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Pharmaceutical Nanotechnology: Applications & Commercialisation

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SMi are proud to present Pharmaceutical Nanotechnology: Applications & Commercialisation, taking place in London on June 29th and 30th, 2011. …

SMi are proud to present Pharmaceutical Nanotechnology: Applications & Commercialisation, taking place in London on June 29th and 30th, 2011.

Nanotechnology is a multidisciplinary scientific field that is currently undergoing undergoing explosive development. Nano-enhanced medicines are opening new opportunities for therapeutic delivery and targeting, technology is also allowing agents that previously could not be used effectively as conventional formulations due to poor bioavailability or drug instability to advance into clinical development.



This case study driven conference will address not only the latest scientific developments, but also the know-how required to successfully translate these discoveries and technologies into a commercially successful product.

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  • 1. Pharmaceutical Nanotechnology: Applications & Commercialisation SMi presents… Wednesday 29th & Thursday 30th June 2011 Copthorne Tara Hotel, LondonREGISTER BY 28th FEBRUARY AND RECEIVE A £300 DISCOUNTREGISTER BY 31st MARCH AND RECEIVE A £100 DISCOUNT KEY SPEAKERS INCLUDE: Thomas Keller Director, Open Innovation GlaxoSmithKline Sergey Pechenov Research Fellow, Parenteral Formulation Development Merck This case study driven Mike Eaton conference will address not Executive Board Member European Technology Platform on Nanomedicines only the latest scientific Molly Stevens developments and their Research Director for Biomedical Materials Imperial College London implementations, but also the know-how required to Jens Uhlemann Head of CC Product Design & Nanotechnology Bayer successfully translate these discoveries and technologies Peter Luke into a commercially successful Senior Director, R&D Business Development Pfizer product. PLUS AN INTERACTIVE POST–CONFERENCE WORKSHOP BY ATTENDING YOU WILL BE ABLE TO: Nanomedicines: Regulatory Challenges and Opportunities • 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 projectwww.pharma-nanotech.co.uk • Case studies addressing the translation of academic research to commercial success Friday 1st July 2011, Copthorne Tara Hotel, London • Network with key industry leaders and identify partnering opportunities Hosted by Brian Kelly, Regulatory Lawyer, Covington & Burling LLP & Simon Holland, Director, Process Understanding & Control, GlaxoSmithKline 8.30am - 1.00pmRegister 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
  • 2. www.pharma- Pharmaceutical Nanotechnology Day One Wednesday 29th June 2011 8.30 Registration & Coffee 12.35 Networking Lunch 9.00 Chairmans Opening Remarks 1.35 New nanomaterials for regenerative medicine Mike Eaton, Executive Board Member, European Technology Platform • Taking tissue engineering products from bench to bedside on Nanomedicines • Materials based approaches for regenerative medicine STRATEGIC OVERVIEW • Design of nanomaterial scaffolds for tissue regeneration • Translation to commercial products and clinical studies KEYNOTE ADDRESS: Molly Stevens, Research Director for Biomedical Materials, Imperial 9.10 Pharmaceutical applications of nanoparticles College London • Pharmaceutically relevant nanoparticles within the nanotechnology landscape • Nanoparticle formulations for bio-efficacy enhancement and for NANO-ENABLED NUCLEIC ACID THERAPEUTIC DELIVERY controlled release • Nanoparticle formulations for biopharmaceuticals delivery 2.10 Delivering siRNA therapeutics • Progress to Date, general issues / obstacles and some solutions Promises, results and challenges of nanotechnology Jens Uhlemann, Head of CC Product Design & Nanotechnology, • Technology and therapeutic updates Bayer • Pros and cons of RNAi delivery methods ENGINEERING, FORMULATION & DRUG DELIVERY • Case study: Lipid nanoparticle–mediated systemic delivery of siRNA to the liver KEYNOTE ADDRESS: Sergey Pechenov, Research Fellow, Parenteral Formulation 9.45 Nanoscale drug delivery systems Development, Merck Comparing available technologies and selecting the best option for your project KEYNOTE ADDRESS: • Role of nanotechnology in targeted drug delivery • Evaluating the available technologies 2.45 Oligonucleotide delivery & formulation • Performance and safety issues Delivery systems for immunostimulatory oligonucleotide agonists • Case study: The development of biodegradable nanoscale drug • Overview delivery systems at Novartis • Case study: Project & data • Looking ahead to future steps in pharmaceutical development • Looking ahead to the future Giancarlo Francese, Project Leader Pharmaceutical Development, Amina Benahmed, Associate Director Nucleic Acid Delivery, Novartis Coley Pharmaceuticals – A Pfizer Company 10.20 Morning Coffee 3.20 Afternoon Tea 10.50 Miniaturisation and modelling of beads milling • Relevant information to get at lab scale in order to help the scale- 3.50 Investigation of chitosan nanoparticle formulations ability Biophysics, intracellular trafficking and structural features • Is it possible to apply similar methodology to that developed for dry Register online at www.pharma-nanotech.co.uk• Alternatively fax milling-micronisation? • Impact of chitosan purity, size and source on nanoparticle formulation • Impact of process parameters and formulation on milling • Biophysical characterization of chitosan/siRNA nanoparticles using performances dynamic light scattering, zeta potential, isothermal titration calorimetry Mostapha Nakach, Pharmaceutical Engineering, Sanofi Aventis • Cellular trafficking events of siRNA; the role of chitosan polymer size • Structure/activity relationships between nanoparticles made of 11.25 Ten development criteria to cross barriers from blood-to-brain using different chitosan polymer sizes nanotechnology • Success criteria based on: 1) safely targeting the blood-brain Michael Keller, Senior Fellow, siRNA Project Leader, Novartis barrier; 2) use of validated drug carriers; 3) translation from lab to clinic 4.25 Nanoparticles for the delivery of oligonucleotides targeting EWS/Fli-1 • Introduction to G-Technology Targeting cancer utilising polyalkycyanoacrylates and diamond • Case study I: glutathione pegylated liposomal doxorubicin (2B3-101) nanoparticles for brain cancer • The prevalence of EWS/Fli-1 oncogene in Ewing sarcoma patients • Case study II: pharma industry partnering model Marco de Boer, Head of Research, to-BBB Technologies • The need to protect antisense oligonucleotides and siRNA until they reach their EWS/Fli-1 mRNA target 12.00 Delivering peptides to the brain • Biodegradable and biocompatible polyalkylcyanoacrylate • The challenge nanoparticles coated with chitozan • Nanoparticle/ nanofibre technology • Developing cationic nanodiamond vectors and evaluating their • Delivering peptides via the intravenous route efficiency for anionic siRNA delivery • Delivering peptides via the oral route • Case study: Oral Enkephalin Claude Paul Malvy, Director, IFSBM, Université Paris-Sud Ijeoma Uchegbu, Professor, Chair in Pharmaceutical Nanoscience, University of London 5.00 Chairmans Closing Remarks and Close of Day One SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your companys marketing strategy. Prime networking 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.ukSupported by
  • 3. -nanotech.co.uk Pharmaceutical Nanotechnology Day Two Thursday 30th June 2011 8.30 Re-registration & Coffee REGULATORY CONSIDERATIONS, IP ISSUES 9.00 Chairmans Opening Remarks & PARTNERING OPPORTUNITIES Thomas Keller, Director of Nanomaterials, GlaxoSmithKline KEYNOTE ADDRESS: 2.00 Regulatory challenges for nanomedicines 9.10 The business case for nanotechnology Specific challenges for assessing nanomaterials within the • Limitations and cost effectiveness comparisons • Benchmarking and the need for agreed industry standard systems existing regulatory framework for medicines and against the for evaluation • Challenges in translational development general background of the precautionary principle • Partnering strategies and opportunities • Borderline and classification issues Thomas Keller, Director of Nanomaterials, GlaxoSmithKline • Limitations of current testing methods 9.50 Enhancing industry-academia partnership in Pharmaceutical • Development, manufacture and characterisation nanotechnology Road to faster commercialisation • Risk management planning • Tailor made innovation funnels • Innovation Box for Implementation of Nanotech Tools (IBINT©) • Reimbursement • Start-up companies : Bridging the gap between industry & • Public perception academia • Strategies to pick "low hanging fruits" to futuristic technologies • Lessons from other sectors • Individual technologies versus a platform of technologies Peter Bogaert, Managing Partner, Covington & Burling LLP • Ability to connect seemingly unconnected dots Challa Kumar, President & CEO, Magnano Technologies Brian Kelly, Associate, Covington & Burling LLP 10.30 Morning Coffee 2.40 Afternoon Tea 11.00 Enabling oncology drug development with nanotechnology • Key challenges in oncology drug discovery • Optimizing the discovery/development interface 3.20 A tour of todays Nanomedicine patent landscape:  predicting • Key technology platforms • Taking a portfolio approach where the future IP battle lines will be drawn • The Nanomedicines Alliance – a pre-competitive consortium for cross-industry collaboration • The current patent landscape of nanotech-enabled Henry Havel, Senior Research Fellow, Product Research and pharmaceutical applications Development, Eli Lilly and Company • The expectation that the commercialization of nanotech-enabled TRANSLATING DISCOVERIES INTO COMMERCIAL SUCCESSES pharmaceuticals will lead to patent battles of epic proportionsyour registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 11.40 Improving translation of academic nanomedicine research • Predictions of the most likely IP battlegrounds and of those who • Companies are increasing relying on Open Innovation for new products are battling • Academic pharmaceutical research is not informed on the Jeffrey Rosedale, Partner, Woodcock Washburn requirements for industrial development • Funding agencies continue to fund non-translatable applied research KEYNOTE ADDRESS: • There is now global competition • How can the system be made much more productive? 3.50 Industry partnering opportunities, open innovation, one solution Mike Eaton, Executive Board Member, European Technology Platform on Nanomedicines • Open innovation- what does it mean for Pharma? • Establishing effective alliances 12.20 Networking Lunch • Public-private partnerships for more effective research 1.20 Building a diversified nanomedicine company • Balancing diversification and focus • Lessons learnt and illustrative case studies • Follow the science Peter Luke, Senior Director, R&D Business Development, Who should attend: • Models that maximize shots on goal • Finding and relying on synergy Worldwide Business Development, Pfizer • Case Study: Nanotope, Inc Christopher Anzalone, President & CEO, Arrowhead Research Corporation 4.30 Chairmans Closing Remarks and Close of Conference CEOs, CSOs, VPs, Directors, Heads, Scientists and Academics focusing on: • Analytical Chemistry • Drug Discovery • Physiochemistry • Regulatory Affairs • Analytical Development • Formulation • Portfolio Management • Solid States • Business Development • Lifecycle Management • Preclinical Development • Toxicology • Chemical Engineering • Licensing • Pre-Formulation • Discovery R&D • Medicinal Chemistry • Process R&D • Drug Delivery • Pharmaceutics • Product Development
  • 4. RNAi, miRNA and siRNAPLUS! SAVE THE DATE FOR THE CO-LOCATED SMi present their 6th conference on… Monday 27th and Tuesday 28th June 2011 Copthorne Tara Hotel, LondonREGISTER BY 28th FEBRUARY AND RECEIVE A £300 DISCOUNTREGISTER BY 31st MARCH AND RECEIVE A £100 DISCOUNT KEY SPEAKERS INCLUDE: Troels Koch VP, Research Division Santaris Pharma RNAi is still a new and exciting Rachel Meyers area of pharmaceutical Vice President, Research and RLD Alnylam development, but with far to go Mike Webb before its vast therapeutic Head, API & Chemistry Analysis, UK GSK potential is fully utilised. This Dmitry Samarsky conference will showcase the Vice President, Technology Development RXi Pharmaceuticals latest progress made ensuring delegates leave fully informed PLUS A HALF-DAY POST-CONFERENCE WORKSHOP Atilla Seyhan Head, RNAi and Compound Deliver & Screens Pfizer of industry developments. BY ATTENDING YOU WILL BE ABLE TO: Laura Sepp-Lorenzino Senior Director and Department Lead – RNA therapeutics Delivery Biology Merck & Co Manipulating exons to treat diseasewww.rnai-event.com • Hear the latest in RNAi therapeutic progression • Learn about the ways top companies are utilising RNAi potential Wednesday 29th June 2011, Copthorne Tara, London • 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 Hosted by Giles Campion, Chief Medical Officer and Senior Vice-President R&D, ProsensaRegister online and receive full information on all of SMi’s conferences 8.30am-12.30pmAlternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
  • 5. HALF DAY POST-CONFERENCE WORKSHOP Nanomedicines: Regulatory Challenges and Opportunities Friday 1st July 2011 8.30am-1.00pm Copthorne Tara Hotel, London In association with:Overview of workshop About the workshop leaders:This workshop aims to give participants an understandingnanopharmaceutical applications and regulatory considerations, Brian Kelly, Regulatory Lawyer, Covington & Burlingincluding an overview of the technology, development considerations, LLPmanufacturing, safety and pricing/reimbursement issues. For Brian Kelly is a regulatory lawyer in the London Lifeexample, many novel applications of medical nanotechnology will Sciences group, whose practice focuses on food andspan the regulatory boundaries between medicinal products, drug law, public and administrative proceedings,including advanced therapy medicinal products, and medical devices. European Union law and product liability and safety. HeGetting the regulatory classification right is crucial in developing and has more than ten years of experience in regulatory matters having firstcommercialising products as different sets of rules govern eachregime. There will be a focus on useful case studies and processes, worked as a journalist covering medical and healthcare regulatory newsproviding a strong, practical take home message to attending before joining Covington. He has a particular interest in advising lifedelegates. science companies on nanotechnology regulatory matters. Mr Kellys advice on general regulatory matters includes borderlineUpon completion of this workshop, attendees should be able to: determinations, tissue and stem cell regulation, adverse event and other• Understand existing and potential nanotechnology-based reporting obligations, manufacturing controls, labeling and promotion, applications pricing and reimbursement/procurement, product life cycle• Understand the special aspects of nanomedicines: development, management and anti-bribery and corruption advice. He has also manufacturing and characterisation advised on EU and national laws governing clinical research, data• Identify the key regulatory challenges: borderline issues, protection, telemedicine/eHealth, and regulatory aspects of mergers and classification, safety and pricing/reimbursement of innovative acquisitions, licensing, and collaborative arrangements. He is an nanomedicines honorary lecturer at University College London. www.cov.com• Understand public perception and ethical considerations that apply to nanopharmaceuticals Simon Holland, Director, Process Understanding & Control, GlaxoSmithKline8.30 Registration & Coffee Simon has worked in the pharmaceutical industry for over 20 years and is an expert in the field of nanoparticle9.00 Welcome & Introductions manufacture. He studied chemistry at Bradford • Experience and backgrounds of participants and hosts • Purpose and scope of the workshop University (UK) followed by a PhD in polymer chemistry at Aston University (UK). He joined BeechamPHARMACEUTICAL FORWARD PLANNER9.10 Nanopharmaceuticals on the market and in Pharmaceuticals, Worthing (UK) in 1986 and worked on the formulation clinical development development of topical and penicillin drug products. After the merger9.50 Development, manufacturing and characterisation of that formed SmithKline Beecham, Simon worked on the development of nanomedicines neurosciences drug products and has focussed on the development of10.30 Morning Coffee bioenhanced formulations for the past 13 years including with a particular emphasis on sub micron compositions. He was the R&D lead11.00 Regulatory challenges: borderline issues, safety and on the commercial scale nanomilling facility project that was opened at other legal and ethical issues GSK Cork (Eire) in 2004. www.gsk.com11.50 Pricing/reimbursement of innovative nanomedicines12.10 Interactions with regulators over nanomedicine issues • Manufacturing licenses • Borderline determinations • Clinical trials12.40 Interactive Discussion Session1.00 Close of WorkshopFEBRUARY 2011 JUNE 201107/08 Parallel Trade 01/02 Pain Therapeutics ABOUT THE SMi PHARMACEUTICAL TEAM21/22 Advances & Progress in Drug Design 27/28 RNAi SMi have been involved in the pharmaceutical23/24 Stem Cells 29/30 Nanotechnology industry since 1993 and have developed a 29/30 Pharmaceutical Portfolio & series of informative and niche events,MARCH 2011 Product Lifecycle covering the latest issues and developments07/08 Imaging in Cancer Drug Development Management surrounding the industry. Events bring14/15 Pharmacovigilance 29/30 KOL Europe (Munich, together senior industry professionals and16/17 Superbugs & Superdrugs Germany) serving companies who have a focus on being23/24 Accelerating patient recruitment & at the forefront of developments in this area. Retention in Clinical Trials JULY 2011 SMi aim to generate informed and topical30/31 Controlled Release 06/07 ADMET discussion through the medium of both 11/12 BioBanking conferences and executive briefings. OurAPRIL 2011 11/12 Social Media in the pharmaceutical events are research-based13/14 Asthma & COPD Pharmaceutical and content driven with regular contact with Industry major industry personnel and cover a wideMAY2011 18/19 Clinical Trial Logistics Asia range of industry sectors.11/12 Generics, Supergenerics and Patent (Singapore) For more information, please visit Strategies 20/21 Pre-Filled Syringes Asia www.smionline.co.uk/pharma16/17 Clinical Trial Logistics (Singapore) All conferences take place in central London, UK – unless indicated otherwise in brackets
  • 6. PHARMACEUTICAL NANOTECHNOLOGY: 4 WAYS TO REGISTER www.pharma-nanotech.co.ukFAX your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd, Great GuildfordPHONE on +44 (0) 870 9090 711 CONFERENCE PRICES Conference: Wednesday 29th & Thursday 30th June 2011, Copthorne Tara Hotel, London, UK Workshop: Friday 1st July 2011, London EARLY BIRD □ Book by 28th February to receive a £300 off the conference Business Square, 30 Great Guildford Street London, SE1 0HS, UK DISCOUNT □ Book by 31st March to receive a £100 off the conferenceDELEGATE DETAILS I would like to attend: (Please tick as appropriate) Fee Total □ Conference & Half Day Workshop £1998.00 + VAT £2397.60 □ Conference only £1399.00 + VAT £1678.80 □ Half Day Workshop only £599.00 + VAT £718.80 VENUE PROMOTIONAL LITERATURE DISTRIBUTIONUnique Reference Number □ Distribution of your company’s promotionalOur Reference LVY17 GROUP DISCOUNTS AVAILABLE literature to all conference attendees £999.00 + VAT £1198.80 CD ROMS/DOCUMENTATIONTitle: Forename:Surname: The Conference fee includes refreshments, lunch, conference papers andJob Title: CD ROM containing all of the presentations.Department/Division: □ Please contact me to book my hotelCompany/Organisation:Please complete fully and clearly in capital letters. Please photocopy for additional delegates. Copthorne Tara Hotel, Scarsdale Place, Kensington, London, W8 5SREmail: PAYMENTAddress: Alternatively call us on +44 (0) 870 9090 711, email: hotels@smi-online.co.uk or fax +44 (0) 870 9090 712Town/City:Post/Zip Code: Country:Direct Tel: Direct Fax: I cannot attend but would like to purchase the following CD ROMs/paper copy documentation: (Shipped 10-14 days after the event) Price TotalMobile: □ The Conference Presentations on CD ROM £499.00 + VAT £598.80Switchboard: □ The Conference Presentations - paper copy £499.00 - £499.00Terms and Conditions of Booking (or only £300 if ordered with a CD ROM)Signature: Date:ACCOUNTS DEPTTitle: Forename:Surname:Email: Payment must be made to SMi Group Ltd, and received before the event, by one of theI agree to be bound by SMis Terms and Conditions of Booking.Address (if different from above): following methods quoting reference Y17 and the delegate’s name. Bookings made within 7 days of the event require payment on booking, methods of payment are below. Please indicate method of payment: Valid From □□/□□ Expiry Date □□/□□Town/City: □ UK BACS Sort Code 300009, Account 00936418Post/Zip Code: Country: □ Wire Transfer Lloyds TSB Bank plc, 39 Threadneedle Street, London, EC2R 8AU Swift (BIC): LOYDGB21013, Account 00936418Direct Tel: Direct Fax: IBAN GB48 LOYD 3000 0900 9364 18 VAT □ Cheque We can only accept Sterling cheques drawn on a UK bank. □ Credit Card □ Visa □ MasterCard □ American Express Card No: All credit card payments will be subject to standard credit card charges. CVV Number □□□□ 3 digit security on reverse of card, 4 digits for AMEX card Cardholder’s Name: Signature: Date: Card Billing Address (If different from above): I agree to be bound by SMis Terms and Conditions of Booking. VAT at 20% is charged on the attendance fees for all delegates. VAT is also charged on CD 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 ROMs and Literature Distribution for all UK customers and for those EU customers not supplying a registration number for their own country here: _______________________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 of □□□□ □□□□ □□□□ □□□□event require payment on booking. CD Roms will not be dispatched until payment has been received.Substitutions/Name Changes: If you are unable to attend you may nominate, in writing, anotherdelegate to take your place at any time prior to the start of the event. Two or more delegates maynot ‘share’ a place at an event. Please make separate bookings for each delegate.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, providingthat cancellation is made in writing and received at least 28 days prior to the start of the event.Regretfully cancellation after this time cannot be accepted. We will however provide the Conferencedocumentation on CD ROM to any delegate who has paid but is unable to attend for any reason. Dueto the interactive nature of the Briefings we are not normally able to provide documentation in thesecircumstances. We cannot accept cancellations of orders placed for Documentation or CD ROM asthese are reproduced specifically to order. If we have to cancel the event for any reason, then we willmake a full refund immediately, but disclaim any further liability.Alterations: It may become necessary for us to make alterations to the content, speakers, timing,venue or date of the event compared to the advertised programme.Data Protection: The SMi Group gathers personal data in accordance with the UK Data Protection Act1998 and we may use this to contact you by telephone, fax, post or email to tell you about otherproducts and services. Unless you tick here □ we may also share your data with third parties offeringcomplementary products or services. If you have any queries or want to update any of the data thatwe hold then please contact our Database Manager databasemanager@smi-online.co.uk or visit ourwebsite www.smi-online.co.uk/updates quoting the URN as detailed above your address on theattached letter.

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