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This case study drivenconference will address notonly the latest scientificdevelopments and theirimplementations, but also theknow-how required tosuccessfully translate thesediscoveries and technologiesinto a commercially successfulproduct.

This case study drivenconference will address notonly the latest scientificdevelopments and theirimplementations, but also theknow-how required tosuccessfully translate thesediscoveries and technologiesinto a commercially successfulproduct.

SMi presents…

Pharmaceutical Nanotechnology: Applications & Commercialisation

Wednesday 29th & Thursday 30th June 2011Copthorne Tara Hotel, London

SMi presents…

Pharmaceutical Nanotechnology: Applications & Commercialisation

Wednesday 29th & Thursday 30th June 2011Copthorne Tara Hotel, London

PLUS AN INTERACTIVE POST–CONFERENCE WORKSHOPFriday 1st July 2011, Copthorne Tara Hotel, London

Nanomedicines: Regulatory Challenges and OpportunitiesHosted by Brian Kelly, Regulatory Lawyer, Covington & Burling LLP &

Simon Holland, Director, Process Understanding & Control, GlaxoSmithKline8.30am - 1.00pm

KEY SPEAKERS INCLUDE:

Thomas KellerDirector, Open Innovation GlaxoSmithKline

Sergey PechenovResearch Fellow, Parenteral Formulation Development Merck

Mike EatonExecutive Board Member European Technology Platform on Nanomedicines

Molly StevensResearch Director for Biomedical MaterialsImperial College London

Jens UhlemannHead of CC Product Design & NanotechnologyBayer

Peter LukeSenior Director, R&D Business DevelopmentPfizer

BY ATTENDING YOU WILL BE ABLE TO:• Hear the latest technology and process developments• Discover the challenges, opportunities and risks ahead• Compare the available technologies and selecting the best option for

your project • Case studies addressing the translation of academic research to

commercial success• Network with key industry leaders and identify partnering opportunities

Pharmaceutical NanotechnologyDay One Wednesday 29th June 2011

Register online at www.pharma-nanotech.co.uk• Alternatively fax

www.pharma-

SPONSORSHIP AND EXHIBITION OPPORTUNITIESSMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company's marketing strategy. Primenetworking opportunities exist to entertain, enhance and expand your client base within the context 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 in promoting your pharmaceutical services to this market?

Contact Kiran Sharma, SMi Marketing on +44 (0) 207 827 6050, or email ksharma@smi-online.co.uk

8.30 Registration & Coffee

9.00 Chairman's Opening RemarksMike Eaton, Executive Board Member, European Technology Platformon Nanomedicines

STRATEGIC OVERVIEW

KEYNOTE ADDRESS:9.10 Pharmaceutical applications of nanoparticles

• Pharmaceutically relevant nanoparticles within the nanotechnologylandscape

• Nanoparticle formulations for bio-efficacy enhancement and forcontrolled release

• Nanoparticle formulations for biopharmaceuticals delivery• Progress to Date, general issues / obstacles and some solutionsJens Uhlemann, Head of CC Product Design & Nanotechnology, Bayer

ENGINEERING, FORMULATION & DRUG DELIVERY

KEYNOTE ADDRESS:9.45 Nanoscale drug delivery systems

Comparing available technologies and selecting the best option for your project• Role of nanotechnology in targeted drug delivery • Evaluating the available technologies• Performance and safety issues• Case study: The development of biodegradable nanoscale drug

delivery systems at Novartis• Looking ahead to future steps in pharmaceutical developmentGiancarlo Francese, Project Leader Pharmaceutical Development,Novartis

10.20 Morning Coffee

10.50 Miniaturisation and modelling of beads milling• Relevant information to get at lab scale in order to help the scale-

ability• Is it possible to apply similar methodology to that developed for dry

milling-micronisation?• Impact of process parameters and formulation on milling

performancesMostapha Nakach, Pharmaceutical Engineering, Sanofi Aventis

11.25 Ten development criteria to cross barriers from blood-to-brain usingnanotechnology• Success criteria based on: 1) safely targeting the blood-brain

barrier; 2) use of validated drug carriers; 3) translation from lab toclinic

• Introduction to G-Technology• Case study I: glutathione pegylated liposomal doxorubicin (2B3-101)

for brain cancer• Case study II: pharma industry partnering modelMarco de Boer, Head of Research, to-BBB Technologies

12.00 Delivering peptides to the brain• The challenge • Nanoparticle/ nanofibre technology• Delivering peptides via the intravenous route• Delivering peptides via the oral route• Case study: Oral EnkephalinIjeoma Uchegbu, Professor, Chair in Pharmaceutical Nanoscience,University of London

12.35 Networking Lunch

1.35 New nanomaterials for regenerative medicine• Taking tissue engineering products from bench to bedside• Materials based approaches for regenerative medicine• Design of nanomaterial scaffolds for tissue regeneration• Translation to commercial products and clinical studiesMolly Stevens, Research Director for Biomedical Materials, ImperialCollege London

NANO-ENABLED NUCLEIC ACID THERAPEUTIC DELIVERY

2.10 Delivering siRNA therapeutics Promises, results and challenges of nanotechnology• Technology and therapeutic updates• Pros and cons of RNAi delivery methods• Case study: Lipid nanoparticle–mediated systemic delivery of siRNA

to the liverSergey Pechenov, Research Fellow, Parenteral FormulationDevelopment, Merck

KEYNOTE ADDRESS:2.45 Oligonucleotide delivery & formulation

Delivery systems for immunostimulatory oligonucleotide agonists• Overview• Case study: Project & data • Looking ahead to the futureAmina Benahmed, Associate Director Nucleic Acid Delivery, Coley Pharmaceuticals – A Pfizer Company

3.20 Afternoon Tea

3.50 Investigation of chitosan nanoparticle formulationsBiophysics, intracellular trafficking and structural features• Impact of chitosan purity, size and source on nanoparticle formulation • Biophysical characterization of chitosan/siRNA nanoparticles using

dynamic light scattering, zeta potential, isothermal titration calorimetry • Cellular trafficking events of siRNA; the role of chitosan polymer size • Structure/activity relationships between nanoparticles made of

different chitosan polymer sizesMichael Keller, Senior Fellow, siRNA Project Leader, Novartis

4.25 Nanoparticles for the delivery of oligonucleotides targeting EWS/Fli-1Targeting cancer utilising polyalkycyanoacrylates and diamond nanoparticles• The prevalence of EWS/Fli-1 oncogene in Ewing sarcoma patients• The need to protect antisense oligonucleotides and siRNA until they

reach their EWS/Fli-1 mRNA target• Biodegradable and biocompatible polyalkylcyanoacrylate

nanoparticles coated with chitozan• Developing cationic nanodiamond vectors and evaluating their

efficiency for anionic siRNA deliveryClaude Paul Malvy, Director, IFSBM, Université Paris-Sud

5.00 Chairman's Closing Remarks and Close of Day One

Supported by

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

Pharmaceutical NanotechnologyDay Two Thursday 30th June 2011-nanotech.co.uk

Who should attend:CEOs, CSOs, VPs, Directors, Heads, Scientists and Academics focusing on:

• Analytical Chemistry• Analytical Development• Business Development• Chemical Engineering• Discovery R&D• Drug Delivery

• Drug Discovery• Formulation• Lifecycle Management• Licensing• Medicinal Chemistry• Pharmaceutics

• Physiochemistry• Portfolio Management• Preclinical Development• Pre-Formulation• Process R&D• Product Development

• Regulatory Affairs• Solid States• Toxicology

8.30 Re-registration & Coffee

9.00 Chairman's Opening RemarksThomas Keller, Director of Nanomaterials, GlaxoSmithKline

KEYNOTE ADDRESS:9.10 The business case for nanotechnology

• Limitations and cost effectiveness comparisons• Benchmarking and the need for agreed industry standard systems

for evaluation• Challenges in translational development• Partnering strategies and opportunitiesThomas Keller, Director of Nanomaterials, GlaxoSmithKline

9.50 Enhancing industry-academia partnership in Pharmaceutical nanotechnologyRoad to faster commercialisation• Tailor made innovation funnels• Innovation Box for Implementation of Nanotech Tools (IBINT©)• Start-up companies : Bridging the gap between industry &

academia • Strategies to pick "low hanging fruits" to futuristic technologies• Individual technologies versus a platform of technologies• Ability to connect seemingly unconnected dotsChalla Kumar, President & CEO, Magnano Technologies

10.30 Morning Coffee

11.00 Enabling oncology drug development with nanotechnology• Key challenges in oncology drug discovery • Optimizing the discovery/development interface • Key technology platforms • Taking a portfolio approach • The Nanomedicines Alliance – a pre-competitive consortium for

cross-industry collaborationHenry Havel, Senior Research Fellow, Product Research andDevelopment, Eli Lilly and Company

TRANSLATING DISCOVERIES INTO COMMERCIAL SUCCESSES

11.40 Improving translation of academic nanomedicine research• Companies are increasing relying on Open Innovation for new

products• Academic pharmaceutical research is not informed on the

requirements for industrial development• Funding agencies continue to fund non-translatable applied

research • There is now global competition• How can the system be made much more productive?Mike Eaton, Executive Board Member, European TechnologyPlatform on Nanomedicines

12.20 Networking Lunch

1.20 Building a diversified nanomedicine company• Balancing diversification and focus • Follow the science • Models that maximize shots on goal • Finding and relying on synergy • Case Study: Nanotope, Inc Christopher Anzalone, President & CEO, Arrowhead ResearchCorporation

REGULATORY CONSIDERATIONS, IP ISSUES

& PARTNERING OPPORTUNITIES

2.00 Regulatory challenges for nanomedicines

Specific challenges for assessing nanomaterials within the

existing regulatory framework for medicines and against the

general background of the precautionary principle

• Borderline and classification issues

• Limitations of current testing methods

• Development, manufacture and characterisation

• Risk management planning

• Reimbursement

• Public perception

• Lessons from other sectors

Peter Bogaert, Managing Partner, Covington & Burling LLP

Brian Kelly, Associate, Covington & Burling LLP

2.40 Afternoon Tea

3.20 A tour of today's Nanomedicine patent landscape:  predicting

where the future IP battle lines will be drawn

• The current patent landscape of nanotech-enabled

pharmaceutical applications

• The expectation that the commercialization of nanotech-enabled

pharmaceuticals will lead to patent battles of epic proportions

• Predictions of the most likely IP battlegrounds and of those who

are battling

Jeffrey Rosedale, Partner, Woodcock Washburn

KEYNOTE ADDRESS:

3.50 Industry partnering opportunities, open innovation, one solution

• Open innovation- what does it mean for Pharma?

• Establishing effective alliances

• Public-private partnerships for more effective research

• Lessons learnt and illustrative case studies

Peter Luke, Senior Director, R&D Business Development,

Worldwide Business Development, Pfizer

4.30 Chairman's Closing Remarks and Close of Conference

REGISTER BY 28th FEBRUARY AND RECEIVE A £300 DISCOUNTREGISTER BY 31st MARCH AND RECEIVE A £100 DISCOUNT

www.rnai-event.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

SMi present their 6th conference on…

RNAi, miRNA and siRNAMonday 27th and Tuesday 28th June 2011

Copthorne Tara Hotel, London

KEY SPEAKERS INCLUDE:

RNAi is still a new and excitingarea of pharmaceuticaldevelopment, but with far to gobefore its vast therapeuticpotential is fully utilised. Thisconference will showcase thelatest progress made ensuringdelegates leave fully informedof industry developments.

Troels KochVP, Research DivisionSantaris Pharma

Rachel MeyersVice President, Research and RLD Alnylam

Mike WebbHead, API & Chemistry Analysis, UKGSK

Dmitry SamarskyVice President, Technology DevelopmentRXi Pharmaceuticals

Atilla SeyhanHead, RNAi and Compound Deliver & ScreensPfizer

Laura Sepp-LorenzinoSenior Director and Department Lead – RNA therapeutics Delivery BiologyMerck & Co

PLUS A HALF-DAY POST-CONFERENCE WORKSHOPWednesday 29th June 2011, Copthorne Tara, London

BY ATTENDING YOU WILL BE ABLE TO:• Hear the latest in RNAi therapeutic progression

• Learn about the ways top companies are utilising RNAi potential

• Study cutting edge approaches at overcoming siRNA delivery issues

• Network with some of the most important industry experts working in RNAi

• Develop a sound strategy of development in response to industry cuts

Manipulating exons to treat diseaseHosted by Giles Campion, Chief Medical Officer and Senior Vice-President R&D, Prosensa

8.30am-12.30pm

PLUS! SAVE THE DATE FOR THE CO-LOCATED

Y

Overview of workshopThis workshop aims to give participants an understandingnanopharmaceutical applications and regulatory considerations,including an overview of the technology, development considerations,manufacturing, safety and pricing/reimbursement issues. Forexample, many novel applications of medical nanotechnology willspan the regulatory boundaries between medicinal products,including advanced therapy medicinal products, and medical devices.Getting the regulatory classification right is crucial in developing andcommercialising products as different sets of rules govern eachregime. There will be a focus on useful case studies and processes,providing a strong, practical take home message to attendingdelegates.

Upon completion of this workshop, attendees should be able to:

• Understand existing and potential nanotechnology-basedapplications

• Understand the special aspects of nanomedicines: development,manufacturing and characterisation

• Identify the key regulatory challenges: borderline issues,classification, safety and pricing/reimbursement of innovativenanomedicines

• Understand public perception and ethical considerations thatapply to nanopharmaceuticals

8.30 Registration & Coffee

9.00 Welcome & Introductions• Experience and backgrounds of participants and hosts• Purpose and scope of the workshop

9.10 Nanopharmaceuticals on the market and in clinical development

9.50 Development, manufacturing and characterisation of nanomedicines

10.30 Morning Coffee

11.00 Regulatory challenges: borderline issues, safety and other legal and ethical issues

11.50 Pricing/reimbursement of innovative nanomedicines

12.10 Interactions with regulators over nanomedicine issues• Manufacturing licenses• Borderline determinations• Clinical trials

12.40 Interactive Discussion Session

1.00 Close of Workshop

About the workshop leaders:

Brian Kelly, Regulatory Lawyer, Covington & BurlingLLPBrian Kelly is a regulatory lawyer in the London LifeSciences group, whose practice focuses on food anddrug law, public and administrative proceedings,European Union law and product liability and safety. He

has more than ten years of experience in regulatory matters having firstworked as a journalist covering medical and healthcare regulatory newsbefore joining Covington. He has a particular interest in advising lifescience companies on nanotechnology regulatory matters. Mr Kelly'sadvice on general regulatory matters includes borderlinedeterminations, tissue and stem cell regulation, adverse event and otherreporting obligations, manufacturing controls, labeling and promotion,pricing and reimbursement/procurement, product life cyclemanagement and anti-bribery and corruption advice. He has alsoadvised on EU and national laws governing clinical research, dataprotection, telemedicine/eHealth, and regulatory aspects of mergers andacquisitions, licensing, and collaborative arrangements. He is anhonorary lecturer at University College London. www.cov.com

Simon Holland, Director, Process Understanding &Control, GlaxoSmithKlineSimon has worked in the pharmaceutical industry forover 20 years and is an expert in the field of nanoparticlemanufacture. He studied chemistry at BradfordUniversity (UK) followed by a PhD in polymer chemistryat Aston University (UK). He joined Beecham

Pharmaceuticals, Worthing (UK) in 1986 and worked on the formulationdevelopment of topical and penicillin drug products. After the mergerthat formed SmithKline Beecham, Simon worked on the development ofneurosciences drug products and has focussed on the development ofbioenhanced formulations for the past 13 years including with aparticular emphasis on sub micron compositions. He was the R&D leadon the commercial scale nanomilling facility project that was opened atGSK Cork (Eire) in 2004. www.gsk.com

In association with:

Nanomedicines: Regulatory Challenges and Opportunities

PHARMACEUTICAL FORWARD PLANNER

HALF DAY POST-CONFERENCE WORKSHOP Friday 1st July 2011

8.30am-1.00pmCopthorne Tara Hotel, London

FEBRUARY 201107/08 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

MAY201111/12 Generics, Supergenerics and Patent

Strategies16/17 Clinical Trial Logistics

JUNE 201101/02 Pain Therapeutics27/28 RNAi29/30 Nanotechnology29/30 Pharmaceutical Portfolio &

Product LifecycleManagement

29/30 KOL Europe (Munich,Germany)

JULY 201106/07 ADMET11/12 BioBanking11/12 Social Media in the

PharmaceuticalIndustry

18/19 Clinical Trial Logistics Asia(Singapore)

20/21 Pre-Filled Syringes Asia(Singapore)

All conferences take place in central London, UK– unless indicated otherwise in brackets

ABOUT THE SMi PHARMACEUTICAL TEAMSMi have been involved in the pharmaceuticalindustry since 1993 and have developed aseries of informative and niche events,covering the latest issues and developmentssurrounding the industry. Events bringtogether senior industry professionals andserving companies who have a focus on beingat the forefront of developments in this area.SMi aim to generate informed and topicaldiscussion through the medium of bothconferences and executive briefings. Ourpharmaceutical events are research-basedand content driven with regular contact withmajor industry personnel and cover a widerange of industry sectors. For more information, please visitwww.smionline.co.uk/pharma

PHARMACEUTICAL NANOTECHNOLOGY:Conference: Wednesday 29th & Thursday 30th June 2011, Copthorne Tara Hotel, London, UK Workshop: Friday 1st July 2011, London

4 WAYS TO REGISTER

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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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