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Pharmaceutical Nanotechnology:
            Applications & Commercialisation
                                           SMi presents…




                      Wednesday 29th & Thursday 30th June 2011
                            Copthorne Tara Hotel, London
REGISTER BY 28th FEBRUARY AND RECEIVE A £300 DISCOUNT
REGISTER 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 project




www.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 - 1.00pm



Register online and receive full information on all of SMi’s conferences
Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
www.pharma-
   Pharmaceutical Nanotechnology
   Day One Wednesday 29th June 2011

   8.30        Registration & Coffee                                                      12.35   Networking Lunch

   9.00        Chairman's 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    Chairman's Closing Remarks and Close of Day One




                                                     SPONSORSHIP AND EXHIBITION OPPORTUNITIES
    SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company's 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.uk


Supported by
-nanotech.co.uk
                                                                                  Pharmaceutical Nanotechnology
                                                                                           Day Two Thursday 30th June 2011

   8.30    Re-registration & Coffee                                                                REGULATORY CONSIDERATIONS, IP ISSUES

   9.00    Chairman's 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 today's 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 proportions




your 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   Chairman's 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
RNAi, miRNA and siRNA
PLUS! SAVE THE DATE FOR THE CO-LOCATED
                           SMi present their 6th conference on…



                        Monday 27th and Tuesday 28th June 2011
                                  Copthorne Tara Hotel, London
REGISTER BY 28th FEBRUARY AND RECEIVE A £300 DISCOUNT
REGISTER 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 disease



www.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, Prosensa




Register online and receive full information on all of SMi’s conferences
                                                    8.30am-12.30pm




Alternatively fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
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 understanding
nanopharmaceutical applications and regulatory considerations,                                      Brian Kelly, Regulatory Lawyer, Covington & Burling
including an overview of the technology, development considerations,                                LLP
manufacturing, safety and pricing/reimbursement issues. For                                         Brian Kelly is a regulatory lawyer in the London Life
example, many novel applications of medical nanotechnology will                                     Sciences group, whose practice focuses on food and
span 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. He
Getting the regulatory classification right is crucial in developing and
                                                                                   has more than ten years of experience in regulatory matters having first
commercialising products as different sets of rules govern each
regime. There will be a focus on useful case studies and processes,                worked as a journalist covering medical and healthcare regulatory news
providing a strong, practical take home message to attending                       before joining Covington. He has a particular interest in advising life
delegates.                                                                         science companies on nanotechnology regulatory matters. Mr Kelly's
                                                                                   advice on general regulatory matters includes borderline
Upon 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, GlaxoSmithKline
8.30    Registration & Coffee                                                                       Simon has worked in the pharmaceutical industry for
                                                                                                    over 20 years and is an expert in the field of nanoparticle
9.00    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 Beecham




PHARMACEUTICAL FORWARD PLANNER
9.10    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 merger
9.50    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 of
10.30   Morning Coffee                                                             bioenhanced formulations for the past 13 years including with a
                                                                                   particular emphasis on sub micron compositions. He was the R&D lead
11.00   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.com
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




FEBRUARY 2011                                                JUNE 2011
07/08  Parallel Trade                                        01/02   Pain Therapeutics
                                                                                                                ABOUT THE SMi PHARMACEUTICAL TEAM
21/22  Advances & Progress in Drug Design                    27/28   RNAi
                                                                                                                SMi have been involved in the pharmaceutical
23/24  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 developments
07/08   Imaging in Cancer Drug Development                           Management
                                                                                                                surrounding the industry. Events bring
14/15   Pharmacovigilance                                    29/30   KOL Europe (Munich,
                                                                                                                together senior industry professionals and
16/17   Superbugs & Superdrugs                                       Germany)
                                                                                                                serving companies who have a focus on being
23/24   Accelerating patient recruitment &
                                                                                                                at the forefront of developments in this area.
        Retention in Clinical Trials                         JULY 2011
                                                                                                                SMi aim to generate informed and topical
30/31   Controlled Release                                   06/07    ADMET
                                                                                                                discussion through the medium of both
                                                             11/12    BioBanking
                                                                                                                conferences and executive briefings. Our
APRIL 2011                                                   11/12    Social Media in the
                                                                                                                pharmaceutical events are research-based
13/14    Asthma & COPD                                                Pharmaceutical
                                                                                                                and content driven with regular contact with
                                                                      Industry
                                                                                                                major industry personnel and cover a wide
MAY2011                                                      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/pharma
16/17   Clinical Trial Logistics                                      (Singapore)
                                                             All conferences take place in central London, UK
                                                             – unless indicated otherwise in brackets
PHARMACEUTICAL NANOTECHNOLOGY:

                                                                                               4 WAYS TO REGISTER
                                                                                            www.pharma-nanotech.co.uk
FAX your booking form to +44 (0) 870 9090 712                                                      POST your booking form to: Events Team, SMi Group Ltd, Great Guildford
PHONE 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 conference




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                                                                                                             □ Half Day Workshop only                                              £599.00    + VAT   £718.80




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Pharmaceutical Nanotechnology: Applications & Commercialisation

  • 1. Pharmaceutical Nanotechnology: Applications & Commercialisation SMi presents… Wednesday 29th & Thursday 30th June 2011 Copthorne Tara Hotel, London REGISTER BY 28th FEBRUARY AND RECEIVE A £300 DISCOUNT REGISTER 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 project www.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 - 1.00pm Register online and receive full information on all of SMi’s conferences Alternatively 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 Chairman's 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 Chairman's Closing Remarks and Close of Day One SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company's 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.uk Supported by
  • 3. -nanotech.co.uk Pharmaceutical Nanotechnology Day Two Thursday 30th June 2011 8.30 Re-registration & Coffee REGULATORY CONSIDERATIONS, IP ISSUES 9.00 Chairman's 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 today's 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 proportions your 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 Chairman's 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 siRNA PLUS! SAVE THE DATE FOR THE CO-LOCATED SMi present their 6th conference on… Monday 27th and Tuesday 28th June 2011 Copthorne Tara Hotel, London REGISTER BY 28th FEBRUARY AND RECEIVE A £300 DISCOUNT REGISTER 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 disease www.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, Prosensa Register online and receive full information on all of SMi’s conferences 8.30am-12.30pm Alternatively 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 understanding nanopharmaceutical applications and regulatory considerations, Brian Kelly, Regulatory Lawyer, Covington & Burling including an overview of the technology, development considerations, LLP manufacturing, safety and pricing/reimbursement issues. For Brian Kelly is a regulatory lawyer in the London Life example, many novel applications of medical nanotechnology will Sciences group, whose practice focuses on food and span 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. He Getting the regulatory classification right is crucial in developing and has more than ten years of experience in regulatory matters having first commercialising products as different sets of rules govern each regime. There will be a focus on useful case studies and processes, worked as a journalist covering medical and healthcare regulatory news providing a strong, practical take home message to attending before joining Covington. He has a particular interest in advising life delegates. science companies on nanotechnology regulatory matters. Mr Kelly's advice on general regulatory matters includes borderline Upon 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, GlaxoSmithKline 8.30 Registration & Coffee Simon has worked in the pharmaceutical industry for over 20 years and is an expert in the field of nanoparticle 9.00 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 Beecham PHARMACEUTICAL FORWARD PLANNER 9.10 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 merger 9.50 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 of 10.30 Morning Coffee bioenhanced formulations for the past 13 years including with a particular emphasis on sub micron compositions. He was the R&D lead 11.00 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.com 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 FEBRUARY 2011 JUNE 2011 07/08 Parallel Trade 01/02 Pain Therapeutics ABOUT THE SMi PHARMACEUTICAL TEAM 21/22 Advances & Progress in Drug Design 27/28 RNAi SMi have been involved in the pharmaceutical 23/24 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 developments 07/08 Imaging in Cancer Drug Development Management surrounding the industry. Events bring 14/15 Pharmacovigilance 29/30 KOL Europe (Munich, together senior industry professionals and 16/17 Superbugs & Superdrugs Germany) serving companies who have a focus on being 23/24 Accelerating patient recruitment & at the forefront of developments in this area. Retention in Clinical Trials JULY 2011 SMi aim to generate informed and topical 30/31 Controlled Release 06/07 ADMET discussion through the medium of both 11/12 BioBanking conferences and executive briefings. Our APRIL 2011 11/12 Social Media in the pharmaceutical events are research-based 13/14 Asthma & COPD Pharmaceutical and content driven with regular contact with Industry major industry personnel and cover a wide MAY2011 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/pharma 16/17 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.uk FAX your booking form to +44 (0) 870 9090 712 POST your booking form to: Events Team, SMi Group Ltd, Great Guildford PHONE 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 conference DELEGATE 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 DISTRIBUTION Unique Reference Number □ Distribution of your company’s promotional Our Reference LVY17 GROUP DISCOUNTS AVAILABLE literature to all conference attendees £999.00 + VAT £1198.80 CD ROMS/DOCUMENTATION Title: Forename: Surname: The Conference fee includes refreshments, lunch, conference papers and Job Title: CD ROM containing all of the presentations. 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