NIH-funded Dietary Supplement Research Center
Missouri University Center for Phytonutrient and Phytochemical Studies
Role of Phytoestrogens in Prostate Cancer Treatment
Estrogens have long been examined for their potential use in treating hormone-dependent prostate cancer. Because of the potential for estrogenic compounds and soy isoflavones as therapeutics, this center sought to identify whether estrogen receptor-alpha (ERa) was involved in prostate tumor progression and whether the soy isoflavone genistein acted to inhibit prostate tumorigenesis through ERa.

Speaker:

Dennis B. Lubahn, Ph.D., is presently an associate professor of biochemistry and child health at the University of Missouri-Columbia. Previously, he was the group leader of cellular biochemistry at Glaxo Research Institute and adjunct associate professor of pediatrics, pathology and laboratories for reproductive biology at the University of North Carolina, Chapel Hill.

Dietary Soy Phytoestrogens - Effects on Cell-mediated Immune Function and Inflammation in Infection
Phytoestrogens present in soy have the potential to impact host immune function. The impact of soy diet and isolated bioactive components from soy in an animal model of chronic infection and inflammation was examined. Hear how the results suggest that dietary supplementation with soy products can impact the production of key regulatory cytokines involved in host defense.

Speaker:

Mark Estes, Ph.D., is a professor in the school of medicine in the department of pediatrics and a senior scientist in the Sealy Center for Vaccine Development at the University of Texas Medical Branch. Previously, Estes was a professor in the school of medicine in the department of molecular biology and immunology at the University of Missouri at Columbia.

Session 2

Small Business Funding Opportunities from NIH
The National Institutes of Health (NIH) has more than $550 million in grant money available for businesses developing innovative health products, services and programs. Find out how your company can apply for this money through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.

Speaker:
Shan S. Wong, Ph.D., currently is a program officer at the National Center for Complementary and Alternative Medicine (NCCAM), a component of the National Institutes of Health (NIH). His job function includes coordinating the NCCAM small business innovation research (SBIR) and small business technology transfer (STTR) program, assisting grantees and reviewing research progress reports.

Speaker:

Professor George A. Kraus, Ph.D., has been a faculty member at Iowa State University since 1976. From 1993 to 1999 he was department chair. His research program involves the development of new synthetic methods and their application to the synthesis of biologically active natural products. He has synthesized antiviral agents from St. John's wort (hypericum) and Echinacea. He is a member of the ACS, ACS Division of Organic Chemistry, ACS Division of Medicinal Chemistry, and the International Society for Antiviral Research.

NIH-funded Dietary Supplement Research Center
University of Illinois, Chicago, Center for Botanical Dietary Supplement Research in Women's Health
Botanical Dietary Supplements with Regard to Women's Health
Botanicals such as black cohosh, red clover, hops, chaste berry, ginseng, black haw, dong quai, valerian, licorice and cranberry have been extensively investigated for their ability to improve women's health. UIC researchers have developed standardized extracts for use in clinical trials, including determining active principles, developing suitable bioassays and investigating toxicity, safety, pharmacokinetcs and mechanisms of action. This presentation will cover the development of red clover and black cohosh standardized dosage forms and their use in Phase I and Phase II clinical studies to determine their effects on reducing hot flashes.

Speaker:

Norman Farnsworth, Ph.D., is the director of the Program for Collaborative Research and the University of Illinois, Chicago/NIH Center for Research on Dietary Supplements. He recently served on the Presidential Commission on the Dietary Supplement Labels and has been, and continues to be active as director of the World Health Organization (WHO), Collaborating Center for Traditional Medicine at UIC.

NIH-funded Dietary Supplement Research Center
University of Arizona Center for Phytomedicine Research
Testing Botanical Extracts for Anti-inflammatory Activity
Major active compounds of several commonly used botanicals have been purported to have anti-inflammatory actions and to be effective in treatment of arthritis or other chronic inflammatory diseases. These include turmeric, ginger and boswellia. The goal of this center is to determine the effect of these supplements on inflammatory mediators and to determine their ability to regulate inflammation. Data will be presented showing the efficacy of these extracts and fractions containing known and potentially novel compounds isolated from the three plants of interest.

Speaker:

R. Clark Lantz, Ph.D., is professor of cell biology and anatomy and deputy director at the Arizona Center for Phytomedicine, University of Arizona. He also serves as director, experimental pathology core and deputy director for the Southwest Environmental Health Science Center at the University of Arizona.

NIH-funded Dietary Supplement Research Center
UCLA Center for Dietary Supplement Research in Botanicals
Herbal Approaches to Cancer
This center studies the effects of a variety of herbs and foods on the development and prevention of cancer. We have the expectation that foods and herbal products, complex mixtures of many phytochemicals, act differently than the isolated compounds derived from them. We are testing this theory to develop safe and effective agents for cancer prevention. This presentation will focus on the major research projects of our center set in the context of cancer patients' use of herbal therapies including red rice yeast, lycopene and flavonoids in green tea.

Speaker:

Mary Hardy, M.D., is associate director for the Center for Research in Dietary Supplements and Botanicals at the University of California, Los Angeles (UCLA). She is the medical director of the Cedars-Sinai Medical Center program in Integrative Medicine. Hardy has conducted systematic reviews of alternative medicine topics for the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplements (ODS) at the RAND Corp. in Los Angeles. She has served as a technical expert adviser in complementary and alternative medicine for the California Board of Medicine.

NIH-funded Dietary Supplement Research Center
Purdue University - University of Alabama Botanical Center for Age Related Diseases
Plant Polyphenols and Age Related Disease
This session will focus on polyphenols and the possible benefits for age related disease. Research will be presented on the influence of botanical supplements on bone resorption in postmenopausal women using accelerator mass spectrometry; the neuroprotective properties of grape seed extract, which is rich in proanthocyanidins; and tea polyphenols and cancer.

Speaker:

Elsa Janle, Ph.D., is a research scientist in the Foods and Nutrition Department at Purdue University and co-director of the In Vivo Core of the Purdue University-University of Alabama NIH Botanical Center for Age Related Diseases. Janle has developed ultrafiltration probe technology for in vivo sampling of the interstitial fluid from the tissues of living animals and applications for use of this technology in diabetes research, drug development, space medicine research and for examining the pharmacokinetics and distribution of active substances in botanical preparations.

Safety Evaluation of Dietary Supplement Ingredients and Products
This session will review approaches to evaluating dietary supplement ingredient and product safety, including an overview of safety data useful in supporting a New Dietary Ingredient (NDI) notification. Reference will be made to current dietary supplement safety issues and the standards of safety that are applied to ensure that a dietary supplement product is reasonably expected to be safe in compliance with the Dietary Supplement Health and Education Act of 1994.

Speaker:

Earle Nestmann, M.Sc., Ph.D., is a recognized authority in toxicology and has extensive experience in regulatory affairs and risk assessment. Prior to joining CANTOX, Nestmann was a research scientist at Health Canada where he was responsible for a program in genetic toxicology and contributed to the development of regulatory policies. He has worked with the World Health Organization, the U.S. National Toxicology Program, the U.S. National Academy of Sciences and a number of trade associations.

Developing and Validating Methods for Dietary Supplements and Finished Products:
An AOAC International Symposium
Hear new thinking regarding validation of dietary supplements and finished products. Jim Roza will be joined by leaders in the dietary supplements community who will present information regarding the impact of cGMP regulations on validation needs, and information on solutions through collaboration.

Moderator:
Jim Roza is the director of quality assurance at NOW Foods and has more than 20 years experience in the dietary supplement and natural foods industry. He is the chair of AOAC International’s Dietary Supplements Task Group, on the board of directors for Citizens for Health, on the board of trustees for the American Herbal Products Association (AHPA) and on the manufacturers' board for the Dietary Supplement Education Alliance (DSEA).
Panelists:
Annette Dickinson, Ph.D., is president of the Council for Responsible Nutrition (CRN), one of the dietary supplement industry’s leading trade associations. Dickinson has more than 30 years experience in the dietary supplement industry. Her most recent publication is CRN’s 2002 edition of The Benefits of Nutritional Supplements, a comprehensive review of the evidence demonstrating the health benefits of core nutritional supplements including multivitamins.	Anita Mishra was appointed principal scientific liaison, government and industry at AOAC International in July 2002. In her role, she works to build relationships and partnerships as well as understand the needs of the scientific community. She provides a mechanism and nexus for constant communication between regulatory agencies, regulated industries and AOAC International.
Michael McGuffin is president of the American Herbal Products Association (AHPA), the national trade association and voice of the herbal supplement industry. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. He is the managing editor of AHPA's Botanical Safety Handbook (1997) and of Herbs of Commerce, Second Edition (2000).	David Seckman is executive director and chief executive officer (CEO) of the National Nutritional Foods Association (NNFA), a California-based, 4,000-member organization of manufacturers, wholesalers and retailers of natural products. Previously, he was vice president for regulatory affairs for the American Health Care Association (AHCA). During his 11-year tenure at AHCA, Seckman increased both the visibility and credibility of the organization with Congress, federal agencies and related groups.

The CEO Perspective
Peek inside the heads of these business leaders as they share their thoughts on such topics as the future of the industry, overall trends, quality issues, the unpredictable stock market, media portrayal and much more. This is your opportunity to pose questions to the visionaries who have helped shape the industry.

Moderator:
Jon Benninger is director of business development for Virgo Publishing's Health and Nutrition Division. He began working in the natural products industry in1990 and joined Virgo Publishing in 1995. Benninger is active in many industry associations and initiatives, and serves as vice president of the Dietary Supplement Education Alliance (DSEA).
Speakers:
Paul Allen is the group vice president of the Nutrition & Health strategic business unit of Cognis where he is responsible for five business segments including Dietary Supplements, Pharmaceuticals & Healthcare, Food Technology, Functional Foods & Medical Nutrition and Animal Nutrition. Under his direction, the unit is slated for considerable growth through new technologies and acquisitions. His responsibilities include plant-based antioxidants, sterols, CLA and botanicals for dietary supplements and functional foods.	Joe Bresse is the vice president of product development and industry relations of General Nutrition Centers. He is a 32-year veteran of the dietary supplement industry. The array of departments that he has worked in has given him a strong understanding of the industry.
Additional speakers to be announced

The Art of Negotiating: Never Pay Too Much, Settle For Too Little or Give In Too Soon
Have you ever paid more than you should have? Learn how to be an effective negotiator by becoming a better communicator and fitting your strategy and tactics to your negotiating "opponent." This expert will share his tricks of the trade and teach you how to break a deadlock, ask for concessions in a way you're more likely to get them, avoid surprises, make fair and lasting agreements, and much more.

Speaker:

John Patrick Dolan's book on negotiations, Negotiate like the Pros, is an all-time best seller. He mastered negotiation through his long, successful career as a trial lawyer. Through his firm LawTalk™, Dolan trains other legal professionals how to excel in this crucial skill and art. Dolan is one of the few recipients of both the National Speakers Association's CPAE "Speaker Hall of Fame" award and Certified Speaking Professional designation. Clients include Xerox, Rockwell and the Texas Rangers.

The Vitamin E Debate
Gamma tocopherol and other vitamin E forms, including tocotrienols, have increasingly received more attention from supplement manufacturers. Are the reformulated vitamin E supplements warranted? Does our understanding of vitamin E, especially the role of other tocopherols and tocotrienols besides alpha-tocopherol, need to be reevaluated?

Hear two experts debate the use of vitamin E and answer these important questions.

Speakers:

Author of The Vitamin E Factor and editor of the scientific book Antioxidant Status, Diet, Nutrition and Health, Andreas Papas, Ph.D., is president of YASOO Health Inc. He also is an adjunct professor at the College of Medicine at East Tennessee State University and senior scientific advisor, cancer prevention at the Institute Harvard School of Epidemiology. A Fulbright Scholar, Papas is a graduate of the University of Illinois and an expert on vitamin E and antioxidants.

Robert V. Acuff, Ph.D., is a professor in the college of medicine and director of the Eastman Center for Nutrition Research at East Tennessee State University and is well published in the area of vitamin E. He was awarded the VERIS Award in 1999 for "Studies on the bioavailability and transport of Vitamin E". Acuff has had more than 60 publications with the majority on vitamin E, antioxidants and bioavailability.

Creating Advertising That Sells
Natural products manufacturers and suppliers spend thousands of dollars annually on print and other forms of trade and consumer advertising. But is it working? Learn effective techniques to make your advertising more compelling and persuasive. Discover ways to strengthen your brand's position in the marketplace and generate greater customer response. Bring examples of your current ads for review and feedback.

Speaker:

Jeff Hilton is co-founder and president of Integrated Marketing Group (IMG), a service company providing marketing and branding assistance to clients in the healthy lifestyles industry. Hilton has been recognized by Advertising Age as one of the nation's Top 100 marketers. He has more than 25 years of broad-based business experience, including 12 years spent within the natural health care industry.

Keynote Speaker
Earvin "Magic" Johnson
Former Los Angeles Laker

With three NBA MVP awards, five NBA championship rings, nine appearances in the NBA finals and as an original member of the 1992 Olympic Dream Team, Magic Johnson certainly is one of basketball's greats.

Off the court, Johnson lends his time to support many worthy causes through the non-profit Magic Johnson Foundation, which awards grants to other non-profit organizations that work to improve the health, educational and social needs of those residing in the inner city.

Hear this all-star give an energetic presentation and take audience questions.

Co-Sponsored by:

New Consumer Research: The Hottest Trends in the Nutritional Marketplace
We are in the midst of a nutritional revolution­with health and wellness being redefined across many aspects of consumer lifestyles. Join the Natural Marketing Institute (NMI) as it unveils newly released data from The NMI Health & Wellness Trends Database (HWTD)­now with five years of consumer health and wellness trends. Focus will include nutritional opportunities relating to functional, fortified and natural products, including the analysis of specific ingredients, dietary supplements, foods/beverages and personal care products. Give your business a powerful tool to stay one step ahead of the trends!

Speaker:

Steve French, managing partner at The Natural Marketing Institute (NMI), has more than 20 years of strategic brand marketing, business development, market research and management experience with PepsiCo, Mars Inc. and Marriott. With bachelor's and master's degrees in marketing, he has extensive knowledge in the world of health and wellness across many consumer segments, trade channels and business situations.

Capturing the Practitioner Market
Why has the healthcare practitioner market not been addressed and what types of challenges lay ahead? Are practitioners open to the use of CAM therapies and what specifics are practitioners looking for in supplements? This session will examine distribution challenges and discuss what kind of education is needed to penetrate this market. Hear if clinical studies are a necessity, and how companies can conduct and support research.

Speaker:

Gina L. Nick, Ph.D., N.D., is the chief scientific officer at Longevity Through Prevention, a consulting firm catering to the nutraceutical industry. Nick is a doctor of naturopathic medicine and a recognized researcher in the area of nutritional science. She was recently honored with a nomination in Marquis' 57th edition of Who's Who in America. Nick is the researcher and formulator of highly reputable nutritional supplements, in consumer and practitioner markets, that have been proven clinically effective through bench and clinical research studies.

The Science of Compliance: What Supplement Marketers and Manufacturers Need to Know About FTC Enforcement
Explore recent Federal Trade Commission (FTC) actions of interest to the dietary supplement and functional food industries and the steps marketers should take to comply with federal truth-in-advertising standards.

Domestic Industry Update
Industry insiders address the current issues facing ingredient suppliers, natural- and healthy-product manufacturers and marketers. Pending legislation can and will affect the way you do business. Hear the latest on issues including Good Manufacturing Practices (GMPs), FDA/FTC enforcement, consumer concerns and more. Stay up to date, don't miss this session.

Speakers:
Michael McGuffin is president of the American Herbal Products Association (AHPA), the national trade association and voice of the herbal supplement industry. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. He is the managing editor of AHPA's Botanical Safety Handbook (1997) and of Herbs of Commerce, Second Edition (2000).	David Seckman is executive director and chief executive officer (CEO) of the National Nutritional Foods Association (NNFA), a California-based, 4,000-member organization of manufacturers, wholesalers and retailers of natural products. Previously, he was vice president for regulatory affairs for the American Health Care Association (AHCA). During his 11-year tenure at AHCA, Seckman increased both the visibility and credibility of the organization with Congress, federal agencies and related groups.
Marc Ullman, partner at Ullman, Shapiro and Ullman, represents clients in matters relating to Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) matters, regulatory issues, Federal Trade Commission (FTC) proceedings and litigation. His practice includes representation relating to FDA compliance including labels, labeling, claims, good manufacturing practices as well as a number of complex proceedings with the FDA relating to the agency's powers under the Dietary Supplement Health and Education Act (DSHEA) of 1994.

How Bioterrorism Affects Your Business
Did you know that every food and dietary supplement company in the world must register with the U.S. FDA by Dec. 12, 2003 in order to import ingredients into the United States? Did you know that every imported food and dietary supplement product will be subject to a "Prior Notification" requirement as of that date? Hear what your rights are and what this means for your company.

Speakers:
LDI Group Inc. is headed by Loren D. Israelsen, who has 20 years of experience in the supplement, phytomedicine and functional food fields. His background includes serving as president of Nature's Way, dietary supplement issue manager to the Trans Atlantic Business Dialogue (TABD), and an advisor to the Office of Dietary Supplements on botanical research priorities. His work as executive director of the Utah Natural Products Alliance (UNPA) was instrumental in the introduction and passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994.	Michael Granville is president and chief executive officer (CEO) of Linnea SA, a Swiss manufacturer of botanical extracts. A substantial segment of Linnea's worldwide business involves imports to the United States through its subsidiary, Linnea Inc. in Easton, Pa. Granville has managed Linnea since 1990, and entered the botanical extract industry a decade earlier as an employee of a group of joint-venture companies, which includes Linnea, formed by the European pharmaceutical groups Ipsen and Schwabe. Currently, he functions as CEO for the Ipsen-Schwabe Joint Ventures.
Robyn Frisch is the president, CEO and founder of ROCHEM International Inc. in Ronkonkoma, NY. She worked for the largest state-run chemical and pharmaceutical trading company in China prior coming to the United States in 1990. With 18 years experience in the pharmaceutical and nutritional industries, she built a strong bridge between customers in the United States and manufacturers of chemical, pharmaceutical and nutritional ingredients in China.

European Industry Update
The industry has grown into a worldwide network of suppliers, manufacturers, marketers and importers. Issues and legislation oversees can change the way we all do business. What does the European Union food directive mean? Will CODEX cause stricter regulations for supplements? Your questions will be answered in this informative session.

Speakers:

John N. Hathcock, Ph.D., vice president, scientific and international affairs, for the Council for Responsible Nutrition (CRN), is responsible for scientific review and regulatory interpretation, especially on safety and international regulatory issues. Hathcock has more than 30 years of experience, including tenures as a professor at Iowa State University and senior scientist at the Food and Drug Administration. He analyzes, develops CRN policy positions and makes presentations on international regulations and issues, including those by the Codex Alimentarius and the European Commission.

In 1996, Penny Viner became the first director of the Health Food Manufacturers' Association (HFMA), the major trade association for the specialist health product industry in the United Kingdom. In August 2003, she retired from the day-to-day management to become vice president, with special responsibility for legal and regulatory affairs. She is also vice president of the European Health Product Manufacturers Association (EHPM), a director of the British Association of Homoeopathic Manufacturers (BAHM) and chairman of the UK Herbal Forum.

Current Regulatory Approach to Health Claims
Using the phytosterols interim final rule as a case study, hear a review of the status and how industry achieved that claim. In addition, an overview of the law on health claims, the push to open the door to more appropriate health claims for dietary supplements through the Pearson cases and the current approach of permitting qualified health claims. The recent enforcement of qualified health claims via discretion letters will be also be addressed.

Speaker:

Diane C. McEnroe, counsel to the firm in Sidley Austin Brown & Wood's New York office, has practiced for 14 years in the areas of food, pharmaceutical and dietary supplement law. She has participated in pharmaceutical patent and Lanham Act litigation, DEA hearings and Federal Trade Commission (FTC) investigations. She regularly counsels clients on issues involving the Nutrition Labeling and Education Act (NLEA), the Dietary Supplement Health and Education Act (DSHEA) and functional food ingredients, and state and federal pharmaceutical regulation.