Orthomedico Inc.
| Booth No. | 2-303 |
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We support FFC system-related scientific evidence acquisition and notification submission, as well as online market research.
When developing a Food with Function Claims, it is crucial to plan with regulatory notification in mind from the clinical trial prepartion stage. In addition, it is important to use scientific evidence to promote your developed product to the outside world so as to increase product recognition. Please join our exhibitor presentations to learn more.
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| Product / Service |
Clinical trial conduction upon request Support for dossier notification as Foods with Function Claims Conduction of clinical trial abroad on behalf of client New Products Provision of market research service using health and medical data New Products Nutrigenomics service New Products |
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| URL | https://www.orthomedico.tokyo/ |
Presentaion
| Date | 10月4日 11:30～11:50 | Location | PJ |
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| Title | A must-see! Questionnaire survey utilizing health and medical data | ||
| Detail | This April, our large-scale investigational research supporting service that utilizes health and medical data we obtained from general consumers was launched. The coverage of this service includes evaluations from sensory evaluation, questionnaire surveys on use and physical experience, to market research during stages of product development. In this presentation, being a service that was developed by Orthomedico through utilizing its experience obtained from years of clinical trial conduction, the features of this service will be discussed. | ||
| Date | 10月4日 13:30～13:50 | Location | PJ |
|---|---|---|---|
| Title | Trend of global functional food research from the aspect of trial registration | ||
| Detail | In the study of functional foods, depending on the results of safety and efficacy studies, the course of research and development can be impacted in many ways, in which the results are reflected in product labelling and health claims. In this presentation, we will analyze and review the Japanese trial registry, UMIN-CTR, and the international version, ClinicalTrials.gov, to predict future trends and areas of potential growth. | ||
| Date | 10月4日 15:30～15:50 | Location | PJ |
|---|---|---|---|
| Title | Get it notified! Evaluation items with industry-wide consensus | ||
| Detail | When reviewing articles to be used for claim substantiation of functional food during regulatory notification, an agreement between whether the evaluation items used in the clinical study can adequately reflect the functionality of the food product to be evaluated and a consensus about whether the evaluation item are widely and generally used in the field should be reached. In this presentation, we will introduce evaluation items that meet the above criteria while referring to various guidelines. | ||
| Date | 10月4日 16:00～16:20 | Location | PJ |
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| Title | Statistical considerations when designing crossover comparison trials | ||
| Detail | A crossover comparison design is one of a RCT design. It is often characterized by having fewer number of cases than a parallel-group comparison design. However, as crossing over of interventions between the active and placebo group occurs, there are various considerations that must be kept in mind. Only through understanding and having control over these considerations can appropriate statistical analysis be performed. In this presentation, we will also elaborate on some of designs that are still in developmental stage. | ||
| Date | 10月5日 12:00～12:20 | Location | PJ |
|---|---|---|---|
| Title | A must-see! Questionnaire survey utilizing health and medical data | ||
| Detail | This April, our large-scale investigational research supporting service that utilizes health and medical data we obtained from general consumers was launched. The coverage of this service includes evaluations from sensory evaluation, questionnaire surveys on use and physical experience, to market research during stages of product development. In this presentation, being a service that was developed by Orthomedico through utilizing its experience obtained from years of clinical trial conduction, the features of this service will be discussed. | ||
| Date | 10月5日 13:30～13:50 | Location | PJ |
|---|---|---|---|
| Title | Present and future of the health food market of the United States and China | ||
| Detail | In recent years, the ongoing trade war between the US and China has had an immense impact on the health food market. In this presentation, the current regulations of the two countries in the midst of confrontation and cooperation will be compared, and the thoughts and directions of the industry, government and consumers will be investigated. Hot topics in the respective health food industries and the latest trends will also be highlighted to identify developmental trends in these two megastates. | ||
| Date | 10月5日 15:00～15:20 | Location | PJ |
|---|---|---|---|
| Title | Get it notified! Evaluation items with industry-wide consensus | ||
| Detail | When reviewing articles to be used for claim substantiation of functional food during regulatory notification, an agreement between whether the evaluation items used in the clinical study can adequately reflect the functionality of the food product to be evaluated and a consensus about whether the evaluation item are widely and generally used in the field should be reached. In this presentation, we will introduce evaluation items that meet the above criteria while referring to various guidelines. | ||
| Date | 10月5日 15:30～15:50 | Location | PJ |
|---|---|---|---|
| Title | Re-looking into the double-blind and randomization methods | ||
| Detail | Blinding and randomization are methods that can minimize systematic bias between the estimated effect and true effect of intervention in clinical trials. However, if these methods are not properly executed, it is impossible to draw scientifically valid conclusions. Understanding that there is high demand for high quality clinical trials, this presentation serves the purpose of reviewing them once again. | ||
| Date | 10月5日 16:00～16:20 | Location | PJ |
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| Title | Clinical studies aimed at novel claim notification | ||
| Detail | With supporting companies on challenging new health claims, Orthomedico has been making efforts to reviewing literatures and designing study in functional categories that have never had any notification being submitted and accepted before. In this presentation, new study designs and related potential health claims will be introduced and discussed. | ||
| Date | 10月6日 11:00～11:20 | Location | PJ |
|---|---|---|---|
| Title | Trend of global functional food research from the aspect of trial registration | ||
| Detail | In the study of functional foods, depending on the results of safety and efficacy studies, the course of research and development can be impacted in many ways, in which the results are reflected in product labelling and health claims. In this presentation, we will analyze and review the Japanese trial registry, UMIN-CTR, and the international version, ClinicalTrials.gov, to predict future trends and areas of potential growth. | ||
| Date | 10月6日 11:30～11:50 | Location | PJ |
|---|---|---|---|
| Title | A must-see! Questionnaire survey utilizing health and medical data | ||
| Detail | This April, our large-scale investigational research supporting service that utilizes health and medical data we obtained from general consumers was launched. The coverage of this service includes evaluations from sensory evaluation, questionnaire surveys on use and physical experience, to market research during stages of product development. In this presentation, being a service that was developed by Orthomedico through utilizing its experience obtained from years of clinical trial conduction, the features of this service will be discussed. | ||
| Date | 10月6日 12:30～13:20 | Location | PJ |
|---|---|---|---|
| Title | The changing landscape of food and nutrition and their present state | ||
| Detail | Ever since 400 B.C., it has been recognized that food can affect human health, body, and spirit, prevent disease and maintain health. In recent years, as technology advances, there has been an increase in nutritional research using a variety of methods. In this presentation, while keeping in mind the trends in nutritional research, the relationship between food, nutrition and health will be discussed. | ||
| Date | 10月6日 14:00～14:50 | Location | PJ |
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| Title | Discovery of novel functional ingredients using analytical technology on gene expression | ||
| Detail | As research on the relationship between gene expression and repression mechanisms and life phenomena progresses, various genes responsible for different life phenomena have been identified. It is a well-known fact that food components and nutrients affect gene expression, and many reports have studied such relationship. In this presentation, we will explain how gene expression analysis technology is used to screen for functionally active ingredients. | ||
| Date | 10月6日 15:00～15:50 | Location | PJ |
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| Title | Preventive medicine and food with function claim | ||
| Detail | A regular diet is important for maintaining good health, and the use of health foods is an option to achieve so. Although a variety of health foods are currently being sold on the market, high-quality clinical trials are essential when evaluating the health functions of foods. In this presentation, methods to evaluate the health function of food products from the viewpoint of preventive medicine will be discussed. | ||
| Date | 10月6日 16:00～16:20 | Location | PJ |
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| Title | Incorporating statistical analysis plans in clinical trials | ||
| Detail | A Statistical Analysis Plan (SAP) is a document that provides a technical and detailed description of a statistical analysis plan for a clinical trial. SAPs are not always necessary, but are important in ensuring quality & reproducibility of results, whiling providing flexibility in the case of any modification. In the presentation, we will discuss how implementation of SAP can improve the quality of clinical trials. | ||