Scientific and Regulatory Affairs

Science, United States

Scientific and Regulatory Affairs

Science, United States
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TORONTO--(BUSINESS WIRE)--Bio Pharma Services, Inc. (Bio Pharma) ended their 10th year anniversary celebrations by announcing the successful EMA inspection of their Toronto based clinical and bioanalytical site. The 5-day inspection which included a complete audit of their clinical, bioanalytical and pharmacokinetic units, was the first inspection conducted by the French National Agency for Medicines and Health Products Safety (ANSM) and the Danish Medicines Agency (DKMA) at Bio Pharma. With the strong and positive outcome of this last inspection, Bio Pharma continues to build on its impressive regulatory achievements, having now completed inspections for all major jurisdictions in the global marketplace. Bio Pharma's outstanding regulatory history includes successful inspections by the US FDA, UK MHRA, Health Canada, Standards Council of Canada and ANVISA. “This EU GCP audit comes on the heels of Bio Pharma successfully renewing its GLP certification with the Standards Council of Canada (SCC) just last week. Our attention to detail and high quality is what sets us apart in the marketplace. I am very proud of our contributions to safe and effective medicines,” stated Bio Pharma’s CEO, Renzo DiCarlo. Andjica Tasic, Vice-President, Quality Assurance and Regulatory Affairs at Bio Pharma added: "The successful outcome of this EMA inspection was years in the making. All of us here at Bio Pharma are committed to continuous improvement in our pursuit of excellence and executing R&D to the highest of standards.” Bio Pharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa clinical trials as well as Bioequivalence trials for international pharmaceutical companies worldwide. With clinical facilities in Columbia, Missouri and Toronto, Canada, Bio Pharma’s total bed capacity sits at 250 with an impressive subject database of healthy volunteers, special populations (which includes post-menopausal females, hypogonadal males, and recreational drug users) and patients. Headquartered in Toronto, Canada, Bio Pharma’s comprehensive services include Bioanalysis at our GLP certified Laboratory, PK/Scientific and Regulatory Affairs, Biostatistical and Safety Data Analysis, Medical Writing and Data Management.


Casgrain A.,University of East Anglia | Collings R.,University of East Anglia | Harvey L.J.,University of East Anglia | Boza J.J.,Scientific and Regulatory Affairs | Fairweather-Tait S.J.,University of East Anglia
American Journal of Clinical Nutrition | Year: 2010

A micronutrient bioavailability workshop, which involved international experts and members of the scientific community and the food industry, with interactive breakout sessions based on synectics principles, was organized by the International Life Sciences Institute Europe Addition of Nutrients to Food Task Force and the European Commission Network of Excellence European Micronutrient Recommendations Aligned. After presentations by experts, a series of "challenge statements" was discussed. The aim was to address topical issues, in particular those that linked bioavailability with the derivation of micronutrient requirements and dietary recommendations, to identify gaps in knowledge and to consider research priorities. Several generic research priorities were identified, including improving the quality of dietary surveys/food composition tables, the need for more metabolic studies that use stable isotopes and high-quality longer-term interventions, and the development of multifactorial mathematical models. Among the common recurrent factors identified as important were polymorphisms/genotype, consideration of the whole diet, chemical form of the micronutrient, and the determination of physiologic requirements. The involvement of all participants in the structured discussions ensured a broad overview of current knowledge, state-of-the-art research, and consideration of priorities for future research. © 2010 American Society for Nutrition.


Dickinson A.,Dickinson Consulting LLC | Mackay D.,Scientific and Regulatory Affairs
Nutrition Journal | Year: 2014

Dietary supplements are used by half to two-thirds of American adults, and the evidence suggests that this usage is one component of a larger effort to develop a healthier lifestyle. Dietary supplement users tend on average to be better educated and to have somewhat higher incomes than nonusers, and these factors may contribute to their health-consciousness. Dietary supplement use also tends to be more prevalent among women than among men, and the prevalence of use increases with age in both men and women. Numerous surveys document that users of dietary supplements are significantly more likely than nonusers to have somewhat better dietary patterns, exercise regularly, maintain a healthy weight, and avoid tobacco products. While supplement users tend to have better diets than nonusers, the differences are relatively small, their diets have some substantial nutrient shortfalls, and their supplement use has been shown to improve the adequacy of nutrient intakes. Overall, the evidence suggests that users of dietary supplements are seeking wellness and are consciously adopting a variety of lifestyle habits that they consider to contribute to healthy living. © 2014 Dickinson and MacKay; licensee BioMed Central Ltd.


Dickinson A.,Dickinson Consulting LLC | Shao A.,Scientific and Regulatory Affairs | Boyon N.,Ipsos Public Affairs | Franco J.C.,Ipsos Public Affairs
Nutrition Journal | Year: 2011

Background: Dietary supplements are regularly used by a majority of the American population, and usage by health professionals is also common. There is considerable interest in usage patterns within the population and in the reasons for using dietary supplements. The "Life.supplemented" Healthcare Professionals 2008 Impact Study (HCP Impact Study) surveyed usage of dietary supplements by physicians in three specialties: cardiology, dermatology, and orthopedics. Methods. The HCP Impact Study was conducted online by Ipsos Public Affairs for the Council for Responsible Nutrition (CRN), a trade association of the dietary supplement industry. Respondents were 900 physicians, including 300 each from three specialties - cardiology, dermatology, and orthopedics. Results: Fifty-seven percent of cardiologists said they use dietary supplements at least occasionally, as did 75% of dermatologists and 73% of orthopedists. The product most commonly reported to be used was a multivitamin, but over 25% in each specialty said they used omega-3 fatty acids and over 20% said they used some botanical supplements. Regular dietary supplement use was reported by 37% of cardiologists, 59% of dermatologists, and 50% of orthopedists. Seventy-two percent of cardiologists, 66% of dermatologists, and 91% of orthopedists reported recommending dietary supplements to their patients. The primary reason given for recommending dietary supplements to patients was for heart health or lowering cholesterol for the cardiologists; benefits for skin, hair and nails for the dermatologists; and bone and joint health for the orthopedists. Conclusions: Reported dietary supplement use was relatively common in this sample of physicians, and when they recommended dietary supplements to patients, they tended to do so for reasons related to their specialty. © 2011 Dickinson et al; licensee BioMed Central Ltd.


Dickinson A.,Dickinson Consulting LLC | MacKay D.,Scientific and Regulatory Affairs | Wong A.,Scientific and Regulatory Affairs
Nutrition Journal | Year: 2015

Background: U.S. nutrition surveys find that intakes of many nutrients fall short of recommendations. The majority of U.S. adults use multivitamins and other dietary supplements as one means of improving nutrient intakes. Some policy makers and health professionals appear reluctant to recommend routine use of dietary supplements to fill nutrient gaps in the diet, in part because they are concerned that people will view the supplements as a substitute for dietary improvement and that the use of supplements may lead to overconsumption of micronutrients. Surveys find that in fact users of dietary supplements tend to have better diets and adopt other healthy habits, suggesting that the supplements are viewed as one aspect of an overall effort to improve wellness. Furthermore, evidence demonstrates that the incidence of excess micronutrient intake is low. We report the results of a survey probing consumer attitudes about the role of dietary supplements. Methods: The Council for Responsible Nutrition funded a survey to measure consumer attitudes about the role of multivitamins, calcium and/or vitamin D supplements, and other supplements in improving dietary intakes. The research was designed and analyzed by FoodMinds and was fielded using Toluna's On-line Omnibus. The weighted sample of 2159 respondents is representative of U.S. adults. Results: Nearly 90 % of the survey respondents agreed that multivitamins and supplements of calcium and/or vitamin D can help meet nutrient needs when desirable intakes are not achieved through food alone. At the same time, 80 % agreed that dietary supplements should not be used to replace healthy dietary or lifestyle habits, and 82 % agreed that people considering taking a high dose, single nutrient supplement should talk with their physician. Conclusions: These results provide additional support for the conclusion that the vast majority of consumers recognize that multivitamins and other supplements can help fill nutrient gaps but should not be viewed as replacements for a healthy diet. This suggests that policy makers and health professionals could feel comfortable recommending rational dietary supplementation as one means of improving nutrient intakes, without being unduly concerned that such a recommendation would lead consumers to discount the importance of good dietary habits. © 2015 Dickinson et al.


Renwick A.G.,University of Southampton | Molinary S.V.,Scientific and Regulatory Affairs
British Journal of Nutrition | Year: 2010

The present review explores the interactions between sweeteners and enteroendocrine cells, and consequences for glucose absorption and insulin release. A combination of in vitro, in situ, molecular biology and clinical studies has formed the basis of our knowledge about the taste receptor proteins in the glucose-sensing enteroendocrine cells and the secretion of incretins by these cells. Low-energy (intense) sweeteners have been used as tools to define the role of intestinal sweet-taste receptors in glucose absorption. Recent studies using animal and human cell lines and knockout mice have shown that low-energy sweeteners can stimulate intestinal enteroendocrine cells to release glucagon-like peptide-1 and glucose-dependent insulinotropic peptide. These studies have given rise to major speculations that the ingestion of food and beverages containing low-energy sweeteners may act via these intestinal mechanisms to increase obesity and the metabolic syndrome due to a loss of equilibrium between taste receptor activation, nutrient assimilation and appetite. However, data from numerous publications on the effects of low-energy sweeteners on appetite, insulin and glucose levels, food intake and body weight have shown that there is no consistent evidence that low-energy sweeteners increase appetite or subsequent food intake, cause insulin release or affect blood pressure in normal subjects. Thus, the data from extensive in vivo studies in human subjects show that low-energy sweeteners do not have any of the adverse effects predicted by in vitro, in situ or knockout studies in animals. © The Authors 2010.


Shao A.,Scientific and Regulatory Affairs
Drug Information Journal | Year: 2011

Published by the US Food and Drug Administration in June 2007, current good manufacturing practices (cGMPs) for dietary supplements (21 CFR Part 111) are now mandatory for all firms that manufacture, package, label, or hold dietary supplements for sale in the United States. Ingredient supplier qualification remains one of the most critical, yet least understood, aspects of the regulation. The increasingly global supply chain and multiple instances of supply chain failures that have led to adverse consequences have elevated the need for proper supplier qualification. However, FDA's expectations for supplier qualification remain unclear, and there is little knowledge of what constitutes industry best practices. Following the precedent set by other FDA-regulated industries, the dietary supplement industry has formed a consortium to address the knowledge and practice gap regarding supplier qualification. The group has developed a series of voluntary guidelines to assist ingredient suppliers and dietary supplement manufacturers with the qualification process. These guidelines, some of which are still under development, are intended to serve as tools or templates on which a firm's own qualification program or standard operating procedures can be based. It is hoped that these guidelines will serve as the basis for future FDA guidance or rule making, should the need arise. Copyright © 2011 Drug Information Association, Inc. All rights reserved.

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