ManuPharma 2019

03 - 04 December, 2019

Steigenberger Frankfurter Hof, Frankfurt

Contact Us: 44 (0) 207 036 1363

Conference Day One – Tuesday 3 December 2019

8:00 am - 8:50 am Registration and welcome coffee

Delivering Industry 4.0

8:50 am - 8:55 am Opening remarks – Will Robinson, Conference Director, ManuPharma

8:55 am - 9:00 am Chair’s opening address and interactive polling

Uwe Küppers, Chairman of Board at MESA International

Uwe Küppers

Chairman of Board
MESA International

9:00 am - 9:20 am KEYNOTE CASE STUDY - Embracing The Global Digital Manufacturing Revolution: What are the pragmatic truths of implementing digitalised manufacturing operations in Pharma?

·         What were the key challenges faced by a major pharma producer when looking to digitalise manufacturing operations on a global scale?
·         How were these challenges overcome and can they be applied universally, or where they specific to the producer/project?
·         How were the parameters for the project set out and delivered?
·         What are the core benefits and ROI delivered from the project? 
Geoffrey Pot, VP Operations at Takeda

Geoffrey Pot

VP Operations
Takeda

9:20 am - 10:00 am KEYNOTE PANEL AND LIVE POLLING – Separating Myth from Reality: How can you decide which Industry 4.0 projects (IoT, robotics, RPA and data analytics) to invest in to deliver a proven ROI?

·         Where have the best investments in IoT and 4.0 tech been made in pharma?
·         What technologies have proved to be more hype than reality in this space, and why?
·         What are the relative benefits of being an early adopter, a fast follower or early/late majority?
Miran Denac, VP Manufacturing Europe at TEVA

Miran Denac

VP Manufacturing Europe
TEVA

Paul Keogh, Snr Director Site Lead at Takeda

Paul Keogh

Snr Director Site Lead
Takeda

Jon-Paul Sherlock, Global Head of Manufacturing Technology Strategy at AstraZeneca

Jon-Paul Sherlock

Global Head of Manufacturing Technology Strategy
AstraZeneca

10:00 am - 10:20 am KEYNOTE AEROSPACE CASE STUDY: How can you effectively establish and drive the cultural shift required for the successful enterprise wide adoption of new digitalised processes?

·         A cutting edge case study from a leader in the aviation industry, applying lessons learnt to pharma
·         What was required on a cultural level in order to drive holistic adoption of digitalisation in manufacturing processes across the entire organisation?
·         Why are these cultural elements absolutely critical to the success or failure of projects?
·         What best practice can be applied, regardless of industry?
Curtis Carson, Head of Engineering Development System at Airbus Defense and Space

Curtis Carson

Head of Engineering Development System
Airbus Defense and Space

10:20 am - 11:00 am Networking Break

Driving Continuous Manufacturing & Continuous Improvement

11:00 am - 11:20 am CASE STUDY – Continuous manufacturing for biologics: From vision to reality

·         Outline of the implementation and scale up of continuous bioreactors
·         What is the relative cost of manufacturing?
·         What level of connectivity was required to implement this process?
·         What lessons learnt and best practice have been derived from the project, to be used in future projects?
Kerstin Seemann, VP, Head of Development and Launch at Merck

Kerstin Seemann

VP, Head of Development and Launch
Merck

11:20 am - 11:40 am OUT OF INDUSTRY CASE STUDY – How can you drive better control of your data to make better and faster decisions, reduce complexity and drive regulatory compliance in manufacturing operations?

·         Why is data at the heart of both the problem and the solution for advanced pharma manufacturing?
·         How can best practice data analysis help producers to significantly reduce complexity and improve quality?
·         What are the effects upon GMP and additional regulatory compliance?
·         What is the cost of implementation and the projected ROI for these proceses?

11:40 am - 12:20 pm KEYNOTE PANEL AND LIVE POLLING: How can you use continuous process verification (CPV) to enable continuous manufacturing whilst best meeting regulatory requirements?

·         What level of real-time monitoring is required?
·         Why are both CPV and automated technology necessary for effective continuous processing?
·         What other elements of industry 4.0 are making continuous processing a reality?
·         How is CPV and continuous processing now seen by regulators as something that will improve quality and adherence to regulatory requirements?
Richard Middleton, Global Director, Engineering & Reliability at Catalent

Richard Middleton

Global Director, Engineering & Reliability
Catalent

Dirk Brandt

Head of Production Technology Centre
Terumo

12:20 pm - 12:40 pm CASE STUDY - How can you develop strategies for the industrialisation of continuous small molecule API manufacturing?

·         Case study of at scale small molecule API manufacture through continuous processing
·         What was required in order to implement the technology, both in terms of buy in and investment?
·         What were the biggest challenges associated with the implementation of the process?
·         What have the outcomes been and the return on investment from implementing continuous manufacturing? 
Steen Søgaard, SVP Manufacturing at Lundbeck

Steen Søgaard

SVP Manufacturing
Lundbeck

12:40 pm - 1:45 pm NETWORKING LUNCH

12:40 pm - 1:40 pm MASTERCLASS – How can the latest manufacturing equipment enable continuous processing?

12:40 pm - 1:40 pm MASTERCLASS – Imagining Your Digital Transformation Journey in Manufacturing

Frederique Bourdoulous, Senior Manufacturing Consultant at Dassault Systèmes

Frederique Bourdoulous

Senior Manufacturing Consultant
Dassault Systèmes

TRACK A – Mastering Digital, Data-Driven Manufacturing and MES

1:45 pm - 1:50 pm Chair’s opening address
Uwe Küppers, Chairman of Board at MESA International

Uwe Küppers

Chairman of Board
MESA International

TRACK A – Mastering Digital, Data-Driven Manufacturing and MES

1:50 pm - 2:10 pm CASE STUDY - How can you simultaneously deliver digital manufacturing use cases across multiple manufacturing sites to deliver significant and positive effects across your manufacturing network on a global scale?
·         Case study of an orchestrated digital manufacturing roll out across several sites
·         What were the biggest challenges associated with implementing this rollout?
·         What best practice can be drawn and applied to future projects?
John O'Sullivan, VP Global Head of IT BioPharma Product Supply at Bayer

John O'Sullivan

VP Global Head of IT BioPharma Product Supply
Bayer

Kalil Lessi, Global IT Business Partner Pharmaceuticals at Bayer

Kalil Lessi

Global IT Business Partner Pharmaceuticals
Bayer

TRACK A – Mastering Digital, Data-Driven Manufacturing and MES

2:10 pm - 2:50 pm PANEL DISCUSSION - How can you use emerging technologies to drive data integrity and ensure accountability in manufacturing operations?
·         What is the importance of data integrity when assuring accountabiltiy in advance manufacturing?
·         What emerging technologies and processes are enabling the assurance of data quality?
·         How are producers and suppliers working together successfully in order to implement these projects?

Mathias Deckers

Lead IT Analyst - Manufacturing
Janssen

Peter Iles-Smith, Head of Technical - Global Manufacturing & Supply at GSK

Peter Iles-Smith

Head of Technical - Global Manufacturing & Supply
GSK

Giandrea Favetti

Site Lead
Alfasigma

Marc Diament, DIrector at Integral Technology Solutions

Marc Diament

DIrector
Integral Technology Solutions

TRACK A – Mastering Digital, Data-Driven Manufacturing and MES

2:50 pm - 3:10 pm INNOVATION SPOTLIGHT 2 x 10 minute case study based showcases, highlighting the most innovative solutions in the market

TRACK A – Mastering Digital, Data-Driven Manufacturing and MES

3:10 pm - 3:30 pm How can you best derive and measure value from your data to make things easier for your manufacturing organisation?
·         Why should digital be a reducer of complexity within the organisation?
·         How can you use data to simplify manufacturing processes and drive ease of use?
·         How can you then quantify the value that you are able to derive from your data and resultantly show ROI to the business?
Peter Iles-Smith, Head of Technical - Global Manufacturing & Supply at GSK

Peter Iles-Smith

Head of Technical - Global Manufacturing & Supply
GSK

TRACK B – Improving Process, Networks and Partnerships

1:45 pm - 1:50 pm Chair’s opening address
Luiz Barberini, Head of External Manufacturing Operations at Bayer

Luiz Barberini

Head of External Manufacturing Operations
Bayer

TRACK B – Improving Process, Networks and Partnerships

1:50 pm - 2:10 pm CASE STUDY - Merging lean with industry 4.0: How can you drive the three core components of digitalisation, lean operating models and people for maximised sucess?
·         An update on the development of industry 4.0 manufacturing techniques at a globally leading manufacturer
·         How has this technology been married with lean methodologies to drive significant efficiencies within the producer?
·         What have been the ongoing problems with implementation and how have these been overcome?
·         What best practice can be drawn from the process?
Antonio Buendia, Head of Global Automation & Digital Strategy - Manufacturing at Novartis

Antonio Buendia

Head of Global Automation & Digital Strategy - Manufacturing
Novartis

TRACK B – Improving Process, Networks and Partnerships

2:10 pm - 2:50 pm OXFORD STYLE DEBATE: Hiring new staff is a better focus than retraining current staff to meet the digital demands required of the workforce of the future: FOR & AGAINST
·         Re-hire: Pulling ‘new blood’ from other industries and at a junior level to enhance the digital capabilities of personnel
·         Re-train: Re-equipping the current pharma manufacturing workforce with the digital skills required through intensive training and development
Emre Ozcan, Global Head of Operations Strategy , Manufacturing & Supply at Merck

Emre Ozcan

Global Head of Operations Strategy , Manufacturing & Supply
Merck

Davide Boccaci, Head of HR Global Manufacturing & Supply at Bristol-Myers Squibb

Davide Boccaci

Head of HR Global Manufacturing & Supply
Bristol-Myers Squibb

Luiz Barberini, Head of External Manufacturing Operations at Bayer

Luiz Barberini

Head of External Manufacturing Operations
Bayer

TRACK B – Improving Process, Networks and Partnerships

2:50 pm - 3:10 pm CASE STUDY - How to work with your partners to deliver best in class oral solid dosage production using the latest technological developments
Christophe Dohr, Site Quality Head at Acino

Christophe Dohr

Site Quality Head
Acino

TRACK B – Improving Process, Networks and Partnerships

3:10 pm - 3:30 pm CASE STUDY - How can you manage strategic partnerships across your manufacturing network that deliver transparency, shared vision and enable successful technological development?
·         Case study of CMO management within the consumer goods verticle of one of the world’s largest producers
·         Why is communication and transparency of the upmost importance when developing CMO partnerships?
·         How does this transparency and communication of a shared plan allow for the development of new technologies and processes in partnership? 
Luiz Barberini, Head of External Manufacturing Operations at Bayer

Luiz Barberini

Head of External Manufacturing Operations
Bayer

MANUFACTURING LEADERS’ BOARDROOM

1:45 pm - 2:45 pm Assessing the reality of industry 4.0 for pharma manufacturing – What can pharma learn from automotive and aerospace, and what must it learn for itself?
90 minutes in total – Chatham House Rule – VP level representatives of pharma producers only
Curtis Carson, Head of Engineering Development System at Airbus Defense and Space

Curtis Carson

Head of Engineering Development System
Airbus Defense and Space

Sama Mbang, Digitalisation & Simulation Manufacturing Manager at Daimler Merceds Benz

Sama Mbang

Digitalisation & Simulation Manufacturing Manager
Daimler Merceds Benz

3:30 pm - 4:10 pm NETWORKING BREAK

3:30 pm - 4:10 pm MASTERCLASS – Industry 4.0: How can you converge IoT, sensors and analytics to transform pharmachem producers into digital enterprises?

3:30 pm - 4:10 pm MASTERCLASS - How can you use the latest clean room technologies to maximise QA/QC in aseptic processes?

TRACK A – Mastering Digital, Data-Driven Manufacturing and MES

4:10 pm - 4:50 pm PANEL DISCUSSION – What are your biggest pain points with manufacturing execution systems selection implementation and how can common pitfalls and challenges be avoided, or overcome?
·         What are the most common mistakes made by pharma producers when selecting and implementing MES systems?
·         Why doesn’t ‘one size fit all’ when looking to connect these systems?
·         What methods of standardisation can be drawn from numerous examples of successful linking?
·         What are the best practices and lessons learned that can be extracted?
Ali Naseer, Associate Director Manufacturing IT at Gilead Sciences

Ali Naseer

Associate Director Manufacturing IT
Gilead Sciences

Martin Fusek, Global Head of MES Program at Merck

Martin Fusek

Global Head of MES Program
Merck

TRACK A – Mastering Digital, Data-Driven Manufacturing and MES

4:50 pm - 5:10 pm CASE STUDY - Step Changes in Manufacturing Operations with Predictive Insights using AI/ML and Pharma 4.0
Toni Manzano, Co-founder & R&D Director at Bigfinite

Toni Manzano

Co-founder & R&D Director
Bigfinite

TRACK B – Improving Process, Networks and Partnerships

4:10 pm - 4:50 pm CASE STUDY INTERACTIVE - How can you best use network analytics and modelling to support digital engineering in pharma manufacturing operations?
·         What are the golden rules when developing a standardised approach to tech transfer?
·         Do these rules apply equaly when driving tech transfer both within the organisation and with partners?
·         What are the root causes of most challenges and failures in successfully tech transfer? 
Gareth Alford, Lead Engineer at GSK

Gareth Alford

Lead Engineer
GSK

Anne Bard, Head of Global Capital Strategy Design at GSK

Anne Bard

Head of Global Capital Strategy Design
GSK

TRACK B – Improving Process, Networks and Partnerships

4:50 pm - 5:10 pm CASE STUDY - How can you drive strategy around CMO management and the commercialisation for drug product and finished goods in biologics?
·         Why are partners crucial to the agility and success of manufacturing networks in the modern day?
·         How can you work with your CMOs to maximise agility, responsiveness to demand and ensure security of supply?
·         How are digitally connected networks enabling significant increases in the agility of manufacturing operations? 
Suyamburam Sathasivam, Global Head of Biologics Manunfacturing at Sun Pharma

Suyamburam Sathasivam

Global Head of Biologics Manunfacturing
Sun Pharma

SYNERGY WORKSHOPS – Talent & Change Management (Limited to 30 attendees) & CREATIVE BOARDROOM - (Limited to 15 attendees) Under ‘Chatham House Rule’

4:10 pm - 5:10 pm SYNERGY WORKSHOP - CMO-Pharma Network Design: How to move beyond the traditional ‘pay-as-a service’ model and build the best commercial agreement to ensure security of supply

Emre Ozcan, Global Head of Operations Strategy , Manufacturing & Supply at Merck

Emre Ozcan

Global Head of Operations Strategy , Manufacturing & Supply
Merck

5:10 pm - 5:15 pm TRANSITION TO MAIN ROOM

Preparing for Digitally Connected Manufacturing

5:15 pm - 5:35 pm CASE STUDY – How digital twins help R&D develop more efficient processes for the production of vaccines

Niels Thomsen, Head of Internet of Things BD at Atos

Niels Thomsen

Head of Internet of Things BD
Atos

Quentin Creed, Head of Business Data & Analytics at Atos

Quentin Creed

Head of Business Data & Analytics
Atos

5:35 pm - 5:55 pm CASE STUDY- How to drive effective analytical process in the age of industry 4.0 and continuous manufacturing


Lorenz Liesum, Global Head of PAT and Statistics at Novartis

Lorenz Liesum

Global Head of PAT and Statistics
Novartis

5:55 pm - 6:15 pm CASE STUDY – How can you drive the combination of AI, simulations, big data and digital process development to enhance cyber-physical manufacturing systems across industries?

·         How is the convergence of technologies helping pharma producers to achieve fully connected manufacturing?
·         What does the picture of industry 4.0 look like in the modern age and how can a range of solution providers help you to achieve that picture?
·         Case study of the convergence of these technologies at Merck AG
·         What lessons learnt and best practices have been drawn from FMCG and applied to pharma? 
Alessandro De Luca, CIO Healthcare at Merck

Alessandro De Luca

CIO Healthcare
Merck

Gustavo Lopez Ghory, Former VP Manufacturing at Proctor & Gamble

Gustavo Lopez Ghory

Former VP Manufacturing
Proctor & Gamble

6:15 pm - 7:15 pm Networking Drinks Reception