ManuPharma 2018

05 - 06 December, 2018

Steigenberger Frankfurter Hof, Frankfurt

Contact Us: 44 (0) 207 036 1363

Agenda Day 1 - Wednesday 5th December 2018

8:00 am - 8:50 am Registration and Welcome Coffee

Driving Industry 4.0 in Pharma

8:50 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 Grünenthal
img

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

Miran Denac - VP Operations Western European TEVA
• 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?
img

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?

Willem Kools - VP Global Head of Technology Management Merck AG
• 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
img

Willem Kools

VP Global Head of Technology Management
Merck AG

9:50 am - 10:10 am CASE STUDY - Industry X.0: How a blueprint for rapid and flexible technological adoption sets the framework to help pharma manufacturers thrive

Markus Hayek - Managing Director Accenture
• Introduction on Industry X.0 in pharma
• Case Study of process mining in pharma operations
• Strategic implications for digitalization in pharma
• Outlook on digitalization trends in pharma
img

Markus Hayek

Managing Director
Accenture

10:10 am - 10:50 am GUEST INSPIRATIONAL SPEAKER - How to influence others and build trust to bring about radical change within your organisation – what I learned working with David Beckham, The Ryder Cup and Formula 1

Doug Spence - Managing Partner Spence Associates
• A highly engaging and interactive session focused upon developing trust and improving
communication with your peers
• How can this improvement lead to radical change within your organisation
• What is your role in bringing about radical change and how can you improve your capacity to
be a fundamental change agent within your organisation?
img

Doug Spence

Managing Partner
Spence Associates

10:50 am - 11:30 am Networking Break

Advancing Continuous Manufacturing

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

Jim Petrusich - Vice President Northwest Analytics
• 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?
img

Jim Petrusich

Vice President
Northwest Analytics

11:50 am - 12:30 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?

Dr. Helge Berg - Director BioManufacturing Science Network Europe Merck Rudolf Haussmann - VP Technical Development and Operations Santhera Thomas Gübeli - Executive Director Global Internal Manufacturing Quality Celgene Albert Codony Ferre - Head of Manufacturing Science & Technology Sandoz
• 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?
img

Dr. Helge Berg

Director BioManufacturing Science Network Europe
Merck

img

Rudolf Haussmann

VP Technical Development and Operations
Santhera

img

Thomas Gübeli

Executive Director Global Internal Manufacturing Quality
Celgene

img

Albert Codony Ferre

Head of Manufacturing Science & Technology
Sandoz

12:30 pm - 12:45 pm CASE STUDY – How to implement new manufacturing technologies from pilot, through scale-up and to commercial use, in order to improve efficiency, agility and quality assurance

• Case study of Eli Lilly’s Kinsale site and technological advancements that have been put in
place at that site
• What do new technological advancement and improvements to site operations and capacity,
such as continuous manufacturing, mean for facilities planning
• Considering the human element and how to best engage your site workforce when
implementing new technologies for assured success

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

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

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

Sebastien Ribault - Senior Director Biotech Process Development and Manufacturing Merck Stephen Closs - VP Global Technical Operations Patheon
• 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?
img

Sebastien Ribault

Senior Director Biotech Process Development and Manufacturing
Merck

img

Stephen Closs

VP Global Technical Operations
Patheon

1:35 pm - 2:35 pm Networking Lunch

1:35 pm - 2:35 pm MASTERCLASS - How to use next generation analytical tools for process and quality improvement in pharma manufacturing

Markus Hayek - Managing Director Accenture
img

Markus Hayek

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 Merck
img

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
Heike Abeck - Director Manufacturing Sciences & Technology Bayer
• 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?
img

Heike Abeck

Director Manufacturing Sciences & Technology
Bayer

TRACK A – Transforming Manufacturing Operations

3:00 pm - 3:40 pm INNOVATION SPOTLIGHTS 3x 10 minute presentations, 10 minute Q&A
Cleanroom technology
Process development
Controlled environments
Contamination management industry 4.0 and operations technology

TRACK A – Transforming Manufacturing Operations

3:40 pm - 4:20 pm CASE STUDY INTERACTIVE - How to develop robust commercial manufacturing partnerships on a global scale in light of macro economic and geopolitical developments
Jos Van Den Heuvel - Director External Manufacturing Johnson & Johnson

img

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

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
Sebastien Fournier - Global Head of Self-Driving Operations Merck
• 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?
img

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
Markus Haase - International Senior Pharma & Life Science Manager Testo

img

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
Domenico Aldi - Head of API Production Abbvie
• 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?
img

Domenico Aldi

Head of API Production
Abbvie

TRACK B – Next Level MES and Digitalisation

3:40 pm - 4:20 pm CASE STUDY INTERACTIVE - How to apply digital intelligence in a biologics supply chain
David Twohig - Practice Lead - Global Consulting ESP
img

David Twohig

Practice Lead - Global Consulting
ESP

Interactive Workshops

2:35 pm - 3:20 pm INTERACTIVE WORKSHOP - The 'Age of Experience': How to streamline production operations to shorten time-to-market, minimise risk and sustain profitability
Guillaume Kerboul - Director of Life Sciences Dassualt Systemes
• 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
Dassualt Systemes

Interactive Workshops

3:20 pm - 4:20 pm KNOWLEDGE MANAGEMENT WORKSHOP - How to develop a roadmap of your products through data acquisition, integration and interpretation, QbD, CPV, document control and retention
David Long - Head of Pharma Centre of Expertise and Business Excellence UCB Biopharma
img

David Long

Head of Pharma Centre of Expertise and Business Excellence
UCB Biopharma

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
Bianca Matthee - VP Manufacturing & Pharmaceutics ProQR Therapeutics
• 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
img

Bianca Matthee

VP Manufacturing & Pharmaceutics
ProQR Therapeutics

Creative Boardrooms

3:40 pm - 4:20 pm Data integrity assurance in pharmaceutical manufacturing for GMP compliance
Peter Iles-Smith - Head of Technical – Global Manufacturing and Supply IT GSK
img

Peter Iles-Smith

Head of Technical – Global Manufacturing and Supply IT
GSK

4:20 pm - 4:40 pm Networking Break

Spearheading Cultural Change

5:00 pm - 5:20 pm CASE STUDY – How to use new approaches in the hiring and performance management of your manufacturing workforce, including gamification, to help achieve the technology, cultural and digital goals of your business

Barbara Sambuco - CEO Industrial Operations Italy BMS Davide Boccacci - HR Lead GPS Italy BMS
• Outline of the key steps taken by a leading pharmaceutical manufacturer in the hiring and
performance management of their workforce to help them in the development of the group
manufacturing strategy
• Looking at the gamification of functions within role versus resultant project success and
productivity
• Exploring the mapping out of the requirements of the organisation in the future,
manufacturing operations within this, and the evolution of the roles of your employees
within these operations.
• How do you align the mapped requirements of your organisation in the future with the
acquisition, training and development of your manufacturing workforce now?
img

Barbara Sambuco

CEO Industrial Operations Italy
BMS

img

Davide Boccacci

HR Lead GPS Italy
BMS

5:20 pm - 5:40 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

Antonio Buendia - Head of Manufacturing Process Control Novartis
• 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
img

Antonio Buendia

Head of Manufacturing Process Control
Novartis

• 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?
img

Andrew Whytock

Head of Pharmaceutical Digitalisation & Innovation
Siemens

img

Emre Ozcan

Director of Global Manufacturing and Supply Strategy
Merck AG

img

Peter Van Brusselt

Senior Director Facilities EMEA
Johnson & Johnson

img

Richard Middleton

Director, Central Engineering - Europe/Asia
Catalent

img

Eamon Judge

European Project Planning Leader
Lilly

6:15 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!