Nutraceuticals- Heaven or Purgatory?
Getting Innovations In Human Health to Market

Date: April 9th, 2008 at 6:30pm
Cost: $25 Pre-Registered, $35 at the door (cash or check only)
Location: (NEW) Wilson Sonsini Goodrich and Rosati
950 Page Mill Road, Palo Alto
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Nutraceuticals- Heaven or Purgatory?
Getting Innovations In Human Health to Market

Trying to get a great nutraceutical to market?
Have a product that could become a nutraceutical?
Attracted by easy market entry?
Attracted by large, accessible markets?
Wondering if it is it trivial to get one to market?

Come join us for a lively discussion on getting into the multibillion dollar nutraceutical market at BioE2E on April 9th, at 7:00pm at 950 Page Mill Rd., Palo Alto. 

Due to the enormous popularity of nutraceuticals to new and emerging companies, we anticipate that is event will sell out rapidly. Unfortunately seating is limited.   Walk-in registration will be available at $35 on a space available basis only. Registration will close when the event sells out, no later than April 7th at noon.

Please RSVP in advance($25).  If the site is overloaded, please try again later.

Americans spend over $135 per year per person on nutraceuticals, for a market size in excess of $40 billion dollars per year.   With low barriers to entry, nutraceuticals can be a great initial revenue stream for many companies.  As consumers become increasingly health focused, and simultaneously follow poor diet and less exercise, people are increasingly aware of the importance of eating well and remaining healthy.  Today's consumers want it all, taste, convenience, and nutritional excellence.  Nutraceuticals are helping companies take advantage of this large and growing market for functional foods and supplements.

While it can seem to be an unregulated market, it is in fact regulated, and regulated very differently from pharmaceuticals.  Learn how to identify health claims that are and aren't allowed, why cure can be a four letter word, and how to thread the needle to a successful label that sells your nutraceutical. 

Our panel will include experts with experience on many aspects of the process of converting science into a nutraceutical product.  We will present illustrative examples and touch on some of the alphabet soup of issues: cGMP, GRAS, NDI, and DSHEA. We will touch on these and other issues of manufacturing and processing.

Panelists will include;

Dwight McKee
David Hoffmeister

Backgrounds

David Hoffmeister
is a partner at Wilson Sonsini Goodrich & Rosati, where he plays a major leadership role in the firm's drug and device regulatory and healthcare law practice within the life sciences practice.

David brings more than 20 years of experience in drug and device regulatory and healthcare law to the firm. He represents pharmaceutical, biotechnology, medical device, diagnostic, and dietary supplement clients, advising them on a variety of regulatory and healthcare issues, such as strategies for obtaining FDA product approvals and clearances, recalls, labeling, and claim support for advertising and promotional materials.

Before joining Wilson Sonsini Goodrich & Rosati, David was senior counsel for drug and device law at Syntex U.S.A., Inc., where his primary focus was advising senior management on worldwide issues affecting the ability of the corporation and its affiliates to develop, manufacture, and distribute pharmaceutical, device, diagnostic, and over-the-counter drugs in compliance with the Federal Food, Drug, and Cosmetics Act, as well as implementing regulations and applicable state and federal healthcare laws.

Dwight L. McKee M.D. has served as Scientific Director of Life Plus International in Batesville, Arkansas since 2001. He has co-authored a text on interactions between drugs, nutrients, and botanicals, published by Elsevier Science in Dec. 2007. He also serves as a consultant to the San Diego Cancer Research Center. Dr. McKee’s experience in medical research, nutritional science, immunology, chemistry, oncology, and complementary medicine make him one of the most knowledgeable researchers and clinicians worldwide.
 
He graduated from Williams College with honors in chemistry in 1970. He received his M.D. degree in 1975 from the University of Kentucky. After an internship at the Washington Hospital Center in Washington, D.C., he became associate medical director of Integral Health Services in Putnam, CT.­the first integrative medicine clinic on the east coast. Over the next twelve years he studied and practiced nutritional and mind/body medicine, along with a full range of complementary medicine disciplines. Thru working with cancer patients in his practice, he became increasingly interested in cancer medicine, which led him in 1988 to return to hospital based post-graduate training in Internal Medicine at Los Angeles County Hospital, Santa Clara Valley medical center, and Stanford University. After becoming board certified in Internal Medicine, he completed a three year fellowship in Hematology and Oncology at Scripps Clinic, in La Jolla, CA, and subsequently became board certified in both disciplines. He was also a visiting scientist at The Scripps Research Institute Immunology division for 2 years, where he pursued advanced studies in immunology, and performed laboratory research in tumor immunology. Since completing training in medical oncology, hematology, and immunology, Dr. McKee has been involved in the development of integrative cancer care, working to create a synthesis between conventional cancer medicine and alternative/complementary medicine. In 2003, he became board certified in nutrition by the Certification Board for Nutrition Specialists, of the American College of Nutrition, and in 2007 he became Board Certified in Integrative and Holistic medicine through the American Board of Holistic Medicine.

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