Sunday, February 07, 2010
2:00pm - 5:00pm

Sponsored by:

Lecturers: Christopher Anzalone, Scott E. McNeil, Wendy R. Sanhai, Max Talbott

Course Description and Outline
Early and midstage industrial developments of nanotechnological tools for biomedical applications and regulatory procedures for the bench to-bedside translation.

Session Introductions: Walter Ulrich, CEO. Houston Technology Center

REGULATION & STANDARDIZATION TRACT
Moderator - Deborah Mansfield, MS, MBA - HTC Director, Life Sciences Program
Scott E. McNeil, Ph.D., Director
Director, Nanotechnology Characterization Laboratory
National Cancer Institute at Frederick

Wendy R. Sanhai, Ph.D.
Senior Scientific Advisor
Office of the Commissioner, FDA
Topic: Nano-Engineered Medical Product Development: An FDA Perspective

Max Talbott MAX TALBOTT LLC Topic: Industry and Government in the Regulation of Nanotechnology Healthcare Products: The Views of Someone Who Has Seen Both Sides

COMMERCIALIZATION TRACT
Moderator - Bill Crow -- HTC Entrepreneur in Residence for NanoEnergy & NanoHealth

Christopher Anzalone, Ph.D.
President and CEO
Arrowhead Research Corporation

Don Payne
President & CEO
BioSpectra Bioscience

Randy K. Goodall, Ph.D.
Co-Founder & CEO
NanoMedical Systems Inc.

Lecturers

		Christopher Anzalone, Ph.D. President and CEO Arrowhead Research Corporation Dr. Anzalone is the President and Chief Executive Officer of Arrowhead Research. He has a wealth of experience in nanotechnology, biotechnology, company-building, and venture capital. As CEO and founder of the Benet Group, Dr. Anzalone has focused on creating and building new nanobiotechnology companies from university-generated science. The Benet Group has investments in two portfolio companies; Nanotope Inc., a tissue regeneration company, and Leonardo Biosystems Inc., a cancer drug delivery company. Prior to Benet, Dr. Anzalone was a partner at the Washington DC-based private equity firm Galway Partners, LLC. There, he was in charge of sourcing, structuring, and building new business ventures and was founding CEO of NanoInk, Inc., a leading nanolithography company. Dr. Anzalone holds a Ph.D. and M.A. in Biology from UCLA and a B.A. in Government from Lawrence University.
		Scott E. McNeil, Ph.D., Director Director, Nanotechnology Characterization Laboratory National Cancer Institute at Frederick Dr. McNeil serves as Director, Nanotechnology Characterization Laboratory for the National Cancer Institute at Frederick where he coordinates pre-clinical characterization of nanomaterials intended for cancer therapeutics and diagnostics. Prior to joining NCI-Frederick (i.e. SAIC-Frederick), he served as Senior Scientist in the Nanotech Initiatives Division at SAIC where he transitioned basic nanotechnology research to government and commercial markets. He advises Industry and State and US Governments on the development of nanotechnology and is a member of several governmental and industrial working groups related to nanotechnology policy, standardization and commercialization. Dr. McNeil's professional career includes tenure as an Army Officer, with tours as Chief of Biochemistry at Tripler Army Medical Center, as a Combat Arms officer in the Gulf War. He is an invited speaker to numerous nanotechnology-related conferences and has six patents pending related to nanotechnology and biotechnology. He received his bachelor's degree in chemistry from Portland State University and his doctorate in cell biology from Oregon Health Sciences University
		Wendy R. Sanhai, Ph.D. Senior Scientific Advisor Office of the Commissioner FDA As Senior Scientific Advisor, Office of the Commissioner, FDA, Dr. Sanhai is responsible for developing and implementing scientific initiatives and strategic alliances under the agency's Critical Path Initiative. In this regard, Dr. Sanhai leads the negotiations of formal agreements on behalf of the FDA and with a range of public-private partners including industry academia, non-profit organizations and other stakeholders. She works closely with FDA scientists in the various centers and with outside collaborators in developing scientific programs with creative business and funding models for the implementation of said programs under the agency's public health mission. Dr. Sanhai has a Ph.D. in biochemistry and structural biology from the School of Medicine, State University of New York at Buffalo and a baccalaureate degree in chemistry from the University of Florida, Gainesville.
		Max Talbott MAX TALBOTT LLC After a 30 year career as a government official and pharmaceutical/biotechnology executive, in 2002, Max Talbott established MAX TALBOTT LLC for the purpose of healthcare industry consulting with special concentrations in regulatory affairs and business development. Since that time, Max has consulted with many companies ranging in size from small, start-up bioteehs to multi-national pharmaceutical / biotechnology / medical device enterprises. During his industrial career, Max participated in over 500 drug, biotech and device development programs. in his government service in FDA's medical device organization, he managed the oversight of hundreds of clinical trials as well as supervised numerous FDA advisory committee meetings. While at FDA, Max was also one of the key participants in the creation and implementation of the 510k, IDE, and PMA regulations. To take advantage of this experience, in creating MAX TALBOTT LLC, Max has established a global network of Associate Experts who support hire in his international consulting efforts. Through this network of Associates, many who have worked for Max at one time in their careers, MAX TALBOTT LLC can deliver the personal support of Max's counsel to all clients on each project as well as on-the-ground tactical and strategic support in the U.S., North, Central and South America, Eastern and Western Europe, India and Asia. The range of global healthcare product regulatory capabilities provided by MAX TALBOTT LLC extends from the preclinical, "pre-IND" stage through registration and into the post-marketing environment.