ManuPharma 2018

05 - 06 December, 2018

Steigenberger Frankfurter Hof, Frankfurt

Contact Us: 44 (0) 207 036 1363

Agenda Day 2 - Thursday 6th December 2018

Advanced Manufacturing Networks and Process Improvement

8:15 am - 8:55 am Networking Coffee

8:55 am - 9:00 am Chair’s opening remarks

Dieter Peters - SVP Operations Grünenthal
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Dieter Peters

SVP Operations
Grünenthal

9:00 am - 9:20 am KEYNOTE CASE STUDY - How to adapt your manufacturing operations to meet the rapidly changing supply chain requirements of personalised and stratified medicine products

Michael Schneider - Head of Strategy - Manufacturing Science & Technology Roche
• How are personalised medicines (e.g. cell gene therapies and specialist oncology products)
changing the end to the supply chain for pharmaceuticals producers?
• What does this mean for manufacturing operations’ place within the supply chain?
• How can manufacturing leaders work with the wider supply chain network of their
organisations to maximise readiness for this transformation?
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Michael Schneider

Head of Strategy - Manufacturing Science & Technology
Roche

• What are the most effective industry 4.0 examples available for real time monitoring of
manufacturing operations?
• Exploring best case examples of technological implementation and scale up
• What are the lessons learnt and best practice drawn from industry 4.0 tech scale up
operations?

Ulf Schrader

Principal Consultant
McKinsey

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Joseph Sendra

VP Manufacturing Engineering & Technology
Johnson & Johnson

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Patrick Hyett

Director IIM Digitisation Lab
GSK

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Björn Fischer

Head of Executive Management Support, Pharmaceuticals Product Supply
Bayer

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Pablo Gonzalez

Head of Strategy and Digital, Biopharma, Global Manufacturing & Supply
Merck

10:00 am - 10:20 am OUT OF INDUSTRY CASE STUDY - How draw lessons learnt from industry 4.0 application in automotive manufacture, for application in pharmaceuticals production

Christian Haupt - Director of Global Operations Grammer AG
• How to achieve productivity in the area of digitalization
• Conception of a Human-Robotics-Collaboration
• Defining the level of automatization needed
• Safety aspects and design of the working station
• Pulling together a roadmap for implementation

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Christian Haupt

Director of Global Operations
Grammer AG

10:20 am - 10:40 am CASE STUDY: How to enable digital transformation in pharmaceutical manufacturing using advanced technology used in the semi-conductor industry

Ashley Howard - EMEA and Global Strategy Manager Pharma Group Applied Materials
• Case study focusing upon the partnership between the world’s leading pharmaceutical
company
• Exploration of how artificially intelligent technologies, in combination with tech from the
semi-conductor industry were effectively implemented within the organisation
• Lessons learnt drawn from the project, the benefits to the organisation, and future
applicability across the industry
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Ashley Howard

EMEA and Global Strategy Manager Pharma Group
Applied Materials

10:40 am - 11:00 am CASE STUDY - How to implement standardisation both internally and in collaboration with your technology partners to develop more effective manufacturing processes

Josef Trapl - Global Head of Technology - Engineering and Manufacturing Takeda
• What are the benefits of the standardisation of processes within your manufacturing network
• What are the most effective methods of process standardisation across external
manufacturing partners as well as internal?
• Exploring key challenges faced in global process standardisation with regards to
manufacturing technology implementation
• Lessons learned and best practice extraction from these challenges

Josef Trapl

Global Head of Technology - Engineering and Manufacturing
Takeda

11:00 am - 11:30 am Networking break

Track A - Ecosystem and partnerships

11:30 am - 12:10 pm CASE STUDY INTERACTIVE - How to implement operational excellence principles in a range of pharma manufacturing sites and significantly save costs using a process of standardisation
Matthew Gill - Director Operations Excellence Abbvie
• What operational excellence principles can be universally
applied across a range of manufacturing sites
• How have the implementation of these principles led to
significant cost savings across a major manufacturer’s network?
• An interactive session where the audience have the
opportunity to discuss, benchmark, and expand upon key areas
of discussion and interest.
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Matthew Gill

Director Operations Excellence
Abbvie

The ‘Paperless Factory’
Josef Kriegmair, Smart Manufacturing Manager, MTU Aero Engines
Site prioritisation
Assuring end to end quality
Cinzia Marcon, Head of Quality Operations Italy, Pfizer
Continuous process verification
Artificial intelligence for self driving manufacturing
Pablo Gonzalez, Technology Business Partner Global Manufacturing, Merck
Lean manufacturing and six sigma
Marco Maioli, Industrial Operations Director, Sigma Tau

Josef Kriegmair

Representative Production Turbine Blade / Structure Castings
MTU Aero Engine

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Cinzia Marcon

Head of Quality Operations Italy
Pfizer

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Pablo Gonzalez

Head of Strategy and Digital, Biopharma, Global Manufacturing & Supply
Merck

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Marco Maioli

Industrial Operations Director
Sigma-Tau

MES & Infotech Interactive Workshops

11:30 am - 12:10 pm INTERACTIVE WORKSHOP – How to use best practice data analytics for predictive site maintenance to improve the stability of your production processes and CPV methods
Martin Fusek - Global Head of IT Testing Service Novartis
• What does best practise data analytics means for you?
• How does predictive maintenance work?
• Why and how this improves the stability of your production
process?
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Martin Fusek

Global Head of IT Testing Service
Novartis

MES & Infotech Interactive Workshops

12:10 pm - 1:00 pm CASE STUDY LED WORKSHOP – How to ensure best practice rollout of fully integrated MES systems and drive shorter implementation times on a global scale
• A highly interactive session, based upon a case study of a fully
integrated MES system rollout
• An opportunity to benchmark against peers, using an example
within industry for reference
• Leave with a greater understanding of how to shorten your
MES rollout implementation times

Manufacturing Leaders Boardroom

11:30 am - 1:00 pm A closed door invitation only boardroom style session reserved for Global Heads of Manufacturing, Global Heads of Tech Ops and SVP level representatives of pharma companies
Tilman Rock - Global Head of Pharma Manufacturing Roche
1. How can you improve your CMO and network management?
2. What are the key advanced manufacturing technologies you
should be investing in and why?
3. What are the latest GMP compliance challenges and how can
you best solve them?
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Tilman Rock

Global Head of Pharma Manufacturing
Roche

1:00 pm - 1:50 pm Networking lunch

1:00 pm - 1:50 pm MASTERCLASS 2

1:00 pm - 1:50 pm Manufacturing Leaders Invitation Only Luncheon

TRACK A - Changing Portfolios and Personalised Medicines

1:50 pm - 2:00 pm Chairman’s remarks
Dr. Helge Berg - Director BioManufacturing Science Network Europe Merck
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Dr. Helge Berg

Director BioManufacturing Science Network Europe
Merck

TRACK A - Changing Portfolios and Personalised Medicines

2:00 pm - 2:40 pm PANEL DISCUSSION - Change management: What key principles should you implement and how can you best influence your workforce to drive a large scale manufacturing transformation project?
Klaus Kunath - Head of Manufacturing Science & Technology, Global Pharma Operations, Merck Merck KGaA Edwin Stoel - Chief Operating Officer Bioforce AG
• An expansion on the change management discussions from
day one of ManuPharma
• What key principles can be universally extracted from a range
of change management projects
• Discussing real life examples of change management
programmes within pharma manufacturing and lessons learnt
across the board
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Klaus Kunath

Head of Manufacturing Science & Technology, Global Pharma Operations, Merck
Merck KGaA

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Edwin Stoel

Chief Operating Officer
Bioforce AG

TRACK A - Changing Portfolios and Personalised Medicines

2:40 pm - 3:20 pm CASE STUDY INTERACTIVE - How to manage design responsibility in the supply chain for combination product components; impact on quality controls and health authority audits for final fill, product assembly and packaging operations
Oliver Shergold - Global Head - Cominbation Products & Device Technology Novartis
• Case study of combination product manufacturing strategy at
one of the world’s largest pharma companies
• Where does design responsibilities sit and how can these be
best managed across the manufacturing network and end to
end supply chain?
• An interactive session where the audience have the
opportunity to discuss, benchmark, and expand upon key areas
of discussion and interest.
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Oliver Shergold

Global Head - Cominbation Products & Device Technology
Novartis

Data & Site Connectivity Workshops

1:50 pm - 2:40 pm PROCESS DEVELOPMENT WORKSHOP: How to industrialise continuous primary processing using modularised platforms and structure, factory integration and process co-development with partners
Gareth Alford - Lead Engineer Advanced Manufacturing Tech GSK Anne Bard - Global Capital Strategy & Design Lead GSK
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Gareth Alford

Lead Engineer Advanced Manufacturing Tech
GSK

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Anne Bard

Global Capital Strategy & Design Lead
GSK

Data & Site Connectivity Workshops

2:40 pm - 3:20 pm CASE STUDY INTERACTIVE - How to ensure standardisation and cost control of manufacturing operations during mergers and acquisitions activity
Marco Maioli - Industrial Operations Director Sigma-Tau
• How can M&A activity adversely affect standardisation of
processes and cost control measures?
• Outline of how, during a significant period of M&A activity,
Sigma Tau have unified manufacturing operations
• An interactive session where the audience have the
opportunity to discuss, benchmark, and expand upon key areas
of discussion and interest.
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Marco Maioli

Industrial Operations Director
Sigma-Tau

Creative Boardrooms

1:50 pm - 3:20 pm How to manage CMO partnerships in challenging geographical regions
• A highly interactive dicsussion focusing upon which
geograhical regions around the globe are the most difficult
when it comes to CMO management
• Why are these regions so difficult and how can these
challenges be best overcome by the industry as a whole
• Come to this session with your own questions and points for
discussion

3:20 pm - 3:50 pm Networking Break

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3:50 pm - 4:10 pm CASE STUDY - How to make critical assessment of CMOs and develop a matrix of action plans accordingly, in order to de-risk your manufacturing network in the context of EU FMD implementation
Marcelo Costa - Global Head of FMD STADA
• An in depth case study of CMO risk assessment and matrix creation in relevance specifically
to upcoming FMD implementation
• Key goals for the project and methods of attaining them
• How can the lessons learnt be applied to other external manufacturing agreements?
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Marcelo Costa

Global Head of FMD
STADA

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4:10 pm - 4:30 pm FIRESIDE CHAT – PAT and QbD: How can you use PAT, best practice tech transfer and QbD to ensure you meet the regulatory and business requirements for product release?
Heike Abeck - Director Manufacturing Sciences & Technology Bayer Cornelia Thieme - Director Global Manufacturing Science Europe Biogen
• An outline of current process analytical technologies (PAT) available to the industry and their
purposes
• How does PAT assist with the incorporation of design quality and QBD into the production
process
• Why is this process being seen as best practice by the regulatory bodies such as the FDA?
• How can PAT implementation lead to readiness for real time product release?
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Heike Abeck

Director Manufacturing Sciences & Technology
Bayer

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Cornelia Thieme

Director Global Manufacturing Science Europe
Biogen

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3:50 pm - 4:30 pm INTERACTIVE WORKSHOP – MES: How to develop a successful supplier management strategy to ensure your MES processes are compliant and cost-effective

4:30 pm - 5:00 pm End of conference