Nov 27 2019
Recently, Buzzreach has been selected as one of the team for “Blockbuster Tokyo”, an acceleration program specializing in drug discovery and medical ventures for contribution to raising awareness in clinical trials and closing the information gap regarding clinical trials information between patients and pharmaceutical companies as well as the development of patient-centred medical services. Operated by Beyond Next Ventures Inc. (Headquarters: Chuo-ku, Tokyo, President and CEO: Tsuyoshi Ito), 19 teams have been selected to participate in the 2019 selection program which will be held in October with the business plan presentation later in March 2020.Beyond Next Ventures Inc.
Beyond Next Ventures Inc. is an independent accelerator that was established in August 2014 and specializes in investing in ventures that aims to innovate in the science and technology field. With the establishment of the No.1 and No. 2 funds in February 2015 and October 2018, the company has assets under management of a little less than 15 billion yen with an abundance of investment experience and excellent management results ranging from commercialization support of university seeds to investment and growth support. Over the years, they have developed various programs such as the “BRAVE Acceleration Program” which is a commercialization support program for researchers and entrepreneurs looking to commercialize cutting-edge technologies and “Blockbuster TOKYO”, which under the support of Tokyo Metropolitan Government aims to provide incubation funding for pharmaceutical and medical start-ups. In February 2019, a shared wet laboratory, “Beyond BioLab TOKYO” was established to provide commercialization support for life science start-ups. The most recent development is the provision of a co-founder matching platform “Co-founders” which will specialize in the creation of a strong founding team through real-world matching support for technology seeds and researchers at universities.Blockbuster TOKYO
This time around they have implemented one of the largest technology-specific acceleration programs In Japan, “Blockbuster TOKYO”. This program provides various kinds of support to accelerate company growth which can be divided into two programs; a seminar program and an acceleration program. In the seminar program, seminars focusing on essential starting and expanding knowledge for pharmaceutical and medical start-ups will be held about once a month. Such seminars talk about venture related knowledge such as entrepreneurship, venture management, fund procurement and knowledge necessary for research and development (R & D) as well as business alliances. The acceleration program, on the other hand, provides more practical support for the teams with specific business plans. That is why there is a requirement for participants to take part in their seminar program prior to this program as they will be supported by necessary human resources that will specifically aid in the development of their plans including well-versed mentors in their respective field such as drug discovery, intellectual property, and marketing.Contact us
Please feel free to inquire using the form below. We will respond as soon as possible between 9:30 and 18:30 (Monday – Friday Japan Tokyo time).
Original media article: Published 04/10/2019, 19 teams selected for “Blockbuster TOKYO”, a training support program specializing in drug discovery and medical ventures
Retrieved from https://prtimes.jp/main/html/rd/p/000000060.000017460.html?fbclid=IwAR3Tehx9N1vq6o32idm7S3VMGLlJ9IfL076O35RkcqfRD7mVeg14lsKlYSw
1) Beyond Next Ventures Inc.: http://beyondnextventures.com
2) BRAVE Acceleration Program : http://brave.team
3) Blockbuster TOKYO : https://blockbuster.tokyo/en/home-en/
4) Beyond BioLAB TOKYO : http://biolab.beyondnextventures.com
5) Co-founders : https://co-founders.team
Nov 20 2019
On August 14th, GLOBIS (Chiyoda-ku, Tokyo; Representative: Yoshito Hori) has selected 14 companies for their acceleration program for start-up companies, “G-STARTUP” and Buzzreach is one of the selected companies.GLOBIS
Since its establishment in 1992, GLOBIS has been promoting business developments with the vision of creating an infrastructure of “human”, “fund” and “wisdom” related to management and creating and reforming society. In terms of “human”, there is the school corporation that provides in-company training programs as well as e-learning and online classes. On the other hand, there are venture capitals that invests and nurtures venture companies for the “funding” side. For the aspects of “wisdom”, information has been promoted through their business and information dissemination site/app “GLOBIS knowledge book”. In order to promote creation and change for society, G1, the general incorporated association also organizes conferences while the general incorporated foundation KIBOW supports disaster recovery.
To date, GLOBIS has invested up to 10 million yen into a business plan contest, GLOBIS Venture Challenge and another 100 million yen in “GLOBIS Alumni Growth Investment”, a program that supports venture companies current students or graduates have started up. In addition to that, they have also invested in more than 150 companies with a total investment of more than 100 billion yen. Through this, it can be seen that GLOBIS Group is vigorously promoting the construction of venture ecosystems and with their most recent launch of “G-STARTUP”, will accelerate the growth of start-up ecosystems.G-STARTUP
Launched in April 2019, “G-STARTUP” aimed to create a platform that can produce 100 unicorn companies. They intend to do this by adopting start-up companies that have the potential to grow into a country representing venture company in the future and providing them with the five infrastructures (human, fund, wisdom, network and large enterprise collaboration) that GLOBIS has cultivated hence aiding the product, business model and team growth.
Human Entrepreneurs of GLOBIS Graduate School of Management with about 7,000 graduates Fund GLOBIS CAPITAL PARTNERS, which has 150 investment companies and accumulated assets of approximately ¥ 100 billion under management Wisdom Book publication with cumulative sales of 3 million copies, “GLOBIS knowledge book” delivering more than 2500 videos and 4000 articles, and “GLOBIS unlimited learning” video learning service with 40,000 registered IDs Network Connection of leaders who are in the forefront of their fields such as politics, economy, business, science and technology, culture etc. Collaboration with Large Companies Possibility of collaborating with hundreds of large corporations with a track record of developing executives
Figure 1: Five infrastructures that GLOBIS provides to entrepreneurs with G-STARTUP
Since the start of the program, recruited entrepreneurs have undergone document screening and interviews before getting selected. Following this, matching events between entrepreneurs and mentors will be held in the future. Since September, Minoru Imano, the representative partner of GLOBIS CAPITAL PARTNERS (GCP) had agreed to set the purpose of this program to create awareness about unicorn companies and provide lectures to educate companies on the latest management knowledge. A demo day will be held in November where venture capital investors and investment engineers including GCP will be participating as investor reviewers.Contact us
Please feel free to inquire using the form below. We will respond as soon as possible between 9:30 and 18:30 (Monday – Friday Japan Tokyo time).
Original media article: Published 16/08/2019, GLOBIS decides 14 companies to adopt G-STARTUP acceleration program
Retrieved from https://www.globis.co.jp/news/release/20190816_globis.html?fbclid=IwAR0lZ0yHVm3-MkbPaOIYBpgQPq5Wj165iUBEIgZmaNxNAojW73nBdS2nuMQ
1) GLOBIS: https://www.globis.co.jp
Oct 02 2019
From the pharmaceutical companies who develop new drugs to the patient who participates in the study, there are various parties that are involved in the conduction of a clinical trial. One of them is the clinical research coordinator (CRC) or more commonly known as the study coordinator. It is usually a medical institution or pharmaceutical company that conducts the clinical trial for the specific drugs, in other words, the middleman between the pharmaceutical company and patients. As clinical trials usually run long-term, there is a need for study coordinators to have constant communication with each patient to ensure that patients are taking the study medications according to the schedule and engage with them to reduce drop-out rates. Therefore, smooth and efficient management is key to a successful clinical trial. Following this, Buzzreach Co. Ltd. is pleased to announce that we have developed the “MiiLike Study Concierge”, a clinical trial management app that prevents participating patients from forgetting and taking too much of study medication and supports the role of the study coordinator. This application will aid in reducing the burden of the study coordinators especially in the coordinator-patient communication side leading to a reduced dropout rate and early approval for new drugs.
Risk of Trial Participant Dropouts
- 1. Risk of Trial Participant Dropouts
- 2. Lack of Study Coordinators and the Circumstances Surrounding It
- 3. Features of the Clinical Trial Management Application
- 4. Main Functions of the Clinical Trial Management Application
- 5. Applicable to All Clinical Research other than Corporate Clinical Trials
- 6. Comments from Takateru Inokawa, CEO of Buzzreach Inc.
- 7. Contact us
As stated above, patient cooperation is essential for clinical trials. To obtain valid data for the applications of a new drug that can be approved by the Ministry of Health, Labour and Welfare, it is necessary for participants to take the appropriate dosage of the prescribed investigational drug. However, according to the Pharmaceutical Affairs Daily (March 29, 2017), there is a 1 out of 4 participant dropout rate due to various reasons. Even if billions of dollars are spent in developing a drug and conducting the clinical trial, if the valid data is not collected due to dropouts, the trial itself may be cancelled. In order for smooth execution of the trial, it is necessary to prevent dropouts. This app not only improves compliance with notifications and alerts on medication consumption schedule but also a message function from the clinical trial staff, mainly the study coordinators, and the industry’s first attempt at the pharmaceutical company itself. This will lift psychological burdens off participating patients and at the same time maintaining awareness of participation in the clinical trial and a close relationship with the medical institution and clinical trial staff.Lack of Study Coordinators and the Circumstances Surrounding It
Japan’s clinical trial data is said to be the best in the world. This is supported by the study coordinators who works at the forefront of the clinical trial market. Recently, however, a shortage of these personnel has become apparent. This field of career is still not widely recognized and the stigmas surrounding it makes it difficult to draw future career paths (Pharmaceutical Affairs Daily, July 28, 2017). One known stigma is gender inequality in the field. As of today, most study coordinators are women and if they are gone, the time taken to deliver new drugs to patients who need new treatments will be delayed. With the ever-increasing development of drugs and clinical trials, the amount of work for study coordinators are increasing rapidly and it is difficult to balance home and work. We aim to reduce the workload by eliminating this situation with the “virtual CRC function” of our app and create a world where drugs can be delivered to patients in need of new drugs as soon as possible.Features of the Clinical Trial Management Application
The clinical trial management application supports the work of a study coordinator and connects patients participating in clinical trials to medical institutions and pharmaceutical companies. Participants can be notified individually in advanced the medication consumption schedule to prevent forgetting or overdosing (medical compliance) which will be confirmed during visits. In addition to that, since the trial management application has a notification function from the trial staff, it is now possible for adjustments of visit date and update on any physical abnormalities through the application rather than through phone which is the main way of communication currently. Furthermore, administrative communications can also be made in advance such as what to bring to the next visit and inspection details, which greatly reduces the burden of medical institutions and study coordinators. Other than that, as the industry’s first attempt to convey a message of “Thank you” by pharmaceutical companies to the participants of the trial can be done through the app via the “Thank you letter function”. This complies with the regulations of the industry as anonymity of participants is preserved. Approval from pharmaceutical companies can be communicated directly when consenting to participate in a clinical trial, during participation or at the end of the trial. This is the first bridging function that connects pharmaceutical companies and patients as part of the patient-centricity established by pharmaceutical companies. Provision cost is set to start from 200,00 yen per month per clinical trial for pharmaceutical companies.
By using this app, patients can monitor the progress of their disease and clinical trials and reduce psychological stress due to receiving messages from pharmaceutical companies that were far away. Since this app is downloaded and used on the patient’s own device, there is no direct stress associated with reducing the cost to provide patient devices for pharmaceutical companies. In recent years, with the increase of in virtual trials and at-home trials that do require basic visits, we can assume the roles of supporting patients, serving as a substitute for study coordinators and bridge between trial staff and patients. In the future, we plan to update the app to a version that can allow the patient to manage his/her health status such as disease management and medical records so that he/she can continue to use it after the trial.Main Functions of the Clinical Trial Management Application
Function Details Visualize and share progress information The patient’s latest information summary screen. Calendar Confirmation of clinical trial visit schedule input, medication status display/input alert function, and screening schedules at other hospitals and departments outside of the trial can also be entered. Disease information Web information about disease information created (owned) by pharmaceutical companies or general epidemiological information. Medication guide Disease-related medication guide information along with disease information. Library Store and view PDF materials for all patients involved in clinical trials, such as clinical trial participation cards. Bulletin board A bulletin board in which pharmaceutical companies, study coordinators, PIs, and committee staff write for patients. The main feature is the thank you message function that conveys the feeling of “thank you” from pharmaceutical companies to patients. *No writing from patients Message Message function that can be sent mainly to patients from study coordinators. * No transmission from patients. Push Notification Ability to receive push notifications even when the app is closed, on the situation of medication, visits, messages, etc. Medication photo upload After taking the medicine, you can take a picture of the reduced amount of medicine with a smartphone camera and upload it. Examination result photo upload A function that, after receiving the screening results, captures the results with a smartphone camera, uploads them for record storage and manages them in time series. Reward function Motivation function to continue application use, improve compliance, and maintain awareness of participation in clinical trials Virtual CRC function Functions that support patients and reduce the burden of study coordinators.
Figure 4: Main Functions of the Clinical Trial Management ApplicationApplicable to All Clinical Research other than Corporate Clinical Trials
The main target for the application is for clinical trials conducted by pharmaceutical companies, but it will also be applied to clinical studies led by doctors and medical institutions. In many clinical studies other than corporate clinical trials, there are many projects that cannot support study coordinators due to budget constraints. This app is designed to include such a cost structure so that it can be applied to projects where such patient support is necessary but sufficient patient support cannot be implemented due to budgetary reasons.Comments from Takateru Inokawa, CEO of Buzzreach Inc.
The quality of clinical trials conducted by Japanese study coordinators is high even at a global scale. It is not shocking to say that this high quality guarantees the quality of clinical trials in Japan. However, there are some instances where the trial patients are not fully supported due to the shortage of study coordinators in the working environment. Therefore, we want to make this app to aid reduce the study coordinator workload and support clinical trials. Through this app, patients who have chosen clinical trial options that were not familiar to them can participate in clinical trials with peace of mind by connecting not only with study coordinator but also with pharmaceutical companies that are doctors and clients.
For future developments, we will not only listen to the voices of pharmaceutical companies but also study coordinators and patients who actually work in the field. One major concern is the engagement with patients after the trial ends. As we know, patients will most likely still be affected by the illnesses after the trial so we aim to create an environment for continuous communication through the app even after the trial via the “support for treatment” function that can be used throughout your lifetime. Patients will be provided better options for treatment and services that enrich their healthy life expectancy enhancing their understanding of their diseases and countermeasures. Furthermore, by optimizing treatment, we will contribute to reducing medical costs and reducing the burden on doctors, creating an environment where people who really need treatment can receive the treatment they need.Contact us
Please feel free to inquire using the form below. We will respond as soon as possible between 9:30 and 18:30 (Monday – Friday Japan Tokyo time).
1. Pharmaceutical Affairs Daily. March 29, 2017. [Subject recruitment status and issues] Searching for subjects, from in-hospital to out-of-hospital-Patient access is an issue.
Retrieved from https://www.yakuji.co.jp/entry57222.html
2. Pharmaceutical Affairs Daily. July 28, 2017. Respect for the clinical trial coordinator.
Retrieved from https://www.yakuji.co.jp/entry59489.html
Jul 30 2019
Marketing is a core component in business management but what is it exactly? According to the Japan Marketing Association, marketing is a comprehensive activity for creating markets through fair competition, with companies and other organizations gaining a global perspective and gaining mutual understanding with customers. Philip Kotler, the father of modern marketing, adds to that saying that marketing is human actions directed at meeting customer needs and desires through an exchange process. The easier way to understand this would just be the creation and maintenance of a market. So why do we need marketing? From the business point of view, it is to promote future sales and profits by communicating with the market which ultimately is the general public or consumers.
Basic marketing compromises of six steps; the discovery of market opportunities, target marketing, market segmentation, positioning setting, building a marketing mix (strategy) and communication.
Figure 1: Basic Flow of Marketing
Discovery of Market Opportunities
- 1. Discovery of Market Opportunities
- 2. Target Marketing
- 3. Market Segmentation
- 4. Positioning Setting
- 5. Building Marketing Mix (Strategy)
- 6. Marketing Communication
- 7. Contact Us
Discovery of market opportunities can be done via a series of processes. First is the environmental analysis to get an idea on the potential influence of various aspects of the environment on business operations. External environmental factors can be divided into macro-environment and micro-environment where macro division includes economy, politics, society and culture while micro division the industry, competition and customer analysis. Internal environment analysis, on the other hand, involves in-house analysis of people, goods, money, the know-how and information.
After getting all the potential factors that may affect the operating business, SWOT or 3C analysis can be done. The SWOT analysis will allow the business to identify its strengths, weaknesses, as well as external opportunities and threats while 3C analysis points out the three key factors a business need to succeed; the company, customers and competitors. From there, business and product critical success factors (CSF) can then be extracted to match the market opportunities for the product.
Figure 2: Example of a SWOT AnalysisTarget Marketing
Next step is target marketing. To do this, we first need to identify the market size and calculate and understand the trends. The market is a collection of potential and apparent needs and wants. Wants are demand for specific things that are not necessary to meet your needs while needs are what the customers are looking for. A good example to differentiate the two would be an office worker wanting to go to work in the morning. The want here would be wanting to get on a train or bus to reach the destination while the need is just to reach the destination which is the office. More specific detail is usually taken into account by businesses and this is the advanced need which in this case is wanting to go to the destination comfortably or quickly. These advanced needs are where businesses strive to differentiate themselves from competitors however if the wants are mistaken as needs, this will lead to wrong product/ service development.
When conducting marketing, determining the target market is an important step. If the market is classified into ‘by market space’, it can be classified into three target markets which are mass market, segment market and each customer. These cannot be considered separately but more organically linked where individual customers are narrowed down from the uniform.
Figure 3: Target MarketsMarket Segmentation
Market segmentation is the division of a market of customers into groups having the same common needs, similar product recognition, value, use and purchasing processes. It can be segmented according to geographical, demographic, psychological, behavioural variables, product usage pattern etc. Segmentation can also be done following the 4R principle; rank, realistic, reach and response.
Once the segments are established, businesses can choose to develop products/services based on different segments. The first type is a single market type where only one market is targeted and superiority and efficiency are pursued in that market. Downturns in this market will directly affect the business. Product specialization type, on the other hand, involves deploying a single product in multiple markets. This is often used by small and medium-sized specialized manufacturers with limited technology and products. Dispatch of new technologies threatens this market type. Another type is the market-specific type. They provide various products and services required by target markets and customers such as a complete set of hardware and software products while the selectively distributed type develops with multiple markets based on marketability and superiority of their products as a measure to diversify corporate risk. Last but not least, is the overall type. This strategy is usually implemented by top companies in the market such as Toyota and Panasonic where they develop all kinds of products that comprehensively cover the entire market.
Figure 4: Market Types
An example of market segmentation in the healthcare industry is by age (in ten years) and gender of patients. Since lifestyle diseases such as obesity, high blood pressure, dyslipidaemia and diabetes affect mostly patients of both genders from age 30 to 50 years of age, this will be the core target for pharmaceutical companies developing treatments for these diseases.Positioning Setting
Positioning; an activity to make your product different from competitor products, and to clearly position superiorly in the customers’ mind, and to define the marketing mix. It is the first step before strategy development in marketing. Positioning can be done based on two parties, the company or the customer however, the latter is more commonly used. As stated before, first, there is a need to identify the differential factors. The best combination of those factors is then selected before building the marketing mix. Example when marketing for Gaster, a drug targeted for gastric and duodenal ulcers, the product concept “Gaster to know” was used where it states the safety margin of the drug, ease of drinking, effective speed and its effects on the conditions; moderate gastric acid secretion/ excellent gastric mucosal protection. The concept is a clear and concrete statement in the client’s language of what benefits the drug gave. In the case of pharmaceuticals, the market is also influenced by the trend of medical research and academic society.Building Marketing Mix (Strategy)
Following that is the building of a marketing mix (strategy). It is a combination of different means that you can control yourself to approach your segments. According to E.J. McCarthy, marketing is based on four elements as theorized in the 4P model; product, price, place and promotion. A product can be a new or improvised form of an older product. You should also be clear on how the product has a differential advantage over other competitive products. Once a clear understanding of the product is achieved, the pricing comes into play. How much profit is set to be gained and what price is acceptable to consumers and competition? The third P then represents place, the setting where products are placed. Are products sold directly to consumers (direct sales) or from a wholesale store to store? The form of sales and transaction conditions should also be determined at this stage. Lastly, promotion is, like the word itself means, the incorporation of various ways to increase awareness of the product in the general public and sales subsequently.Marketing Communication
The last step in marketing is the communication stage. It links with the last stage of the 4P model stated above which is promotion. In order to promote a product, information needs to be disseminated via communication in ways including human sales, advertising, sales promotion and public relations.
Human Sales Sales staff directly directs products and services to consumers and sales associates
Appeal and sell.
Advertisement Informing / understanding / inducing an image of an “enterprise / product / service”
Cultivate and brand.
Sales Promotion Make a good impression on the product, have it tried, have it used continuously, make it stand out in the store, etc.
Secure a lot of display space in the stores.
Ask the people involved in sales to sell.
Public Relations Have the media take-up products from a “third party” perspective, gain confidence and high sensitivity, and foster good relationships with consumers and various other people around the company.Figure 5: Different Ways to Promote a Product
It is important to understand that products cannot be sold simply by raising product recognition with advertisements. In order to effectively market a product, a combination of these different ways stated above are to be used. Therefore, it is necessary to understand each feature, function and purpose as well as the current situation of the customer and product life cycle to productively apply each technique in a different situation. The effective combination and interlocking of human sales, advertisement, sales promotion and public relations is known as communication or promotion mix.Contact us
Jul 12 2019
Through these past decades, we have seen a constant development in the healthcare industry including the increase in clinical trials annually. However, public awareness of this subject is still limited hence the importance of clinical trial information relay to the public. Like any other processes, there are procedural guidelines to ensure efficiency and smoothness of the process. Clinical trials are not a new concept. Since, 1999, the Ministry of Health and Welfare (now Ministry of Health, Labour and Welfare) have already received the final report of “Study Group for Smoothly Promoting Clinical Trials”. This was then taken into consideration by the Pharmaceutical Evaluation Committee of Japan Pharmaceutical Manufacturers Association and Clinical Evaluation Committee to formulate the “Information provision procedure for recruitment of subjects involved in clinical trials” in March 2000. This is further revised in 2008 based on regulatory guidelines (shown below) issued thereafter.
Information Provision Means
- 1. Information Provision Means
- 2. Information Content
- 3. Restrictions on Expression Used in Providing Information
- 4. Things to Take into Account by Information Provider
- 5. Others
- 6. Conclusion
- 7. Contact us
There are many possible ways to do this especially through media such as posters, newspapers, magazines, flyers, televisions, radios or homepages on the Internet. However, compulsion such as force handing flyers is not permitted.Information Content
Information on clinical trials can only be disclosed according to the extent indicated by the consent/ explanatory document and clinical trial protocol. Recruitment of subjects for clinical trials, on the other hand, are only provided items indicated by the Ministry of Health, Labour and Welfare, Drug Countermeasures Division. The Medical Law (2007) states that “The general name (component name) or the development code may be used for promoting information provision on clinical trials” as providing information using media such as the Internet which is operated by a public organization for the purpose of information disclosure is not considered to be an advertisement. However, under the Pharmaceutical Affairs Law, it is prohibited to advertise non-approved drugs excluding the names of the disease targeted and brand names. Therefore, it is advised to not display the name of the study drug as well as the development code. If the promotion of the medical institution and its achievement in clinical trials is to be included, it should be based on the Medical Law.
Below shows a list of points to take into consideration for appropriate information provisions:
• Terms such as ‘new drug’, ‘new treatment’, and ‘new medical care’ should not be used without explanations about it being a trial.
• Glossaries can be included for questions like “What is a clinical trial”, “What is an anti-XX drug?”, and “What is an XXX disease?” so subjects can have a better understanding of what they are participating in. It is also possible to incorporate a brief overview about the company and its aim such as “selling or developing medicines in dozens of countries around the world”.
• If there is a statement about examining effectiveness and safety of the drug in Japan from now on, it is possible to post that this investigational drug has already been released overseas as a therapeutic agent for XXX disease.
• Following that, if the same statement of examining effectiveness and safety of the drug in Japan from now onwards is stated, it is also possible to post that this investigational drug has already been marketed as a therapeutic agent for XXX disease in Japan.
Information Provision Contents Suitability Name of study drug (including trial code) X (see Note 1) Expected efficacy or effectiveness of the investigational drug (see Note 2) △ Expected use or dose of study drug ○ Target disease name and symptom name ○ Target criteria ○ Trial purpose (see Note 3) ○ Clinical trial content ○ Subject burden reduction (see Note 4) ○ Name of the clinical trial site (see Note 5) ○ Investigator name, Department name (see Note 5) ○ Sponsor name ○ Recruitment period ○ Contact (see Note 6) ○
Figure 1: Information Provided for Subject Recruitment
Note 1: Since under the Pharmaceutical Affairs Law, advertising of unapproved drugs is prohibited, the name of the investigational drug, a general name (component name) or a development code is not advised to be provided during information provision.
Note 2: Some expressions are possible as shown below. For example, “anti-XXX disease drugs” can be used. However, we do not use expressions that imply effects such as “effective for XXX diseases” or “improve symptoms of XXX disease”.
Note 3: The purpose of the clinical trial should be concise and easily understood, such as “to confirm the efficacy and safety” or “to investigate the influence on disease progression”
Note 4: Subject burden reduction can be described as the contents of various burden reduction and the amount of burden reduction. However, expressions using the payment of money as an incentive is not accepted.
Note 5: The name of the trial site medical institution can be described if it is reviewed by the clinical trial review board of the clinical trial site medical institution, approved by the director of the medical institution, and the medical institution can respond to inquiries.
Note 6: As a contact point, indicate when, where, and in what way it is possible to inquire. For example, reception time, reception desk, telephone number, fax number, Internet home page address, E-mail address, location, etc. may be considered. When making inquiries, avoid asking for the personal information of the person making the inquiry. If personal information is obtained, action will be taken in accordance with the Act on the Protection of Personal Information.Restrictions on Expression Used in Providing Information
In order to accurately convey the information, it is necessary to pay attention to the following:
• False or exaggerated expressions
• An expression that depreciates the research drug and product of another company
• An expression that misleads using medical or pharmaceutical experts as a guarantee or recommendation
• An expression that induces the feeling of discomfort or anxiety
• Misleading expressions that suggest quality, efficacy, safety etc.
• An expression that impairs quality
• Expressions that use the payment of money as an incentive
• Displays that impair advertisement quality, such as exaggerating the amount of money
• Expressions that would suggest participating in the trial being recognised as a source of incomeThings to Take into Account by Information Provider
The informant should always consider the sensitivity of subject information. The propriety of content, as well as the method of information provision, should be discussed with the sponsor in advance. It is also important to notify the Pharmaceuticals and Medical Devices Agency 30 days prior to the start date of information provision and 2 weeks or more before the date of submission of clinical trial planning.Others
1) Inquiry Window
Inquiry window should be established in preparation of an inquiry. It is recommended that the inquiry office prepare a procedure document that states the procedure, method, scope etc. of the response so that appropriate response can be made towards future inquiries. In order to protect the privacy of applicants, unnecessary questions regarding privacy are not to be asked and if personal information is obtained in the process, actions will be taken in accordance with the Personal Information Protection Act.
2) Recruitment Period
Regarding the end date of the recruitment period, to prevent any confusion to the subjects, it can be presented on the information provision medium.Conclusion
The list above provides a guideline to the way of information provision for the recruitment of subjects involved in clinical trials, however, it is always good for information providers to keep in mind that information provided should be useful and easy to understand for the subjects.Contact us
Published November 2008, Pharmaceutical Evaluation Committee of Japan Pharmaceutical Manufacturers Association
Information provision procedure for recruiting subjects involved in clinical trials (Revised Edition)
Retrieved from http://www.jpma.or.jp/about/basis/guide/pdf/200811-information.pdf
Jul 02 2019
Buzzreach Co., Ltd. (Head office: Meguro-ku, Tokyo; CEO: Takateru Inokawa), who is currently developing clinical trial information infrastructure for patients is pleased to announce that the clinical trial information platform “puzz” has been released on March 5, 2019 allowing access to approximately 2.5 million clinical trial applicant database from partner companies, healthcare media, etc. We will also announce that we have raised approximately 50 million yen in seed round funding led by KLab Venture Partners Co., Ltd. for the purpose of further development of this service.
The clinical trial dissemination platform “puzz” for pharmaceutical companies/ medical institutions
- 1. The clinical trial dissemination platform “Puzz” for pharmaceutical companies/ medical institutions
- 2. Information matching platform Smt (Search My Trial) for general consumers
- 3. Major Issue in the Industry: Low Availability of Clinical Trial Information
- 4. Comments from Takateru Inokawa, Representative Director, Buzzreach Co., Ltd.
- 5. Fundings
- 6. Future Business Developments
- 7. Contact us
Puzz is a clinical trial information dissemination platform for pharmaceutical companies and medical institutions to publish and disseminate clinical trial information to the general consumers as well as enquiring patients allowing them to apply for clinical studies. On puzz, clinical trials information can be registered not only at the medical institution level but also at a project level, enabling detailed settings and information deployment. By posting clinical trial information on puzz, information can be disseminated to a patient database, healthcare media, patient’s association etc. The registration fee for puzz is free of charge however there is a paid plan option where we can support multiple projects of different duration. In addition, the clinical trial information posted on puzz links with the clinical trial matching platform smt (Search My Trial * beta version) operated by our company hence enabling the matching of trial information to patients seeking new treatments. This will allow us to provide an infrastructure for managing patient information in clinical trials. The process of drug development is costly, and this is usually due to the extension of enrollment period therefore, pharmaceutical companies are constantly aiming to finish development in the shortest possible time. By introducing puzz (beta version), several pharmaceutical companies have shortened enrollment period by two months, reducing costs by about 45 million yen.Information matching platform smt (Search My Trial) for general consumers
Smt is a service that matches patients, families and general consumers seeking information on new treatments and drugs on the web with all clinical trial information in Japan. You can not only specify on clinical trial information that is appropriate for your own or your family’s situation but also the neighbourhood in which the relevant clinical trials are conducted (*The name of the medical institution is usually masked and only area information is available). This will open a new pathway for patients in the sense that they could participate in “clinical trials” as a new option other than the treatments they are getting from a general doctor.Major Issue in the Industry: Low Availability of Clinical Trial Information
Clinical trials play an essential part in ensuring that new drugs are safe and effective. However, with only limited sites providing information on ongoing trials, it proves to be a challenging task for patients who are not satisfied with their current treatments to look up new trials that may be lifechanging for their conditions. The number of clinical trials conducted in Japan is increasing annually and 693 clinical trial plans were notified in 2017 (National Institute of Health and Medical Technology Pharmaceutical and Medical Devices Agency https://www.pmda.go.jp/review-services/trials/0014.html). Among them, 136 are undergoing clinical trial plan submissions showing that many new drugs have reached the clinical trial phase every year. Furthermore, there has been a shift of trends for drug development for treatments towards untreatable diseases such as cancer, dementia, psychiatric diseases, childhood diseases, rare diseases, gynaecological diseases, etc. These drugs may be the only chance for some patients in later stages of diseases and without efficient conveyance of information to these patients, they may just miss their chance to treating the disease and prolonging their life. Therefore, based on the current situation, we have released trial matching platforms smt and puzz in order to eliminate the information gap between patients, pharmaceutical companies and medical institutions. Not only will patients receive the information on new drugs efficiently, but the drug development cost will also be lowered due to the participant referring.Comments from Takateru Inokawa, CEO, Buzzreach Co., Ltd.
At the moment, relaying information on clinical trials to patients accelerates development leading to a reduction in development costs, and more than anything else, new options and hope to patients. Patients are also given full transparency of new drug development status that pharmaceutical companies are working on. We provide puzz and smt (Search My Trial) to connect as many new clinical trial information to people suffering from illnesses. Although there are several companies specializing in recruiting patients for clinical trials and most of them have registered members, those registered members are just awaiting clinical trials for their particular disease since most information on clinical trials is not open to the public. On the other hand, most trials are delayed due to the lack of participants. In order to close this gap, we will open clinical trial information registered on our platform to various companies, media and organizations to improve the availability of this information to the people. Clinical trials are an essential part of the future development of healthcare in Japan. Patients who participate in the trials are representatives of the disease. There are hundreds and thousands of people who suffer from similar conditions who have no clue about clinical trials. We hope that more people will learn about clinical trials, participate in them and contribute to the further development of healthcare as much as possible.Fundings
In December 2018, approximately 50 million yen was raised by third-party allotment, led by KLab Venture Partners Co., Ltd. With this funding, we will focus on other services that focus on patients seeking a better environment than the current IT-based environment, as well as expanding the current puzz and smt services we have released this time.Future Business Developments
In order to provide patients with better treatment options, we will develop a service that delivers optimal information for each patient with the provision of clinical trial information. In the spring of 2019, we plan to connect investigators and participating patients, release a patient management app that solves various problems, and start creating a community where patients and pharmaceutical companies connect with each other based on “clinical trials.”Contact us
Jul 01 2019
According to the demographics of Ministry of Health, Labour and Welfare in 2017, the top killer of the Japanese population is cancer, followed by heart disease, brain vascular disease, old age and pneumonia so what do these diseases have in common? Like most diseases, it all comes down to personal lifestyle habits. There may be arguments that genetics is also an important factor that may increase the risk of disease but excluding genetics, lifestyle plays quite a big role in the quality of life.
Figure 1: Causes of Death Among the Japanese Population
Lifestyle Habits that Lead to Diseases
- 1. Lifestyle Habits that Lead to Diseases
- 2. Issue Regarding the Lifestyle-Related Diseases Market
- 3. DTC (Direct to Consumer) Marketing
- 4. Contact us
When a healthy person acquires irregular lifestyle habits such as lack of exercise, inappropriate eating (calories, salt, excess fat intake), stress, drinking and smoking, it may accumulate to increase the risk of acquiring lifestyle-related diseases such as obesity, high blood sugar, high blood pressure and lipidemia. During this period, if measures are taken and the person follows specific health instructions daily, there is still a high probability for prevention of disease. However, without proper steps taken, the disease will aggravate and progress further to become visceral fat syndrome and hypertension. During this stage, drug treatments are already needed in addition to lifestyle changes to prevent further aggravation but not all patients will have the will to follow these instructions. If diseases persist, they may progress to severe complications such as ischemic heart disease (myocardial infection, angina pectoris), stroke (brain haemorrhage, cerebral infarction) and diabetes complication. This is where care is needed to aid the person in performing life functions since they may be half body paralysed and having conditions that interfere with daily life like dementia. From these, we can clearly see how small lifestyle changes can lead to major impacts not only towards a person’s health but also the country’s economic particularly the medical cost.
Figure 2: Lifestyle Habits that can Lead to Disease Progression and Measures taken by the Healthcare Industry to overcome this.
Steps Taken by the Healthcare Industry to Overcome this Problem
To overcome this predicament, the healthcare industry has put in a lot of effort into promoting the maintenance of a healthy lifestyle. By providing health management support such as dietary instructions, exercise therapy and manufacturing of health foods etc., they help people manage their daily lifestyle and avoid acquiring an irregular lifestyle. People are also encouraged to perform medical check-ups annually and prevent from smoking and drinking.Issue Regarding the Lifestyle-Related Diseases Market
A major issue for lifestyle-related diseases market is the low visit rate during mild disease periods. This may be due to people taking conditions lightly since medical costs are high or ignorance. Good examples are dyslipidemia and high blood pressure where 97% and 70% of the patients are untreated respectively.
Figure 3: The Percentage of Treated (Blue) VS Untreated (Orange) Patients of Various Diseases including Diabetes, High Blood Pressure (Hypertension) and Dyslipidemia (From left to right)
Pathways Patients Take after Disease Onset
When a healthy person is contracted with a disease or illness, there are several pathways that the person will take. If the patient is knowledgeable, he/she will first collect information on the disease and look up medical institutions available that can treat the disease. From there, he/she will either visit a specialist who will give a proper diagnosis of the disease and provide proper treatment or just a general hospital or clinic where they will be advised. However, as stated above, there is usually a low visit rate if the disease is mild or only during the early stages. For these people who are not admitted into hospitals, they will either just get over-the-counter (OTC) drugs (medicines sold directly to a consumer without a prescription from a healthcare professional) or not get treated which is not advisable.
Figure 4: Possible Pathways taken by Patients after onset of Diseases.DTC (Direct to Consumer) Marketing
Therefore, to increase public awareness of diseases and the new drugs that are arriving in the market, pharmaceutical companies are currently using the DTC (Direct to Consumer) Marketing. Public awareness of the disease will first be raised by dissemination of information to media and medical consumers via publicity, web sites, advertisements, civil open lectures as well as health events etc. Market researchers will then contact physicians to further their knowledge on the disease as well as introduce them to the new drug. This will allow physicians to have better understanding of the drug so that they can prescribe the drugs better to future patients, promoting patient consultations. This will not only provide the patients with the most updated information of new drugs that may aid treating their disease but also secure a stable market for pharmaceutical companies so further research can be done to improve current treatments.Contact us
Figure 1: Demographic statistics of Ministry of Health, Labor and Welfare 2017
Figure 3: Tokyo Comprehensive Health Insurance Association Council (Toshokyo), available online at: http://to-so-kyo.org/?q=node/1063
Figure 4: DTC Marketing / Furukawa Takashi Quote from Kirishima Pass
Jun 24 2019
Over the past few decades, the lifespan of humans has increased quite remarkably due to better healthcare technologies, improved living conditions as well as nutrition. In Japan, currently, the average life span of a Japanese man is 80 and 86 for woman, and with the steady increase in statistics over the years, it is expected to have the highest ageing rate among all developed countries by 2025. From there, you would think it is an improvement so why is it considered a problem? While lifespan is increasing, healthspan of a person, the period of time in which the person is considered generally healthy and less susceptible to diseases due to old age, is not increasing as rapidly resulting in a larger gap between these two periods. A good example would be in Japan, although the lifespan of a typical man is 80 years, the healthspan is only 71. This leaves a 9 years period in between where the man has a higher risk of contracting diseases and illnesses resulting in an increase in medical expenses.
Figure 1: Average Lifespan and Healthspan of the Japanese Population
Current Healthcare Industry
- 1. Current Healthcare Industry
- 2. Overview of the Current Market and the Key Players
- 3. Japanese HealthTech Landscape
- 4. Contact us
With the increasing need to maintain and promote the health of the consumers, there is a constant growth of the healthcare industry and is an area that is expected to see continuous growth over the next few decades. Furthermore, Abe administration has also included “prolonging of the peoples’ healthspan” as one of the themes of the “strategic market creation plan” in the Japan Rebirth Strategy. In this plan, it is clearly stated that areas such as health promotion, prevention, life support services, medicines and medical devices should be fostered as a strategic area where growth potential is to be expected while curbing the ever-expanding medical expenses.
To have a clearer idea on the scale of this industry, we first have to look at the macroeconomic factors impacting it and a simple way to do this is a PEST analysis (Political, Economic, Society and Technological analysis).
Politics Economy ・ Strategy for growth
・ Implementation of measures to control medical expenses and long-term care expenses
・ Enforcement of laws on pharmaceuticals and medical devices etc.
・ Legislation and deregulation of new fields such as regenerative medicine
・ Rise of medical expenses, long-term care expenses
・ Lapse of large drug patents expired
・ Supplying of healthcare venture funds
・ Deepening industry-university collaboration
Society Technology ・ Growing population increase
・ Higher health awareness
・ Crisis of medical care in rural area
・ Promotion of technology transfer
・ Development of regenerative medicine technology including IT and miniaturization of medical related equipment leading to a price decline
Figure 2: PEST Analysis of the Healthcare Industry
According to the Ministry of Health, Labour and Welfare, the current medical cost is approximately 49.6 trillion yen and by 2030, it will increase to about 54 trillion yen. Following this, the market size will also have an approximate increase of about 10 trillion yen every decade putting the healthcare industry with predicted market size of 37 trillion yen by 2030 further proving the continuous growth and expansion of the industry in the future.
Figure 3: Medical Cost and Market Size of the Healthcare Industry in recent decadesOverview of the Current Market and the Key Players
At the mention of healthcare industry, the first key players that come to mind must be pharmaceutical companies, medical institutions, drug wholesalers etc. however, the market involves a whole range of business types ranging from manufacturer to service industry. Listed below are the various business types that are classified under healthcare with the services that they provide and the key players in each area.
Healthcare Needs Product or Services Provided Key Players Maintaining a Good Health Smartwatch with fitness, portable apps and cloud services to help maintain health, and record personal physical conditions Fitness club, Mobile Application / Cloud Service Vendor, Smart Devices Manufacturer and Producer of Healthy Food Treatment of Illnesses and Injuries Manufacture and sales of medical services, pharmaceuticals and medical devices (treatment equipment, testing and diagnostic equipment, etc.) Medical Institutions, Pharmaceutical Companies, Medical Device Specialists, General Electronics Manufacturers, Drug Wholesalers and Drug Stores Improving Physical Disability Care service, manufacture, sale of welfare, care equipment Care Company, Care Equipment Manufacturer, Car Manufacturer and Care Equipment Distributor Healthcare Business Support Support for drug development (development contract, dispatch of support personnel, etc.), outsourcing services for medical institutions (cleaning, nursing assistance, food service, facility management, etc.), medical IT services/products (electronic medical records, telemedicine systems, etc.) CRO (Drug Development Contract Agency), SMO (Clinical Trial Facility Support Agency), Building Maintenance Company, Staffing Agency, Food Service Company, Software Vendor and System Integrator
Figure 4: Healthcare Market and the Players Involved
Therefore, with these huge ranges of variety in businesses involved, they will serve as business opportunities for small and medium-sized companies as well as venture companies as the market expands.Japanese HealthTech Landscape
The figure below shows the Japanese Health Tech Landscape as of 2017. From left to right, it shows companies involved in the maintenance of health as well as prevention of diseases to those involved in treatment and discovery of cures to providing caregiving services and equipment on the far right. From a top-down direction, on the other hand, shows larger companies that sell services business to business in comparison with smaller companies on the bottom selling services via business to the consumer directly.
Japanese Digital Health Start Up Landscape
Figure 1: Statistics taken from Average life span: Ministry of Health, Labor and Welfare “2013 simple life table”, Healthy life span: Ministry of Health, Labor and Welfare “2013 simple life table”, “2013 demographics statistics” “2013 National Life Basic Survey” Ministry of Internal Affairs and Communications “2012 estimate Calculated from “population”
Figure 2 & 4: Japan Intelligence Mart
Figure 3: Based on the Ministry of Health, Labor and Welfare “Estimates of social security expenses” and “Japan revival strategy-JAPAN is BACK-”