Brendan FishNPI - PT DirectorGlaxoSmithKline

Andreas SchreinerTechnical R&D / Orals CH TechnologyPlatform LeaderNovartis

Martin H. DeardenCorporate MicrobiologistUCB

Michael LeaneSenior Research InvestigatorBristol-Myers Squibb

Peter JonesLead, Manufacturing Sciences &TechnologyOxford BioMedica

Jesús ZurdoHead of Innovation, BiopharmaDevelopment, Lonza Biologics

David LathburyVice President of Chemical DevelopmentAlbany Molecular Research

Simon CooperDirector, Process Development Technology & Scale-upMylan

Paul MatejtschukPrincipal ScientistNIBSC

Dave GervaisSenior Process ScientistHealth Protection Agency

Zoltan NagyProfessor of Chemical EngineeringPurdue University

Ronan O'KennedyHead of Cell Culture Process DevelopmentFujifilm Diosynth Biotechnologies

KEY SPEAKERS INCLUDE:

KEY BENEFITS OF ATTENDING:• Decrease development risks and overall costs for small molecule, biologic and ATMPs• Evaluate and consistently meet CQAs throughout development and production• Improve product value, maturity and performance • Streamline R&D and pre-market reviews• Increase regulatory compliance and flexibility• Meet patient needs and maximise performance requirements

SMi present their inaugural conference on...

Quality by DesignOptimising process development, manufacturing and performance

Wednesday 23rd & Thursday 24th January 2013, Copthorne Tara Hotel Kensington, London, UK

www.QbD-conference.comRegister online and receive full information on all of SMi’s conferencesAlternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

REGISTER BY 28TH SEPTEMBER AND RECEIVE A £300 DISCOUNTREGISTER BY 31ST OCTOBER AND RECEIVE A £100 DISCOUNT

Sponsored by

A: Quality by Design: The Route to Supply Chain Excellence

Workshop Leader: Hedley Rees, Managing Director, Biotech PharmaFlow

8.30am - 12.40pm

B: Quality by Design and Multivariate Analysis

Workshop Leader: Brad Swarbrick, Vice Presidentof Business Development, CAMO Software

8.30am - 4.30pm

PLUS TWO INTERACTIVE PRE–CONFERENCE WORKSHOPSTuesday 22nd January 2013, Copthorne Tara Hotel Kensington, London, UK

Register online at www.QbD-conference.com • Alternatively fax

8.30 Registration & Coffee

9.00 Chairman's Opening RemarksBrendan Fish, NPI - PT Director, GlaxoSmithKline

Quality & Process Analytical Concepts

OPENING ADDRESS9.10 Implementing QbD in early development

• The foundation stone of QbD is process understanding• Many observations made in early development are neglected until

later on in development• This represents a missed opportunityDavid Lathbury, Vice President of Chemical Development, AMRI

9.50 Drug substance design requirements• Biopharmaceutical and drug product manufacturing considerations

when optimising drug substance properties• Use of modelling tools and institutional knowledge to assist the

process • How to efficiently manage the QBD paradigm through the

development cycle Michael Leane, Senior Research Investigator, Bristol-Myers Squibb

10.30 Morning Coffee

10.50 Novel feedback control-based Quality by Design approaches forcrystallisation processes using composite PAT-array and acrystallisation process informatics system• Application of composite process analytical technology (PAT) array

for monitoring crystallisation processes.• Presentation of the Crystallisation Process Informatics System

(CryPRINS) as an intelligent decision support and control system forcrystallisation product design

• Direct design and rapid scale-up of crystallisation processes usingconcentration feedback control and automated direct nucleationcontrol (ADNC)

• Application of ADNC for the control of size, shape, polymorphic formand purity of pharmaceutical products

• Controlling crystal shape distribution using growth modifiers• Monitoring and control of continuous crystallisation systemsZoltan Nagy, Professor of Chemical Engineering, Purdue University

11.30 Scale-up and advances in drug substance design for solid oraldosage forms• Finding base matters that require low amounts of material and have

predictive values• Drug substance scale up challenges for synthesis and isolation• Finding the optimal route of synthesis for scale up• Case StudyAndreas Schreiner, Technical R&D / Orals CH Technology PlatformLeader, Novartis

12.10 Networking Lunch

1.30 Practical statistics for effective QbD in development from design ofexperiments to design space• Connecting the dots from the factory floor to the patient outcomes• Presenting statistical software solutions to achieve effectively QbD

in development• Numerous examples on processes, analytical procedures and bioassays• Effective implementation of Q8 applied from small molecules to vaccinesBruno Boulanger, CSO, Arlenda

Biopharmaceutical Development & Manufacturing

2.10 Early risk mitigation approaches for selecting & designing betterand safer biopharmaceuticals and avoid downstream complications• Where ‘research’ meets ‘development’. Selecting and designing

quality & functional attributes in lead candidates (pre-process QbD?)• Early assessment of developability & safety to reduce attrition and costs• In silico tools to predict and tune down developability &

immunogenicity issues• Early (surrogate) parameters for risk assessment. When the devil

is not in the detailJesús Zurdo, Head of Innovation, Biopharma Development, Lonza Biologics

2. 50 Designing quality into a biomanufacturing facility• Traditional D,I,O and P Qualification activities vs verification

following the ASTM E 2500 guideline- a paradigm shift• Facility verification against a nominal process (multi product

facilities). Choosing the product and process• Impact of Critical Quality Attributes (CQA), Critical Process

Parameters (CPP) and ICH Q 8 impact on traditional validationapproaches

• A new approach and lessons learned (ASTM E2500)Martin Dearden, Corporate Microbiologist, UCB

3.30 Afternoon Tea

3.50 The use of risk management to ensure the quality of viral vectors forclinical trial use• How do we ensure full traceability of starting materials for viral

vectors?• What are the risks associated with the starting material for GMP

manufacture of viral vectors?• How can the hazards be mitigated?• Possible issues due to the novelty of such IMPs and disease targets• Our experience to dateEleanor Berrie, Qualified Person, University of Oxford ClinicalBioManufacturing Facility

Panel Discussion4.30 QbD - where are we and what are the prospects for the future?

Panellists will share strategies to move therapeutic entities fromcreation to development and commercialisation. How can scientificevidence and molecular pharmacology best link with manufacturingprocess parameters and clinical activity relationships? Improvingreal-time monitoring, specifications and product analysis for APIs,excipients, biologics and ATMPs to maximise patient benefit will all be considered. Jesús Zurdo, Head of Innovation, Biopharma Development, Lonza BiologicsMartin Dearden, Corporate Microbiologist, UCB Eleanor Berrie, Qualified Person, University of Oxford ClinicalBioManufacturing FacilityMichael Leane, Senior Research Investigator, Bristol-Myers Squibb

5.10 Chairman's Closing Remarks and Close of Day One

Quality by DesignDay One | Wednesday 23rd January 2013 www.QbD-con

Supported by

Arlenda is a company of experts specialized in Applied Modelling and Statistics as well as statistical risk-preventionstrategies for the (bio-) pharmaceutical industry. Our consultancy services cover Early Clinical Phases, Non-Clinicaldevelopment and specialized software development for QbD implementation. For pharmaceutical development andmanufacturing, we provide advice and effectively implement the QbD paradigm. We also provide statistical solutionsdedicated to the life-cycle of processes and analytical methods. For research and early clinical development, we areproficient in the design and analysis of pre-clinical and clinical studies in a way that can maximize the success of newtreatments through the use of modelling and Bayesian methodologies. For more information, please visit Arlenda at:www.arlenda.com

West is a global manufacturer of components and systems for injectable drug delivery, including stoppers and seals forvials, and closures and disposable components used in syringe, IV and blood collection systems. The Company alsoprovides products with application to the personal care, food and beverage markets. Headquartered in Lionville,Pennsylvania, West supports its partners and customers from 50 locations throughout North America, South America,Europe, Mexico, Japan, Asia and Australia. For more information, please visit West at: www.westpharma.com.

Sponsored by

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and brandingpackages, uniquely tailored to complement your company’smarketing strategy. Prime networking opportunities exist

to entertain, enhance and expand your client base within thecontext of an independent discussion specific to your industry.Should you wish to join the increasing number of companies

benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or

email: amalick@smi-online.co.uk

Want to know how you can get involved? Interested inpromoting your pharmaceutical services to this market?

Contact Margaret Mugema, SMi Marketing on +44 (0) 20 7827 6072 or email mmugema@smi-online.co.uk

your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

8.30 Registration & Coffee

9.00 Chairman's Opening RemarksPeter Jones, Lead, Manufacturing Sciences and Technology, OxfordBioMedica

Critical Process Parameters and Critical Quality Attributes

OPENING ADDRESS9.10 Using QbD & PAT to enhance process understanding

• Managing the high dimensional data available from PAT• Maximising the information extracted from data• Risk-based decision making from available knowledge• Understanding the benefits of the approachesGary Montague, Head, School of Chemical Engineering and AdvancedMaterials, Newcastle University

9.50 Decisional tools for the design of robust and cost-effectivebioprocesses • Decisional tools work carried out in the EPSRC Centre for Innovative

Manufacturing in emergent macromolecular therapies • Tools enabling greater process understanding through modelling and

optimisation and hence help achieve QbD• Demonstration of tools with case studies on the optimisation of

purification sequence, equipment sizing and operating parameters ofbiopharmaceutical manufacturing processes

Sofia Simaria, Research Associate, Biochemical Engineering,University College London

10.30 Morning Coffee

10.50 Using design of experiment in the lyophilisation of biological materials • Lyophilization: the process benefits & challenges • Application of DoE in formulation development • Model studies of DoE in formulation development• Considerations for DoE in freeze drying cycle optimisationPaul Matejtschuk, Principal Scientist, NIBSC

11.30 New elastomeric formulation and the relevance of QBD in primarypackaging development• Lyophilization stoppers and moisture content in lyophilized drugs• New generation elastomeric materials for parenteral applications• Clean seals and new plastic closures for lyophilized drug productsSascha Karhoefer, Manager, Injectable Container Solutions, WestPharma

12.10 Networking Lunch

Optimising Process Development

1.30 Implementing product and process monitoring in biopharmaceuticalmanufacturing• Understanding the link between process variables and product quality

attributes • Demonstration of the effect of process changes on both in-process

intermediates and final product quality• Utilising historical manufacturing data to establish acceptable ranges

for process variables• Conducting process validation batches on legacy products, using in-

process and final product monitoringDave Gervais, Senior Process Scientist, Health Protection Agency

2.10 Formulation problems for inhaled generics • Defining the product profile • Understanding the design space? • Building a design space as applied to blendingSimon Cooper, Director, Process Development Technology & Scale-up,Mylan

2. 50 Process design to process qualification and beyond• Using data in early-phase manufacturing for QbD• Benefits for a fuller QbD programme• Decreasing QbD timelines by effective use of early phase dataRonan O'Kennedy, Head of Cell Culture Process Development, FujifilmDiosynth Biotechnologies

3.30 Afternoon Tea

3.50 How the key principles of PAT can reduce business risk in the supplychain• How data collection and analysis leads to process understanding• How the reduction of waste can be achieved throughout the supply

chain process• How you must understand the system and how it changes• How you can embed the approach in your organisationTom Cochrane, Business Process Development Manager, NappPharmaceuticals

4.30 Chairman’s Closing Remarks and Close of Day Two

Quality by DesignDay Two | Thursday 24th January 2013nference.com

Who should attend:Chief Executive Officers, Chief Scientific Officers, Chief Technology Officers, Vice Presidents,Professors, Heads, Directors, Principal Scientists, Managers, Project/Team Leaders in:

• Active Pharmaceutical Ingredients • Advanced Analytical Sciences/Analytical

Development• Vaccine Development and Production• Antibody Development and Production• Advanced Therapy Medicinal Products• Materials Science• Chemical Engineering• Chemistry, Manufacturing and Control

• Research and Development• Tabletting • Process Analytical Technology • Laboratory Information Management Systems • Product Lifecycle Management • Good Manufacturing Practice • Formulation Science • Stability Testing• Lyophilisation

Overview of workshopThis workshop explores the underpinning principles of QbD as theyrelate to building, managing and perfecting supply chains that cancompete on a world stage.

The contention throughout is that early engagement in drugdiscovery and development is the only sustainable way to build thevital foundation for success. The workshop will demonstrate how theEnd-to-end supply chain (i.e. production system) starts with theconsumer’s (patient) definition of value, and aligns a value stream todeliver fit-for-purpose products into patient hands.

Why you should attend:• Discover practical ways to remediate deep-rooted supply chain

issues using QbD• Learn the regulator’s expectations for supply chain integrity

improvement and compliance to GDP• Work through issues in the end-to-end supply chain, in teams,

based on a case study simulation• Study the critical activities that must take place to prepare a

clinical supply chain for commercial launch using a real-lifecase study of a $1bn drug

Programme8.30 Registration and coffee

9.00 Organising for supply chain success through theproduction system• Defining stakeholder involvement and responsibilities• Voice of the customer (VoC) and critical-to-quality

attributes (CTQs)• Aligning the value stream

10.00 Case study problem for the group to map a typicalsupply chain.• Mapping the end-to-end supply chain• Carrying out a maturity path assessment (MPA)• Group review of current state value stream map

11.20 Coffee break

11.40 Finding issues/opportunities for QbD and developing afuture state. • Using lean thinking to drive out Value Stream waste• What QbD can learn from modern production systems• Developing a blueprint for success

12.40 End of workshop

About the workshop hostHedley Rees is a consultant in Pharmaceutical SupplyChain Management. Assignments span early stageclinical trial supply chains up to complex multi-productsupply networks. Prior to this, Hedley held seniorpositions at Bayer, British Biotech, Vernalis, Johnson &Johnson and OSI Pharmaceuticals. He graduated as aproduction engineer from the University of Wales and

holds an Executive MBA from Cranfield University School ofManagement. He is a corporate member of the Chartered Instituteof Purchasing and Supply (MCIPS), a former member of the UKBioIndustry Association’s (BIA) Manufacturing Advisory Committeeand on the Advisory Boards of the International Institute for AdvancedPurchasing & Supply (IIAPS) and Marken. Hedley is author of “SupplyChain Management in the Drug Industry”, published by J Wiley &Sons, NJ.

About Biotech PharmaFlowBiotech PharmaFlow are specialists in providing supply-chainmanagement services to the pharmaceutical sector. We helpsponsor companies and their key stakeholders to release value,excess cost and risk vulnerability from their supply-chains, as theybring new molecular entities through to market or marketingpartners. Utilising appropriate tools, techniques and processesdeveloped through over 25 years experience in the industry,PharmaFlow can deliver responsive, resilient and cost effectivesupply-chains at any and every stage of development andcommercialisation.

Who can benefit from our services?If you are a sponsor company in Pharmaceuticals, Biotech orBiopharmaceuticals, a Contract Manufacturing Organisation, aContract Research Organisation, a Third Party Logistics ServiceProvider, Venture Capitalist or University Innovator, PharmaFlowcan help with your value proposition.

In association with

HALF-DAY PRE-CONFERENCE WORKSHOP

Tuesday 22nd January 20138.30am – 12.40pm

Copthorne Tara Hotel Kensington, London, UK

A: Quality by Design: The Routeto Supply Chain Excellence

Workshop Leader: Hedley Rees, Managing Director, Biotech PharmaFlow

Overview of workshopMultivariate data analysis (MVA) and design of experiments (DoE)are powerful analytical tools that play a key role in theimplementation of QbD initiatives. They enable deeper product andprocess understanding at each stage of the product lifecycle, byidentifying the underlying variables and the relationships betweenthem in complex data sets. Through better process understanding,organisations can implement more effective control strategies andaddress potential quality issues at an early stage.

Why you should attend:• Receive regulatory guidance pointing to the use of MVA

and DoE methodology• Critically assess the importance of MVA and DoE in the

successful implementation of QbD• Interpret the outputs of DoE and MVA for better understanding

and continuous improvement• Understand the concept of Multivariate Statistical Process

Control and how it compliments current measurement methods• Learn how to integrate DoE and MVA in practice (high level

explanation)

ProgrammePart 1: The link between the new FDA Process ValidationGuidance and Quality by Design8.30 Registration and coffee 9.00 The new FDA guidance on Process Validation

• How this differs from previous guidance• How the new guidance supports QbD

10.00 Case study: application of guidance to a solid dose unitoperation.

11.30 Coffee break 11.50 Pragmatic use of the guidance to achieve QbD for new

and legacy products. 12.50 End of part 1

Part 2: High level overview of the role of Multivariate Analysisfor achieving QbD and PAT objectives1.30 An introduction to the principles of multivariate

analysis• Regulatory guidance pointing to the use of

Multivariate Analysis (MVA) and Design of Experiment(DoE) methodology

• The importance of MVA and DoE in the successfulimplementation of QbD

3.00 Coffee break3.20 Examples of the application of DoE and MVA to process data4.10 Conclusions and considerations when making QbD

regulatory submissions4.30 End of part 2

About CAMO SoftwareFounded in 1984, CAMO Software is a recognized leader inMultivariate Data Analysis and Design of Experiments software.

More than 25,000 people in 3,000 organizations rely on TheUnscrambler® X software range for its ease of use, powerfulmultivariate methods and outstanding data visualization tools. It letsthem explore and understand complex data, improve process orequipment monitoring and build better predictive models.

Our powerful analytical solutions are used in the life sciences,manufacturing, energy, resources and technology sectors, enablingorganizations to reduce R&D costs, improve process and productquality and make more informed decisions through deeper datainsights. www.camo.com

About the workshop hostBrad Swarbrick is Vice President of Business Development at CAMOSoftware AS. He has over 20 years’ experience in applyingmultivariate analysis and design of experiment methodology in awide range industry segments including agriculture,pharmaceuticals and petrochemicals.

Brad was part of Pfizer’s Global PAT team in 2002 and from theremoved to Sigma Pharmaceuticals where he developed the entire PATprogram, specializing in applying NIR spectroscopy to processunderstanding. In 2006, Brad worked as a senior consultant inprocess analytics and statistics for SeerPharma, SE Asia’s largestpharmaceutical consultancy.

In 2008, Brad moved to CAMO software to further develop industryawareness of MVA and DoE methodology. He currently oversees thedevelopment and commercialization of software solutions forprocess applications and is active in a number of working groupson process communications and PAT/QbD.

In association with

FULL-DAY PRE-CONFERENCE WORKSHOP

Tuesday 22nd January 20138.30am – 4.30pm

Copthorne Tara Hotel Kensington, London, UK

B: Quality by Design: and Multivariate Analysise

Workshop Leader: Brad Swarbrick, Vice President of BusinessDevelopment, CAMO Software

QUALITY BY DESIGNConference: Wednesday 23rd & Thursday 24th January 2013, Copthorne Tara Hotel Kensington, London, UK Workshops: Tuesday 22nd January 2013, Copthorne Tara Hotel Kensington, London, UK

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