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Click here for information on our co-located conference: RNAi, miRNA, and siRNA, taking place on the 27th-28th June 2011

 Pharmaceutical Nanotechnology: Applications & Commercialisation

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SMi Presents...

Pharmaceutical Nanotechnology: Applications & Commercialisation

 

About the conference

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 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.

The conference will address:

Engineering, formulation & drug delivery: Comparing available technologies and selecting the best option for your project, advancements in miniaturisation and crossing the blood-brain-barrier using nanotechnologies

Nano-enabled nucleic acid therapeutic delivery: Oligonucleotide and siRNA therapeutic delivery

Translating discoveries into commercial successes: The business case for nanotechnology, improving translation of academic nanomedicine research and case studies covering the transition from academic work to industrial application

Regulatory considerations, IP issues & partnering opportunities: Regulatory challenges for nanomedicines and industry partnering opportunities, issues and solutions

 

Interested in speaking at the conference?  Contact the Conference Producer.

For sponsorship and exhibition opportunities, Contact our Sponsorship Department.

 Medical and Scientific Affairs

 

 

 

  

Make sure you save the date for our half day post-conference workshop

Associated with the conference there will be a half-day interactive workshop on "Nanomedicines: Regulatory Challenges and Opportunities", taking place on Friday 1st of July. This workshop will give participants an understanding nanopharmaceutical applications and regulatory considerations, including an overview of the technology, development considerations, manufacturing, safety and pricing/reimbursement issues.

Leading this workshop will be Brian Kelly, Regulatory Lawyer, Covington & Burling LLP and Simon Holland, Director, Process Understanding & Control, GlaxoSmithKline.  To see more information about the workshop, please see the comprehensive workshop page

Workshop hosted by:

 

Who should attend this event?

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

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Mike Eaton

Mike Eaton, Executive Board Member, European Technology Platform on Nanomedicines

9:10 Nanotechnology in Pharma industry

Deepak Murpani

Deepak Murpani, Vice President, Product Development, Genepharm

  • Applications/ Advantages
  • Review of existing nanotechnologies
  • Opportunities/ Technical challenges
  • Converting challenges to opportunities using right technology
  • Reaping benefits of Nanotechnology as a Brand company
  • Creating new opportunities for Generic/ Supergeneric company
  • Case studies
  • Future potential of Nano in Pharma
  • 9:45 Nanoscale drug delivery systems

    Giancarlo Francese

    Giancarlo Francese, Project Leader, Pharmaceutical Development, Novartis

  • 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 development
  • 10:20 Morning Coffee

    11:25 Miniaturisation and modelling of beads milling

    Mostafa Nakach

    Mostafa Nakach, Head of Pharmaceutical Engineering Group, Sanofi-Aventis R&D

  • 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 performances
  • 12:00 Ten development criteria to cross barriers from blood-to-brain using nanotechnology

    Marco de Boer

    Marco de Boer, Head of Research, to-BBB technologies BV

  • Success criteria based on: 1) safely targeting the blood-brain barrier; 2) use of validated drug carriers; 3) translation from lab to clinic
  • Introduction to G-Technology
  • Case study I: glutathione pegylated liposomal doxorubicin (2B3-101) for brain cancer
  • Case study II: pharma industry partnering model
  • 12:35 Delivering peptides to the brain

    Ijeoma Uchegbu

    Ijeoma Uchegbu, Scientific Secretary CRS, Chair in Pharmaceutical Nanoscience, University Of London

  • The challenge
  • Nanoparticle/ nanofibre technology
  • Delivering peptides via the intravenous route
  • Delivering peptides via the oral route
  • Case study: Oral Enkephalin
  • 13:10 Networking Lunch

    14:10 New nanomaterials for regenerative medicine

    Molly Stevens

    Molly Stevens, Professor of Biomedical Materials and Regenerative Medicine, Imperial College London

  • Materials based approaches for regenerative medicine
  • Design of nanomaterial scaffolds for tissue regeneration
  • Translation to commercial products and clinical studies
  • 14:45 Nanoparticles for the delivery of oligonucleotides targeting EWS/Fli-1

    Claude Paul Malvy

    Claude Paul Malvy, Director, IFSBM, Universite Paris Sud

  • 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 delivery
  • 15:20 Afternoon Tea

    15:55 Delivering siRNA therapeutics

    Sergey Pechenov

    Sergey Pechenov, Research Fellow, siRNA Therapeutics, Merck & Co., Inc.

  • Technology and therapeutic updates
  • Pros and cons of RNAi delivery methods
  • Case study: Lipid nanoparticle-mediated systemic delivery of siRNA to the liver
  • 16:30 Investigation of chitosan nanoparticle formulations

    Michael Keller

    Michael Keller, Senior Fellow, siRNA Project Leader, Technical Research and Development (TRD), Novartis Pharma

  • 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 sizes
  • 17:05 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Thomas Keller

    Thomas Keller, Director, Open Innovation, GlaxoSmithKline

    9:10 The business case for nanotechnology

    Thomas Keller

    Thomas Keller, Director, Open Innovation, GlaxoSmithKline

  • Limitations and cost effectiveness comparisons
  • Benchmarking and the need for agreed industry standard systems for evaluation
  • Challenges in translational development
  • Partnering strategies and opportunities
  • 9:45 Enabling oncology drug development with nanotechnology

    Henry Havel

    Henry Havel, Senior Research Fellow, Product Research and Development, Eli Lilly And Company

  • 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 collaboration
  • 10:20 Morning Coffee

    10:50 Improving translation of academic nanomedicine research

    Mike Eaton

    Mike Eaton, Executive Board Member, European Technology Platform on Nanomedicines

  • 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?
  • 11:25 Building a diversified nanomedicine company

    Christopher  Anzalone

    Christopher Anzalone, CEO, Calando Pharmaceuticals

  • Balancing diversification and focus
  • Follow the science
  • Models that maximize shots on goal
  • Finding and relying on synergy
  • Case Study: Nanotope, Inc
  • 12:00 Networking Lunch

    13:00 Regulatory challenges for nanomedicines

  • 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

    Peter Bogaert, Managing Partner, Covington & Burling

    Brian Kelly

    Brian Kelly, Associate, Covington & Burling Llp

    13:35 Regulatory considerations of Nanomedicines

    Ashish Kohli

    Ashish Kohli, Assessment Unit Manager, Cardiovascular and Diabetes Products, MHRA

  • Defining nanomedicines
  • Key challenges for a regulator in the assessment of these products
  • Experience to date
  • 14:10 A tour of today's Nanomedicine patent landscape: predicting where the future IP battle lines will be drawn

    Jeffrey Rosedale

    Jeffrey Rosedale, Partner, Woodcock Washburn LLP

  • 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
  • 14:45 Drug Delivery and Nanostructuring: Divergent Effects

  • BioSilicon Technology:  
  • Stabilization of amorphous forms. 
  • Enhanced dissolution and bioavailability of poorly soluble molecules
  • Tethadur Systems:         
  • Protein adsorption
  • Sustained release of Anti-Bodies
  • Paul Ashton

    Paul Ashton, President & CEO, pSivida

    15:20 Chairman’s Closing Remarks and Close of Day Two

    15:30 Afternoon Tea

    +

    Workshops

    Nanomedicines: Regulatory Challenges and Opportunities
    Workshop

    Nanomedicines: Regulatory Challenges and Opportunities

    Copthorne Tara Hotel
    1st July 2011
    London, United Kingdom

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    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

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    WHAT IS CPD?

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