Spherix Health Sciences consultants are credentialed professionals with the experience, expertise, and management skills to provide clients unparalleled efficient and effective support.
Claire L. Kruger, Ph.D., D.A.B.T.
CEO, COO, and Director of Health Sciences
Dr. Claire Kruger is a toxicologist with more than 20 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 U.S. and international regulatory arenas. She has conducted toxicity evaluations of food contaminants, as well as health risk assessments and exposure assessments of drugs, cosmetics, and pesticides. Dr. Kruger’s clients include food, drug, and dietary supplement manufacturers, agricultural producers, biotechnology companies, trade associations, and law firms.
Robert A. Lodder, Ph.D.
President
In addition to his position at Spherix, Dr. Lodder is a professor of Pharmaceutical Sciences at the College of Pharmacy, University of Kentucky Medical Center. He was also appointed by the Food and Drug Administration to serve on their Process Analytical Technologies (PAT) subcommittee, which aims to revolutionize the pharmaceutical industry by replacing the GMP standards under which drugs have been released for the past 40 years with new, science-based PAT methods. Dr. Lodder has conducted mathematical studies aimed at solving the "false-sample" problem and the results have been applied to pharmaceutical quality control and the detection of product tampering in foods and pharmaceuticals.
A. Wallace Hayes, Ph.D., D.A.B.T.
Principal Advisor
Dr. Hayes is a toxicologist with over 30 years of experience in industry and academics. Dr. Hayes also holds an appointment with Harvard School of Public Health. Previously, Dr. Hayes held the position of 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 Vice-President of Corporate Product Integrity at the Gillette Company, he had management responsibility for the safety evaluation of a variety of consumer products, plant safety, environmental stewardship, and quality control, responsible for regulatory and toxicology issues worldwide.
Yongming Lu, Ph.D.
Senior Science Director
Dr. Yongming Lu has more than 18 years of experience in analytical chemistry, biochemical and environmental engineering, and has expertise is in the development of upstream and downstream biotechnology processes. His specialized areas of study and practical application include microbial, mammalian and plant cell culture, immobilization technology, and bioreactor and bio-reaction kinetics. Dr. Lu has extensive experience in the evaluation of production processes as they relate to the evaluation of safety for production of foods, pharmaceuticals, nutraceuticals, and cosmetics.
Nancy L. Booth, Ph.D.
Senior Science Consultant
Dr. Nancy Booth is a Science Consultant at Spherix. She has diverse training in the areas of organic/bio-organic chemistry, pharmacognosy, natural products, dietary supplements, and cancer. Her primary area of expertise is in the scientific evaluation of botanical dietary supplements, development of high-throughput screening assays, and drug discovery. She also has experience in anticancer signal transduction pathways utilizing death receptors, estrogenic phytochemicals, and optimizing in vitro bioassays for use with natural products.
Dietrich Conze, Ph.D.
Consultant
Dr. Dietrich Conze is a Science Consultant at Spherix. He is a cell and molecular biologist specializing in the signal transduction pathways that regulate innate and adaptive immunity, inflammation, and tumorigenesis. As part of Spherix’s Health Sciences Division, Dr. Conze is responsible for supporting the regulatory and scientific needs of his clients.
Roger A. Clemens, Ph.D.
Senior Consultant
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.
Ronald S. Slesinski, Ph.D.
Senior Consultant
Dr. Ronald Slesinski assists Spherix with respect to food, chemical and pesticide companies with a wide range of regulatory and scientific issues, including pesticide residue and analytical studies, antimicrobial and bio-pesticide registrations with EPA and preparation of safety profiles for pesticides, food additives and drug products. He is a board-certified toxicologist with over 30 years of experience in academia, toxicology testing and regulatory affairs.
Nathalie Chevreau, Ph.D., RD
Consultant
Dr. Nathalie Chevreau is an independent consultant working with Spherix in the areas of Nutrition and Food Regulation. She has spent the past 26 years lending her scientific knowledge to the research, design, development, validation and support of a long line of successful nutraceutical and cosmetic formulations.
Susan Trimbo, Ph.D.
Consultant
Dr. Susan Trimbo is an independent consultant providing strategic scientific and regulatory services to companies focused on Health and Nutrition. Dr. Trimbo is also a consultant with Spherix Consulting who has more than 25 years of industry experience in the areas of Medical Nutrition and Consumer Health Products. Prior to her work as a consultant, Dr. Trimbo was Senior Vice President, Scientific Affairs for General Nutrition Company with broad responsibilities that covered product design, clinical testing, product safety and regulatory compliance. Prior to GNC, Dr. Trimbo was Senior Director of Nutritional Sciences-Worldwide at Wyeth Consumer Healthcare (now Pfizer Consumer Healthcare) where she focused on a range of activities related to the design and launch of new dietary supplement products. Dr. Trimbo also has had extensive experience with product claims and consumer communications. Earlier, Dr. Trimbo held various Research and Development roles at Clintec International, a Baxter-Nestle medical nutrition venture. In that capacity, Dr Trimbo was involved in the development, testing and marketing of a large number of medical foods and nutritional drugs.
Susan Phillips, M.S.
Science Consultant
Susan Phillips has been a scientific consultant since 1994 in the Washington DC area. She has provided scientific, regulatory and strategic support to clients concerning product development and the safety evaluation of direct and indirect food additives, GRAS substances, industrial chemicals, and pesticides. Ms. Phillips’ technical support includes the evaluation of biochemistry, organic chemistry and toxicity data based on actual laboratory expertise.
International Network:
John Howlett, BSc.
International Resource Consultant
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.
Nino Binns, BSc, Ph.D.
International Resource Consultant
Dr. Nino Binns is an independent international resource consultant working with Spherix in the area of Nutrition and Food Regulation. Dr. Binns has more than 30 years’ experience with the food industry. She provides guidance on regulatory strategy and nutrition policy for clients engaged in food manufacturing and ingredient development. Her particular area of focus is currently EU novel foods and health claims. Dr. Binns has a Ph.D. in nutrition from the University of London and is a visiting Professor in nutrition at the Northern Ireland Centre for Food & Health, University of Ulster at Coleraine in Northern Ireland.
Silvia Berlanga de Moraes Barros, M.Sc., Ph.D.
Latin America
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.
Tetsuo Satoh, Ph.D.
Japan
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.
S.K. Gupta, M.Sc., Ph.D., D.Sc.
South Asia
Dr. S.K. Gupta is currently Dean and Director General of the Institute of Clinical Research in India, which is one of the premier and pioneering institutes in India. He was formerly Head of the Department of Pharmacology at the All India Institute of Medical Sciences (AIIMS), New Delhi, and also the founder of National Pharmacovigilance Center at AIIMS.
Govinder Flora, Ph.D.
International Resource Consultant
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.