Claire L. Kruger, Ph.D., D.A.B.T.

President, Spherix Consulting, a division of ChromaDex, Inc.

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Full Bio

Dr. Claire Kruger is President of Spherix Consulting, Inc. With more than 25 years of consulting experience, her primary area of expertise is in foods, consumer products and pharmaceuticals, where she provides scientific, regulatory, and strategic support to clients in both the US and international regulatory arenas. She has designed, placed, monitored, evaluated and published results from toxicology studies ranging from acute to carcinogenicity in rodent, non-rodent and non-human primates for use in product approvals. Dr. Kruger has conducted toxicity evaluations of food, food contaminants, and dietary supplements, as well as health risk assessments and exposure assessments of drugs, cosmetics, and pesticides. Her clients include food, drug, and dietary supplement manufacturers, agricultural producers, biotechnology companies, trade associations, and law firms.

Dietrich Conze, Ph.D.

Senior Science Director

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Full Bio

Dr. Dietrich Conze is a Senior Science Director at Spherix Consulting. He is a cell and molecular biologist specializing in the signal transduction pathways that regulate innate and adaptive immunity, inflammation, and tumorigenesis. Dr. Conze is responsible for the critical evaluation of scientific literature, design and interpretation of preclinical and clinical studies for food ingredients, dietary supplements and pharmaceuticals, and the preparation of reports for regulatory submissions, Generally Recognized As Safe (GRAS) dossiers, New Dietary Ingredient Notifications (NDIN), Novel Foods Submissions, Investigational New Drug Applications (IND), and New Drug Applications (NDA).

Nicole Beauchamp, Ph.D.

Staff Science Consultant

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Full Bio

Nicole Beauchamp is a staff science consultant at Spherix Consulting. Dr. Beauchamp provides guidance regarding dietary supplements, food ingredients, pharmaceuticals, chemistry, biochemistry, and analytical method development, particularly in the preparation of Generally Recognized As Safe (GRAS) dossiers, New Dietary Ingredient Notifications (NDIN), Novel Foods Submissions, Investigational New Drug Applications (IND), and New Drug Applications (NDA). Her goal is to provide clients with a clear understanding of the science that is appropriate to use in demonstrating the safety and/or efficacy of their products.

Yuting Zhou, Ph.D.

Staff Science Consultant

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Full Bio

Dr. Zhou is a Staff Science Consultant at Spherix Consulting. She is a food and nutrition scientist with more than 5 years of regulatory review experience. As a member of Spherix Consulting, Dr. Zhou is responsible for critical evaluation of scientific literature, design and interpretation of preclinical and clinical studies for food ingredients, dietary supplements and pharmaceuticals, and the preparation of health risk assessments and regulatory compliance dossiers for GRAS dossiers, New Dietary Ingredient Notifications (NDIN), Novel Foods Submissions, Investigational New Drug Applications (IND), and New Drug Applications (NDA).

A. Wallace Hayes, Ph.D., D.A.B.T.

Senior Science Advisor

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Full Bio

Dr. Hayes is a toxicologist with over 35 years of experience in industry and academics. He is a Senior Science Advisor at Spherix Consulting, providing strategic, scientific and regulatory guidance. Dr. Hayes also holds appointments at the Harvard School of Public Health as a Visiting Scientist and with the School of Public Health, University of Massachusetts, Amherst as a Research Professor. Previously, Dr. Hayes held the position of Vice President and Corporate Toxicologist for RJR Nabisco with responsibility for all regulatory and toxicology issues related to the safety of ingredients and food contact substances for food and drink products worldwide. Subsequently, as Corporate Vice-President of Product Integrity at the Gillette Company, he had management responsibility for the safety evaluation and regulatory compliance of a variety of consumer products, plant safety, environmental stewardship, and quality control. While at Gillette, Dr. Hayes was responsible for managing regulatory and toxicology issues worldwide. All contact substances used in Gillette products (including personal care products) were cleared within his division. Dr. Hayes previously served on the CTFA Research Council, addressing issues related to flavors and fragrances. Dr. Hayes has interacted with regulatory bodies worldwide including Canada, Japan, South Korea, EU and Latin America as well as the US FDA. the US EPA and the US DOD. Dr Hayes is currently a member of the Food Advisor Committee, US Food and Drug Administration.

Troy Rhonemus, MS

Chief Operating Officer, ChromaDex

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Full Bio

Mr. Troy Rhonemus is a top-performing and high-integrity leader with more than 15 years of experience managing operations and supply chain, business strategies, and the roll-out of new processes, technologies, and products. As an advisor to Spherix Consulting, Mr. Rhonemus will provide ongoing strategic and scientific guidance to our clients to improve the supply chain management of raw materials to meet FDA regulation by developing supply chain strategies, auditing manufacturers, and assisting in the management of suppliers from countries outside the US.

Robert A. Lodder, Jr. Ph.D.

Professor, University of Kentucky

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Full Bio

Dr. Robert A. Lodder serves as a Senior Science Advisor at Spherix Consulting as well as a Professor of Pharmaceutical Sciences at the University of Kentucky College of Pharmacy. He has joint appointments at the University in the Analytical Chemistry division of the Department of Chemistry and the Electrical and Computer Engineering department in the College of Engineering, and an active interdisciplinary research group that averages about a dozen members. He has over 25 years of experience with drugs and medical devices. He is an entrepreneur and has designed and operated laboratories and facilities for drug discovery, drug development, and device development, and has 28 patents and pending patent applications for inventions made in the laboratories. He has worked with Spherix Consulting for seven years, joining the company at the same time as its President, Dr. Claire Kruger. At Spherix Consulting, Dr. Lodder provides computer simulation and modeling support to the company as well as drug and medical device expertise.

Roger A. Clemens, Ph.D.

Senior Consultant

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Full Bio

Dr. Roger A. Clemens is Associate Director of the Regulatory Science program and Adjunct Professor of Pharmacology and Pharmaceutical Sciences within the USC School of Pharmacy, and is the consulting Scientific Advisor for ETHorn. He is a consultant with Spherix, providing strategic, scientific and regulatory guidance for clients. Dr. Clemens was the Director of Analytical Research at USC for 5 years, and the Scientific Advisor for Nestlé USA for more than 21 years. He has published more than 50 original manuscripts in nutrition and food science, participated in more than 200 invited domestic and international lectures, and served as an expert panel member for the food industry, scientific organizations, trade associations and regulatory agencies in the United States and Canada.

Thomas E. Sox, Ph.D., J.D.

Senior Consultant

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Full Bio

Dr. Thomas Sox is a consultant with over 34 years of experience in consumer goods, OTC pharmaceuticals, foods, and dietary supplements. Dr. Sox’s expertise includes broad skills in management of internal and external research projects, intellectual property development, technology evaluation, and rapid mastery of new science areas. His legal expertise focuses on intellectual property law.

International Network:

John Howlett, BSc.

International Resource Consultant-EU

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Full Bio

Mr. Howlett is a consultant in the United Kingdom with more than 37 years of experience in food regulatory and scientific affairs. He is an independent international resource consultant working with Spherix to provide strategic, scientific and regulatory guidance for clients. Mr. Howlett completed his BSc in 1970 in Molecular Biology at King’s College, University of London. He served as a consultant to the Food and Agricultural Organization of the United Nations (FAO) from 1982-1985, in the preparation of working papers for the Joint FAO/WHO Expert Committee on Food Additives (JECFA). He provided support for the JECFA Secretariat from 2004-2005, served as a member of JECFA from 1986-1990, and participated in meetings of JECFA as WHO temporary advisor from 1991-1995. In addition, Mr. Howlett has previously served as chairman of a WHO task group in 1988, and chairman of a workshop convened in 1998 by the European Training and Assessment Foundation (ETAF). Mr. Howlett has written more than 45 peer-reviewed publications.

 

Dieter Schrenk, MD, PhD

International Resource Consultant-EU/Germany

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Full Bio

Prof. Dieter Schrenk is a full professor and head of Department of Food Chemistry & Toxicology, University of Kaiserslautern, Germany. He has made relevant scientific contributions to the toxicology of dioxins and related persistent contaminants, worked on mechanisms of tumor promotion and nutrition and colorectal cancer. He served and is still serving in several toxicological committees at the national and the European level dealing with risk assessment of food contaminants and environmental pollutants, in particular in panels and working groups of EFSA. Prof. Schrenk is a well-recognized member of the European Toxicological scene having contributed to the advancement of basic and applied science in the field of toxicology.

Silvia Berlanga de Moraes Barros, M.Sc., Ph.D.

International Resource Consultant-Latin America

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Full Bio

Dr. Barros is a toxicologist with more than 30 years of experience in academia. She is an independent international resource consultant working with Spherix to provide strategic, scientific and regulatory guidance for clients in the area of risk assessment and ADME for the chemical and pesticide industry.

Govinder Flora, Ph.D.

International Resource Consultant-India

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Full Bio

Dr. Flora is a Toxicologist with more than 15 years of experience in the area of biochemical toxicology his primary area of expertise is in food toxicology, heavy metal toxicology, drugs of abuse and biodefense vaccine and therapeutics development. He has been involved in evaluating the safety of foods, novel foods, food additives, Generally Recognized as Safe (GRAS) substances, and dietary supplements. He is also involved in the development and review of protocols, critical review of scientific literature and preparation of safety evaluations in support of food ingredients used in dietary supplements and consumer products.

Joe Zhou, Ph.D.

International Resource Consultant-China

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Full Bio

Joe Zhou is an analytical chemist with more than 20 years of expertise in food safety, quality assurance and quality control (QA/QC), GMP protocols and audits, and analytical method validation. Dr. Zhou currently serves as an independent consultant providing food safety and quality assurance services to food ingredient companies mainly based China. He conducts food safety and GMP audits of Chinese suppliers for US-based multi-national food companies using internationally recognized standards. He also assists Spherix Consulting in providing regulatory services to Chinese clients for US and EU ingredient submissions.

Tetsuo Satoh, Ph.D.

International Resource Consultant-Japan

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Full Bio

Dr. Satoh is an independent international resource consultant with more than 40 years of experience, working with Spherix to provide strategic, scientific and regulatory guidance for clients. His primary research interest is the molecular mechanisms of metabolic activation of pharmacologically active chemicals.