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  • Process & performance improvement
  • Regulatory compliance
  • Engineering, facilities & technology
  • Supply chain integration

DAY 1, 1 December 2014

12:00-12:50
12:50-13:00
13:00-13:35
keynote

Nurturing a high-performance culture: the critical contribution and stability of senior talent

  • Creating a dynamic company - actively encouraging individuals and giving support to apply knowledge in a smarter way and to come up with creative, well-reasoned solutions
  • Attracting the best talent - appealing to a work-force from over 30 different countries
  • Implementing high potential and talent management programmes - develop and grow the most promising management of the future

Helen Barry
HR Director
Lake Region Medical
Ireland

13:35-14:10
keynote

Launch of Operational Excellence program in March 2014

Top down approach with first step: training (of 80% of Site staff); 8 waste and 5 S deployment

Implementation of visual management on shop floor and set a management cockpit across function

Value stream map analysis- identification of main saving potential

Set KPI and launch action plan on main potential saving

Track and report saving (reduction of deviation, improvement of documentation quality; reduction of throughput time)

Frédéric Zwahlen
Vice President Supply Chain
Vifor SA
Switzerland

14:10-14:45
workshop

Spray dried dispersions offer an effective and scalable approach for improving drug bioavailability

 

 

  • Specific topics that will be discussed include:
  1. The selection and optimisation of robust SDD formulations
  2. Spray drying scale-up using a Quality-by-Design (QbD) framework; and
  3. Process design considerations for manufacturing dispersions with highly potent active pharmaceutical ingredients (API’s)

Becky Taillon
Group Leader for Spray Drying Process Development
Bend Research part of Capsugels Dose Form Solutions

workshop

The significant growth in the pharma sector in the Middle East presents certain challenges that can be turned into opportunities.  King Abdullah Economic City, in Saudi Arabia, is a major contributor to creating these opportunities and thus a destination for drug manufacturers.

  • A dedicated clean zone for pharmaceutical cluster in the new logistics and manufacturing hub on the Red Sea
  • 100% foreign ownership
  • Access to Saudi Arabia, the fastest growth market in the Middle East, GCC and beyond  
  • A fully integrated city with a relaxed live-work-play environment 

Rowan M Kelly
Senior Director, Head of Business Development IV
EMAAREC
Saudi Arabia

14:45-14:50
14:50-15:25
process & performance improvement

Principles of problem solving and continuous improvement

 

  • Building and deploying robust training and coaching plan, creating behavioral standards
  • Prioritising the “right” problems / opportunities
  • Visualisation and follow-up
  • Recognising success
  • Tackle the most common pitfall, adapt to fit your organisation’s main difficulties
  • Extending the concept to benefit the whole supply-chain

Guenaelle Piou
Lean Coach
Astrazeneca
Sweden

regulatory compliance

Updating systems efficiently with assurances throughout the lifecycle of the product

  • Breaking the tradition - how to get regulators on board when replacing testing with improved equipment
  • What exactly the regulator wants to see in order to pass the audit first time round
  • Exploring the future of audits from ‘tick-box’ to other measures of effectiveness that ensure quality control and satisfy regulatory demands

 

Michael Chetcuti
Quality Assessor
Malta Medicines Authority
Malta

engineering, facilities & technology

The Biopharmaceutical industry is more than 30 years old. Increasing requirements from regulatory authorities and demand for biopharmaceuticals has led to ever growing layers of complexity around equipment and facilities that are essentially based on traditional chemical engineering and stainless steel technology.

  • As such, compliance comes at a steadily increasing capital and operational cost and together with overall declining R&D productivity and intensifying pressure on pricing this leads to a non-sustainable downward spiral for the pharmaceutical industry
  • New approaches towards how biopharmaceutical processes are developed and manufacturing are absolutely needed
  • Major advances have been achieved in the last decade with regard to process design, productivity and the development of new technologies based on single-use technologies. The next frontier is a rethinking of facility lay-out and biomanufacturing in general that enables to tackle the social, demographic and environmental challenges ahead while remaining economically sustainable

Matthew Sanders
Director, Process Architecture Improvement
GSK
Belgium

supply chain integration

Aligning working practices through structured communication processes in order to form a successful partnership

 

 

  • Harmonise and simplify Supply Chain and Vendor Management Systems through 'Client' organisation in collaboration with Outsourced Manufacturing Committee stakeholders

  • Risk Management, identify, analyse, evaluate and remediate potential risks related to vendor management activities from key stakeholders

  • Building a governance structure with appropriate parties at all levels in order to harness the expertise of your CMO

  • Integrating vendors into the company management structure to maintain open communication and collaboration to meet long-term objectives
  • Collaborating with smaller suppliers by incorporating banks as a third party to facilitate finance and allow business transactions

Hitesh Varambhia
Interim Director, Head of External Manufacturing APAC, Corporate QA Commercial Pharma
UCB
Belgium

15:25-15:30
15:30-16:05
workshop

Creating a culture of sustained continuous improvement in global pharmaceutical warehousing for GSK

 The programme to implement operational excellence across GSK’s global warehousing network is on track to exceed all targets. Shay Keane, GSK’s Global Lean Warehousing Lead, will bring to life this journey and leave delegates with thought-provoking action points of how to achieve operational excellence in any pharmaceutical warehousing environment. He will discuss:

 

  • The critical importance of engaging and coaching employees to ensure they have the skills and confidence to sustain and continuously improve performance
  • The significance of training and coaching site leaders in operational excellence and the managerial style and behaviours  that are required to sustain it
  • The creation of ‘model sites’ that show how everything works together in a harmonised system, which can then be used to inspire sites joining the programme later.

Paul Brooks
Consulting
Unipart

workshop

Gain total control over your extended supply chain through integrated messaging, applications, and data analytics across your network of collaborating and trading partners

  • Frictionless Commerce – Share information and transact seamlessly across your global trading partner network
  • Clear Visibility – Answer key questions; “where are my materials?”, “was my booking confirmed?”,  “when did the product arrive at customer?”
  • Market Driven – Build outside-in flexibility supply that quickly responds to external drivers and disparate demands
  • ERP Agnostic – Get unstuck – a ‘Come-As-You-Are’ approach removes traditional integration and collaboration  barriers
  • Highly Scalable and Secure – Powered by latest generation Infrastructure and Platform as a Service technologies (IaaS and PaaS).  The ‘Network Effect’ maximises benefits and accelerates value from key supply chain functions

 

Robert Nientker
Senior Sales Executive
Elemica
Netherlands

16:05-17:00
17:00-17:35
process & performance improvement

Case study / examples how to transform offerings and commercial models together with hospitals to deliver
greater economic value and optimise healthcare delivery with:

 

•Lean / operational excellence

•Investigating lab managed services

•Care pathway management

Tim Schwarting
Program/Project Manager, Device Manufacturing & Development, LSS Black Belt
Medtronic
Denmark

regulatory compliance

Achieving incorporated QbD principles through a combination of innovative, robust process analytics, model-predictive control and flexible automation

  • Fully engaging with IT stakeholders and data quality from the offset as full QbD starts from a comprehensive control strategy of raw materials and cell banks
  • Reducing timelines through an integrated centralised data management concept so drugs pass through the FDA filing processes significantly faster
  • Understanding the business case for a QbD drug – examining the longer term financial savings

Dr Bhupinder Singh Bhoop
Dean Faculty of Pharmaceutical Sciences
Education Institution
India

engineering, facilities & technology

Simple and effective solutions has created the change and increased out put:

  • LEAN initiatives and creating a continuous improving culture
  • Dynamic planning and scheduling on the shop floor
  • Manage change in an ever changing world of variation
  • Connecting flows through serialising

Niels Lynge Agerbæk
Director, Operations
Xellia
Denmark

supply chain integration

Practical challenges of serialisation, opportunities and  some latest developments in the industry at the MES & process minds  

  • Serialisation: What is the impact and what are the timelines?
  • Why you need to act NOW, which –hidden- challenges you need to overcome and what you can do about them
  • The future of serialisation and how you or the industry should be prepared for it

Marcel De Grutter
Business Technology Head Operation/QC - Established Pharmaceutical Division IT
Abbott Laboratories
The Netherlands

17:35-17:40
17:40-18:15
keynote

How Lundbeck encouraged and inspired the organisation and gradually transformed it to a Lean culture 

  • How leadership development was utilised to build the Lean culture and the right leadership behaviour
  • How Lundbeck drive the principles of operational excellence into the organisation and the minds and hearts of the employees
  • Lundbeck was recognised with a SHINGO Silver Medallion in 2012 as the first European company and the first pharmaceutical company globally

Christian Houborg
Vice President, Service and Technical Operations and Lean
Lundbeck
Denmark

18:15-18:25

DAY 2, 2 December 2014

07:30-08:00
08:00-08:45
keynote

Oral solid dose formulation & manufacturing considerations for high potency compounds

 

 

Liquid fill hard capsule (LFHC) and soft gel formulations offer optimal safety in formulation, scale-up and manufacturing of challenging compounds.  This presentation will address scientific and practical aspects of process design relative to pharmaceutical development, scale-up and commercial production of LFHC-based formulations.

 Specific topics that will be discussed include:

  • Formulation and application considerations using lipid, liquid and semi-solid technologies
  • Key considerations and steps required for safe and effective drug formulation using LFHC and soft gels
  • Safe handling protocols and infrastructure considerations in commercial scale manufacturing

Alyn McNaughton
Director of Analytical and Developemtn Sciences, Encap Drug Delivery
Capsugel
UK

08:45-08:50
08:50-09:00
09:00-09:35
keynote

Predicting the regulatory landscape over the next five years

  • Will the trend for increasing regulations continue despite rising costs?
  • Overcoming the challenges of rising costs and increased regulations to remain competitive
  • Developing a robust communication strategy between pharma companies and regulatory bodies

Dr Keith Chidwick
Pharmaceutical Assessor
MHRA

09:35-10:10
keynote

Design review of existing assembly lines with all stakeholders involved in workshops (12 workshops with Operators, Technicians, Engineers and Supplier)

  • Nearly 200 ideas collected, prioritised, consolidated. More than 75 % translated into design
  • Close collaboration with supplier during design phase (Novo reps present on supplier site)
  • 10 weeks test program at supplier. Assembly line run by Novo operators and technicians (mirroring Novo production setup)
  • Thorough validation (FAT, SAT, IQ-OQ-PQ)
  • Training program
  • Established performance management framework linking KPI from Mangement level to shopfloor based on data and lean principles
  • Very promising performance data after startup of production

Carsten Thorngreen
Director, Pre-Assembly Production in Device Manufacturing & Sourcing
Novo Nordisk
Denmark

Morten Søvndahl Johannessen
Lean Partner, Pre-Assembly Production in Device Manufacturing & Sourcing
Novo Nordisk
Denmark

10:10-11:30
11:30-12:05
process & performance improvement

Integrating Lean and Six Sigma into all aspects of daily activities to improve efficiency by altering description emphasis

  • Transforming a programme to a culture by amending wording to reflect the day-in, day-out efficient routine
  • Re-branding improvement programmes as need-based systems where a lacking is identified and tools deployed in the most efficient manner
  • Developing a work-force that are capable of acting proficiently, using Lean and Six Sigma, but are unaware of this complete integration

Deirdre Cooney
Director Operational Excellence
Amgen
Ireland

regulatory compliance

Visualisation and driving Operational Efficiencies

 
 
  • The challenges associated with standardisation in a multi-national corporation are large, but there are strong business and technical drivers for a standardised IT and Automation Systems Portfolio.
  • Having a common technical platform is a key enabler for effective, efficient and compliant data integration and reporting.
  • The role of Governance is critical in ensuring that source solutions are maintained and that the right information is presented to the right people at the right time.

 

 

 

Richard Williams
Lead, Manufacturing IT
Eli Lilly
UK

engineering, facilities & technology

A comprehensive study in applications of PAT, MVDA, DoE,and QbD

 

The first 7 levels of PAT

  • Development of reproducible fully automated processes
  • Plant characterisation and simple model based control
  • Enhanced target product and substrate at-line monitoring
  • Applications of spectroscopic analysis and MVDA for in-line monitoring of substrates and products
  • Process modelling and parameter identification with DoE
  • Upstream optimisation with a fully automated multi-bioreactor
  • QbD compliant process development-from risk analysis to the design and control space

Prof. Dr. Ing Reiner Luttmann
Head of Research of Bioprocess Engineering Analytical Techniques
Hamburg University of Applied Sciences
Germany

supply chain integration

The Falsified Medicines Directive (FMD) is the biggest event to happen within the European supply chain for decades and introduces measures to strengthen the legitimate supply chain.  But how will it impact the illegal supply chains via the internet?

 

  • The rise of counterfeit medicines sold via illegal websites takes patients outside of their national health systems and is harming patients.
  • The introduction of .pharmacy (dotpharmacy) as a Generic Top Level Domain name (gTLD) along with the Common Logo (part of the FMD) represents big opportunities that need to be turned in to success stories. 
  • Collaborative actions involving all stakeholders will be discussed as a way forward to realise and safeguard these milestone opportunities.

Mike Isles
Executive Director
European Alliance for Access to Safer Medicines
UK

12:05-12:10
12:10-12:45
workshop

Global quality workflow:  How automating a risk-based quality management system can streamline the complex quality lifecycle

 

 

•  The challenges of a complex product lifecycle
•  
How organisations can overcome manual processes, and implement an automated global quality workflow
•  
How risk management improves the level and efficiency of compliance
•  
The various risk management tools available to streamline compliance in the automated QMS
•  
How one company began their journey to operational excellence with a global quality workflow

 

 

Alexandre Alain
Life Science Product Manager
EtQ, Inc.

workshop

Operational excellence + simulations: Bringing predictive analysis to biotech

 

  • Using Operational Excellence as a starting point for simulations
  • Using real data from your plant historians to build predictive simulations
  • How simulations can help increase throughput by 30% or more with little or no capital investment?
  • Case studies with, and without, a simulation model to show the benefit to manufacturers

Rick Johnston
Founder and Principal
Bio-G

workshop

Future proofing pharma operations in the world of adverse change

 

 

  • Overcoming the many barriers to effective operations.
  • Understanding cost drivers in a world where we measure conversion cost, but do not know how to change it.
  • Optimising Cost of Operations while enhancing flexibility by using differentiated planning architectures.
  • Thinking end To end and rightsizing and positioning Inventory, so that it adds value to the business.
  • Thinking outside of the box of legacy thinking and lean posturing.

Dr John Harhen
Director
Orbsen Consulting
Ireland

12:45-12:50
12:50-13:25
13:25-14:30
14:30-15:05
process & performance improvement

Is lean thinking the antidote for lazy thinking?

 

  • Six business case studies of how lean transformation exposed and transformed lazy thinking to lean thinking
  • Design for success: create artificially what you hoped would occur naturally
  • Reduce defects: when increase speed caused increase quality 
  • Customer centric: why all the questions, all the time 
  • Lazy layout: we never knew the rules but we obeyed
  • Crazy planning: how can they work like that? 
  • Lean Journey: it’s more than a mapping exercise.

Dermot O'Rourke
Site Operational Excellence Lead
Ipsen
Ireland

regulatory compliance

Guaranteeing validation robustness throughout the manufacturing process through a repeatable system to ensure compliancy requirements

  • Measuring and evaluating process stability and process capability in order to meet regulatory requirements and guarantee quality
  • Meeting the GAMP guidelines for computer validation and 21 CFR Part 11 for electronic records to ensure integrity and reliability of records
  • Building validation as part of the complete life cycle of a computer system in order to satisfy Annex 11 of the European GMP directive

Thurloch O'Criodain
Global Lead Quality Steward
Novartis
Switzerland

supply chain integration

Lowering process costs and improving supplier integration through improved efficiency of supply chain management

 

  • Developing visibility across partners and obtaining efficiencies through end to end process and network optimisation
  • Understand main drivers and key challenges during the redesign of complex supply chains
  • Using supply chain as a source of competitive advantage

Murillo Xavier
Strategic Development, Industry Standard Servers (ISS) Supply chain
HP
US

15:05-15:10
15:10-15:45

Process & performance improvement

  • Transforming OPEX into a company mind-set
  • Creating sustainable improvement
  • Establishing the next level of OPEX

    

 

Regulatory Compliance

  • Implementing the most effective quality KPIs
  • Increasing efficiency whilst maintaining quality
  • Reducing complexity of operations while managing risk

 

Engineering facilities and technology

  • Further reducing contamination in clean rooms
  • Certifying quality and reliability during equipment procurement
  • Safe and efficient API production

 

Supply chain integration

  • Reducing time to market
  • Adhering to varied serialisation legislation
  • Guaranteeing global track and trace compliance


15:45-16:45
16:45-17:20
keynote

What is the future of the use of data and technology in the pharmaceutical industry?

  • Shop-floor data metrics – the impact of hand-held devices at the manufacturing stage
  • Connecting patients to the manufacturers in order to assess supply and demand in real-time
  • Exploring the potential impact this will have on the pharma manufacturing industry

Joaquín Santos Benito
Senior Director External Supply Integration
Janssen
Spain

17:20-17:25
17:25-18:00
18:00-18:15
18:15-19:15

DAY 3, 3 December 2014

07:30-08:00
08:00-08:50
08:50-09:00
09:00-09:35
keynote

Driving continuous improvement though the company vision to build a highly engaged and adaptable workforce

 

  • Integrating VSMs into the CII process to create a scheduled pipeline of products that reduces costs
  • Employing the CII process to map the extended supply chain, from tier two raw material suppliers, through to primary and secondary distribution centres
  • Making the customer central by running a customer connection programme on site

Franck Demarest
Lead
Rexam
France

09:35-10:10
keynote

Designing and executing serialisation programs under capital and resource constraints

  • Where to start thinking about serialisation programs
  • Cost saving strategies for CMOs before, during and after serialisation programs
  • How to help your CMOs to align their serialisation objectives and timeline
  • What if you are too late? How to expedite serialisation programs
  • CMO network risk assessment & management strategies to ensure minimum disruption of supply

Dr. Evren Ozkaya
Founder, CEO
Supply Chain Wizard
US

10:10-11:30
11:30-12:05
process & performance improvement

Consolidating the right combination of tools to enhance processing systems and deliver high quality products under intense time constraints

AstraZeneca logo

  • Deploying effective systems to accelerate drug development processes to support clinical programmes and commercial supply chains in operations under the severe pressures of compressed timelines
  • Exploring the latest advancements in the pharmaceutical development field which have the potential to expedite the delivery of robust products and processes, whilst enabling rapid commercialisation
  • Reviewing examples of innovation in predictive science, automation, process analytical technology and advanced manufacturing technologies with reference to applications in drug development programmes


Marcel de Matas
Principle Scientist Product Design & Innovation
Astrazeneca
UK

regulatory compliance

Finding the right balance between excellence, efficiency and speed

  • Step by Step guide to QbD Implementation in Generic Industry
  • Utilisation of the right tools and methodologies to achieve the desired balance between speed and excellence
  • Desired state vs. Current state-how to get there
  • QbD as an enabler of bringing the highest quality robust products to the market

Meital Cohen
R&D, QbD and DOE lead
Teva
Israel

engineering, facilities & technology

This initiative is the one started to be implemented in our Biotech Division 3 years ago and it is by far the most successful one of our continuous improvement program.

 

  • DDFP is the results of our several lessons learnt on trying to eliminate the human error due to the interaction between the technician and the different elements of the process such as equipment, tools, material, etc.
  • Elimination of product discards, reduction on deviations, yield improvement and much better analysis during our Capa investigation as well as safety improvement  are the main benefits that the company has been obtained from this initiative.
  • DDFP is today the main element of our Compliance Excellence program and it is highly appreciated by authorities.

Victor Torres
Global Engineering Director
Baxter
France

12:05-12:10
12:10-12:45
12:45-14:15
14:15-15:00
keynote-think tank

Assessing the trend for product volume to reduce whilst number of products increases

(An interactive panel discussion focusing on thought provoking challenges being led by the speaker. Opportunity to have the audience involved by posing challenges or tasks to be completed as a group)

  • Addressing the increasing pipeline in order to maintain profitability long-term
  • Balancing the increasing costly quality requirements with decreasing margins
  • Delivering the complexity in the supply chain caused by the change in model

Dr. Evren Ozkaya
Founder, CEO
Supply Chain Wizard
US

15:00-15:10