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.
Conference agenda
Experience and backgrounds of participants and hosts
Purpose and scope of the workshop
Nanopharmaceuticals on the market and in clinical development Development, manufacturing and characterisation of nanomedicines Regulatory challenges: borderline issues, safety and other legal and ethical issues Pricing/reimbursement of innovative nanomedicines Interactions with regulators over nanomedicine issues
Manufacturing licenses
Borderline determinations
Clinical trials
Interactive Discussion Session Chairman's Opening Remarks Mike Eaton, Executive Board Member, European Technology Platform on Nanomedicines Nanotechnology in Pharma industry 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
Nanoscale drug delivery systems 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
Miniaturisation and modelling of beads milling 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
Ten development criteria to cross barriers from blood-to-brain using nanotechnology 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
Delivering peptides to the brain 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
New nanomaterials for regenerative medicine 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
Nanoparticles for the delivery of oligonucleotides targeting EWS/Fli-1 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
Delivering siRNA therapeutics 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
Investigation of chitosan nanoparticle formulations 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
Chairman’s Closing Remarks and Close of Day One Chairman's Opening Remarks Thomas Keller, Director, Open Innovation, GlaxoSmithKline The business case for nanotechnology 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
Enabling oncology drug development with nanotechnology 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
Improving translation of academic nanomedicine research 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?
Building a diversified nanomedicine company 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
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, Managing Partner, Covington & Burling Brian Kelly, Associate, Covington & Burling Llp Regulatory considerations of Nanomedicines 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
A tour of today's Nanomedicine patent landscape: predicting where the future IP battle lines will be drawn 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
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, President & CEO, pSivida Chairman’s Closing Remarks and Close of Day Two
Workshops
Copthorne Tara Hotel 1 July 2011 London, United Kingdom
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