Agenda
DAY ONE - October 23rd, 2008
8.30-9.30 Registration and Morning Coffee
9.30-12.30 NANOMEDICINE INTELLECTUAL PROPERTY WORKSHOP: Nanomedicine Patent Strategy: A Global Perspective (including US, Europe, North America, and Japan)
Global law firm, Foley & Lardner, invite delegates to join them for an interactive workshop featuring three leading practitioners from the US, Europe and Japan to discuss global patent strategy in the nanomedicine field. The workshop will include comparative case studies of successful strategies employed on a global basis to obtain maximum patent protection in the key jurisdictions. Additional areas to be covered in the workshop are as follows:
- Protecting combination products that incorporate nanomaterials for targeted drug delivery
- Strategies for broadly claiming small particle formulations
- Understanding how much data is needed to support broad nanomedicine claims in the key jurisdictions of the US, Europe and Japan
- Major global trends impacting the scope of protection in nanomedicine inventions
Foley & Lardner LLP, International Law Firm and Patent Agents, US
Lead: Mr Stephen Maebius
12.30-1.30 Lunch
2.00-2.40 Chair’s Opening Speech & Masterclass
Masterclass: Nanotechnology and Medicines Development
Professor Ijeoma Uchegbu, Department of Pharmaceutics, School of Pharmacy, University of London, UK
2.40-3.20 Dendrimers in Pharmaceutical Applications
Presentation to cover:
- An update on the clinical progress of clinical candidate Vivagel®, a vaginal microbicide for the prevention of transmission of HIV and HSV 2 based on a dendrimer nanoparticle SPL7013.
- An overview of the application of dendrimers to drug delivery and pharmacokinetic modification
- A summary of the data arising from studies to date in the areas of drug half life extension, payload targeting and controlled release.
David Owen, BSc(Hons) PhD, VP Research, Starpharma Pty Ltd, Australia
3.20-3.40 Coffee
3.40-4.20 Nanoparticle-Mediated Systemic Tumour Suppressor Gene Delivery for Lung Cancer: Moving Beyond the Laboratory
Presentation to cover:
- Lung cancer epidemiology
- Current treatment strategies
- New and effective therapies for lung cancer treatment
- Development of a systemic gene-based nanoparticle therapy for lung cancer
- Early phase I clinical trial results for systemic nanoparticle therapy
Professor Rajagopal Ramesh, Department of Thoracic and Cardiovascular Surgery, M.D. Anderson Cancer Center, USA
4.20-5.00 Nanomedicines for the Enhancement of Drug Bioavailability
Presentation to cover:
- Overview of nanomerics technology
- How to enhance drug bioavailabilty
Professor Ijeoma Uchegbu, Co-Founder and Technical Director, Nanomerics, UK
5.00-5.15 Chair’s Closing Remarks
5.15-6.45 Wine Reception
DAY TWO - October 24th, 2008
8.30-9.00 Registration and Morning Coffee
9.00-9.10 Chair’s Opening Speech
Professor Larry Sternson, President and CEO, Avidimer Therapeutics, and Research Professor of Internal Medicine, College of Medicine, University of Michigan, USA
9.10-9.50 Polyelectrolytes in Medicine: Multifunctional Nanotools
Presentation to cover:
- Polyelectrolytes as drugs
- Immune protection tools
- Nanostructured layers
- Nanocoating to induce transport through the blood-brain barrier
Dr Silke Krol, Senior Scientist and Head of the NanoBioMed Group, Laboratory for Nanodiagnostics, Drug Delivery and Analysis at the Center of Molecular Biomedicine (CBM), Italy
9.50-10.30 Nanofunctional Interfaces for Nanoscale Biomedical Imaging
Presentation to cover:
- The evolution of nanoscale analytics in the life sciences
- Molecular imaging in biological and pharmaceutical research
- Ultra-sensitive detection of low-abundant biomolecules
- From microscale to nanoscale molecular imaging
Dr Christof Fattinger, Head of Microtechnologies and Automation, Discovery Technologies, Roche, Switzerland
10.30-11.00 Coffee
11.00-11.40 Nanodrug Clinical Case Study and Manufacturing-Scalability Issues
Presentation to cover:
- Scalability issues for manufacturing nanodrugs
- Topical delivery of nanomedicines
- DermaVir patch: phase-II trial outcomes
Dr. Julianna Lisziewicz, CEO, Genetic Immunity, Hungary/USA
11.40-12.20 FDA Considerations for the Regulation of Nanomaterial-containing Products: a Perspective from the CDER
Presentation to cover:
- Update on nanopharmaceuticals for FDA review
- Key aspects of the evaluation and review of nanoscale materials
- Activities that FDA/CDER has initiated, in order to prepare for the review and evaluation of nanopharmaceuticals
Dr Nakissa Sadrieh, Associate Director for Research Policy and Implementation, Center for Drug Evaluation and Research, Food and Drug Administration, USA
12.20-1.50 Lunch
2.00-2.40 Keynote Address: Overcoming Big Challenges in Making Small Products to Make Big Differences in Drug Targeting
Presentation to cover:
- The challenges in manufacturing nanomolecular drug candidates with the purity, quality and potency suitable for clinical evaluation; addressing the need for batch-to-batch consistency
- Approaches to enhance the specificity and efficiency of site specific drug delivery while achieving safety
- Why smaller is better
- The pharmacology, toxicology and pharmacokinetics of nanomolecular drug candidates
- How size changes everything
Professor Larry Sternson, President and CEO, Avidimer Therapeutics, and Research Professor of Internal Medicine, College of Medicine, University of Michigan, USA
2.40-3.20 Beyond Nano-Publicity - A Realistic Business Case for Pharma
Presentation to cover:
- Nanomaterial platforms
- Drug delivery systems
- Development partnerships and barriers
Dr Thomas Keller, Director - Biophysical Sensors & Nanomaterials, GlaxoSmithKline Research & Development, UK
3.20-3.40 Coffee
3.40-4.20 RNAi NanoplexTM Technology for Systemic Delivery of siRNA Therapeutics for the Treatment of Cancer
Presentation to cover:
- Overview of RNAi as a potential therapeutic modality
- Challenges of developing RNAi-based therapeutics
- Validating and improving methods for systemic delivery of siRNA
- RNAi Nanoplex™ technology: a promising approach for systemic delivery of RNAi therapeutics
Dr Xiaodong Yang, Vice President, Research and Preclinical Development, Intradigm Corp., USA
4.20-5.00 The Competitive Landscape of Nanotechnology in Drug Delivery
Presentation to cover:
- Nanobiotech innovations overview
- Companies active in nanotechnology
- Impact of nanotechnology on drug and device manufacturers
- Technical, operational and IP positions for nanobiotechnology research and development
Mark Bünger, Research Director, Lux Research, USA
5.00-5.15 Chair’s Closing Remarks