Michael KellerPDU Parenteral, Topical and siRNA LeadNovartis

Andy LewisDirectorIpsen

Petra WicklandtCMC DevelopmentMerck

Howard StevensProfessor of Exploratory Drug DiscoveryUniversity of Strathclyde

David ElderExternalisation DirectorGlaxoSmithKline

Monica RosaDirectorSigmoidPharma

Navnit ShahDistinguished ScientistRoche

Mark WilsonDirector, Collaboration ManagementGlaxoSmithKline

Dmitry SamarskyTechnology & Business DevelopmentRibobio

Richard ElkesSenior Research ScientistMerck KGaA

KEY SPEAKERS INCLUDE:

The only conference in Europe to focus specifically on controlled release:• Discover the very latest developments in this innovative and booming industry • New for 2013:

- Investigating structure-activity relationships of siRNA nanoparticles- Challenges of pre-clinical gastro-retentive dosage form development- Numerous case studies from big pharma laboratories – such as GSKs formulation

development programme• Meet, share knowledge and do business with key industry professionals, leadingacademics and healthcare representatives

INTERACTIVE HALF DAY WORKSHOPWednesday 20th March 2013, Copthorne Tara Hotel, London, UK

SMi present their 10th annual conference on…

Controlled ReleaseMonday 18th and Tuesday 19th March 2013

Copthorne Tara Hotel, London, UK

REGISTER BY 7TH DECEMBER AND RECEIVE A £300 DISCOUNTREGISTER BY 18TH JANUARY AND RECEIVE A £200 DISCOUNT

SMART Formulation design: Tools and strategies for complex formulation design and problem solving

Workshop Leaders: Howard Stevens, Chairman, Bio-Images Group LtdCarol Thomson, COO, Drug Delivery International

8.30am – 12.30pm

www.controlledrelease.co.ukRegister 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

Sponsored by

Register online at www.controlledrelease.co.uk • Alternatively fa

Supported by

8.30 Registration and Coffee

9.00 Chairman's Opening RemarksHoward Stevens, Professor, University of Strathclyde

9.10 Development and Scale-Up of Controlled Release Formulations:An Industrial Perspective• Choices among controlled-release approaches for product

formulation• Issues and challenges in the development of controlled-release

products• Scale-up and development considerations, problems and

approaches• The origins and development of the DiffCORETM controlled

release technology• Case study of a formulation development programmeMark Wilson, Director, Collaboration Management,GlaxoSmithKline

9.50 How to optimise the CMC deliverables in times of decreasingresources and increasing requirements• CMC resources are limited and restructuring processes and

efficiency programmes lead to decreasing resources• At the same time challenging drug properties and drug delivery

technologies together with regulatory requirements areincreasing resource demand

• Merck concepts of clear differentiation according to priority• Medium priority are applied via "minimal paradigm" - Success

triggered resourcing taking into account potential delays due toCMC deliverables

• Which CMC deliverables are regarded as minimal for each phaseand what can be backloaded?

Petra Wicklandt, CMC- Development, Merck & Co

10.30 Morning Coffee

Development of time delayed peptide delivery

11.00 Patient focussed peptide delivery• Limitations of established methods of peptide delivery• Integrating the needs and requirements of patients into the

development of peptide drug products• Future prospects for the peptide deliveryAndy Lewis, Director Novel Formulation Technologies, Ipsen

11.40 Time delayed drug delivery - The Chronotherapeutic Challenge• Commercial opportunities of chronotherapeutics• Pharmaceutical formulation - the drug delivery challenge• Visualisation of drug release in humans• Chronotherapeutic clinical development case studiesHoward Stevens, Professor, University Of Strathclyde

12.20 Networking Lunch

RNA and controlled release drug delivery

1.50 Self assembled siRNA/chitosan nanoparticles: processparameters, structure and bioactivity in vitro and vivo• Investigating structure-activity relationships of siRNA

nanoparticles• Polymer based siRNA nanoparticles: a QbD approach• The importance to control and define excipient quality for the

final DPMichael Keller, Senior Fellow, siRNA Project Leader, TechnicalResearch and Development (TRD), Novartis Pharma

2.30 Non-viral delivery of self-amplifying RNA vaccines• Novartis has developed the SAM vaccine platform• The platform takes advantage of cell-free RNA production from

a transcription reaction and delivery with a synthetic deliverysystem

• The broad utility of this novel vaccine technology has beendemonstrated with genes encoding antigens from severalpathogens and found to elicit broad and potent protectiveimmune responses

• Responses are comparable to viral delivery technology, butwithout the inherent limitations of viral vectors

Andrew Geall, Platform Technology Leader, Novartis Vaccines And Diagnostics Inc

3.10 Afternoon Tea

3.40 Solid drug dispersions: Drug-Polymer miscibility and relevanceto HME• Amorphous drugs may enhance the dissolution performance

and thus bioavailability of BCSclass II drug compounds• Physical stability is the principle drawback of this approach • Discussion of the prediction and comparison of drug solubility

and miscibility in polymeric systemsGavin Andrews, Senior Lecturer in Pharmaceutics, Queens University Belfast

4.20 The impact of changing the site of manufacture for controlledrelease products• Introduction• Regulatory requirements• Technology transfer (TT)• Assessing obstacles with site changes• Key challenges• SummaryDavid Elder, Externalisation Director, GlaxoSmithKline

5.00 Chairman's Closing Remarks and Close of Day One

Controlled ReleaseDay One | Monday 18th March 2013 www.controlled

Bachem is an independent, technology-based, biochemicals company providing full service to pharma andbiotech industry. Bachem specialises in process development and manufacturing of peptide and smallmolecule APIs, HPAPIs, and innovative research reagents. Clinalfa® is Bachem’s brand name for sterileproducts, produced and released for use in approved clinical studies. www.bachem.com

Sponsored by

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

• Nanomedicine• Drug Delivery• Drug Development• Formulation• Business Development

Who should attend this conference:You should attend this event if you are a Director, Area Head, Chief Executive,CSO, or Vice President within the Pharmaceutical or Healthcare industry withresponsibilities in the following areas:

• Product Development• Research & Development• Global Alliances• Technical Sciences / Design

8.30 Re-registration and Coffee

9.00 Chairman's Opening RemarksHoward Stevens, Professor, University of Strathclyde

9.10 Application of controlled release formulations in inhalationdevelopment• Why controlled release in inhalation• Formulation strategies and challenges• Case study: stability of different salbutamol sulphate

formulations• Dissolution testing methods for inhaled products• Case study: milling versus micronisation - impact of process on

surface properties and dissolution rateFrank Thielmann, Operational Lead, Inhalation New Solids,Novartis Pharma AG

Oligonucleotides delivery

9.50 Delivery of oligonucleotides in vivo: from basic principles totherapeutic applications• Multiple challenges of the oligonucleotide delivery in vivo• Diverse approaches for systemic and local delivery of

olignucleotidesDmitry Samarsky, Executive Vice President, RiboBio

10.30 Morning Coffee

11.00 A novel oligonucleotide that up-regulate serum albumin anddown-regulate liver carcinogenesis • Introductions to oligonucleotides• Effects of up-regulation of serum albumin• Pathways for down-regulation in liver carcinsogenesisNagy Habib, Professor Department of Surgery & Cancer,Imperial College London

11.40 Controlled Release improving Patient Care• Drugs must be delivered in a way that provides the best available

risk/benefit ratio• The rout, regimen and profile of delivery may affect patient care

and QoL• Creative approached in Controlled Delivery are central to

improving patient care• Consideration of optimum delivery begins in early drug

developmentJohn Fox, Chief Development Officer, Merrion Pharmaceuticals

12.20 Networking Lunch

Oral drug delivery: The latest developments

1.50 Challenges of pre-clinical gastro-retentive dosage formdevelopment• Drivers for GR technology• Approaches to GR• Overview of challenges with in vitro and animal model

assessmentsRichard Elkes, Senior Research Scientist, Merck KGaA

2.30 Design of Supersaturated Delivery system for improvingbioavailability of poorly soluble drugs : Application of Amorphoussolid dispersion• Design of supersaturated delivery system requires thorough

understanding of thermodynamics and kinetic aspects• Discussion of supersaturated system consisting of amorphous

solid dispersion• Focus on how polymers and their connection as well as their

physic-chemical properties as well as solid dispersion processesplay a role in maintaining superstation

• Case studyNavnit Shah, Distinguished Research Leader, Roche Pharmaceuticals

3.10 Afternoon Tea

3.40 Single multiple pill - SmPil - Innovative solution for oral delivery• Insight on the SmPill technology• Case studies highlighting SmPill - enabled formulations for

different drug classes (poorly soluble drugs, peptides and oralvaccines)

• Examples of translating formulation concepts into preclinicaland clinical products

Monica Rosa, Head of Production, Sigmoid Pharma Limited

4.20 Intellectual property issues in controlled release • Novelty and inventive step issues to tackle in securing patent

protection for controlled release formulations• Regulatory data protection / market exclusivity protection for

controlled release formulations• Long term legal perspectives on product life cycle management

using controlled release formulations Gerry Kamstra, Partner, Bird & Bird

5.00 Chairman's Closing Remarks and Close of Day Two

Day Two | Tuesday 19th March 2013drelease.co.uk

Want to know how you can getinvolved? Interested in promotingyour pharmaceutical services to

this market?

Contact Cathy Bishop, SMi Marketing on +44 (0) 20 7827 6134

or email cbishop@smi-online.co.uk

Overview of workshopThis workshop will review strategies for design anddevelopment of complex formulations using innovativetools such as clinical imaging and Intellicap for regionalabsorption studies. The application of such tools toformulation problem solving will also be reviewed. ASMART approach to formulation design that integrates invitro and in vivo studies can speed up the developmentpipeline and maximise the opportunities for clinicalsuccess.

Why you should attend:This workshop is of interest to anyone involved in themanagement of formulation design and developmentprojects. Or those seeking to streamline theirdevelopment pipeline to reduce costs and improveefficiency.

Programme8.30 Registration & Coffee

9.00 Welcome & Introductions • What is SMART formulation design and why do

you need it?

9.10 Formulation design and development strategies • The formulation solutions matrix• Engineered design strategies for simple and

effective results• Incorporating flexibility for customisable solutions

·• Identifying critical quality parameters

9.45 Clinical tools to support and direct an informeddevelopment programme • Gamma scintigraphic imaging to directly visualise

formulation performance • Regional absorption studies using state-of-the-

art wireless technology• IVIVC

10.45 Morning Refreshments

11.00 The SMART solution - a case study • Simplifying a complex formulation the SMART

way

12.10 Discussion session • Accelerate your formulation development

programmes using the SMART concept

12.45 Close of workshop

About the workshop host Professor Howard Stevens is a founder of bothBio-Images Research and Drug DeliveryInternational and chairs the board of the Group.He is a world renowned scientist with a long andimpressive track record of turning leading edgescience into commercially profitable ventures.His career spans four decades of management

in industrial research and development in the UK and Europein large multinationals and small drug delivery companies. Hehas been involved in the formation of several successful spin-out businesses and served as the Pfizer Professor of DrugDelivery at the University of Strathclyde from 1998-2009

About the organisation The Bio-Images Group specialises in the development andclinical testing of drug formulations. The Group comprisesDrug Delivery International (DDi), providing custom drugreformulation and IP development services and Bio-ImagesResearch, a specialised clinical research organisation thatprovides clinical studies to evaluate the performance of drugdelivery systems in volunteers and patients.

HALF-DAY POST-CONFERENCE Wednesday 20th March 2013

8.30am – 12.30pmCopthorne Tara Hotel, London, UK

SMART Formulation design: Tools and strategies for complex

formulation design and problem solving

Workshop Leaders: Howard Stevens, Chairman, Bio-Images Group LtdCarol Thomson, COO, Drug Delivery International

SMI PHARMACEUTICALFORWARD PLANNER 2013

JANUARY

Biomarkers Summit16 – 17 January 2013, London

Social Media in the Pharma Industry23 – 24 January 2013, London

Quality by Design23 – 24 January 2013, London

Pre-Filled Syringes28 – 29 January 2013, London

Pharmaceutical Microbiology30 – 31 January 2013, London

FEBRUARY

Parallel Trade6 – 7 February 2013, London

Advances and Progress in Drug Design18 – 19 February 2013, London

Lyophilisation - Freeze Drying in Pharmaceuticalsand Biopharmaceuticals

25 – 26 February 2013, London

MARCH

Superbugs & Superdrugs - A Focus on Antibacterials4 – 5 March 2013, London

Imaging in Cancer Drug Development13 – 14 March 2013, London

Controlled Release18 – 19 March 2013, London

Paediatric Clinical Trials20 – 21 March 2013, London

APRIL

Adaptive Designs8 – 9 April 2013, London

Asthma & COPD15 – 16 April 2013, London

Pharmaceutical Portfolio & Lifecycle Management17 – 18 April 2013, London

MAY

Generics, Supergenerics& Patent Strategies

13 – 14 May 2013, London

Pain Therapeutics20 – 21 May 2013, London

ADC Summit20 – 21 May 2013, London

Clinical Trial Logistics22 – 23 May 2013, London

JUNE

RNAi & Nanotechnology5 – 6 June 2013, London

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising andbranding packages, uniquely tailored tocomplement your company’s marketing strategy.Prime networking opportunities exist to entertain,enhance and expand your client base within thecontext of an independent discussion specific toyour industry. Should you wish to join theincreasing number of companies benefiting fromsponsoring our conferences please call: AliaMalick on +44 (0) 20 7827 6168 or email:amalick@smi-online.co.uk

CONTROLLED RELEASEConference: Monday 18th & Tuesday 19th March 2013, Copthorne Tara Hotel, London, UK Workshop: Wednesday 20th March 2013, Copthorne Tara Hotel, London, UK

4 WAYS TO REGISTER

FAX your booking form to +44 (0) 870 9090 712PHONE on +44 (0) 870 9090 711

www.controlledrelease.co.ukPOST your booking form to: Events Team, SMi Group Ltd, 2nd Floor South,Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK

If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email them at events@smi-online.co.uk

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Cancellation: If you wish to cancel your attendance at an event and you are unable to send asubstitute, then we will refund/credit 50% of the due fee less a £50 administration charge,providing that cancellation is made in writing and received at least 28 days prior to the start of theevent. Regretfully cancellation after this time cannot be accepted. We will however provide theconferences documentation via the Document Portal to any delegate who has paid but is unable toattend for any reason. Due to the interactive nature of the Briefings we are not normally able toprovide documentation in these circumstances. We cannot accept cancellations of orders placedfor Documentation or the Document Portal as these are reproduced specifically to order. If we haveto cancel the event for any reason, then we will make a full refund immediately, but disclaim anyfurther liability.

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VENUE Copthorne Tara Hotel, Scarsdale Place, Kensington, London W8 5SR

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