ManuPharma 2017

December 06-December 07, 2017

Steigenberger Frankfurter Hof, Frankfurt

Contact Us: 44 (0) 207 036 1363

Day 1 - Wednesday 6th December 2017

Registration and welcome coffee

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

Igniting your Future Manufacturing Strategy

8:50 AM - 9:00 AM Opening remarks – Will Robinson, WBR

9:00 AM - 9:10 AM Chair’s opening address and networking activity



9:10 AM - 9:30 AM INSPIRATIONAL OPENING KEYNOTE: How to drive pharmaceutical manufacturing transformation through a process of cultural change from ‘manufacturing and volume’ to ‘patient-centric’ and deliver true value to your customer

Wolfgang Baiker, Head of Human Pharma Supply, Head of Global Quality and Head of Biopharma Business Unit, Boehringer Ingelheim
Wolfgang Baiker, Member Human Pharma Executive Committee, Head of Human Pharma Supply, Head of Global Quality and Head of Biopharma Business Unit, Boehringer Ingelheim
In addition to membership of Boehringer Ingelheim's Pharma Executive Committee, Wolfgang is also Head of Human Pharma Supply, Head of Global Quality and Head of Biopharma Business Unit at the company. He has been with the organisation for 26 years, holding positions including VP International Project Management, Snr. VP of Development and Member of the Board of Managing Directors for CBD Biopharmaceuticals and Operations during that period.

img

Wolfgang Baiker

Head of Human Pharma Supply, Head of Global Quality and Head of Biopharma Business Unit
Boehringer Ingelheim

9:30 AM - 10:10 AM ALL STAR PANEL How can pharma and CMOs best form innovation-led strategic partnerships to progress Advanced Manufacturing Technology implementation and upscale from R&D stage to commercial?

Anne Marie de Jonge Schuermans, Vice President Global Supply Chain Ops & Strategic Partnerships, Biogen Silke Gotthardt, VP Launch Transfer Operations, Boehringer Ingelheim Aude Cazenave, Technical Director, Aesica Stephen Closs, Vice President, Global Technical Operations
· How can you design and implement the tech transfer of brand new manufacturing technology into your internal or CMO’s manufacturing site
· How can you work with the CMO to assign resources and experts to the Advanced Manufacturing Technology implementation strategy
· How can you effectively transition technology into the commercial environment?
· How to set up effective communication between R&D, operations and commercial teams to ensure the smooth transition of technology
· How can you set up a flexible team to redirect sources as and when they are needed
· How to ensure that the original concept of the brand new innovative technology is not lost during scale up
· How to set up a plan to continue to support the sites as a tech services team
· How can you work with the CMO to choose the right vendors?

img

Anne Marie de Jonge Schuermans

Vice President Global Supply Chain Ops & Strategic Partnerships
Biogen
img

Silke Gotthardt

VP Launch Transfer Operations
Boehringer Ingelheim
img

Aude Cazenave

Technical Director
Aesica
img

Stephen Closs

Vice President
Global Technical Operations

10:10 AM - 10:30 AM STRATEGIC KEYNOTE: How to enable your manufacturing workforce; equipping your people with the skills and capabilities for digital readiness and the leveraging of current technologies

Teresa Rodo, SVP Pharma Operations, Merck

Teresa Rodo

SVP Pharma Operations
Merck

10:30 AM - 11:10 AM Networking Break

Embracing Advanced Manufacturing Tech and Continuous Manufacturing

11:10 AM - 11:45 AM ALL STAR PANEL What is the right infrastructure you need to encourage manufacturing innovation? Exploring operations, centres of excellence, pilot plants and technology labs

Klaus Kunath, Head of Manufacturing Science & Technology, Global Pharma Operations, Merck , Merck KGaA Marianne Leth, VP Manufacturing and GM , Biogen Vijay Surapaneni, VP Engineering and Capacity Planning, Catalent , ,
· How can you choose the right infrastructure to align with your innovation strategy?
· How can you take operational decisions to help encourage innovation?
· How can you decide whether to prioritise operations, centres of excellence, pilot plants or technology labs?
· How can you determine if you’ll get a return on investment from encouraging manufacturing innovation?

img

Klaus Kunath

Head of Manufacturing Science & Technology, Global Pharma Operations, Merck
Merck KGaA
img

Marianne Leth

VP Manufacturing and GM
Biogen

Vijay Surapaneni

VP Engineering and Capacity Planning
Catalent

11:45 AM - 12:05 PM CASE STUDY: What evidence is there that continuous manufacturing in pharma is taking off?

Markus Hayek, Managing Director, Accenture

img

Markus Hayek

Managing Director
Accenture

12:05 PM - 12:25 PM CONTINUOUS MANUFACTURING KEYNOTE From pilot to commercial manufacturing: How to make decisions on primary vs. secondary process, new vs. established products and API vs. drug product to ensure ROI on your continuous manufacturing process

Aude Cazenave, Technical Director, Aesica

img

Aude Cazenave

Technical Director
Aesica

12:25 PM - 12:45 PM FIRESIDE CHAT Why pharma must embrace Continuous Manufacturing in order to optimise efficiency and reduce costs

Craig Johnston, Operations Director, Strathclyde Institute of Pharmacy and Biomedical Sciences Jean Philippe Giraud, Director, Head of Technical Transfers, Global Manufacturing & Supply , Merck Serono
FOR
· The capabilities of continuous manufacturing technology, following recent advancements, allow for successful production of the full range of small molecule and biologics, with improved efficiency
AGAINST:
· Continuous manufacturing technology is not yet advanced enough to successfully manufacture a full range of pharmaceutical products (small molecule through to biologics) successfully, cost effectively and compliantly
FOR: Craig Johnston, Industrial Director, CMAC
Craig is Industry Director at (CMAC) Continuous Manufacturing and Crystallisation. He works with industry including tier 1 multi nationals eg GSK, AZ, Novartis, Bayer and technology companies. Established in 2011, CMAC now has 120 staff across its network of 7 leading universities. It conducts leading research in continuous manufacturing with particle focus
AGAINST: Jean Philippe Giraud, Director, Head of Technical Transfers, Global Manufacturing & Supply, Merck Serono
Jean-Philippe leads the implementation of all technical transfers for Merck's global pharma organisation. His current remit includes 40 transfers ongoing around the global, leading a team of seven technical transfer managers and a PMO manager. His key focuses are upon supporting pharma reliability and volume growth by executing CMO and internal dual sourcing strategy, localising manufacturing operations where possible to maintain market access (particularly in emerging markets) and supporting supply flexibility add scalability

img

Craig Johnston

Operations Director
Strathclyde Institute of Pharmacy and Biomedical Sciences
img

Jean Philippe Giraud

Director, Head of Technical Transfers, Global Manufacturing & Supply
Merck Serono

12:45 PM - 1:40 PM DRILL DOWN ROUNDTABLES How to implement a specific advanced manufacturing technology / Take this opportunity to discuss how to overcome the key challenges to the move towards advanced manufacturing technologies with your senior peers

Mary Moran, Director - Manufacturing Science & Technology , Bristol Myers Squibb Clive Badman, Head of Pre-Competitive Collaboration - GSK, Chairman - CMAC Geoffrey Pot, Senior Director Manufacturing and Process Science , Shire Adam Warzecha, Contiuous Improvement Champion EMEA , Shire Vijay Surapaneni, VP Engineering and Capacity Planning, Catalent Mark Wright, Site Lead, Piramal
1. Advanced Manufacturing Technology
Mary Moran, Director Manufacturing Science & Technology, Bristol Myers Squibb
Mary has held a number of senior positions at Britol Myers Squibb over the 22+ years with the company, inculding Manufacturing Manager, OPEX Director and Tech Transfer & External Manufacturing Director. In her current role her core focus is upon continuous improvement and development of advanced manufacturing technology and techniques within the organisation.
2. Continuous Manufacturing
Clive Badman, Head of Pre-Competitive Collaboration , GSK
3. Localised Sterile Manufacturing
4. Digitalisation
Geoffrey Pot, Senior Director Manufacturing and Process Science, Shire
Geoffrey has more than 15 years of experience in the Biotech / Pharmaceutical environment, and is now managing an international team of more than 200 individuals across 8 different plants in Europe and US. Developing and coaching team members to become a high performing team is key which has been demonstrated through strong operational results.
5. Additive Manufacturing/3D Printing
6. Smart Sensors
7. Single-use Equipment
Mark Wright, Site Lead, Piramal
8. Continuous Improvement
Adam Warzecha, Continous Improvement Champion, EMEA Plant Management, Shire
Adam's key responsibilities are to lead and accelerate deployment of Shire Continuous Improvement mind sets and behaviours, systems, tools, mechanisms and processes throughout all site functions to create a continuously learning and improving organization. In doing so his team aim to provide a key competitive advantage for Technical Operations that is instrumental in how Shire achieve their breakthrough objectives for Supply Value Proposition and ultimately the company’s vision.
9. Manufacturing Focused CAPEX Investment Strategy
Vijay Surapaneni, VP Engineering and Capacity Planning, Catalent
Vijay is accountable for developing and implementing strategy and delivering operational commitments, functional excellence objectives, and linkages during the expansion and growth of Drug Delivery Solutions sites for Catalent, on a global scale. Within this role his remit is to drive and execute the growth strategies for Biologics, Blow Fill Seal, Formulation Development, Analytical Services, Inhalation Technologies and Integrated Oral Solid Dosage while delivering on the operational metrics for safety, quality, delivery and cost.

img

Mary Moran

Director - Manufacturing Science & Technology
Bristol Myers Squibb
img

Clive Badman

Head of Pre-Competitive Collaboration - GSK
Chairman - CMAC
img

Geoffrey Pot

Senior Director Manufacturing and Process Science
Shire
img

Adam Warzecha

Contiuous Improvement Champion EMEA
Shire

Vijay Surapaneni

VP Engineering and Capacity Planning
Catalent

Mark Wright

Site Lead
Piramal

1:40 PM - 2:40 PM Networking Lunch

1:40 PM - 2:40 PM MASTERCLASS 1

TRACK A – Transforming Manufacturing Operations

2:40 PM - 2:50 PM Opening remarks from the chair Magda Papadaki, Head of Manufacturing Innovation, ABPI

TRACK A – Transforming Manufacturing Operations

2:50 PM - 3:10 PM OUR STORY How to implement a collaborative model to accelerate new technologies into your manufacturing sites

Clive Badman, Head of Pre-Competitive Collaboration - GSK, Chairman - CMAC
· How pre-competitive collaboration significantly catalyses manufacturing innovation in the industry
· Resultant effects upon overall manufacturing strategy
· How can you get involved in collaborative technological development for pharmaceutical manufacturing?
Clive Badman, Head of Pre-Competitive Collaboration , GSK
Clive is responsible for examining opportunities for collaboration in either Industry/Academia or Industry/Industry situations at GSK. The aim is to drive forward improvement, efficiency and technologies through pre-comoetitive collaboration. He has previously held positions at GSK including VP Investigational Materials Supply and VP Process Technologies and Pilot Plants.

img

Clive Badman

Head of Pre-Competitive Collaboration - GSK
Chairman - CMAC

TRACK A – Transforming Manufacturing Operations

3:10 PM - 3:50 PM ALL STAR PANEL Continuous Process Verification (CPV) - How can you optimise your data integrity, collection and integration to improve efficiency in your manufacturing systems?

Magda Papadaki, Head of Manufacturing Innovation, ABPI Thomas Wickert, Head of Microbial Fermentation & Enzymes, Roche Diagnostics , , Paul Hanson, Director Commercial Technical Operations, Takeda Mary Moran, Director - Manufacturing Science & Technology , Bristol Myers Squibb
· How can you best use CPV to demonstrate your products are being produced to the same standard of quality?
· How can you ensure your generated data is protected to meet data integrity regulatory requirements?
· How can you use MES to help with automated CPV?
· How can you make sure your automated CPV is visible, clear and key responsibilities are assigned?
· To what extent can you automate the data reporting and data collection?
· Are there any key areas where CPV implementation is falling behind and what can be put in place to improve?

img

Magda Papadaki

Head of Manufacturing Innovation
ABPI

Thomas Wickert

Head of Microbial Fermentation & Enzymes
Roche Diagnostics

Paul Hanson

Director Commercial Technical Operations
Takeda
img

Mary Moran

Director - Manufacturing Science & Technology
Bristol Myers Squibb

TRACK A – Transforming Manufacturing Operations

3:50 PM - 4:30 PM QUICK FIRE INNOVATION PRESENTATIONS

10 mins Localised sterile manufacturing for a high-value, low volume product
10 mins Single-use equipment
10 mins 3D Printing/Additive Manufacturing
10 mins Continuous manufacturing
Joint Q&A with audience

TRACK B – Digital Innovation

2:40 PM - 2:50 PM Opening remarks from the chair Bharath Sundararaman, Global Leader Supply Chain Visibility and Analytics, Merck

TRACK B – Digital Innovation

2:50 PM - 3:10 PM OUR STORY How to use advanced customer data analytics to improve your PLM (Product Lifecycle Management) and help develop a leaner and more flexible manufacturing strategy

Kumaran Krishnan, Associate Director MSL and Digital Transformation , Teva Pharmaceuticals
· How gaining greater visibility on the demands and usage of the patient can help refine manufacturing strategy
· Case study of using end to end data analysis, throughout a product's entire lifecycle and working from the patient backwards, let to Teva developing a leaner and more adaptive manufacturing strategy

Kumaran is currently based in Amsterdam where he is spearheading the digital transformation program for Teva across the entire organisation, across the entire supply chain. His deep understanding around the optimisation of the medical affairs function within pharmaceutical companies (having spent over a decade at Sanofi in various functions) gives him a unique view point on the knock on effect that greater visibility on demand from the patient will have upon manufacturing strategy.

img

Kumaran Krishnan

Associate Director MSL and Digital Transformation
Teva Pharmaceuticals

TRACK B – Digital Innovation

3:10 PM - 3:50 PM CASE STUDY INTERACTIVE How can implementing data analytics end-to-end and across all stakeholders in your manufacturing process achieve ultimate agility when dealing with the changing needs of your business?

· Where is the best place to start when implementing data analytics tools across your organisation?
· Which areas do you prioritise in order to get the best ROI early on?
· How can data analytics assit with providing significantly improved agility with your manufacturing strategy and the changing appetites of your organisation?
Bharath partners with senior supply chain and manufacturing executives across Merck in identifying opportunities to drive best in class performance through advanced statistics, data mining, rich visualisation and new technologies. He is responsible for driving digital transformation at Merck using big data, cloud and mobility, IoT and advanced analytics.

TRACK B – Digital Innovation

3:50 PM - 4:30 PM QUICK FIRE INNOVATION PRESENTATIONS

10 mins Big data analytics
10 mins Industrial cyber security
10 mins Cloud Platforms
10 mins MES/Automation
Joint Q&A with audience

SYNERGY WORKSHOPS Limited to 30 attendees

2:40 PM - 3:50 PM TALENT AND WORKFORCE WORKSHOP - What skills does your manufacturing talent need, how can you expand your network and how can you enable your people to embrace advanced manufacturing?

Sandra Lee, Managing Director - Operations, Accord Healthcare
· How to identify what areas of talent are lacking in your organisation
· How to decide how you will fill the talent gap – upskilling existing staff vs. internal recruitment vs. outsourcing recruitment
· How to develop relationships with Universities in order to support the future development of the local workforce
What are the best ways to expand your network and encourage talent to join your organisation?
Sandra Lee, Managing Director - Operations, Accord Healthcare
Sandra has held the position of Managing Director of Operations at Accord for almost five years, where she has been responsible for building the talent and workforce within the organistion in an effort to bolster the manufacturing capacity and grow in adherence with the companies strategies. Prior to Accord she held numerous senior production and manufacturing roles at Ciba Pharmaceuticals, Novartis, Boehringer Ingelheim and Fisher Clinical Services, with over 25 years of experience in industry.

img

Sandra Lee

Managing Director - Operations
Accord Healthcare

SYNERGY WORKSHOPS Limited to 30 attendees

3:50 PM - 5:30 PM CHANGE MANAGEMENT WORKSHOP – What are the simplest ways to engage your people in a new manufacturing strategy or technology?

Joe Codamo, Head of Operations , Sanofi
· What are the key challenges to managing organisational change and how can they be overcome?
· What are the best ways to achieve buy-in from across your organisation?
· How can you encourage a culture of innovation and transformation that will support a new manufacturing technology?
· How can you best respond to fears and uncertainty around adopting new manufacturing technology?
· How can you integrate new teams and new job functions within the wider business?

Joe is currently responsible for both biologics & chemistry operations at Sanofi's Vitry-sur-Seine site in Paris. He has held a number of senior leadership roles in biopharmaceutical development and manufacturing over the last 14 years including General Management, multi-product Project Management and MSAT at Patheon and DSM. He is an expert in fast-track technology transfers, scale-up and validation of mammalian cell culture bioprocesses. Joe is also an experienced and energetic change leader who has been involved in site specific and global culture change programs across bio manufacturing networks in Europe, USA and Australia.

img

Joe Codamo

Head of Operations
Sanofi

4:30 PM - 5:10 PM Afternoon Networking Break

5:10 PM - 5:30 PM INTER INDUSTRY GUEST SPEAKER - Why data is the new oil for digital manufacturing and how you can use it to gain a competitive advantage

Michael De Poortere, Global Analytical Technology Centre Director , Dow Chemical


img

Michael De Poortere

Global Analytical Technology Centre Director
Dow Chemical

5:30 PM - 6:00 PM INSPIRATIONAL GUEST SPEAKER – How to identify and mitigate cyber security risks in an ever more connected and data driven industry

Malcolm Warr, Chair, Tranzparency Group

img

Malcolm Warr

Chair
Tranzparency Group

6:00 PM - 6:30 PM Networking Reception

Your opportunity to relax, discuss challenges, exchange ideas and make new contacts in an informal setting!