hoffmann-La Roche Ltd, Switzerland
11.30 – 12.00 Panel Discussion
Moderated session with the keynote speakers + Q&A
12.00 – 13.00 Lunch
Breakout Sessions
Track Leader: Chris Mullen
Plants and Facilities
Track Leader: Jean-François Duliere
IT and Automation
Track Leader: Chris Reid
13.00 – 13.40

What are the Challenges of Operating Flexible and Shared Production Plant?

Chris Mullen, Head of Operations, Fujifilm Diosynth Biotechnologies, UK

How do Microreactors and Continuous Processes Impact Facility Design?

Patrice Coumet, Senior Pharmaceutical Engineering and GXP Compliance Expert, Technip Life Sciences, France
Marc Bertrand, Department Manager - Life Sciences Engineering, Technip Life Sciences, France

Establishing Automation Strategies for Flexible Facilities

Peter Iles-Smith, Manufacturing IT Technical Director - Global Manufacturing & Supply IT, GSK, UK

13.40 – 14.20

Cleaning Standards in Multi-Product Facilities

Dr. Andreas Flueckiger, Chief Occupational Health Officer, F.Hoffmann-La Roche Ltd, Switzerland

How to Increase the Flexibility by Standardisation for Vaccine Facility Design (Case Study)

Klaus Hermansen, Senior Technology Partner, Vaccines, NNE Pharmaplan, Denmark


Benefits and Challenges when Moving from a Batch Process to Continuous

Ivo Backx, Business Development solutions for Life Sciences Industries, Siemens AG, Belgium

14.20 – 15.00

Manufacture of Biological Investigational Medicinal Products in Multi-Product Facilities. Potency Toxicity and Banding

Colin Gall, Fujifilm Diosynth Biotechnologies, UK

Planning the Optimal Pharma-Production Facility Using Software Tools

Ingrid Hutter, Scientific Professional, Pixon, Switzerland


Establishing Environmental Controls in Shared/Flexible Facilities

Trevor Swift,  Director of Operations, Life Science Advanced Solutions, Global Workplace Solutions, UK

15.00 – 15.30 Networking Break
15.30 – 16.10

Filling Systems for the Future

Klaus Ullherr, Packaging Technology, Product Manager, Robert Bosch GmbH, Germany
Isabelle Uettwiller, Head of Validation Lab, Sartorius Stedim Biotech, France

Key Topics in Sustainable Environmental Control and HVAC (Addressing Air Exchange Rates, Filtration and Cross-Contamination Control)

Maintaining Compliance with a Flexible

Chris Morse, Product Manager, Honeywell Process Solutions, UK

16.10 – 16.50

Review of R.A.B.S. and Isolators and Assessment of Benefits and Risks

Niall O'Meara, Director of Manufacturing, Amgen, Ireland

Disposable-Stainless Steel Hybrid Facilities 
Challenges, Risks and Gains for Bioprocess Development and Production

Joachim Baer, Associate Director of Upstream Manufacturing Sciences, Boehringer Ingelheim GmbH Biopharmaceutical Operations, Germany

Facilitating Flexible Manufacturing through IT Data Standards

David Stokes, Consultant, Percipient, UK
Yves Samson, Director, Kereon AG, Switzerland

16.50 – 17.30 Buffer and Media Preparation for New and Expanding Facilities

Adam Sokolnicki,  Biomanufacturing Engineer,  EMD Millipore, USA

Economic Risk Minimisation of Single Use Cell Culture - Scale Up vs. Scale Out

Miriam Monge,  Vice President Sales & Marketing, Biopharm Services Ltd, France

17.30 – 18.30 Networking Drinks
19.00 – 22.00 Networking Dinner

Tuesday, 1 October 2013

Breakout Sessions
Track Leader: Chris Mullen
Plants and Facilities
Track Leader: Jean-François Duliere
IT and Automation
Track Leader: Chris Reid
08.30 – 09.10

Ballroom Concept

Julian Wilkins, Founder and Vice President, PharmaConsult Us Inc., USA

New Strategies for Aseptic Filling for Emerging Markets

Benoît Verjans, Scientific Advisor, Aseptic Technologies, Belgium
Lilja Jan, Director Commercial Management, Key Plants, Sweden
The Impact of Evolving Serialisation Requirements on the Broader Pharmaceutical Industry

Liam O'Riordan, Serialisation Director, ESP, Ireland
09.10 – 09.50 ConsiGma™, the Continuous Manufacturing Platform for Flexible Pharmaceutical Solid Dosage Production

Kris Schoeters,  Product Manager Continuous Processing,  GEA Pharma Systems, Belgium

Modular Plant Design - Cheaper and More Efficient?

Robert Dream, Principal, HDR COMPANY LLC, USA

Integrated PAT Data Management as a Key Enabler for Continuous Manufacturing in Life Sciences

Jan Verelst, Business Development Manager SIPAT / PAT-QbD / Pharma / Life Sciences, Siemens, Belgium

09.50 – 10.20 Networking Break
10.20 – 11.00

Continuous Flow Reactors: An Opportunity for the Development of Flexible and Sustainable Production Processes

Dr Charlotte Wiles,  Chief Technology Officer , Chemtrix, UK


Transforming the Sourcing Biologics

Bart van Praag,  CEO, Dove Tail Integrated Systems, Netherlands

Implementation of Quality by Design Using MES

Philip Rees MSc, Senior Manager, Aston Life Sciences, Switzerland


11.00 – 11.40 Outsourcing Breakdown of Responsibilities between Contractor and Contract Giver

Dr. Andreas Rothmund,  Qualified Person, Vetter Pharma-Fertigung GmbH & Co. KG, Germany

Sustainability and Resource Efficiency of the Flexible Facility

Kia Salin,  Environmental Strategist, Swedish Medical Products Agency, Sweden

Validation through Industrial Virtualisation

Philippe Baron, adn Europe
11.40 – 12.20 Continuous Processing in Biotech Production: An Alternative to a Modern Single Use, Batch, Facility?

Thomas Daszkowski, VP Process Development and Optimisation,  Bayer Technology Services

How to Design and Size Equipment to Implement Lean Production Organisation

Robert J E Bowen, Director, Facilities Integration Ltd, UK

Model-Based Design and Simulation Tool Demonstration

Damien Marchand, Technical Sales Specialist, Dassault Systèmes, France
12.40 – 13.20

Update of the EMA Workshop on Dedicated Facilities

Stephanie Wilkins, PE, Owner, PharmaConsult US, Inc, USA

13.20 – 14.20 Lunch
14.20 – 15.40

Demonstrator Workshops

Richard Denk, Hecht Technologie GmbH, Germany
Dr Rob Lammens, Consultant, University of Bonn, Germany
Stephen Boswell, Director S3 Process Limited GEA, UK
Hartmut vom Bay,Vice President Gerteis, Switzerland
Jean-Pascal Zambaux, Président, Disposable-Lab SAS, France

15.40– 16.20 Quality Assurance Agreements    
– Challenges for the Development, Manufacture, Testing, Storage and Distribution of Intermediates, Active Pharmaceutical Ingredients and Investigational Products

Barry Oliver, Head of Quality, Commercial Business, Fujifilm Diosynth Biotechnologies, UK

What Challenges Regulatory Requirements Set from Plant and Facility Design Perspective? Impact of New Chapters 3-5 and Toolkit for Toxicology

Peter Marshall, Principal Technology Engineer, AstraZeneca, UK

Paperless Lab to Support Quality by Design (QbD) Initiatives

Peter Boogaard, Founder, Industrial Lab Automation, Netherlands
16.20 – 16.50 Networking Break
16.50 – 17.20

Wrap-Up: How Easy it is to Move from Down-Scale to Up-Scale Process with Flexible Manufacturing?

Chris Mullen, Head of Operations, Fujifilm Diosynth Biotechnologies, UK
Jean-François Duliere, Pharmaceutical Process Technologist, Technip Life Sciences, France
Chris Reid, Owner, Integrity Solutions Ltd, UK

17.20 – 17.50

Flexible Manufacturing A Way Forward?

Thomas Zimmer, Senior Vice President, Boehringer Ingelheim GmbH, Germany

17.50 Conference Adjourns

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