Book by 17th December to receive a £200 early bird discount off the conference

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

Accompanying the growth of thecontrolled release industry is anincreasing range of issues thatrequire attention and furtherresearch. This conference willdisplay cutting edgedevelopments in bioavailability,drug delivery and formulation,also addressing some of thenewest technologies available.

SMi present their 8th conference on

Controlled ReleaseScientific Progress and Commercial Opportunities

Wednesday 30th and Thursday 31st March 2011Copthorne Tara Hotel, London, UK

PLUS AN INTERACTIVE PRE–CONFERENCE WORKSHOPTuesday 29th March 2011

Ocular Drug Delivery: Identifying Advances andOpportunities

Hosted by Dr Hong Guo, Vice President of Research, pSivida

1.30pm - 5.00pm

Sponsored by

KEY SPEAKERS INCLUDE:

Dr. Didier BazileGlobal Head of Drug Delivery Technologies and Innovation Sanofi-Aventis

Professor Lisbeth IllumCEOCritical Pharmaceuticals

Dr. Andrew BryantProgram Manager – Novel Drug Delivery SystemsPfizer

Dr. Frank ThielmannSenior Fellow - PDU Inhalation Novartis

Dr. Joel RichardSenior Director - Head of Drug Product Development IPSEN

Dr. Stefan Bassarab Director - Pharmaceutical Development Boehringer-Ingelheim

BY ATTENDING YOU WILL BE ABLE TO:• Hear the latest developments in controlled release technology• Discover successful approaches to various methods of drug delivery• Learn how to increase formulation bioavailability and efficacy • Take examples of success from the event

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

Hovione is an international company dedicated to the cGMP development and manufacture of APIs and Intermediate DrugProducts via particle design, serving exclusively the pharmaceutical industry. With FDA inspected sites in US, Portugal,Ireland and China, the company also offers integrated API, particle design and formulation development andmanufacturing. www.hovione.com

Quotient Clinical, a strategic business unit of Quotient Bioresearch, combines the experience and capabilities ofPharmaceutical Profiles and the former Inveresk clinical unit in the UK. Our expertise in early clinical development rangesfrom First-in-Human through to Proof-of-Concept, augmented by our unique capabilities in drug product optimisation and14C enabled drug development. www.quotientbioresearch.com

Sponsored by

Supported by

8.30 Registration & Coffee

9.00 Chairman's Opening RemarksProfessor Howard Stevens, Professor of Drug Delivery, StrathclydeUniversity

STRATEGIC OVERVIEW

9.05 Physical Methods for Controlled Release of Drugs• Reminder, why controlled release anyway?• Challenges and obstacles• Existing technologies• Unmet needs and progress still required?Dr. Andrew Bryant, Program Manager - Novel Drug DeliverySystems, Pfizer

9.40 Overcoming Poor Bioavailability through Amorphous Solid Dispersions• Current and foreseeable needs for solubilization platforms• The role of solid dispersions in the pharmaceutical industry • Key technologies for manufacturing solid dispersions• An illustrative case studyDr. Filipe Gaspar, Director of Particle Design (R&D), Hovione

10.20 Increasing Bioavailability – Strategies for Overcoming Biological Barriers• Understanding biological barriers • Strategies to increase transport across biological barriers• Nanosystems engineering and mechanism of actionDr. Andreas Schatzlein, Reader in Cancer Pharmacology, School ofPharmacy, University of London

10.55 Morning Coffee

11.25 Data-driven Strategies in the development of controlled release formulations• Limitations of the current development paradigm for controlled

release products• The role of human regional absorption studies to direct the

development of controlled release formulations• Investigating factors affecting regional drug absorption• The application of rapid formulation development concepts to

optimise controlled release products in humansDr. Alyson Connor, Senior Research Fellow, Quotient Bioresearch,Clinical Sciences

NASAL AND PARENTERAL DRUG DELIVERY

12.05 Nasal delivery of macromolecules – are we there yet?• Recent developments and success stories• Issues still to tackle• Novel applicationsProfessor Lisbeth Illum, CEO, Critical Pharmaceuticals Limited

12.40 Networking Lunch

1.40 Parenteral Biologics Delivery: Key Challenges and Perspectives• Lifecycle management of biologics: context and expectations for

new delivery systems and routes of administration • Strategies developed for production of long acting protein

therapeutics • Protein engineering and post-translational modifications to

prolong half life

• Depot formulations based on biodegradable and/or naturalpolymers and lipids for injectable sustained-release formulationsof proteins

• High concentration formulations of mAbs for subcutaneousadministration

• Alternative non-invasive routes and delivery systems • Examples of successful and promising strategies and technologies Dr. Joel Richard, Senior Director, Head of Drug ProductDevelopment, IPSEN

2.15 Injectable Sustained Release of Proteins• Why sustained release? • State of the art – successes and limitations• Technology choices• Next generation of sustained release technologiesDr. Andy Lewis, Operations Director, Critical PharmaceuticalsLimited

2.50 Afternoon Tea

BUSINESS STRATEGY

3.20 Partnering approaches in the controlled release industry• Role of partnerships/ alliances in drug delivery • What are the opportunities and challenges? • Reaching a successful partnering in drug deliveryMr. Olivier Drap, R&D Business Development, Pfizer

SiRNA, PROTEIN AND CHRONO THERAPUTICS

3.55 sd-rxRNA: The novel class of the RNAi compounds with potential therapeutic applications• Delivery is a major challenge for the development of RNAi

therapeutics• RXi has developed a novel class of RNAi compounds termed “self

delivering rxRNA” or sd-rxRNA™, that combines beneficialproperties of the RNAi and conventional antisense technologies

• The combination enables robust cellular uptake of the moleculesand silencing of the target genes

• In vivo efficacy has been achieved using local administration of thenew compounds

Dr. Dmitry Samarsky, Vice President- Technology Development, RXI Pharmaceuticals

4.30 Requirements for manufacturing PLGA based sustained release forms of therapeutic proteins• Adjustment and control of particle size• Optimization and control of protein load• Analytical tools relevant to characterize micro particlesDr. Stefan Bassarab, Director, Pharmaceutical Development,Boehringer-Ingelheim

5.05 Time for a new look at drug delivery: the Chronopharmaceutical opportunity• Chronobiology of the GI tract• Chronotherapeutics and the disease state • Chronopharmaceutical drug delivery opportunitiesProfessor Howard Stevens, Chairman, Drug Delivery InternationalLtd

5.40 Chairman's Closing Remarks and Close of Day One

Controlled ReleaseDay One Wednesday 30th March 2011 www.controlled

x your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711Who should attend:Chief Executives, Chief Scientific Officers, Vice Presidents, Heads,Directors, Principal Scientists and Managers in the following areas:

SMi ControlledRelease pastdelegatebreakdown

• Controlled Release• Drug Delivery• Drug Development • Nanotechnology• Formulation• Business Development • Regulatory and Technical Affairs • Product Development

• R&D • Inhalation• Operations • Global Alliances • Product Development • Technology Development • Technical Sciences• Particle Design

8.30 Re-Registration & Coffee

9.00 Chairman's Opening Remarks

Professor Howard Stevens, Professor of Drug Delivery,

Strathclyde University

NANOTECHNOLOGY

9.05 Nanotechnology: state-of-the-art in pharmaceutical applications

• Opportunities for drug delivery

• Clinical research and Market situation

• Regulatory status

• Examples of successful implementations

Dr. Mario Maio, Head of Formulation & Process Development

Department, Merck

9.40 Development and clinical production of microsphere

formulations

• The added value of controlled release drug delivery technologies

• Success factors in the process development, scale-up and

manufacturing of microsphere-based formulations

• Case study: Phase II clinical proof of concept with a controlled

release formulation of interferon alpha

Mr. Gerben Moolhuizen, Chief Business Officer, OctoPlus

10.20 Nanotechnologies tools in candidate selection for the

intravenous route

• Tackling solubility issues in early development,

• Added value of nanotechnologies for the intravenous route,

• Points to consider in nano-objects development,

• Drug Delivery based candidate design.

Dr. Didier Bazile, Global Head of Drug Delivery Technologies and

Innovation, Sanofi-Aventis

10.55 Morning coffee

HOT MELT EXTRUSION

11.25 Hot Melt Extrusion Concept and Application

• Definition and Hot Melt Extrusion History

• Advantages and different equipment

• Parameters Affecting Extrusion

• Micro-pelletization

Dr. Hassan Mohammad, Principal Scientist, Mundipharma

Research LTD

ORAL, TOPICAL, INHALATORY AND OCULAR DRUG DELIVERY

12.00 Approaches and gaps in establishing hypromellose matrix robustness• Polymer grade selection• Release mechanism understanding• Review of in vitro test methods and models• Review of in vivo study typesMr. Richard Elkes, Formulation R&D, Merck Sharp & Dohme

12.35 Networking Lunch

1.35 Gastroretention for oral controlled release of drugs • Is it a worthwhile mechanism to explore?• Gastrointestinal diseases and controlled release• Approaches – successes and failuresProfessor Clive Wilson, Professor of Pharmaceutics, StrathclydeUniversity

2.10 Topical delivery by multifunctional lipid liquid crystalline systems• Phase change triggered adhesion to mucosal and dermal

surfaces• Local delivery and sustained release from lipid liquid crystalline

surface films• Permeation enhancement through interactions between liquid

crystal nanoparticle carriers and biological surfacesDr. Fredrik Tiberg, President & CEO, Camurus

2.45 Afternoon Tea

3.15 Review of controlled release strategies for inhaled therapies• The need for controlled release formulations in inhaled products • Formulation strategies • In-vitro testing approachesDr. Frank Thielmann, Senior Fellow PDU Inhalation, Novartis

3.50 Drug delivery to the eye: From ocular barriers to the approaches to enhance drug bioavailability• Structure and physiology of the eye in relation to drug

bioavailability• Approaches used to improve precorneal retention• Approaches used to facilitate corneal drug permeabilityDr. Vitaliy Khutoryanskiy, Lecturer in Pharmaceutics, Universityof Reading

4.25 Chairman’s Closing Remarks and Close of Day Two

Controlled ReleaseDay Two Thursday 31st March 2011drelease.co.uk

Overview of workshopThis workshop shall thoroughly investigate the currentstate of ocular drug delivery in pharmaceuticals and willprovide invaluable advice on catering for unmet medicalneeds in the field.  By firstly providing a comprehensiveoverview of the current products and dosage forms thatare available and then addressing the specificadvantages of both topical and intravitreal methods ofdelivery, this session will use tangible examples ofsuccess to benchmark best practice in ocular drugdelivery. Finally it will focus on local drug deliveryapproaches in particular, including methods ofcontrolled release and its application in the treatment ofspecific clinical diseases.

1.30 Registration & Coffee

2.00 Welcome & Introductions

2.10 Overview of Ocular Pharmaceutical Products• Common dosage forms in Ophthalmology• Unmet medical needs • Challenges of Ocular Drug Delivery

2.50 The Ocular Drug Delivery Technologies• A fast growing industry• Success of a topic eye drop• Success of a intravitreal injection• Case study

3.30 Afternoon Coffee

3.50 Local Drug Delivery Approaches• Specific clinical diseases• Sustained local delivery• Implants• Biodegrable delivery systems

4.30 Discussion Session

5.00 Close of Workshop

About the workshop leader:Dr. Hong Guo has served as the Company’s Vice Presidentof Research since November 2009 having previously servedas Director of Research from January 2006 to November2009. Prior to joining pSivida, Hong served as the Director ofPreformulation and as a Senior Scientist for ControlDelivery Systems where she was one of the originalinventors of both the Medidur and Retisert sustainedrelease drug delivery systems. Prior to joining CDS, Hongwas a Post-Doctoral Research Scientist at New England EyeCentre and at the University of Kentucky. Hong receivedMasters of Science in Medicinal Chemistry and a Bachelorof Science degree in Pharmacy from China PharmaceuticalUniversity and Ph.D. in Medicinal Chemistry from theUniversity of Heidelberg, Germany.

About pSividapSivida is a world leader in the development of tiny,sustained release, drug delivery products and technologiesthat are administered by implantation, insertion or injection.The company develops products to treat serious, unmet,medical needs alone or in partnership with othercompanies. pSivida has developed devices that are so smallthey are FDA approved to be administered into the eye andonce administered they release their drug for months andyears. pSivida is also developing a series of additionalminiaturized, bioerodible technologies designed to providelong term (months and years) release to virtually any site inthe body.

In association with:

HALF DAY PRE-CONFERENCE WORKSHOP Tuesday 29th March 2011

1.30pm - 5pmCopthorne Tara Hotel, Central London

Ocular Drug Delivery: IdentifyingAdvances and Opportunities

Hosted by Dr. Hong Guo, Vice President of Research, pSivida

PHARMACEUTICALFORWARD PLANNER

DECEMBER 201001/02 Cold Chain Distribution

JANUARY 201117/18 Pharmaceutical Microbiology19/20 Pre-Filled Syringes24/25 Paediatric Clinical Trials26/27 Social Media in the Pharmaceutical

Industry31/1 Biomarkers Summit

FEBRUARY 201102/03 Adaptive Designs in Clinical Drug

Development07/08 Parallel Trade21/22 Advances & Progress in Drug Design23/24 Stem Cells

MARCH 201107/08 Imaging in Cancer Drug Development14/15 Pharmacovigilance16/17 Superbugs & Superdrugs23/24 Accelerating Patient Recruitment &

Retention in Clinical Trials30/31 Controlled Release

APRIL 201113/14 Asthma & COPD

MAY 201111/12 Generics, Supergenerics and Patent

Strategies16/17 Clinical Trial Logistics

JUNE 201101/02 Pain Therapeutics27/28 Nanotechnology27/28 RNAi29/30 Pharmaceutical Portfolio & Product

Lifecycle Management29/30 KOL Europe (Munich, Germany)

JULY 201106/07 BioBanking06/07 ADMET11/12 Freeze Drying18/19 Clinical Trial Logistics Asia (Singapore)20/21 Pre-Filled Syringes Asia (Singapore)All conferences take place in central London, UK – unlessindicated otherwise in brackets

Want to know how you can get involved?Interested in promoting your pharmaceutical

services to this market?

Contact Kiran Sharma SMi Marketing on+44 (0)20 7827 6050 or

email: ksharma@smi-online.co.uk

SPONSORSHIP AND EXHIBITION OPPORTUNITIES

SMi offer sponsorship, exhibition, advertising andbranding packages, uniquely tailored to complement

your company's marketing strategy. Primenetworking opportunities exist to entertain, enhanceand expand your client base within the context of anindependent discussion specific to your industry.Should you wish to join the increasing number of

companies benefiting from sponsoring ourconferences please call:

Alia Malick on +44 (0) 20 7827 6168 or

email: amalick@smi-online.co.uk

CONTROLLED RELEASEConference: Wednesday 30th and Thursday 31st March 2011, Copthorne Tara Hotel, London, UK Workshop: Tuesday 29th March 2011, London

4 WAYS TO REGISTER

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

PHONE on +44 (0) 870 9090 711

www.controlledrelease.co.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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I cannot attend but would like to purchase the following CD ROMs/paper copydocumentation: (Shipped 10-14 days after the event) Price Total□ The Conference Presentations on CD ROM £499.00 + VAT £586.33□ The Conference Presentations - paper copy £499.00 - £499.00

(or only £300 if ordered with a CD ROM)

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POST your booking form to: Events Team, SMi Group Ltd, Great GuildfordBusiness Square, 30 Great Guildford Street London, SE1 0HS, UK

Payment: If payment is not made at the time of booking, then an invoice will be issued and must bepaid immediately and prior to the start of the event. If payment has not been received then credit carddetails will be requested and payment taken before entry to the event. Bookings within 7 days ofevent require payment on booking. CD Roms will not be dispatched until payment has been received.

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

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