Nanotechnology – Current Regulation and Future Prospects

is being presented by Dr. Tony Lockett, Medical Director, with Information Change Organisation Ltd and airs on Thursday, May 20, 2010. For more details or to register, please visit our site at www.fxconferences.com

Nanotechnology is an emotional subject for a public concerned about the perceived threat from so-called frankenfoods. The initial response from government has been to do nothing specific, and until recently drugs based on nanomaterials were treated as new chemical entities (NCE). This has led to a considerable delay in the development of nanomaterials – particularly those for medical uses, where full toxicological assessment was often required prior to using these materials in humans.

There are signs that this is changing. The realization that many nanoparticles are in fact natural, and that materials can self assemble in biological systems, has forced a change in the way we think about nanotechnology. However, there is widespread concern over development of national policies to control this technology, and many fear local regulation will lead to commercial interests being put before safety and efficacy. They believe transnational regulation is required – similar to that exercised by the International Conference on Harmonization with regard to pharmaceutical development – to counterbalance commercial interests.

This audio conference presentation will provide an overview of current regulations governing nanotechnology, and discuss future regulatory strategies.

Phase I Studies with Hepatitis C Compounds in Healthy Volunteers and Patients - Views from Inside

New Chemical Entities (NCEs) that increase the percentage of sustained viral response with current standard treatment for hepatitis C have great marketing potential. Protease inhibitors, polymerase inhibitors, interferons, enzyme inhibitors, viral entry blockers, TLR agonists and oligonucleotides all seek to be included in the future armamentarium. Whether these different classes of compounds can fit together and lead to a successful combination treatment is still unknown. Registration of these NCEs is a long and arduous path, with no guarantee of success.

Drawing on his expertise and 19 years of experience, in this audio conference Dr. van Vliet provides an inside look at opportunities and obstacles when developing a hepatitis C compound, and discusses the critical steps necessary to optimize the chances of the NCE -- condensed Phase I development programs, subsequent proof of concept studies to verify efficacy, and competition for patients versus Phase III trials.

Phase I Studies with Hepatitis C Compounds in Healthy Volunteers and Patients - Views from Inside is being presented by Dr. Andre van Vliet, Vice President of Medical Affairs, Early Development Services, with PRA International and airs on Tuesday, April 14, 2009. For more details or to register, please visit our site at www.fxconferences.com