David
William Kennedy Acheson, MD, FRCP, Assistant Commissioner for Food
Protection for the U.S. Food and Drug Administration, graduated from the
University of London Medical School, and following training in internal medicine
and infectious diseases in the United Kingdom, moved to the New England Medical
Center and Tufts University. Acheson was chief medical officer at the Food and
Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN).
Subsequently, he also became the director of CFSAN’s Food Safety and Security
Staff and in January 2005, the staff was expanded to become the Office of Food
Safety, Defense and Outreach. In January 2007, the office was further expanded
to become the Office of Food Defense, Communication and Emergency Response. On
May 1, 2007, Acheson assumed the position of FDA Assistant Commissioner for Food
Protection to provide advice and counsel to the commissioner on strategic and
substantive food safety and food defense matters. Acheson is a fellow of both
the Royal College of Physicians (London) and the Infectious Disease Society of
America.
Michael Bradley is an expert in FDA regulations that govern
pharmaceuticals, foods (including nutritional supplements) and cosmetics. His
regulatory expertise includes GMP regulations for foods and drugs,
labeling regulations for food, drugs and cosmetics as well as a working
knowledge of FDA administrative and regulatory practices. Bradley developed this
expertise while working for Shuster Laboratories Inc., a consulting firm based
in Quincy, Mass. From December 1996 to April 1999 he was director of regulatory
affairs at Leiner Health Products Inc. From April 1999 to October 2000 he was
director of quality assurance at Leiner Health Products Inc. Currently he is the
director nutritional scientific affairs for the Perrigo Company of South
Carolina. In this position, he serves as a member of the nutrition planning
team, which is responsible for all the strategic and administrative business
planning for the dietary supplement division. His responsibilities include the
design and implementation for new product development, quality control testing,
and quality assurance/compliance requirements for the Perrigo dietary supplement
division. In his current assignment, he is responsible for implementing lean
manufacturing and six sigma principles in the laboratory operations to align
testing and compliance activities to customer expectations (Voice of Customer).
Bill H. Frankos, Ph.D., serves as the director, Division of Dietary
Supplement Programs (DDSP) for the FDA. Dr. Frankos directs and coordinates
policy, budget, personnel and administrative activities within the division. He
advises on policy and management issues and decision, and provides expert advice
and assistance to the director of the Office of Nutrition, Labeling, and Dietary
Supplements, and other key FDA officials on dietary supplement programs, new
dietary ingredient safety assessments, good manufacturing practices, adverse
reaction monitoring, and related activities pertaining to dietary supplements.
Dr. Frankos is responsible for the full implementation of DSHEA through the
interpretation and enforcement of dietary supplement requirements that ensure
the safety and truthful labeling of dietary supplements, and support legislative
compliance, enforcement and public affairs initiatives. Dr. Frankos received his
master’s of science degree in molecular biology from the University of Maryland,
and his Ph.D. in pharmacology and toxicology from the University of Maryland
Pharmacy School. He has over 30 years of experience in the toxicological and
pharmacological evaluation of data used to assess the safety of nutritional
supplements, foods and food additives, drugs, medical devices, cosmetics and
environmental chemicals.
Rick Perlman has been in the pharmaceutical industry for more than 25
years, with particular experience in the areas of quality assurance and
operations. He has been a member of the American Society for Quality (ASQ) since
1991, and has been actively involved in that organization’s Food, Drug and
Cosmetic Division since 2000. Perlman served the FDC Division board in
successive leadership positions for five years, actively supporting ASQ’s
volunteer leaders. In 2005, Perlman served as division chairman, overseeing the
Economic Case for Quality, co-sponsorship of an event celebrating the 100th
anniversary of the FDA, and standard activities such as FDC Conferences and
discussion groups. He currently serves as ASQ’s Internet liaison and speaks at
various division conferences; he was also instrumental in launching the
development of a new certification for pharmaceutical professionals.
Andrew Shao, Ph.D., is vice president, scientific and regulatory affairs,
for the Council for Responsible Nutrition (CRN). Shao has an extensive
background in human nutrition research and an in-depth knowledge of dietary
supplement regulatory affairs and product development. Prior to joining CRN he
worked in scientific affairs for General Nutrition Corp. (GNC), and prior to
that in research and development for Kemin Health (formerly Kemin Foods). He has
authored or co-authored articles and abstracts published in peer-reviewed
scientific journals. He earned a doctorate degree in nutritional biochemistry
and a master’s degree in human nutrition science from Tufts University and a
bachelor’s degree in biology from Brandeis University. Shao is a member of the
American Society for Nutrition, the American College of Nutrition, the North
American Association for the Study of Obesity, and the National Strength and
Conditioning Association and the American Society for Nutrition.
Alexa Smith is the Global Regulatory Services Manager for Colorcon and has been with Colorcon since June 1997. Colorcon is global manufacturer of custom-formulated color systems, excipients and related specialty ingredients for the pharmaceutical, nutritional supplement, food and cosmetic industries. In her current role, she is primarily responsible for supporting customer's regulatory needs related to their use of Colorcon products. Smith is active in the International Pharmaceutical Excipient Council's (IPEC) Excipient Qualification Committee and was the chair of their sub-committee working on Standardized Supplier Questionnaire Development and currently is chair for their Quality Agreement Template sub-committee. She is also active in the Regulatory Affairs Committee of the Council for Responsible Nutrition (CRN) and served as president of the Philadelphia Chapter of the Regulatory Affairs Professional Society (RAPS) from 2005-2006. She also holds a position as adjunct assistant professor at Temple University teaching classes in excipient and dietary supplement regulation. She earned her master's degree in quality assurance and regulatory affairs from Temple University, a bachelor's degree in animal sciences from Virginia Polytechnic Institute and State University and is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society.
Debbie
Trinker is the vice president of regulatory affairs at Kemin Health, L.C.,
where she is responsible for global regulatory compliance of the company’s
dietary ingredients. Trinker has more than twenty years of experience in
FDA-regulated industries manufacturing and distributing food, food additives,
dietary ingredients/supplements, prescription and over-the-counter drugs,
including related commercial and intellectual property areas of practice, such
as licensing and other agreement work, trademarks and unfair competition.
Previously, she was senior vice president of regulatory affairs and assistant
general counsel for Rexall Sundown Inc. Also, she was an attorney at the law
firm of Keller and Heckman in Washington, D.C. Trinker has published and
presented on food and drug law topics, including regulatory issues related to
dietary supplements and foods. She earned her bachelor’s degree from
Northwestern University and her law degree from Georgetown University.
Dallas
Wait is a principal and product chemistry expert with Gradient Corporation.
His work includes conducting forensic chemistry investigations, resolving
product chemistry issues, designing test method and quality assurance programs,
determining the reliability of chemistry measurements and sampling procedures,
and providing regulatory comment and expert testimony. He is on the editorial
board for three peer-reviewed journals, and is an active member of the American
Chemical Society (ACS), the Association of Official Analytical Chemists (AOAC),
the American Society for Testing and Materials (ASTM), and the American Oil
Chemists' Society (AOCS). Prior to joining Gradient in 1989, for eleven years he
was the vice president and technical director for ENSECO, a nationally prominent
testing laboratory involved, in part, with developing testing protocols and
characterizing consumer products. He earned his doctorate degree in chemistry
from the University of Rhode Island.
David
William Kennedy Acheson, MD, FRCP, Assistant Commissioner for Food
Protection for the U.S. Food and Drug Administration, graduated from the
University of London Medical School, and following training in internal medicine
and infectious diseases in the United Kingdom, moved to the New England Medical
Center and Tufts University. Acheson was chief medical officer at the Food and
Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN).
Subsequently, he also became the director of CFSAN’s Food Safety and Security
Staff and in January 2005, the staff was expanded to become the Office of Food
Safety, Defense and Outreach. In January 2007, the office was further expanded
to become the Office of Food Defense, Communication and Emergency Response. On
May 1, 2007, Acheson assumed the position of FDA Assistant Commissioner for Food
Protection to provide advice and counsel to the commissioner on strategic and
substantive food safety and food defense matters. Acheson is a fellow of both
the Royal College of Physicians (London) and the Infectious Disease Society of
America.
Andrew Shao, Ph.D., is vice president, scientific and regulatory affairs,
for the Council for Responsible Nutrition (CRN). Shao has an extensive
background in human nutrition research and an in-depth knowledge of dietary
supplement regulatory affairs and product development. Prior to joining CRN he
worked in scientific affairs for General Nutrition Corp. (GNC), and prior to
that in research and development for Kemin Health (formerly Kemin Foods). He has
authored or co-authored articles and abstracts published in peer-reviewed
scientific journals. He earned a doctorate degree in nutritional biochemistry
and a master’s degree in human nutrition science from Tufts University and a
bachelor’s degree in biology from Brandeis University. Shao is a member of the
American Society for Nutrition, the American College of Nutrition, the North
American Association for the Study of Obesity, and the National Strength and
Conditioning Association and the American Society for Nutrition.
Alexa Smith is the Global Regulatory Services Manager for Colorcon and has been with Colorcon since June 1997. Colorcon is global manufacturer of custom-formulated color systems, excipients and related specialty ingredients for the pharmaceutical, nutritional supplement, food and cosmetic industries. In her current role, she is primarily responsible for supporting customer's regulatory needs related to their use of Colorcon products. Smith is active in the International Pharmaceutical Excipient Council's (IPEC) Excipient Qualification Committee and was the chair of their sub-committee working on Standardized Supplier Questionnaire Development and currently is chair for their Quality Agreement Template sub-committee. She is also active in the Regulatory Affairs Committee of the Council for Responsible Nutrition (CRN) and served as president of the Philadelphia Chapter of the Regulatory Affairs Professional Society (RAPS) from 2005-2006. She also holds a position as adjunct assistant professor at Temple University teaching classes in excipient and dietary supplement regulation. She earned her master's degree in quality assurance and regulatory affairs from Temple University, a bachelor's degree in animal sciences from Virginia Polytechnic Institute and State University and is Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professional Society.
Debbie
Trinker is the vice president of regulatory affairs at Kemin Health, L.C.,
where she is responsible for global regulatory compliance of the company’s
dietary ingredients. Trinker has more than twenty years of experience in
FDA-regulated industries manufacturing and distributing food, food additives,
dietary ingredients/supplements, prescription and over-the-counter drugs,
including related commercial and intellectual property areas of practice, such
as licensing and other agreement work, trademarks and unfair competition.
Previously, she was senior vice president of regulatory affairs and assistant
general counsel for Rexall Sundown Inc. Also, she was an attorney at the law
firm of Keller and Heckman in Washington, D.C. Trinker has published and
presented on food and drug law topics, including regulatory issues related to
dietary supplements and foods. She earned her bachelor’s degree from
Northwestern University and her law degree from Georgetown University.
Dallas
Wait is a principal and product chemistry expert with Gradient Corporation.
His work includes conducting forensic chemistry investigations, resolving
product chemistry issues, designing test method and quality assurance programs,
determining the reliability of chemistry measurements and sampling procedures,
and providing regulatory comment and expert testimony. He is on the editorial
board for three peer-reviewed journals, and is an active member of the American
Chemical Society (ACS), the Association of Official Analytical Chemists (AOAC),
the American Society for Testing and Materials (ASTM), and the American Oil
Chemists' Society (AOCS). Prior to joining Gradient in 1989, for eleven years he
was the vice president and technical director for ENSECO, a nationally prominent
testing laboratory involved, in part, with developing testing protocols and
characterizing consumer products. He earned his doctorate degree in chemistry
from the University of Rhode Island.