ManuPharma 2018

05 - 06 December, 2018

Steigenberger Frankfurter Hof, Frankfurt

Contact Us: 44 (0) 207 036 1363

Agenda Day 1

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

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
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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

9:30 am - 9:50 am KEYNOTE CASE STUDY 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
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Silke Gotthardt

VP Launch Transfer Operations
Boehringer Ingelheim

9:50 am - 10:10 am CASE STUDY – Creating a vision for holistic transformation: How to drive a step-by-step approach best invest your resources in technology, culture-change and digitalisation to ensure your entire manufacturing network is prepared to implement a major change

Antonio Buendia - Head of Manufacturing Process Control Novartis
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Antonio Buendia

Head of Manufacturing Process Control
Novartis

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
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Doug Spence

Managing Partner
Spence Associates

10:50 am - 11:30 am Networking Break

8:00 am - 8:30 am CASE STUDY – How to implement continuous manufacturing from pilot, through scale-up, to commercial use to improve efficiency, agility and quality assurance

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
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Dr. Helge Berg

Director BioManufacturing Science Network Europe
Merck

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Rudolf Haussmann

VP Technical Development and Operations
Santhera

12:30 pm - 12:50 pm FIRESIDE CHAT – 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?

Cornelia Thieme - Director Global Manufacturing Science Europe Biogen Willem Kools - VP Global Head of Technology Management Merck AG
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Cornelia Thieme

Director Global Manufacturing Science Europe
Biogen

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Willem Kools

VP Global Head of Technology Management
Merck AG

12:50 pm - 1:20 pm OXFORD STYLE DEBATE – CPV is the only way to achieve real-time quality and compliance monitoring in continuous manufacturing FOR AND AGAINST

Sebastien Ribault - Senior Director Biotech Process Development and Manufacturing Merck
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Sebastien Ribault

Senior Director Biotech Process Development and Manufacturing
Merck

1:20 pm - 1:30 pm INTERACTIVE POLLING SESSION The key challenge holding back the development of the pharmaceutical manufacturing industry is: A.) Fear of the unknown by producers B.) Outdated regulatory framework

1:30 pm - 2:35 pm Networking Lunch

1:30 pm - 2:20 pm MASTERCLASS 1

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
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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
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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 ensure scaleabilty, successful project delivery and regulatory compliance of combination product manufacture whilst meeting significant increases in demand
Oliver Shergold - Global Head - Cominbation Products & Device Technology Novartis
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Oliver Shergold

Global Head - Cominbation Products & Device Technology
Novartis

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 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 Domenico Marini - Head of API Production Abbott
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Domenico Aldi

Head of API Production
Abbvie

Domenico Marini

Head of API Production
Abbott

TRACK B – Next Level MES and Digitalisation

3:00 pm - 3:40 pm INNOVATION SPOTLIGHTS 3x 10 minute presentations, 10 minute Q&A
Manufacturing execution systems,
data integrity services
advanced data analytics and cyber security for pharma manufacture

TRACK B – Next Level MES and Digitalisation

8:00 am - 8:30 am CASE STUDY INTERACTIVE - How near real-time production data delivered through next level MES allows for optimal use of personnel, equipment and materials

Producer-Specific Interactive Workshops

2:35 pm - 3:40 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

Producer-Specific Interactive Workshops

3:40 pm - 4:20 pm BIOLOGICS WORKSHOP - How can you best formulate and execute manufacturing strategies specifically for specialised and personalised medicines

Lean Manufacturing Creative Boardroom

2:35 pm - 4:20 pm How to use lean manufacturing transformation principles to shorten your lead times and improve the reliability of your processes

4:20 pm - 4:40 pm Networking Break

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 Boccaci - HR Lead GPS Italy BMS
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Barbara Sambuco

CEO Industrial Operations Italy
BMS

Davide Boccaci

HR Lead GPS Italy
BMS

5:20 pm - 6:00 pm 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?

Emre Ozcan - Director of Global Manufacturing and Supply Strategy Merck AG Richard Middleton - Director, Central Engineering - Europe/Asia Catalent Gary Butler - VP Site Director Avara
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Emre Ozcan

Director of Global Manufacturing and Supply Strategy
Merck AG

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Richard Middleton

Director, Central Engineering - Europe/Asia
Catalent

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Gary Butler

VP Site Director
Avara

6:00 pm - 6:55 pm German Christmas Market Themed Networking Reception - Your opportunity to relax, discuss challenges, exchange ideas and make new contacts in an informal setting!