Healthcare Venture Conference KYOTO

HVC KYOTO 2017Don’t miss out on the upcoming innovations in Healthcare!

HVC (Healthcare Venture Conference) KYOTO is a platform that supports new innovative startups aiming to expand their business into the global market in the healthcare field. The first HVC KYOTO 2017 was held on August 4 (Friday) at the Kyoto Research Park (KRP) as part of JETRO’s regional contribution projects. All sessions were presented in English. Over 160 participants, from not only healthcare but also a wide variety of other backgrounds, attended the conference.

Representing the organizers, Kenichi Ishihara, Chief Director of JETRO Kyoto gave the opening address, emphasizing that the success of this conference would serve as a driving force in the innovation system in the healthcare field. The programs mainly consisted of short presentations made by 10 innovative startups, many of them related with Kyoto University, and open mentoring sessions. Latest models of innovation creating activities were introduced in other sessions. In parallel with these sessions, exhibits were displayed and, after the sessions, 14 individual meetings were held for matching presenters and partners.
For details of each session, please refer to the following:

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Conference Program: Aug.4th 2017 @ Kyoto Research Park

10:00 - 10:05

Opening Note

Kenichi Ishihara, Chief Director, JETRO Kyoto

10:05 - 10:30

Session1:1. Boston/Cambridge, Massachusetts: a Great Location for Healthcare StartupsElizabeth Steele, Senior Director, Economic Development & Global Affairs, Massachusetts Biotechnology Council

In the Boston/Cambridge area, whose strength has historically been in biotechnology, 18 of the top 20 biggest global pharmaceutical companies are located. The three best features of this area are “a high educational level,” “good access to capital” and “support from the state government.” The evidence for these features lies in the fact that employment in this field has increased by 28% and the total area of laboratories has increased by 56% in the last decade. With regard to funding, the amount of National Institute of Health (NIH) grants in this area is the second largest behind the State of California, while the amount per capita is the largest. The amount of venture capital investment has been increasing every year, reaching $3.3 billion in 2016. With the help of these funds, there are as many as 1,700 ongoing drug discovery pipeline projects, mainly on cancer research.

Massachusetts Biotechnology Council (MassBio), which supports the biotechnology industry in Massachusetts, was founded in 1986 as a private nonprofit organization by just six member companies. It has now grown to an organization of more than 1,000 member companies. Mass Bio organizes forums for its members to provide them with information on industry trends and emerging technologies, as well as regular information sharing events. It also offers joint purchasing programs; promotes, as Team Massachusetts, public relations activities and international interchange; continues lobbying the government; and helps the startups. In its entrepreneur mentorship program, MassCONNECT, teams of pharmaceutical experts, who serve as mentors, and entrepreneurs provide candidate startups with mentoring services as well as opportunities for them to match up with investors. Some graduates of this program have established promising startups.
As explained above, with a cluster of outstanding researchers and an excellent investment environment, the Boston/Cambridge area is optimal for entrepreneurs to new and growing startups.

Elizabeth Steele

[Speaker Profile]Elizabeth is the Director of Economic Development & Global Affairs. Previously, she was MassBio's Director of Events where she planned and oversaw all Signature Events for the organization. Before joining MassBio, Elizabeth spent five years at the Massachusetts Office of International Trade & Investment, where she managed foreign direct investment for the Commonwealth of Massachusetts and was a main organizer of Governor Patrick’s Innovation Economy Missions to Israel, the United Kingdom, and Brazil. Elizabeth also worked at the 2010 Winter Olympic Games in Vancouver where she provided large scale transportation management.
Elizabeth is a graduate of Clemson University with a BS in Political Science. She also holds an MPA and MS in Political Science with an International Relations specialization from Suffolk University.
MassBIO website: https://www.massbio.org/

10:30 - 10:45

Session2: KYOTO-SPARK, Opportunity for the Drug Development in AcademiaTomoyoshi Koyanagi, Associate Professor, Medical Science & Business Liaison Organization, Kyoto University

There is no ecosystem available in Kyoto for bringing about healthcare innovation. To translate outstanding research results into products, a system to organize people and funds is necessary. This is why we launched HVC KYOTO.

To cross the “death valley” of drug discovery, we need an incubation system to translate scientific discoveries into verifiable data and a marketplace to generate funds to move on to the next step. HVC KYOTO was founded to create such a marketplace. The role of incubation has now changed from the provision of a “place” alone to the provision of a combination of “people, goods and funds.” KYOTO-SPARK was established by Kyoto University to address this new trend in incubation.

SPARK is a practical training program designed to help facilitate translational research in drug discovery. The program was started at Stanford University in 2006, based on the concept of “bench to bedside.” SPARK provides university researchers with educational assistance to achieve the translation of basic medical research into clinical applications as well as mentoring, and also funding opportunities. There are now many SPARK programs throughout the world.

One of the advantageous features of KYOTO-SPARK is mentoring by volunteer advisors with 20 to 30 years of expertise and experience in different fields. We invite the university’s researchers to bring their projects and give them lectures and mentoring to help them develop strategies to translate important research results into products. The goal is to achieve technology transfer in the industry and create startups.

Our focus is not only on intangible efforts but also on tangible results. In new research facilities of Kyoto University, we have created spaces dedicated to incubation where researchers can start their research on the day they move in. Our goal is to establish an ecosystem in Kyoto, in cooperation with those interested from Japan and abroad.

Tomoyoshi Koyanagi

[Speaker Profile]Dr. Koyanagi is serving for academic society as a business development manager focusing on development of early stage technologies for clinical application of basic science. Through his experience as a scientist in Stanford University, he realized the importance of startups eco-system in Silicon Valley area and its impact for academic society. That experience motivated him to engage in commercialization of state-of-art technologies into healthcare products. Based on his hands on experiences in drug discovery and regenerative medicine product development, he serves for Kyoto University to discover early stage technology and consults scientists to develop their science to be innovative products for the community.
KYOTO-SPARK website: http://www.kyoto-spark.med.kyoto-u.ac.jp/en/

10:45 - 11:00

Break - 15 minutes

11:00 - 13:00

Session310 Innovative Startup Presentations

Presentation #1AFI Corporation's businessTakaharu Enjoji, CEO, AFI Corporation

AFI Corporation aims to make fluid electric filtering and sorting technology, an innovative separation technology called “FES” for short, a global standard. AFI, our company’s name, is an abbreviation of Advanced Filtration Industries Technology. AFI’s core technology, FES, is an innovative separation technology combining electric measuring technology and fluid control technology. FES makes it possible to separate target cells and impurities without prior labeling. We provide our products using FES to address problems faced by many industries.

FES is divided into two types: “continuous separation type” used to separate cells, such as iPS cells, and “concentration separation type” used to detect bacteria. Our first product launched in 2016 was ELESTA, a highly sensitive device in a simplified model to detect bacteria quickly using concentration separation type technology. The target market of ELESTA is the quality inspection market for foods and beverages. We are currently developing products under the ELESTA series, including products targeting the market of clinical research using circulating tumor cells (CTCs) and those targeting the market of cell separation for iPS and other cells, which are scheduled to be launched in 2018 and following years.

[Mentors’ comments]

  • “If it is proven that bacteria can be removed entirely, there would be a huge market for the product as filters for intravenous administration of cells and other parenteral administration.” Sham Nikam, Takeda Pharmaceuticals
  • “While the presentation was focused on the introduction of technological features, I think it would be more effective to show customer benefits and differences from the products of other companies.” Elizabeth Steele, MassBIO

[Speaker Profile]Mr. Enjoji worked at SHIGEMATSU WORKS of an industrial respirator manufacturer as a chief engineer of R&D division for ten years. He founded FILTECHNO JAPAN in 2007 specialized to dielectrophoresis (DEP) technology, a sort of electrostatic phenomena, and developed flow-separation tools of microorganisms for university and food/beverage industry researchers. In 2013, He founded AFI Corporation and started to develop the rapid microorganisms detection equipment “ELESTA” based on DEP technologies. He assumed CEO in 2014. He holds a PhD in engineering from Tokyo Metropolitan University in 2012. His specialty is microbiology and DEP.
AFI Corporation website: http://afi.co.jp/

Presentation #2Drug Discovery based on Glycan TechnologyHirofumi Ochiai, Manager, Research & Development, GlyTech, Inc.

GlyTech aims to develop biopharmaceuticals using technology for manufacturing human-type sugar chains and glycosylation technology. Peptides and proteins play a key role in the development of biopharmaceuticals. However, there are technical issues that still need to be addressed, such as poor water-solubility, short half-life, and complicated QC. An important element in resolving these issues is sugar chains. Our company manufactures innovative biopharmaceuticals using chemical sugar chain modification methods.

We possess the technology to mass-produce N-glycans (ca. 10 kg scale), and to synthesize any homogeneous glycoprotein or glycopeptide by chemical glycosylation. With these technologies, we have successfully chemically synthesized homogeneous interferon β. In addition, multiple-glycosylation of this interferon β improves its antitumor effects and prolongs its therapeutic efficacy. We have also been successful in improving the functions of not only proteins but also peptides (somatostatins) by glycosylation. Our aim is to have our glycosylation technology used by researchers engaged in developing innovative biopharmaceuticals, as a tool to improve the functions of peptides and proteins.

[Mentors’ comments]

  • “The technology has huge potential in the biopharmaceutical field.” Dong Wu, Johnson & Johnson INNOVATION
  • “It is desirable to first focus on a certain chemical to prove that this technology functions well, before dealing with another chemical product.” Craig Garner, SPARK Berlin

[Speaker Profile]Hirofumi Ochiai received his Ph.D. from Kyoto University in 2005. After postdoctoral research at Konan University and the University of Maryland School of Medicine, he moved to Otsuka Chemical Co., Ltd. in 2009. In 2013 he joined GlyTech, Inc., where he has been working as a researcher.
GlyTech, Inc. website: http://www.glytech.jp/en/

Presentation #3HACARUS challenging the healthcare industry with the unique AIKenshin Fujiwara, CEO, Hacarus Inc.

Hacarus develops applications designed to help companies to manage their employees’ health, covering diet, blood-sugar levels, blood pressure, exercise, and other health-related information. The company’s name “Hacarus” is derived from the Japanese word “hakaru” meaning “to measure.” This application uses artificial intelligence (AI) to provide health-related information and propose recipes that help improve the user’s health based on information obtained from the user on his/her diet, exercise and other lifestyle factors. The gathered information is stored in the cloud so that staff in charge of administrative and other relevant duties at Hacarus’s customer companies can access it to check the health conditions of employees online. This kind of service has already been provided around the world.

The major feature of our service lies in AI. Although, this type of service usually uses “deep learning technology”, ours does not. Unlike deep learning technology, which requires large amounts of data and calculation, the “sparse modeling technology” we use needs only a small amount of data and calculation to help the algorithm to choose a solution. With this remarkable technology, calculation can be performed even with an ordinary laptop computer.

We have formed a global team to develop products in the Philippines. Our target customers are fitness clubs, insurance companies and other sorts of companies. We have alliances with welfare services providers for major companies and are seeking new partnerships with organizations in Japan and abroad.

[Mentors’ comments]

  • “There are already 10 to 20 competitive applications. It is therefore important to find a way to differentiate yours from others.” Dong Wu, Johnson & Johnson INNOVATION
  • “While your business is going well in Japan, cultural differences may pose obstacles in foreign countries. I find it a good idea to develop partnerships with health-conscious membership organizations.” Craig Garner, SPARK Berlin

[Speaker Profile]Kenshin is the CEO at Hacarus, a healthcare technology startup based in Kyoto, Japan. Previously he worked on the Playstation for Sony Computer Entertainment and was part of a startup derived from the Israeli Military. In the past 15 years, Kenshin co-founded several tech startups with two successful exits. The fist startup was acquired by a Japanese public company, and the second startup was sold to a US company. Since 2010, Kenshin has been living in Kyoto rediscovering the strengths of intellectual property owned by local universities and the richness of food culture that Kyoto has to offer. Born in Shiga in 1976, Kenshin holds a Computer Science degree from California State University.
Hacarus Inc. website: https://hacarus.com/

Presentation #4Cardiac cells derived from iPS cellsKenji Kakuta, President & CEO, iHeart Japan Corporation

iHeart Japan is a venture company, established in 2013, to develop iPS cell-derived regenerative medicinal products for heart failure. The base technologies were invented by Prof. Jun Yamashita at Center for iPS Cell Research and Application, Kyoto University. We have successfully raised money from venture capital funds, and have obtained several Governmental grants. iHeart Japan is tied-up with Takara Bio Inc. in Japan, China, South Korea and India, who has been already selling cardiomyocytes etc. as research tools licensed by iHeart.

In this presentation, I will introduce iPS cell-derived layered cardiac cell sheets, one of the main products under development. We are able to layer so many cardiac cell sheets differentiated from iPS cells by special lamination technology using gelatin hydrogel microspheres. Without such special technology, cells in laminated cell sheets shall not live so long, due to lack of oxygen and nutrition. On the other hand, our lamination technology keeps them alive for one week, at least. Furthermore, efficacy of the layered cardiac cell sheets was indicated by two animal studies of rats and pigs for myocardial infarction.

We are aiming to start a clinical trial in 2020. In parallel with the preparation for the clinical trial, we have also started preparing for clinical research at Kyoto University. The potential market size is expected to exceed ¥25 billion in Japan. We are seeking for partnerships with major companies to fulfill our mission to save patients around the world.

[Mentors’ comments]

  • “Many companies are interested in regenerative medicine because it is cutting-edge technology. Depending on the patent status, it is a very attractive technology for larger than medium-sized pharmaceutical companies.” Sham Nikam, Takeda Pharmaceutical
  • “While regenerative medicine is a very hot field, there are issues that need to be addressed, such as the production efficiency of iPS cells and whether or not significantly better therapeutic effects can be achieved than with standard therapy, in addition to licensing issues.” Dong Wu, Johnson & Johnson INNOVATION

[Speaker Profile]Prior to iHeart Japan Corporation, he worked for investment company, being in charge of venture capital investment in bio-tech companies.
iHeart Japan Corporation website: http://www.iheartjapan.jp/en_index.html

Presentation #5A new class of anti-DNA viral drugsMasafumi Kuroishi, CEO, KinoPharma, Inc.

KinoPharma develops drugs targeting kinases. There are two types of viruses: RNA viruses, such as Ebola and influenza, and DNA viruses, such as adenovirus. Our products target DNA viruses.

For example, more than 6 million people in Japan, the U.S. and Europe are infected every year with viruses associated with epidemic keratoconjunctivitis (EKC) accompanied by high fever, swelling and pain, for which no effective therapy is available. To treat human papillomavirus (HPV) infection, a cause of cervical cancer, the vaccine is used in 63% of patients in the U.S. but only in 4% in Japan. We are making efforts to address this issue.

Antiviral drugs generally inhibit the ability of a DNA virus by targeting its enzymes and proteins. For this reason, it is necessary to develop a different drug for each virus. A drug developed with our technology can inhibit intracellular enzymes that are used by a DNA virus to proliferate in the host cell, and therefore can be effective against different types of viruses. This compound was discovered and patented by Prof. Hagiwara at Kyoto University.

In our development pipeline, there is an eye drop for treating keratoconjunctivitis, for which a partnership has been established. We are now preparing an application to the U.S. FDA. A skin patch for treating viral warts is in Phase 1&2 clinical studies at Kyoto University Hospital. We are also preparing clinical studies on a tablet for cervical cancer in cooperation with Kyoto University. There is also a drug formulation for intravenous injection, which has the largest market, for which preparation for animal studies is ongoing. We are inviting development partners and investors for all these projects.

[Mentors’ comments]

  • “This is a very cutting-edge area and a large market is anticipated. However, there are other companies that have already been active in developing drugs in this area. You need to clearly differentiate your products from others and also demonstrate their safety.” Sham Nikam, Takeda Pharmaceutical
  • “You should take more time to explain the safety and efficacy of the technology. It is also better to explain the market size of each pipeline as well as the benefits and key points for differentiation.” Elizabeth Steele, MassBIO

[Speaker Profile]He founded Watervein Partners in 2002, and incubated and invested in technology created in academia in the field of biopharma. He was appointed CEO at Kinopharma in 2011 and since then has been working on the development of new concept antiviral drugs.
KinoPharma, Inc. website: http://www.kinopharma.com/english/

Presentation #6High quality iPS cell-derived cardiomyocytes which are differentiated under xeno-free and cytokine free conditionsNaohiro Makita, President, Myoridge Co. Ltd.

Myoridge is a Kyoto University-based startup developing drug discovery tools using iPS cell-derived cardiomyocytes. Cardiomyocytes can be used for two purposes: for regenerative medicine such as transplantation therapy, and for drug discovery tools. The cardiomyocytes we provide have seven features: 1) low-cost, 2) high purity, 3) uniformity between lots, 4) no animal-derived ingredients contained, 5) high mature cardiac marker expression, 6) formation of mature muscle fibers, and 7) high drug responsiveness.

We are a startup founded in 2016 based on technology developed by Dr. Itsunari Minami at Kyoto University. Patents related to the differentiation inducing technology and culture media are owned by Kyoto University. Our cardiomyocytes are high-purity: 93–98% are made of ventricular myocardial cells. Expressions of HERG, KCNQ1, Kir2.1 and other markers are higher than in other products. As disturbance of pulse rates was detected in a cytotoxic test using nifedipine, they are suitable for drug discovery and toxicity tests.

[Mentors’ comments]

  • “In a presentation, you need to clarify who the users are and what will be provided as a product. If you provide your product as a drug discovery tool, you also need to show what types of myocardial cells are present and in what ratio, and whether or not the distribution is uniform.” Craig Garner, SPARK Berlin
  • “You need to demonstrate that expressions of ion-channel markers are higher in your cardiomyocytes than in those of other companies.” Sham Nikam, Takeda Pharmaceutical

[Speaker Profile]He belongs to Kyoto University Graduate School of Engineering. He supported research in a laboratory of Itsunari Minami at iCeMS, Kyoto University. He established Myoridge Co. Ltd. with Shinichi Sueta who is a director, CTO in order to make use of research results of Minami for innovative drug development.
Myoridge Co. Ltd. website: http://myoridge.co.jp/

Presentation #7Regcell Co., Ltd. - Generate innovative cell therapy by controlling the immune systemNaoto Matsuda, CEO, Regcell Co., Ltd.

RegCell develops new drugs for autoimmune disease and cancers using immunosuppression technology. I have been suffering from pollinosis for nearly 20 years. The development of pollinosis and other allergic diseases is associated with autoimmune cells, such as T-cells, and Tregs which control them. As Tregs decrease, T-cells are activated and attack cell tissues, causing autoimmune diseases such as diabetes. We have developed an ex-vivo Treg culture system to suppress excessively activated T-cells to control autoimmune diseases.

RegCell has two business projects: one is related to allergies, autoimmune diseases and organ transplantation, for which the ex-vivo Treg culture system is used; the other is cytotoxic T-cell (CTL) therapy for cancer where iPS cell-derived CTL cells are produced.

At our company, Professor Emeritus Sakaguchi at Osaka University, a prominent immunologist, serves as CTO, and Prof. Kawamoto at Kyoto University as scientific advisor. We have received about ¥600 million in funds. We are planning to establish key technology by the end of this year, establish a manufacturing process and conduct pre-clinical trials during 2018 and 2019, and start clinical trials in 2020. We believe that it is possible to develop new therapeutic methods by controlling the autoimmune system.

[Mentors’ comments]

  • “Cell therapy has become a much-discussed topic. However, conducting clinical research is different from establishing a therapeutic method. You therefore have to overcome two major issues: patents and partnerships.” Dong Wu, Johnson & Johnson INNOVATION
  • “A large number of patients for this therapeutic method can be expected. To make your presentation more convincing, it is better to include numerical rationales, such as the number of patients and the size of the market.” Elizabeth Steele, MassBIO

[Speaker Profile]He started his career with Fujifilm Corporation after obtaining Master's degree in Organic Science at Waseda University. In 2015, he joined iPS Portal Inc. as Vice President, Manager and Executive Secretariat. He then became CEO of Regcell Co. Ltd. when the company was founded in Jan. 2016.
Regcell Co., Ltd. website: http://regcell.jp/

Presentation #8Introduction of innovative binder selection technology contributing to the discovery of small molecule drugs.Naoki Tarui, CEO, SEEDSUPPLY Inc.

SEEDSUPPLY is a spin-out from the Entrepreneurship Venture Program of Takeda Pharmaceutical Company. High throughput screening (HTS) has been used in various drug discoveries since the 1990’s. Recently, however, the number of tractable targets has decreased. We provide two services: one is a search for chemical compounds for drug candidates to which conventional HTS cannot be applied, and the other is a search for binding proteins with unknown target molecules.

In our services, we use binder selection technology, our proprietary technology applicable not only to soluble proteins but also to various target molecules, such as microsomes and DNA/RNA. When combined with Takeda’s library of 400,000 chemical compounds, it can be used for all sorts of screenings. Our services are available either through contract, online, or through joint development. Our aim is to contribute to the research and development of different types of pharmaceutical companies.

[Mentors’ comments]

  • “To be more user-friendly, you should clarify whether users can access Takeda’s entire library of 400,000 compounds, and whether you intend to construct your own library.” Dong Wu, Johnson & Johnson INNOVATION

[Comment from audience]

  • “Your presentation should clarify, if we find an interesting compound in Takeda’s library, whether or not joint development with the university’s project is possible, and if possible, how to handle patenting issues and the likely cost.” Masatoshi Hagiwara, Director, Kyoto University Medical Science and Business Liaison Organization (KUMBL)

[Speaker Profile]He had been engaged in drug discovery for Takeda over the past 20 years. His technological efforts especially for constructing chemical library and for following systematic screening successively identified dozens of drug seeds. One of the candidates, named Takecab, finally launched to the market in 2015.
SEEDSUPPLY Inc. website: http://www.seedsupply.co.jp/

Presentation #9Autism spectrum disorder drug discovery and its related businessYuji Kogami, President & CEO, SkySea Pharmaceutical Inc.

SkySea Pharmaceutical is a startup aiming to develop the world’s first autism spectrum disorder drug. Prof. Shuto at Hokkaido University serves as our advisor. Under his direction, we are engaged in drug discovery using oxytocin derivatives. We also use technology developed by Prof. Higashida at Kanazawa University, who developed a unique animal model of autism spectrum disorder. Concurrently with this drug discovery, we are developing a diagnostic test kit using an anti-oxytocin antibody. We are also engaged in the joint development of a compound that prolongs the duration of the in vivo effects of oxytocin. We are also conducting joint research with multiple companies to search for substances that prolong the duration of the effects of oxytocin as well as exosomes.

We have derived 2 candidate compounds from a new oxytocin derivative discovered by Prof. Shuto. In an initial experiment on rats, the effects of oxytocin were enhanced. A preclinical trial is scheduled to start within this year or next year. We have also obtained favorable experimental results in the business development of exosomes.

We will need about 1 billion yen until the completion of preclinical trials in our development projects. We are planning to collect funds for the projects from venture capitals (VCs) and business companies. Our aim is to license them out or move into M&A upon moving to the Phase 2 clinical trial.

[Mentors’ comments]

  • “You have synthesized an oxytocin derivative. You should explain why it is necessary to use a derivative instead of oxytocin itself.” Sham Nikam, Takeda Pharmaceutical
  • “You have a very promising candidate, an oxytocin derivative. So you should focus on the derivative rather than expanding your research to exosomes, which have not yet been fully elucidated and for which no manufacturing process has been established.” Craig Garner, SPARK Berlin

[Speaker Profile]He started his career with Toyo Brewery Co., Ltd. in 1986. When the company merged with Asahi Kasei Co., Ltd., he joined the synthetic laboratory at Asahi Kasei Co. Ltd. In 2006, he founded PRISM Bio Lab Co., Ltd. with 2 other members and led the company’s R&D activity. He also founded D.D.P. Co. Ltd (2010) and became the President & CEO before establishing SkySea Pharmaceutical Inc. in 2015.
SkySea Pharmaceutical Inc. website: http://www.skyseapharma.com/

Presentation #10Development of endometrial microbiome testing for reproductive healthYoko Nagai, Co-founder & CTO, Varinos Inc.

Varinos, a still-infant startup established in February 2017, is engaged in contract analysis using a next-generation sequencer. Our aim is to provide genomic medicine. As the first step, we provide genomic analysis to bring innovation in infertility treatment. Our customers are obstetricians and gynecologists and our aim is to save the end users, namely, patients receiving fertility treatment. In Japan, about 400,000 patients received IVF treatment last year. Although the treatment costs about ¥1.5 million, 70% of the patients failed to achieve pregnancy and 85.5% of them asked for improvement in pregnancy rates.

Last year, an astonishing study result was reported: pregnancy and fertility rates are higher in women with Lactobacillus-dominated microbiota than those with non-Lactobacillus-dominated microbiota. This report shows that Lactobacillus-dominated endometrial microbiota may be a crucial factor in protecting mother’s body and fertilized embryos from infection by other viruses. In response to the reported result, we will develop a new intrauterine flora inspection service related to the endometrial microbiome. We extract DNA from an endometrial sample taken from an infertility treatment patient, which is sent to us from a doctor, and amplify and sequence the extracted DNA to analyze the microbiome to send the report of the analysis back to the doctor.

We opened a laboratory in July this year in Shinagawa, where we started a pilot study involving four infertility treatment clinics and 60 patients. Because the endometrial environment can be easily changed with a supplement and an intrauterine douche, we will start clinical research on interventional medicine in January 2018.

[Mentors’ comments]

  • “Your efforts are focused on addressing important unmet needs and providing diagnostic solutions. I also commend the fact that you take the approach of cooperating with doctors to achieve change.” Craig Garner, SPARK Berlin
  • “While microbiome has drawn keen interest from researchers, there are two major issues: one is the technical issue that there are no global standards for sampling testing, and the other is associated with targeting strategies, because the issues that need to be addressed and the best way to raise funds will differ depending on whether or not your service is targeted at consumers and whether your business is directed toward medical practice, such as improving the effects of IVF.” Dong Wu, Johnson & Johnson INNOVATION

[Speaker Profile]In 2014, she joined Illumina KK as a sequencing specialist to consulting and encourage human genome research. In 2017, she founded Varinos Inc., a biotechnology company focused on clinical genomic test development and service, with Dr. Sakuraba, a clinical specialist of Illumina KK. Their aim is to provide genome medicine to everyone.
Varinos Inc. website: http://varinos.strikingly.com/

13:00 - 14:00

Break - 1 hour

10:30 - 10:45

Session4:SPARK Berlin: Enhancing Translation and Entrepreneurship in AcademiaCraig Garner, Founder, SPARK-Berlin

The concept of SPARK is simple: turning good ideas into great products. It is, however, very difficult to translate an idea into a product. We need to educate researchers about what starting up a business entails and what the industry seeks. SPARK is an educational system where mentoring is provided by volunteer experts in industry who are willing to make use of their expertise for the sake of society and younger people.

SPARK was founded by Prof. Daria Mochly-Rosen of Stanford University based on her experience. After her efforts to transfer technological results achieved at the university had been refused by many major pharmaceutical companies, she started up business on her own. She then left the university for a while to fully engage in the development and eventually sold her project to Amgen for more than $300 million. She then returned to Stanford, to find that many of the research projects at the university were not progressing very well. To address this fact, she founded SPARK.

The achievements of Stanford SPARK include the completion of 73 projects out of 110 programs during the last decade. 31 projects are now in the clinical trial phase. Inspired by these achievements, SPARK programs have been established throughout the world to share learning. SPARK-Berlin, one of such programs, was established three years ago.

Unlike at Stanford, the consciousness of researchers in the Berlin area is not directed to commercialization. There is no ecosystem, and insufficient educational and mentoring programs. In the last three years, SPARK-Berlin has made various efforts, including education, project management, advice by experts, and establishment of a global network. Our efforts to establish an ecosystem are still ongoing, but multiple projects have already been launched.

To replicate SPARK, you will need elements such as the development of champion projects, experienced program directors, volunteer mentors, collaboration with TLO, core facilities, and funds. The key to achieving effective development programs lies in collaboration with a wide range of people.

Craig Garner

[Speaker Profile]Prof. Craig Garner received his doctoral degree in Biochemistry at Purdue University and did his postdoctoral studies at the Friedrich Miescher Institute in Basel, CH and was a junior group leader at the Center for Molecular Neurobiology in Hamburg. His most recent faculty appointment was at Stanford University as Professor in the Department of Psychiatry and Behavioral Science, where he co-directed the Stanford Down syndrome Center. In 2014, he became a Scientist/co-Speaker of the DZNE-Berlin: German Center for Neurodegenerative diseases and Professor at the Charité –Universitätsmedizin Berlin. In 2015, he co-founded SPARK-Berlin to help educate academic scholars about translation and entrepreneurship. He has also founded three biotech companies, “Balance Therapeutics” and “Stealth Biosciences” and Navan Technologies. He maintains an active basic research program focused on the molecular and physiological mechanisms of synapse assembly and function in health and neurodegenerative diseases.
SPARK BERLIN website: http://www.spark-bih-berlin.org/

14:30 - 15:30

Session5Open Innovation Initiative at Global Healthcare Companies

Presentation #1Johnson & Johnson, Make the ConnectionDong Wu, Head, Johnson & Johnson Innovation Asia Pacific, Johnson & Johnson Innovation LLC

Johnson & Johnson started its business 130 years ago selling first aid kits, antiseptics, and dyspepsia tablets. The company has since grown into one of the leading healthcare companies in the world. We have made huge investments not only internally but also externally to fulfill our dream to become the most innovative healthcare company in the world.

Innovation needs partners. To build partnerships, we established Johnson & Johnson Innovation, under which about 170 members are playing an active role around the world. To be as close as possible to the local ecosystems, Johnson & Johnson Innovation’s activities center on innovation centers in four cities around the world: Boston, San Francisco, London and Shanghai. With the primary objective to be involved in actual deals, these innovation centers have assessed some 8,000 projects during the last four years and have made more than 400 investments.

JLABS, with an incubation function, and JJDC with an investment function mainly targeting pharmaceuticals, medical devices and consumer, have also been established, allowing us to become involved in innovation at an earlier stage than before. We are open to collaborating with anyone with a “disruptive technology” and alignment with Johnson & Johnson’s business objectives.

Concentration of resources is an important factor in innovation. In Boston, as introduced in Session 1, there is a cluster of hospitals in addition to some thousands of companies within a compact area of 2 km by 0.5 km. It is important to create this level of concentrated effort in building an ecosystem.

JLABS was established as part of Johnson & Johnson Innovation’s activities for the purpose of creating a physical incubation system within the ecosystem. JLABS is an integration of elements that are scattered in conventional ecosystems, such as capital investments required for starting up a healthcare company and specialists as well as investors and business partners. JLABS offices are located in eight sites in North America and are occupied by a total of 140 companies. 50 companies have so far graduated, and more than 30 collaborative projects have been generated.

JLABS provides opportunities for education and exchange in addition to facilities and equipment. When providing such opportunities, JLABS places emphasis on the idea of “no strings attached.” An important feature here is that, because Johnson & Johnson does not attract entrepreneurs with investment capital or other attractive offers, it is possible for them to cooperate with external investors and other pharmaceutical companies in providing educational programs and interchange opportunities.

Johnson & Johnson Innovation hopes to serve as a bridge to help startups accelerate innovations through its functions.

Dong Wu

[Speaker Profile]Dong is Head of Johnson & Johnson Innovation, Asia Pacific. He is responsible for Johnson & Johnson Innovation within the Asia Pacific region. He joined the Innovation team from Johnson & Johnson’s Consumer business where he was Vice President of R&D, responsible for the Global Engineering Organization and leading the transformation of the emerging markets R&D groups. In that role, he led the exploration of new product opportunities for Johnson & Johnson in global markets.
Prior to joining Johnson & Johnson, Dong worked at Unilever where he held various positions in Quality Assurance, Manufacturing and Research & Development. Dong became part of the team that founded the Unilever Regional Innovation Center in Shanghai, where he was acting head of the Development Laboratory. He then became Manufacturing General Manager and Site General Manager of the Hefei plant, Unilever’s largest manufacturing site worldwide. During his career at Unilever, he worked in China, the UK, the U.S. and Japan.
Dong has a Bachelor’s degree in Applied Chemistry from Fudan University and an MBA from China Europe International Business School.
Johnson & Johnson INNOVATION website: https://www.jnjinnovation.com/

Presentation #2"Entrepreneurship Venture Program" Takeda's new approach for R&D innovationSham Nikam, Vice President, Head of Innovation and Entrepreneurship, Takeda Pharmaceutical Company Ltd.
Hiroshi Nagabukuro, Senior Director, Head EVP Operation, Innovation and Entrepreneurship, Research, Takeda Pharmaceutical Company Ltd.

The pharmaceutical industry has become very dynamic. It is no longer enough for pharmaceutical companies to be engaged in research and development in a specific region alone; rather, they need to expand research efforts globally. Amid its ongoing efforts to become more innovative, Takeda Pharmaceutical Company has opened the Shonan Research Center to make it a place to foster world-level innovation.

We are considering building an ecosystem that promotes innovations and startups to make our pipeline more robust to ensure the sustainable supply of medicines that matter. It now costs ¥170 billion to develop a new medicine and, moreover, the success rate is low. This situation is abnormal. With the present limited investment capital, it is impossible to maintain the status quo. We need a new R&D model.

A new R&D model should be designed in a way that allows us to translate animal research to human tissue research, use advanced data analysis, and increase the success rate of clinical trials through cooperation between industry and academia. To do so, external innovations by startups play a vital role.

With focus on three therapeutic areas and vaccines, we have reorganized our R&D sites worldwide. We have spun out other therapeutic areas and have provided licenses to startups. Some projects have been growing successfully. What we have learned from these experiences is that development on a small scale is more likely to lead to success than that on a large scale.

The Entrepreneurship Venture Program (EVP) of Takeda Pharmaceutical Company takes a different approach from that used by SPARK to creating biotech startups. EVP supports Takeda’s researchers in their efforts to become successful entrepreneurs based on their own experience and technology. EVP receives candidate proposals from researchers, and offers seed funds for three years to selected proposals to enable the researchers to start up a business at Shonan Research Center. Those awarded with the seed funding will then improve their business plan with the help of experts and be engaged in development to move on to the next stage. After one year of preparation, we received 31 applications for EVP, out of which 9 projects, including SEEDSUPPLY, were launched under the program. Shonan Research Center is aiming to become the hub of the ecosystem through EVP activities.

Sham Nikam, Hiroshi Nagabukuro

[Speaker Profile]Sham NikamSham Nikam is the Vice-President, Head of Innovation and Entrepreneurship at Takeda Pharmaceuticals Company Ltd., based in Shonan/Fujisawa, Japan. He is responsible for identifying entrepreneurship opportunities for Takeda employees through creative use of Takeda assets, capabilities and infrastructure.
Prior to Takeda, he was the Head of Global Discovery at Nycomed in Germany. He also served as the CSO of Mumbai, India site with responsibilities that included for scientific strategy and interactions of Nycomed with Indian academia and pharma industry.
Sham’s significant pharma R&D experience also includes more than 20 years in increasing leadership roles at Parke-Davis/Pfizer in Ann Arbor, and another 8 years at Smith Kline and French Labs and Sandoz. He delivered several clinical candidates for different indications and managed a portfolio of more than 15 discovery projects. He also has over 35 patents, peer reviewed journal articles, reviews and more to his credit.
Hiroshi NagabukuroHiroshi Nagabukuro is currently a senior director of Innovation & Entrepreneurship, where he is heading Entrepreneurship Venture Program operation, which supports creating multiple spin-out startups. Hiroshi has a strong passion to create life science ecosystem in Japan/Asia. He also serves as a visiting fellow at Yokohama City University, School of Medicine.
He has strong background in pharmacology with >twenty years' experience in drug discovery for multiple therapeutic areas including 15 years at Takeda and 5 years at Merck Research laboratories. During his tenure at both Takeda and Merck, he brought a number of preclinical candidate compounds into first in human through proof of concept trials. He is an author of >20 peer reviewed journal articles and 8 patents.
Takeda Pharmaceutical Company Ltd. website: https://www.takeda.com/

15:30

Closing

15:40 - 18:00

14 Individual business matching meetings between Startups and Partners

10:00 - 15:30

Poster Exhibition of Speakers, Partners, and Organizers

21 Companies and Organizations exhibited their posters outside of the conference room. Participants and exhibitors had networking time during coffee and lunch break.

Comments from Participants

  • I was surprised to find so many Startups coming out from Universities. It is great that they have the ability to present their technology in front of global investors as well as domestic investors.
  • Very interesting and informative sessions!
  • Very informative event. My mind as researcher can get a different focus towards driving new research.
  • Session#3 Q&A from mentor is very productive and clarified strength/weakness of each presenter/opportunities.

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