ManuPharma 2017

December 06-December 07, 2017

Steigenberger Frankfurter Hof, Frankfurt

Contact Us: 44 (0) 207 036 1363

Day 2 - Thursday 7th December 2017

Industry 4.0 and Smart Manufacturing

9:00 AM - 9:10 AM Opening remarks – Will Robinson, Programme Director, WBR

9:10 AM - 9:20 AM Chair’s opening address and networking activity

Magda Papadaki, Head of Manufacturing Innovation, ABPI

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Magda Papadaki

Head of Manufacturing Innovation
ABPI

9:20 AM - 9:40 AM OPENING KEYNOTE Advanced data analytics: How to collect and analyse data across your manufacturing sites, and ensure timely data integration for smart decision making to increase your speed to market

Silke Gotthardt, VP Launch Transfer Operations, Boehringer Ingelheim Ulla Hutzler-Gardt, Executive Director - Head of IS Business Partnering , Boehringer-Ingelheim
· How can you connect and communicate effectively across manufacturing and IT teams?
· How can you work with CMOs to exchange information and create a fully visible data collection and analytics process?
· How can you ensure data integrity across your internal and external manufacturing sites
· How to use data analytics to gain useful insight and outcomes from your data collection?
· How can you use the ‘power of data’ to improve your pharmaceutical manufacturing process?
· How can you use predictive analytics to improve your process and manage risk?
· How can you effectively assess the software you have in place to handle the data?
· How to source and choose the right vendors to help with data analysis

Dr. Silke Gotthardt currently works as VP of Launch and Transfer Operation for Boehringer Ingelheim, where she is the central connecting point within the deveopment organisation. She is also the key point of contact for Boehringer Ingelheim's global network of sites, managing both internal site operations and external CMO activity.

Ulla is currently leading the IT operations quality group at Boehringer Engleheim, consisting of 30 personnel spread across the USA, Europe, China and Japan. Within this role she is currently spearheading a global data trending project, working closely with quality assurance processes for the group. Additional focuses include outage management, lab info systems and HSE, all within the contect of operational support for the company.

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Silke Gotthardt

VP Launch Transfer Operations
Boehringer Ingelheim

Ulla Hutzler-Gardt

Executive Director - Head of IS Business Partnering
Boehringer-Ingelheim

9:40 AM - 10:00 AM KEYNOTE Case Study - Augmented Reality @ work. How to create a smart manufacturing application to improve performance, quality and ROI and facilitate important culture change

Dirk Schrader, EVP - Head of Technical Operations, Vifor Pharma
· What are the possibilities of using augmented reality and simulation to implement predictive maintenance?
· How can you ensure your data is accurate to be used within the process?
· What are the main areas this new technology can be best integrated within your process?
· How can training and development compliment the adoption of this new technology?
· How can you make the business case for investment in these forms of technology?
· How close are we to adopting this new technology?

Dirk leads TechOps for the third biggest and fastest growing pharmaceutical company in Switzerland. Vifor Pharma has five manufacturing sites and about 700 people in Tech Ops. Dirk joined Vifor Pharma in 2012, coming from Astra Zeneca where he lead the Asia Pacific/Japan Manufacturing & Supply and their global Lean & Operational Excellence Program. Prior to that he was with Bristol Myers-Squibb and Bayer HealthCare. He will introduce a real “smart manufacturing” application for which Vifor Pharma is the global pilot. Using Augmented Reality technology, the system developed by Goodly Innovations helps Vifor Pharma to significantly reduce set up and change-over times and more…

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Dirk Schrader

EVP - Head of Technical Operations
Vifor Pharma

10:00 AM - 10:40 AM ALL STAR PANEL Industry 4.0, IIoT, cloud systems and connected sites: What does it mean for the pharma industry what do you need to know to remain competitive?

Magda Papadaki, Head of Manufacturing Innovation, ABPI Andy Jones, Head of Manufacturing Science and Technology , AstraZeneca Roman Necina, VP Process Science & Technical Services, Shire Dirk Schrader, EVP - Head of Technical Operations, Vifor Pharma
· What does Industry 4.0 really mean for pharma?
· What are the examples of Industry 4.0 projects that have already been implemented?
· How can you implement a strategy to connect your sites through the exchanging data and ‘Industrial Internet of Things’?
· To what extent will the ‘Industrial Internet of Things’ meet the regulatory requirements for data integrity?
· How can you prioritise what data to collect, and how can it be stored and used?
· How can you use cloud storage to collect and handle large volumes of data?

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Magda Papadaki

Head of Manufacturing Innovation
ABPI
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Andy Jones

Head of Manufacturing Science and Technology
AstraZeneca
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Roman Necina

VP Process Science & Technical Services
Shire
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Dirk Schrader

EVP - Head of Technical Operations
Vifor Pharma

10:40 AM - 11:00 AM OUR STORY How can you ensure flexibility and agility in the transfer and scale-up of launch products to increase speed to market?

Rudolf Hausmann, VP Technical Development & Operations, Santhera Pharmaceuticals Ltd
· How can you ensure your manufacturing scale-up processes are as flexible and agile as possible?
· How can you ensure your manufacturing strategy will support strategic business requirements ?
· How to set up an effective partnership with the R&D, operations and commercial teams
· How can you communicate effectively with the R&D and commercial teams to ensure the product reaches the market as quickly as possible?

Rudolf has over ten years experience in Big Pharma and more than eight years in Small Biotech, with strong expertise in pharmaceutical production, development & project leadership as well as CMO management and alliance management. At Santhera he is responsible for all chemical, pharmaceutical and analytical R&D, packaging, TRA, quality assurance and commercial supply, as well as key responsibility for technical development and operational strategy and budget for the entire organisation.

Rudolf Hausmann

VP Technical Development & Operations
Santhera Pharmaceuticals Ltd

11:00 AM - 11:40 AM Morning Networking Break

11:00 AM - 11:40 AM MASTERCLASS 2

New Frontiers in Global Operational Excellence

11:40 AM - 12:00 PM OUR STORY How to develop an agile and flexible manufacturing strategy that manages the complexity of higher value smaller volume products

Brian Boland, Manufacturing Technology Director, Bristol Myers Squibb
· How can you plan to repurpose your strategy to ensure increased flexibility for smaller-size batches?
· How can you implement process control and monitoring on a small scale?
· How can you work with your distribution and commercial team to coordinate your manufacturing process to meet patient requirements?
· How can you adapt your MES process to meet the needs of small-scale personalised medicines manufacturing?
· To what extent can you prepare for providing manufacturing kits within pharmacies themselves?

Brian is accountable for the Manufacturing Technology Function, in the BMS External Manufacturing organisation, which is responsible for Process Development/Technical Transfer and Robustness Assessment and Improvement and Project Management, as well Technical Support for all materials sourced from external suppliers. The External Manufacturing organisation manages supply of materials (Actives/Intermediates/Regulatory Starting Materials/Drug Product and Primary and Secondary Packaging, including Labelling and Artwork Management) from over 100 Contract Manufacturing Organisations

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Brian Boland

Manufacturing Technology Director
Bristol Myers Squibb

12:00 PM - 12:20 PM Automation developments to meet pharmaceutical plant requirements of the future

Matthias Maaz , Director Life Sciences, Honeywell Process Solutions

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Matthias Maaz

Director Life Sciences
Honeywell Process Solutions

12:20 PM - 12:30 PM OUR STORY: How improving people, process and workflow can lead to optimised manufacturing operations

Stephane De Saint Jean, Director of Industrial Operations , BioMerieux
In his current role Stephane heads industrial operations for eight manufacturing sites across France, Italy and Spain, with responsibility for annual OPEX of €165m, CAPEX of €35m and over 1800 employees. He has 20 years of experience in different industrial environments, with strong knowledge in manufacturing operations, culture and strategy, and a focus upon autonomous team development and motivation management. Further areas of expertise include process and equipment capabilities improvement and product flow reliability including agility deployment.

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Stephane De Saint Jean

Director of Industrial Operations
BioMerieux
1. Data Analytics
Michael De Poortere, Global Analytical Technology Centre Director, The Dow Chemical Company
2. Industrial Cyber-Security
Malcolm Warr OBE, Chair - Tranzparency Group, Board Member - Holyrood Forum
3. Augmented/Virtual Reality
Frédéric Zwahlen, Vice President - Pharmaceutical Manufacturing, Vifor Pharma
4. Manufacturing risk & integrity management
Marco Maioli, Industrial Operations Director, Sigma-tau
Marco has worked across a number of different positions within industrial operations, from quality assurance to lean manufacturing, operations management and product transfer. Prior to Sigma-tau he was an industrial technology expert at Sanofi as well as holding positions within manufacturing and operational excellence at the CMO; Catalent.
5. MES
Martin Fusek, Global Head of IT Testing Service,
6. IIoT
7. Advanced robotics
8. Predictive maintenance
9. Laboratory Information Systems
Ulla Hutzler-Gardt, Executive Director - Head of IS Business Partnering, Boehringer Ingelheim

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Michael De Poortere

Global Analytical Technology Centre Director
Dow Chemical
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Malcolm Warr

Chair
Tranzparency Group
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Marco Maioli

Industrial Operations Director
Sigma-Tau
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Martin Fusek

Global Head of IT Testing Service
Novartis

Ulla Hutzler-Gardt

Executive Director - Head of IS Business Partnering
Boehringer-Ingelheim
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Frederic Zwahlen

Vice President, Head of Pharmaceutical Manufacturing
ViforPharma

1:30 PM - 2:30 PM Networking Lunch

TRACK A – Operational Innovation

2:30 PM - 2:40 PM Opening remarks from the chair

Magda Papadaki, Head of Manufacturing Innovation, ABPI

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Magda Papadaki

Head of Manufacturing Innovation
ABPI

TRACK A – Operational Innovation

2:40 PM - 3:00 PM OUR STORY: How to build lean and flexible manufacturing strategies for small scale biologics using single use equipment

Mark Wright, Site Lead, Piramal
· How can you develop a highly lean manufacturing strategy and processes whilst dealing with extremely strict parameters for manufacture
· Case study of process implementation for a CMO where contamination issues, highly potent APIs, short production runs and single use equipment all play a key role
· What are the associated challenges and how does a lean and flexible process and strategy overcome these?

Mark is currently responsible for the Piramal ADC conjugation unite at Grangemouth in Scotland. Priot to this he held the position of Head of Development within the company and numerous positions before this, having been with the company for over 10 years. Within his currently role he is responsible for driving manufacturing strategy across the board for the site, pioneering a number of methodologies in the process.

Mark Wright

Site Lead
Piramal

TRACK A – Operational Innovation

3:00 PM - 3:40 PM CASE STUDY INTERACTIVE How to leverage statistical process control strategies to drive a nascent continuous process verification (CPV) program

Paul Hanson, Director Commercial Technical Operations, Takeda
· How an innovative usage of process control, using statistical analysis, is fuelling CPV at Takeda
· What the initial drivers behind the initiative were and how it came into existence
· What were the early indicators and lessons learnt from the CPV programme, and what level of success has there been thus far?

Paul Hanson is currently head of the commercial biologics API programs at Takeda. In this role he has begun leveraging statistical process control strategies to drive Takeda's nascent continuous process verification program. This program reduces the company's API supply chain risk through improved line-of-site into the commercial production process.

Paul Hanson

Director Commercial Technical Operations
Takeda

TRACK A – Operational Innovation

3:40 PM - 4:00 PM OUR STORY How to use emerging technologies to modernise pharmaceutical and bio-processing development and manufacture - the 'intelligent factory' concept

Andy Jones, Head of Manufacturing Science and Technology , AstraZeneca
· What are the manufacturing strategies that AstraZeneca identified as having the potential for improvement through emerging technology?
· How was the developmet of process understanding and control strategy forumalted?
· How did this then evolve into a more specific opportunities around the creation of an API control strategy, the development of CPV, continuous manufacturing and advanced process control?
· What were the key successes and milestones in the implemetation of the above strategies?

Andy is currently the Head of Manufacturing Science and Technology at AstraZeneca. In his current role he is spearheading AstraZeneca's drive into manufacturing innovation, including the adoption of key ideas and methodologies around the use of big data, advanced analytics and process control in pharmaceutical manufacture.

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Andy Jones

Head of Manufacturing Science and Technology
AstraZeneca

TRACK B – Mastering MES and Digital Manufacturing

2:30 PM - 2:40 PM Opening Remarks from the Chair

TRACK B – Mastering MES and Digital Manufacturing

2:40 PM - 3:00 PM OUR STORY How to optimise efficiency in MES rollout using a standardised methodology

Martin Fusek, Global Head of IT Testing Service , Novartis
· How can standardisation revolutionise MES implementation
· Why this method’s efficacy improves as scale increases
· Lessons learnt from a global rollout to 60+ sites across the globe, at one of the world’s largest pharmaceutical companies
· How to extract best practice from these experiences

Over the past two years Martin has set up and lead the global testing centre of Excellence for Novartis, providing managed testing serviecs for IT application of all business areas of one of the world's largest pharmaceutical companies. Much of this focus has been upon the manufacturing execution systems within the organisation. He held a number of senior MES and TechOps IT focused roles within the industry before joining Novartis, including Head of TechOps IT at Salutas Pharma and MES Manager for HEXAL AG.

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Martin Fusek

Global Head of IT Testing Service
Novartis

TRACK B – Mastering MES and Digital Manufacturing

3:00 PM - 3:40 PM CASE STUDY INTERACTIVE Achieving the ‘paperless site’ dream: How can you use MES to enhance EBR (electronic batch records) and beyond to weighing, dispensing, log books, cost savings and process improvement?

Coline Monnard, Process Data Specialist, UCB BioPharma
· What steps can you put in place to integrate your MES into one simple robust process?
· How can you build the best technically skilled team to implement and run a paperless manufacturing site?
· How can you ensure your paperless manufacturing plant will meet data integrity requirements?
· How can you best evaluate which vendors can help you to include weighing, dispensing, log books, cost savings and process improvement within your MES system?
· How can you work with the quality team to optimise quality in your paperless manufacturing site?

David heads a team responsible for defining and implementing the long term strategy for the manufacture and analytical control of UCB products throughout their life cycle. Alongside this he also leads a team implementing a Knowledge management roadmap for UCB's products through data acquisition, integration and interpretation, QbD, CPV, document control and retention.

Coline Monnard

Process Data Specialist
UCB BioPharma

TRACK B – Mastering MES and Digital Manufacturing

3:40 PM - 4:00 PM FIRESIDE CHAT: Why digital manufacturing should be the number one manufacturing investment priority for pharma

Edith Norrant, Innovation, Technology & Sciences Director, UCB Pharma
· Why should key decision makers and budget holders within pharma view manufacturing digitalisation as more worthy of investment than operational or process focused expenditure?
· How is it possible to ascertain the relative ROI from digital expenditure vs. operational innovation or process focused investment?

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Edith Norrant

Innovation, Technology & Sciences Director
UCB Pharma

SYNERGY WORKSHOPS Limited to 30 attendees

2:30 PM - 4:00 PM INDUSTRY 4.0 WORKSHOP - Sharing experiences on Industry 4.0 projects: What went wrong and what did we learn?

Ulrich Korneck, Head of Global Operational Excellence and Vice President, Merck
Ulrich is head of Global Operational Excellence with Merck’s Biopharma operations, including manufacturing operations, with a global remit. He joined from Merck in January 2015 from Porsche Consulting’s Pharmaceuticals, Biotech and Medical Device Practice. Ulrich has previously held management positions with Boehringer Ingelheim and Camelot Management Consultants.

Ulrich Korneck

Head of Global Operational Excellence and Vice President
Merck

4:00 PM - 4:30 PM Afternoon Networking Break

Rethinking your Organisational Processes and Culture

4:30 PM - 5:00 PM ALL STAR PANEL Global Operational Excellence: How can you optimise the link between people, process and technology to ensure the robust harmonisation of processes and GMP compliance across sites globally

Magda Papadaki, Head of Manufacturing Innovation, ABPI Sandra Lee, Managing Director - Operations, Accord Healthcare Philipp Goepel, Vice President Head of Manufacturing - Plant Manager Bovenau, Richter-Helm BioLogics Frederic Zwahlen, Vice President, Head of Pharmaceutical Manufacturing, ViforPharma
· How can you balance optimising your processes globally vs. making them realistic for local sites?
· How can you set up an internal structure and assign responsibility to ensure processes are controlled globally across all sites?
· How can you ensure your global operational excellence process provides a return on investment?
· How can you ensure your global processes incorporate local laws and regulations?
· How to make sure your manufacturing processes do not change from site to site – what steps can you put in place to avoid this?

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Magda Papadaki

Head of Manufacturing Innovation
ABPI
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Sandra Lee

Managing Director - Operations
Accord Healthcare

Philipp Goepel

Vice President Head of Manufacturing - Plant Manager Bovenau
Richter-Helm BioLogics
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Frederic Zwahlen

Vice President, Head of Pharmaceutical Manufacturing
ViforPharma

5:00 PM - 5:20 PM End of Conference