Nanotechnology in the Pharmaceutical Industry
Session 106 
Technology Track
The industry is facing unprecedented pressure to bring products to the market faster and with a higher probability of success. Nanotechnology presents an avenue for companies to improve upon existing safe therapies and enjoy patent protection via a 505b2 regulatory route, or significant increase the bioavailability of New Molecular Entities in development. Understanding the technical and regulatory hurdles necessary to safely and effectively leverage nanotechnology is the first step to realizing the potential benefits of this approach.
Session Description
This session will discuss nanotechnology approaches developed for pharmaceutical applications and technologies including: fullerenes (buckyballs) as drug carriers, nanotubules for drug delivery, nanoparticles (e.g., liposomes, dendrimers, micelles), nanospheres, molecular nanotechnology, and the potential integration of nanotechnology and drug-delivery platforms (i.e. Micro-Electro-Mechanical Systems or MEMS). You will learn the strengths and weaknesses of these different approaches to leverage the full potential of these emerging technology platforms.
At the conclusion of this session, participants will:
- Understand the technical, quality, and regulatory considerations of nanotechnology
- Understand the potential applications for nanotechnology within the life sciences arena
- Understand the limitations and hurdles to implementing nanotechnology today
- Understand the challenges facing Pharma today in implementing nanotechnology
- Discuss with thought leaders what is on the horizon in terms of nanotechnology
Leaders
Speakers
- Jeff Campie, USA
- Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
- Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
- Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
- Edwin Melendez, Principle Consultant, Parexel, USA
- Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
- Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
- Julian Wilkins, Vice President, PharmaConsult US Inc, USA
- Paul Wreglesworth, Independent Consultant, United Kingdom


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