ManuPharma 2019

03 - 04 December, 2019

Steigenberger Frankfurter Hof, Frankfurt

Contact Us: 44 (0) 207 036 1363

Agenda Day 1 - Wednesday 5th December 2018

8:00 am - 8:55 am Registration and Welcome Coffee

Driving Industry 4.0 in Pharma

8:55 am - 9:00 am Opening remarks – Will Robinson, ManuPharma Programme Director

9:00 am - 9:10 am Chair’s opening remarks

Dieter Peters, SVP Operations at Grünenthal

Dieter Peters

SVP Operations
Grünenthal

9:10 am - 9:30 am INSPIRATIONAL KEYNOTE– How to implement an Industry 4.0 project as part of your manufacturing strategy to improve site and network agility, reduce time to market and optimise manufacturing quality

• An strategic overview of how industry 4.0 technology is being used at a major
pharmaceutical producer
• How is this affecting the agility of the manufacturing operations?
• How do these technologies positively affect quality assurance?
• How is time to market reduced through technological implementation?
Miran Denac, VP Operations Western European at TEVA

Miran Denac

VP Operations Western European
TEVA

9:30 am - 9:50 am How can you best work with regulators and your suppliers to develop continuous manufacturing processes for both small molecule and biologics and ensure correct and compliant implementation?

• With expanding markets globally and rising price pressures, the bio- and pharma industry is looking
for flexibility, increase speed of development and cost reductions while improving quality.
• This is driving a continuous evolution towards new generation processes with key focus on
process intensification, single use and process analytics.
• This evolution is happening today and several case studies will be presented of how
intensified or continuous processes are enabled through different approaches.
• These case studies will demonstrate that next generation processes are being introduced
today and are continuously evolving
Willem Kools, VP Global Head of Technology Management at Merck AG

Willem Kools

VP Global Head of Technology Management
Merck AG

9:50 am - 10:10 am CASE STUDY - Beyond the Pilot - A perspective on how to scale up digital capabilities in pharma manufacturing

  • The digital transformation is well underway in most pharmaceutical companies with many insular pilots being run - but what is the value of all these initiatives as a whole?
  • This keynote lecture will look at how to move beyond pilots and scale up the digitalization efforts
  • Where should the focus be placed on and what needs to considered before investment?

Markus Hayek, Managing Director at Accenture Strategy

Markus Hayek

Managing Director
Accenture Strategy

10:10 am - 10:50 am KEYNOTE PANEL DISCUSSION – New investments: How should you decide where, when and how to invest in new technology for your infrastructure, sites and processes to maximise ROI?

• Considering need vs. cost, maturity of technology
• What are the cost vs. benefit implications of being an innovator, early adopter, fast follower,
or late adopter?
• Focus upon the infrastructure required for innovation
• Which sites should you invest in and where do you choose to focus investments?
Andrew Whytock, Head of Pharmaceutical Digitalisation & Innovation at Siemens

Andrew Whytock

Head of Pharmaceutical Digitalisation & Innovation
Siemens

Emre Ozcan, Director of Global Manufacturing and Supply Strategy at Merck AG

Emre Ozcan

Director of Global Manufacturing and Supply Strategy
Merck AG

Peter Van Brusselt, Senior Director Facilities EMEA at Johnson & Johnson

Peter Van Brusselt

Senior Director Facilities EMEA
Johnson & Johnson

Richard Middleton, Global Director, Large Engineering Projects at Catalent

Richard Middleton

Global Director, Large Engineering Projects
Catalent

10:50 am - 11:30 am Networking Break

Step Change in Technical Operations and Continuous Manufacturing

11:30 am - 11:50 am CASE STUDY - How new technological developments designed for intelligent manufacturing enable continuous process verification

• Specifying the use of foundational manufacturing analytics, CPV Stage 3 is not simply
monitoring production processes – it’s about improving them in real time
• This keynote case study will examine how a leading pharmaceutical company is leveraging
foundational Industry 4.0 manufacturing analytics approaches to deliver CPV Stage 3
• What is the return on investment being realised by this delivery?
Peter Guilfoyle, Vice President at Northwest Analytics

Peter Guilfoyle

Vice President
Northwest Analytics

11:50 am - 12:45 pm PANEL DISCUSSION – Collaborative CPV: How can you best collaborate with your CMOs and vendors during the development of your manufacturing strategy to ensure your CPV method is standardised and connected?

• Considerations around what other factors may be crucial to real time quality and compliance
assurance
• Does the combination of continuous manufacturing with continuous process verification
assure complete compliance or just improve it?
• What regulatory considerations should be taken into account when looking at CPV and
partner management?
Dr. Helge Berg, Director BioManufacturing Science Network Europe at Merck

Dr. Helge Berg

Director BioManufacturing Science Network Europe
Merck

Rudolf Haussmann, VP Technical Development and Operations at Santhera

Rudolf Haussmann

VP Technical Development and Operations
Santhera

Thomas Gübeli, Executive Director Global Internal Manufacturing Quality at Celgene

Thomas Gübeli

Executive Director Global Internal Manufacturing Quality
Celgene

12:45 pm - 1:05 pm CASE STUDY - How to improve batch execution with the latest automation technology

• Flexible batch manufacturing
• Skid based facilities
• Modern HMI supporting operator efficiency
• Data analytics – how to handle big data
• Data integration supporting faster batch release
Matthias Maaz, Director Life Sciences at Honeywell Process Solutions

Matthias Maaz

Director Life Sciences
Honeywell Process Solutions

1:05 pm - 1:35 pm OXFORD STYLE DEBATE – Technological level of advancement and compatibility should be the most important factor when determining CMO partners FOR AND AGAINST

• What are the key parameters for consideration and their respective importance?
• What methods of risk mitigation can be used in establishing a make or buy strategy?
• Is technology the number one most important factor in today’s manufacturing climate, when
choosing a CMO partner?
Dieter Peters, SVP Operations at Grünenthal

Dieter Peters

SVP Operations
Grünenthal

Stephen Closs, VP Global Technical Operations at Patheon

Stephen Closs

VP Global Technical Operations
Patheon

Thierry Cournez, Vice President E2E Processing Solutions at Merck

Thierry Cournez

Vice President E2E Processing Solutions
Merck

1:35 pm - 2:35 pm Networking Lunch

1:35 pm - 2:35 pm MASTERCLASS - Beyond the pilot - How to scale up digital holistically

Markus Hayek, Managing Director at Accenture Strategy

Markus Hayek

Managing Director
Accenture Strategy

Russell Rasmus, Managing Director at Accenture

Russell Rasmus

Managing Director
Accenture

TRACK A – Transforming Manufacturing Operations

2:35 pm - 2:40 pm Opening remarks from the chair
Dr. Helge Berg, Director BioManufacturing Science Network Europe at Merck

Dr. Helge Berg

Director BioManufacturing Science Network Europe
Merck

TRACK A – Transforming Manufacturing Operations

2:40 pm - 3:00 pm CASE STUDY– Why 'one size does not fit all' for tech transfer projects across different manufacturing sites and what key areas should be tailored to maximise success
• Why does a completely standardised
approach to technology transfer projects not
work across a range of manufacturing sites?
• What are the key elements that set
different products and sites apart and how
can you foresee these?
• What are the most effective manners of
modifying tech transfer strategies for
different sites to maximise the success of
these projects?
Heike Abeck, Director Manufacturing Sciences & Technology at Bayer

Heike Abeck

Director Manufacturing Sciences & Technology
Bayer

TRACK A – Transforming Manufacturing Operations

3:00 pm - 3:20 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
• 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?

Marcelo Costa, Global Head of FMD at STADA

Marcelo Costa

Global Head of FMD
STADA

TRACK A – Transforming Manufacturing Operations

3:20 pm - 4:00 pm CASE STUDY INTERACTIVE - What are the learnings and insights concerning the localization of pharmaceutical manufacturing and packaging in Russia
•What are the best ways in which to enter into and manage contract manufacturing partnerships, which de-risk your manufacturing network
•What effect can macro economic and geopolitical developments have upon these agreements, what risks can these play, and how can they be mitigated?
•Case study focusing upon Russian external manufacturing partnerships
•What other lessons can be learnt from the world’s largest pharma manufacturer around external manufacturing agreements and processes?

Jos Van Den Heuvel, Director External Manufacturing at Johnson & Johnson

Jos Van Den Heuvel

Director External Manufacturing
Johnson & Johnson

TRACK B – Next Level MES and Digitalisation

2:35 pm - 2:40 pm Opening remarks from the chair
Dieter Peters, SVP Operations at Grünenthal

Dieter Peters

SVP Operations
Grünenthal

TRACK B – Next Level MES and Digitalisation

2:40 pm - 3:00 pm Topic of presentation TBC – focus upon self driving manufacturing processes through technology
• Case study of the use of artificial
intelligence in the manufacturing
operations and end to end supply chain of
a major global pharma manufacturer
• Application at scale of innovative new
technology
• Lessons learnt from this new project and
extraction of best practice
• What difference has the technology
made to the manufacturing strategy and
capabilities of the company?
Sebastien Fournier, Global Head of Self-Driving Operations at Merck

Sebastien Fournier

Global Head of Self-Driving Operations
Merck

TRACK B – Next Level MES and Digitalisation

3:00 pm - 3:20 pm More confidence – less paper. How digitization of environmental monitoring on your manufacturing site helps you to make swift decisions and avoid loss of money
·          How to optimize the monitoring of environmental parameters in production
·          How to replace different systems in the same company with one single use system in place
·          Benefits for you as an audited company to have data from different sites available for a short term audit
·          Merging the monitoring from manufacturing over transport to storage – Total Cold Chain Control
Markus Haase, International Senior Pharma & Life Science Manager at Testo

Markus Haase

International Senior Pharma & Life Science Manager
Testo

TRACK B – Next Level MES and Digitalisation

3:20 pm - 3:40 pm CASE STUDY – How to unify multiple legacy digital systems, including ERP/MES/batch recording systems, to improve the compliance, quality and real time batch monitoring of your manufacturing process
•What are the best methods of unifying multiple disparate manufacturing info-tech systems
•What are the most common issues associated with the unification of multiple legacy systems and what are the best ways of overcoming them? 
•What are the positive effects of this unification upon quality, visibility an resultant compliance?

Domenico Aldi, Head of API Production at Abbvie

Domenico Aldi

Head of API Production
Abbvie

TRACK B – Next Level MES and Digitalisation

3:20 pm - 3:40 pm CASE STUDY – How to unify multiple legacy digital systems, including ERP/MES/batch recording systems, to improve the compliance, quality and real time batch monitoring of your manufacturing process
• What are the best methods of unifying
multiple disparate manufacturing info-tech
systems
• What are the most common issues
associated with the unification of multiple
legacy systems and what are the best ways
of overcoming them?
• What are the positive effects of this
unification upon quality, visibility an
resultant compliance?
Domenico Aldi, Head of API Production at Abbvie

Domenico Aldi

Head of API Production
Abbvie

TRACK B – Next Level MES and Digitalisation

3:20 pm - 4:00 pm CASE STUDY INTERACTIVE - How to apply digital intelligence in a biologics supply chain
•Outline of new MES developments within pharma manufacturing
•What are the capabilities of these developments and what are their transformative effects?
•What is the knock on effect of this technology’s implementation upon resource management including personnel, equipment and materials

David Twohig, Practice Lead - Global Consulting at ESP

David Twohig

Practice Lead - Global Consulting
ESP

Interactive Workshops

2:35 pm - 3:20 pm INTERACTIVE WORKSHOP - Why digitalization is the key to transforming development and manufacturing
• Exploring the modularisation of platforms
and process structure within continuous
processing.
• What does this standardisation mean, both
internally and with external partners?
• Interactive discussion designed to highlight
different approaches.
Guillaume Kerboul, Director of Life Sciences at Dassualt Systemes

Guillaume Kerboul

Director of Life Sciences
Dassualt Systemes

Interactive Workshops

3:20 pm - 4:00 pm PROCESS DEVELOPMENT WORKSHOP: How to industrialise continuous primary processing using modularised platforms and structure, factory integration and process co-development with partners
•How to industrialise continuous primary processing using modularised platforms and structure, factory integration and process co-development with partners
•Exploring the modularisation of platforms and process structure within continuous processing.
•What does this standardisation mean, both internally and with external partners?
•Interactive discussion designed to highlight different approaches. 

Gareth Alford, Lead Engineer Advanced Manufacturing Tech at GSK

Gareth Alford

Lead Engineer Advanced Manufacturing Tech
GSK

Anne Bard, Global Capital Strategy & Design Lead at GSK

Anne Bard

Global Capital Strategy & Design Lead
GSK

Creative Boardrooms

2:35 pm - 3:00 pm Transition time

Creative Boardrooms

3:00 pm - 3:40 pm How can you best formulate and execute manufacturing strategies specifically for specialised and personalised medicines
• A frank, open and highly interactive
discussion around manufacturing strategies
related to developing product portfolios
• How are new products affecting the
manufacturing execution strategies of
pharma companies of all sizes
• Come to this session with questions for
your peers and points for discussion
Bianca Matthee, VP Manufacturing & Pharmaceutics at ProQR Therapeutics

Bianca Matthee

VP Manufacturing & Pharmaceutics
ProQR Therapeutics

Creative Boardrooms

3:30 pm - 4:00 pm Data integrity assurance in pharmaceutical manufacturing for GMP compliance
•A closed door and wholly interactive discussion focused upon data and GMP related challneges in the industry
•Discover how your methods of data integrity assurance compare to those of your peers
•Come to this session with questions for your peers and points for discussion

Peter Iles-Smith, Head of Technical – Global Manufacturing and Supply IT at GSK

Peter Iles-Smith

Head of Technical – Global Manufacturing and Supply IT
GSK

4:00 pm - 4:40 pm Networking Break

Spearheading Cultural Change

4:40 pm - 5:00 pm CASE STUDY - How to implement standardisation both internally and in collaboration with your technology partners to develop more effective manufacturing processes

• 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

5:00 pm - 5:20 pm CASE STUDY – Creating a vision for holistic transformation: How to drive a step-by-step approach to resource investment in technology, culture-change and digitalisation readiness, to ensure your entire manufacturing network is prepared for transformation

• Overview of the merging of the traditional and research manufacturing units with generic
manufacturing to create a single ‘tech ops’ division
• What are the key challenges associated with strategising, introducing and implementing a
plan for an organisation of over 140,000 employees?
• Why is a step by step approach, creating a vision of the transformation and establishing
benchmarks to realise the plan, the best approach?
• Why is the approach applicable to producers of all sizes across the pharma industry?
• What are the benefits of focusing upon the champions of technology (the 20% of the
organisation) and implementing change through this empowered minority
Antonio Buendia, Head of Manufacturing Process Control at Novartis

Antonio Buendia

Head of Manufacturing Process Control
Novartis

5:20 pm - 5:30 pm Chair’s Closing Remarks

Dieter Peters, SVP Operations at Grünenthal

Dieter Peters

SVP Operations
Grünenthal

5:30 pm - 7:00 pm German Christmas Market Themed Networking Reception - Your opportunity to relax, discuss challenges, exchange ideas and make new contacts in an informal setting!