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Tuesday, March 5
9:00am Welcome and Opening Remarks James Greenwood, Biotechnology Innovation Organization (BIO); Yoshiaki Tsukamoto, Japan Bioindustry Association (JBA) show more Description Remarks from the event organizers to set the themes for the conference. Time Tuesday, Mar 5 9:00AM - 9:15AM Location Grand Ballroom, West Speakers James Greenwood Biotechnology Innovation Organization (BIO) Yoshiaki Tsukamoto Japan Bioindustry Association (JBA)
9:15am How is the Drug Pricing Reform Initiative Affecting Patient Access, Investment, and Innovation in Japan? show more Description The Japanese government is pursuing a series of policy reforms that affect the pricing of medicines involving new cost-effectiveness frameworks and other reimbursement guidelines that poorly align with the value of biotechnology innovations, many of which are already treating patients successfully in other countries. This panel will explain the reform initiative and discuss the implications for future therapeutic development. Time Tuesday, Mar 5 9:15AM - 10:00AM Location Grand Ballroom, West
10:15am Chitose Biologics Shinya Kojima, Chitose Biologics show more Description Proud to be the world's best in efficient production, we develop for the world supercells used by bio pharmaceutics. Moreover we want to showcase the ability of supercells in any way possible and by creating a bio pharmaceutics production system we aim to speed up the development of bio pharmaceutics and significantly reduce the cost of production. Company Description/Mission Statement Time Tuesday, Mar 5 10:15AM - 10:30AM Location Drawing Room Speakers Shinya Kojima Chitose Biologics Reshaping Tumor Microenvironments via Immunotherapies show more Description Current CAR-T therapies have shown significant benefits attacking hematological malignancies, and currently approved checkpoint inhibitors are highly but selectively effective in their impact on solid tumors. This session will examine the next wave of innovation in immunotherapies for leveraging knowledge of how tumor microenvironments develop to create treatments able to demonstrate more durable effects on shrinking tumors across wider ranges of patients. Time Tuesday, Mar 5 10:15AM - 10:55AM Location Coriander
10:30am NB Health Laboratory Co. Ltd. Kiyoshi Takayama, NB Health Laboratory Co., Ltd show more Description NBHL has expertise in generating of functional mAbs targeting multispanning membrane protein such as GPCRs and established MoGRAA discovery engine. Using this technology, we are discovering promising lead mAbs targeting GPCRs for fibrosis, metabolic diseases, cancer, infection and ocular diseases which are attractive for pharmaceuticals. We would like to show the latest technology of MoGRAA discovery engine and the property of MoGRAA mAbs targeting GPCRs for chemokines, peptides and lipid mediators. We propose to run drug discovery programs using these leads mAbs. Company Description/Mission Statement Time Tuesday, Mar 5 10:30AM - 10:45AM Location Drawing Room Speakers Kiyoshi Takayama NB Health Laboratory Co., Ltd
10:45am Trianni, Inc. Linda Masat, Trianni, Inc show more Description Trianni, Inc. is a biotech company specializing in human antibody discovery platform technology. Our existing asset is a cutting-edge platform enabling efficient discovery of fully-human monoclonal antibodies. The Trianni Mouse offers biologic drug discoverers a best-in-class solution for the isolation therapeutic antibody candidates. Benefits over older conventional mouse immunization + humanization approaches include superior lead panels with respect to potency and diversity along with speed to the clinic and lower operating costs. Company Description/Mission Statement Time Tuesday, Mar 5 10:45AM - 11:00AM Location Drawing Room Speakers Linda Masat Trianni, Inc
11:00am Anima Biotech Inc. Yochi Slonim, Anima Biotech Inc. show more Description Anima Biotech is advancing Translation Control Therapeutics, the first platform for the discovery of small molecule drugs that specifically control mRNA translation as a new strategy against many diseases. With novel biology that monitors the translation of proteins and proprietary cloud-based software, we identify drug candidates that modulate a target protein’s production. We develop a pipeline across therapeutic areas and partner with Pharma for their targets including our $1B+ collaboration with Lilly for the discovery and development of translation inhibitors of several targets. Our approach was further validated with 5 granted patents, 14 peer reviewed publications and 17 scientific collaborations. Company Description/Mission Statement Time Tuesday, Mar 5 11:00AM - 11:15AM Location Drawing Room Speakers Yochi Slonim Anima Biotech Inc. Turning RNA Interference Research into Medicines Masako Nakamura, Alnylam Pharmaceuticals show more Description The approval of the first siRNA-based therapeutic this year has opened the door for companies to pursue expansion of this class of medicines. Deal activity, the progress of academics, and a favorable regulatory environment in Japan have contributed to interest in the field. This session will provide updates on current approaches and techniques for this pipeline of therapeutics. Time Tuesday, Mar 5 11:00AM - 11:55AM Location Coriander Speakers Masako Nakamura Alnylam Pharmaceuticals
11:15am BioXcel Therapeutics Vikas Sharma, Bioxcel Therapeutics show more Description BioXcel Therapeutics, Inc. is a publicly traded clinical stage biotech company leveraging the power of Artificial Intelligence to advance the next wave of medicines, initially targeting oncology indications and CNS diseases. The company’s lead therapeutic candidates are BXCL501, a proprietary sublingual formulation of an anesthetic for the treatment of acute agitation, with the potential to expand into other neuropsychiatric and neurodegenerative disorders, and, BXCL701, a DPP8-9/FAP inhibitor with broad potential application in oncology indications, both as a monotherapy and in combination with immuno-oncology agents, and The company’s strategy is to apply a drug re-innovation approach to develop therapeutic candidates with a high probability of clinical and regulatory success more quickly and at a lower cost than traditional research and development approaches. Please visit www.bioxceltherapeutics.com for more information. Company Description/Mission Statement Time Tuesday, Mar 5 11:15AM - 11:30AM Location Drawing Room Speakers Vikas Sharma Bioxcel Therapeutics
11:30am TAGCyx Biotechnologies Inc. Aki Mochizuki, TAGCyx Biotechnologies Inc. show more Description TAGCyx provides unique DNA aptamer with proprietary artificial nucleic acid base. Aptamer is an alternative but better option to antibody. Our innovative technology platform, named Xenoligo®, utilises 'unnatural' nucleic acid base pairs (Ds and Px) on top of natural nucleotide. Our base pair can be amplified with PCR, thus generation of aptamer using the process called SELEX is easier and faster than conventional aptamer technologies. Incorporating just Ds molecule which is hydrophobic, our DNA aptamer shows high steric diversity and binds to protein target hydrophobically. Therefore, our DNA aptamers can achieve high affinity with the Kd as high as pico molar order, and high specificity to various therapeutic targets. We seek collaboration opportunity with pharmaceutical companies and biotech ventures to generate new Xenoligo®, for their targets of interest as API or delivery tools. Company Description/Mission Statement Time Tuesday, Mar 5 11:30AM - 11:45AM Location Drawing Room Speakers Aki Mochizuki TAGCyx Biotechnologies Inc.
12:45pm Keynote Chat: Tatsuya Kondo, MD, PhD, Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Tatsuya Kondo, Pharmaceuticals and Medical Devices Agency (PMDA), Japan show more Description Keynote Chat: Tatsuya Kondo, MD, PhD, Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Time Tuesday, Mar 5 12:45PM - 1:25PM Speakers Tatsuya Kondo Pharmaceuticals and Medical Devices Agency (PMDA), Japan
1:45pm VORONOI Inc. Jaeyoung Ahn, VORONOI Inc. show more Description VORONOI primarily develops small molecule inhibitors of kinases using kinase profiling and molecular modeling. Major TAs are oncology, CNS, and auto-immune diseases. VORONOI's business focuses on discovery, pre-clinical, and early stage clinical trials, and therefore, partnering with pharmas capable for late stage clinical trials and marketing/sales is key to success for our lead compounds showing promising efficacy data. We not only develop compounds on our own, but also license in promising compounds from global research institutes and universities including Dana Farber Cancer Institute (DFCI). We are targeting to begin 3-4 clinical trials in 2019, and one is soon to be started (IND filing submited). We have 8-9 compounds under pre-clinical development and plan to add more compounds to our pipeline in 2019 Company Description/Mission Statement Time Tuesday, Mar 5 1:45PM - 2:00PM Location Drawing Room Speakers Jaeyoung Ahn VORONOI Inc.
2:00pm Bridging External Innovation and Internal R&D for New Patient Therapies Jinzi Wu, PhD, Ascletis Pharma Inc.; Niels Emmerich, PhD, AbbVie show more Description Strategic application of licensing agreements accelerates the path of an idea for a new medicine to get from the research laboratory to the patient needing treatment. This panel will discuss trends in licensing with a focus on cross-border applications. Time Tuesday, Mar 5 2:00PM - 2:55PM Location Coriander Speakers Jinzi Wu, PhD Ascletis Pharma Inc. Niels Emmerich, PhD AbbVie CanBas Co., Ltd. Takumi Kawabe, CanBas Co., Ltd. show more Description CanBas is aiming to find a cure for cancer patients. Its lead oncology drug candidate is a unique calmodulin modulator CBP501 that increases platinum influx specifically into tumor cells. It showed promising sings of activities in platinum refractory/resistant ovarian cancer and malignant pleural mesothelioma populations in combination with platinum. CanBas identified additional unique MoA of CBP501 that are 1) induction of tumor immunogenic cell death, 2) suppression of M2 macrophages, 3) reduction of cancer stem cell population, and 4) suppression of migration, invasion and epithelial-to-mesenchymal transition of tumor cells. Given positive preclinical data, CanBas is running a Phase Ib study in the USA with CBP501+Cisplatin+Nivolumab triple drug combination. Expansion cohort on pancreatic and MSS colon cancer had started based on promising dose finding cohort results including a partial response in a heavily pretreated pancreatic cancer patient with other multiple long SDs. Company Description/Mission Statement Time Tuesday, Mar 5 2:00PM - 2:15PM Location Drawing Room Speakers Takumi Kawabe CanBas Co., Ltd.
2:15pm Omicsway Anton Buzdin, Omicsway show more Description Omicsway is specialized on advanced bioinformatics of gene expression data. Our major area is finding molecular markers of tumor response to target therapy. We use original algorithms for quantitative measuring molecular pathway activation based on high throughput gene expression data. We built a proprietary database of >3.000 human molecular pathways with ~10.000 genes involved, and uniformly annotated function of each gene product in every pathway. Pathway activation strength is calculated and used as predictor of tumor response to target drugs. We generated second-opinion system for clinical oncologists and tested it in clinical investigation for a prospective cohort of recurrent/metastatic tumor patients. ~46% of off-label prescriptions were made based on this second opinion system, showing short-term observed objective response in ~60% of the cases. We seek for partnerships to promote our second opinion system Oncobox in the specific fields of colorectal, kidney and brain tumors. Company Description/Mission Statement Time Tuesday, Mar 5 2:15PM - 2:30PM Location Drawing Room Speakers Anton Buzdin Omicsway
2:30pm AUM Biosciences Vishal Doshi, AUM Biosciences show more Description Founded by 2 ex-Quintiles (Now IQVIA) and industry veterans, AUM Biosciences is an oncology-focused biotechnology company headquartered in Singapore that develops innovative and affordable medicines for patients in Asia and globally. The founders and the management team have over 75 years of combined oncology drug development experience, and track record of developing and executing various virtual drug development models in the Industry. AUM’s pipeline includes a novel, small molecule targeted therapy which has the potential to address high unmet medical needs in various solid and liquid tumours. Additionally, it has an undisclosed pipeline of additional pre-clinical and phase I ready programs. Pipeline focus is on small molecules targeted therapies with a mandate of clear biomarker driven strategies for every asset in the pipeline. AUM harnesses the power of precision medicine and digital technologies to accelerate the drug development timelines to unlock the value of innovation. Company Description/Mission Statement Time Tuesday, Mar 5 2:30PM - 2:45PM Location Drawing Room Speakers Vishal Doshi AUM Biosciences
2:45pm Hangzhou Sinorda Pharmaceutical Co., Ltd PINGSHENG HU, Hangzhou Sinorda Pharmaceutical Co., Ltd show more Description Sinorda is a biotech company focusing on the innovative drug development in China with wide cooperation with industries, academic researches, CMOs and CROs and authorities. Sinorda has projects portfolio in clinical phases and experienced management team integrated from China, US and EU regions that can secure project development in low cost, low risk and fast launch on market. Sinorda aims to be an innovative, strong and fast growing pharmaceutical company in China with fast IPO in financial market. Company Description/Mission Statement Time Tuesday, Mar 5 2:45PM - 3:00PM Location Drawing Room Speakers PINGSHENG HU Hangzhou Sinorda Pharmaceutical Co., Ltd
3:00pm ACT Genomics Angus Wu, ACT Genomics show more Description ACT Genomics is a leading Asia cancer molecular information company. We partner with biopharma to facilitate translational research, biomarker exploration, CDX development, and commercialization. Headquartered in Taipei, Taiwan, we have regional offices in Shanghai, Tokyo, Hong Kong, and Singapore to cover the major markets in Asia. With proprietary NGS-based assays, chip-based multiplex qPCR platform and strong bio-informatics team, we offer solutions for biomarker discovery, patient stratification, and comprehensive cancer molecular analysis focusing to biopharmaceutical partners who are developing targeted therapies, immune checkpoint inhibitors, and cancer vaccines. Also, we are the only Asia-based company participating FOCR-led TMB harmonization program where we have demonstrated superior accuracy data resulted from unique assay development and computational algorithm. We look forward to meeting you and to discussing how to facilitate your drug development programs. Company Description/Mission Statement Time Tuesday, Mar 5 3:00PM - 3:15PM Location Drawing Room Speakers Angus Wu ACT Genomics Explaining CFIUS and New Investment Regulations in the United States Jun Bao, Impact Therapeutics; Wenseng "Wendy" Pan, JD, PhD, Sidley Austin LLP show more Description New national security regulations in the United States are changing the landscape for cross-border investments in biotechnology. In November 2018, new rules for a “pilot program” apply to foreign investors into U.S. companies who now need to file with the Committee on Foreign Investment in the United States (CFIUS) to approve covered transactions before entering licensing deals or other equity investments. This session will update market participants on the evolving national security review process and its impact on the biotechnology industry, as well as consider how additional rules may impact future business development and investment opportunities. Time Tuesday, Mar 5 3:00PM - 3:55PM Location Coriander Speakers Jun Bao Impact Therapeutics Wenseng "Wendy" Pan, JD, PhD Sidley Austin LLP
3:15pm Cidara Therapeutics Neil Abdollahian, Cidara Therapeutics show more Description Cidara is a clinical-stage biotechnology company focused on developing new anti-infectives that have the potential to transform the standard of care and save or improve patients’ lives. The company is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial in the treatment of candidemia and invasive candidiasis and plans to initiate a second Phase 3 trial in the prophylaxis of invasive fungal infections. Rezafungin has improved pharmacokinetics compared to existing echinocandins and the potential for expanded utility across patient settings. It is the only once-weekly product candidate in development for the treatment and prevention of life-threatening invasive fungal infections. Cidara also is leveraging its novel Cloudbreak™ platform to develop antibody-drug conjugates for the treatment of serious viral and Gram-negative bacterial infections. Company Description/Mission Statement Time Tuesday, Mar 5 3:15PM - 3:30PM Location Drawing Room Speakers Neil Abdollahian Cidara Therapeutics
3:30pm Oncocross Yirang Kim, Oncocross show more Description Oncocross is a biotech venture based in Seoul, South Korea. The company has developed a AI drug discovery platform (ReDRUG Algorithm). The platform is designed to find new indications for novel, commercial , and previously failed drugs. Using gene expression pattern analysis with a targeted drug the AI platform goes through multiple big data microarray, SNP, and patient data analysis to find potential disease candidates. Currently, Oncocross is working with local pharmaceuticals with clinical phase II pipelines to discover other potential indications for their novel therapeutics. Company Description/Mission Statement Time Tuesday, Mar 5 3:30PM - 3:45PM Location Drawing Room Speakers Yirang Kim Oncocross
3:45pm Precision NanoSystems Inc. James Taylor, Precision NanoSystems Inc. show more Description Precision NanoSystems (PNI) is a global leader in innovative solutions for the discovery, development, and manufacture of novel nanoparticle medicines. PNI's proprietary microfluidics technology, the NanoAssemblr platform is the de-facto platform used by over 85 pharma/biotech and 80 academic customers. The technology provides a turnkey solution to making nanoparticle based therapeutics under conditions are uniform, controlled and reproducible leading to faster development times, easier to scale up and leading to higher production yields. PNI is looking to license the NanoAssemblr platform for clinical manufacturing of nanomedicines. Based on novel nanoparticle chemistry, PNI has also developed a proprietary non-viral delivery platform for in-vitro/ex-vivo transfection into primary cells such as iPSCs, T cells and other immune cells. PNI is partnering with companies in the gene and cell therapy areas to enable use of their delivery platform in varied therapeutic applications. Company Description/Mission Statement Time Tuesday, Mar 5 3:45PM - 4:00PM Location Drawing Room Speakers James Taylor Precision NanoSystems Inc.
4:00pm Access as a Policy Choice: Measuring Openness to Innovation & Creativity Patrick Kilbride, U.S. Chamber of Commerce show more Description Market access is a precondition to patient access. New research from the Global Innovation Policy Center of the U.S. Chamber of Commerce points to market access barriers worldwide limiting the availability of a wide range of innovative and creative technologies, from movies to software to biotechnology. Time Tuesday, Mar 5 4:00PM - 4:25PM Location Coriander Speakers Patrick Kilbride U.S. Chamber of Commerce Susmed, Inc. Shintaro Morizane, Susmed, Inc. show more Description From the experience of developing insomnia treatment application, we develop a data management system conforming to Japanese regulation. Company Description/Mission Statement Time Tuesday, Mar 5 4:00PM - 4:15PM Location Drawing Room Speakers Shintaro Morizane Susmed, Inc.
4:15pm Daré Bioscience Sabrina Johnson, Daré Bioscience, Inc. show more Description Daré Bioscience is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women’s sexual health, vaginal health, fertility, and contraception. The company’s mission is to identify, develop and bring to market a portfolio of novel, differentiated therapies that expand treatment options, improve outcomes and facilitate convenience for women in the areas of contraception, vaginal health, sexual health, and fertility. Daré’s product portfolio includes potential first-in-class candidates in clinical development: Ovaprene®, a non-hormonal, monthly contraceptive vaginal ring; and Sildenafil Cream, 3.6%, a potential treatment for female sexual arousal disorder utilizing the active ingredient in Viagra®, as well as a proprietary solution-to-gel formulation of clindamycin to treat bacterial vaginosis via a single application, DARE-BV1. Company Description/Mission Statement Time Tuesday, Mar 5 4:15PM - 4:30PM Location Drawing Room Speakers Sabrina Johnson Daré Bioscience, Inc.
4:30pm Market Outlook—Finding Opportunities During Global Trade Downturns Patrick Kilbride, U.S. Chamber of Commerce; Hayato Watanabe, Locust Walk show more Description Despite a near record year for biopharma IPOs and acceleration in the pace of new drug approvals around the world, most stock indices are dealing with higher volatility and a disappointing performance across 2018 versus prior years. Uncertainty about international trade and tariff disputes are suggesting a slowdown of future macroeconomic growth. However, trade agreement negotiations continue among different partners and individual biopharma deals still seem to generate positive market reactions. This session will explore what are the controllable factors within the biopharma sector to inspire investor support and what likely macroeconomic developments should be considered when planning for 2019 and beyond. Time Tuesday, Mar 5 4:30PM - 5:25PM Location Coriander Speakers Patrick Kilbride U.S. Chamber of Commerce Hayato Watanabe Locust Walk Shaperon Jeong Tae Kim, Shaperon show more Description Shaperon is a biotech company navigating in the universe of immunology and inflammation. Its flagship small molecule, HY209, is a TGR5 receptor agonist (first of its kind to treat inflammatory diseases) with pharmacological mode of action best suited for complex inflammatory conditions. Our R&D pipeline includes the treatment for atopic dermatitis (phase I completed), sepsis (phase I IND submission), ulcerative colitis/alzheimer's disease (pre-clinical). By blocking NF-kB signaling, HY209 inhibits TSLP gene expression. What makes HY209 unique is its dual MoA. In addition to blocking NF-kB signaling, HY209 increases the number of regulatory T cells s, thus restoring Th1/Th2 balance. In DNCB animal model, HY209-treated group demonstrated excellent outcome in lowering pro-inflammatory proteins such as lgE, IL-4, IL-13, IL-33, and TSLP, normalizing epidermal/dermal thickness, and lowering number of infiltrating cells, thus resulting in better efficacy than existing treatment options. Company Description/Mission Statement Time Tuesday, Mar 5 4:30PM - 4:45PM Location Drawing Room Speakers Jeong Tae Kim Shaperon
4:45pm Gene Therapy Center Austria (GTCA) | Takeda Larissa Kahr, Takeda show more Description Cost-effective solutions for cGMP manufacturing of high quality AAV based Gene Therapy Products More than 400 gene therapy products are currently in clinical development. The adeno-associated virus (AAV) is increasingly used for gene delivery. Manufacturing of gene therapy products is characterized by high process complexity and low yield. Over the last years various teams have been successfully working on process improvements. Today industry efforts are no longer focusing on technical issues but on reproducibility, compliance and cost of goods. The Gene Therapy Center Austria developed a scalable and robust AAV platform process applicable for different (all) AAVs and capable of delivering high quality AAV gene therapy products at low cost of goods. The Gene Therapy Center Austria progresses gene therapy products seamlessly to commercial manufacturing performing all steps from inoculum to filling at one site. Company Description/Mission Statement Time Tuesday, Mar 5 4:45PM - 5:00PM Location Drawing Room Speakers Larissa Kahr Takeda
5:00pm EditForce Inc. Yuki Tanabe, EditForce Inc. show more Description EditForce Inc. is a technology start-up company established in 2015 in Fukuoka, Japan. We are specialized in designing and producing sequence-specific binding proteins to RNA or DNA based on PPR (Pentatricopeptide repeat) motif. Our technology is novel and will be a powerful alternative to existing technologies for gene editing (CRISPR/Cas9, TALEN, ZFN) and RNA silencing (siRNA, anti-sense, etc.). We aspire to partner with pharma and biotech who are keen to develop new therapies for human diseases through PPR technology. Company Description/Mission Statement Time Tuesday, Mar 5 5:00PM - 5:15PM Location Drawing Room Speakers Yuki Tanabe EditForce Inc.
5:15pm Merck Life Science/BioReliance End-to-End Solutions Steven Lin, Merck Life Science/BioReliance End-to-End Solutions show more Description Merck is a leading science and technology company in healthcare, life science and performance materials. BioReliance® End-to-End Solutions (Within Merck Life Science) encompass service and support for both emerging biotech and major biopharmaceutical companies that seek to accelerate process development, clinical drug production, and conceptual facilities design. As a trusted partner, we facilitate success by enabling our clients at any step from early-stage Process Development through commercial Facilities Design - anywhere in the world - having flexible solutions that optimize performance and providing guidance based upon first-hand experience. We operate our own in-house bioproduction facilities and convey our expertise to clients as they progress on their drug development journey, with an emphasis on Single-Use technologies and high-performance upstream and downstream systems. Company Description/Mission Statement Time Tuesday, Mar 5 5:15PM - 5:30PM Location Drawing Room Speakers Steven Lin Merck Life Science/BioReliance End-to-End Solutions
5:30pm Juvabis AG Sven Hobbie, Juvabis AG show more Description Juvabis is an IND-stage company that designs and develops a next generation of aminoglycoside antibiotics to overcome antimicrobial resistance and improve the safety of this drug class. Structural uniqueness of its proprietary leads warrants potent bactericidal activity against clinical pathogens that are resistant to all other aminoglycosides currently in clinical use, including 16S rRNA methyltransferase resistance often encountered in priority pathogens. Another key differentiator of the Juvabis portfolio is an improved safety profile when compared to other aminoglycoside antibiotics, by virtue of a proprietary screening platform and rational lead optimization towards increased target selectivity. Juvabis strives to develop the best-in-class aminoglycoside antibiotics for highly developed healthcare systems, as well as providing innovative solutions for resource-limited settings in low- and middle-income countries. Company Description/Mission Statement Time Tuesday, Mar 5 5:30PM - 5:45PM Location Drawing Room Speakers Sven Hobbie Juvabis AG
5:45pm AlivaMab Discovery Services & Ablexis Larry Green, AlivaMab Discovery Services and Ablexis show more Description The AlivaMab Mouse, developed by Ablexis, is a best-in-class transgenic platform that is currently licensed to eight of the top 15 pharma, such as Novartis, Pfizer, Janssen and Boehringer Ingelheim, as well as other biopharma companies. The design of the AlivaMab Mouse supports successful antibody drug discovery and development through robust immune responses that are diverse in sequence and epitope recognition, yielding antibodies with high affinity, potency, specificity and developability. The AlivaMab Mouse is available for licensing on a non-exclusive basis through Ablexis, but for those companies interested in out-sourcing, access to the AlivaMab Mouse platform is also available through AlivaMab Discovery Services (ADS). Through our extensive experience and capabilities, in combination with the AlivaMab Mouse, our team of experts provide pharma and biotech companies the foundation for a streamlined and de-risked path from discovery to development through to commercialization. Company Description/Mission Statement Time Tuesday, Mar 5 5:45PM - 6:00PM Location Drawing Room Speakers Larry Green AlivaMab Discovery Services and Ablexis
Wednesday, March 6
8:30am AIMM Therapeutics BV John Womelsdorf, AIMM Therapeutics BV show more Description AIMM is a preclinical stage company in the process of advancing 2 antibodies into the clinic. Company Description/Mission Statement Time Wednesday, Mar 6 8:30AM - 8:45AM Location Drawing Room Speakers John Womelsdorf AIMM Therapeutics BV
8:45am Kleo Pharmaceuticals Doug Manion, Kleo Pharmaceuticals show more Description Kleo Pharmaceuticals is a unique immuno-oncology company developing next-generation bispecific compounds designed to emulate or enhance the activity of biologics. Similar to complex biologic drugs, Kleo’s compounds recruit the immune system to destroy cancer cells, but unlike biologics, Kleo’s compounds are smaller and more versatile, leading to potentially improved safety and efficacy. They are also much faster and less costly to design and produce, particularly against novel targets. The company is advancing several drug candidates based on its proprietary technology platforms, all of which are modular in design and enable rapid generation of novel immunotherapies that can be optimized against certain cancers, or enhance the properties of existing immunotherapies. These include Antibody Recruiting Molecules (ARMs), Synthetic Antibody Mimics (SyAMs) and Monoclonal Antibody Therapy Enhancers (MATEs). For more information visit http://kleopharmaceuticals.com. Company Description/Mission Statement Time Wednesday, Mar 6 8:45AM - 9:00AM Location Drawing Room Speakers Doug Manion Kleo Pharmaceuticals
9:00am Deploying Artificial Intelligence (AI) to Improve R&D Productivity Jimmy Yen-Chu Lin, Insilico Taiwan; Kazumi Hakamada, LPixel show more Description Using Artificial Intelligence in biopharmaceutical R&D has the potential to lower costs, target patient populations more effectively, improve efficiency, and ultimately bring new medicines to market more quickly. Companies attending this session can learn more about the technology and human capital required to incorporate AI into their business operations. Speakers will provide information on data challenges, privacy concerns, and the regulatory environment. Time Wednesday, Mar 6 9:00AM - 9:55AM Location Coriander Speakers Jimmy Yen-Chu Lin Insilico Taiwan Kazumi Hakamada LPixel iHeart Japan Corporation Kenji Kakuta, iHeart Japan Corporation show more Description Developing an allogeneic regenerative medicinal product for severe heart failure, which is made from iPS cell. Company Description/Mission Statement Time Wednesday, Mar 6 9:00AM - 9:15AM Location Drawing Room Speakers Kenji Kakuta iHeart Japan Corporation
9:15am BioInvent International AB Martin Welschof, BioInvent International show more Description BioInvent International AB (OMXS: BINV), is focused on the discovery and development of novel and first-in-class and best-in-class immuno-modulatory antibodies to treat cancer. The Company’s lead program BI-1206 is currently in Phase l/lla for non-Hodgkin lymphoma and chronic lymphatic leukemia. BioInvent’s pre-clinical portfolio is focused on targeting key immune suppressive cells of the tumor microenvironment relevant to solid and hematologic cancers, including regulatory T cells, tumor-associated myeloid cells and mechanisms of antibody drug-resistance. The Company has a strategic research collaboration with Pfizer Inc., and partnerships with Transgene, Bayer Pharma, Daiichi Sankyo, and Mitsubishi Tanabe Pharma. BioInvent generates near term revenues from its fully integrated manufacturing unit producing antibodies for third parties for research through to late-stage clinical trials. Company Description/Mission Statement Time Wednesday, Mar 6 9:15AM - 9:30AM Location Drawing Room Speakers Martin Welschof BioInvent International
9:30am AIVITA Biomedical Hans Keirstead, AIVITA Biomedical show more Description AIVITA Biomedical is a clinical stage biotech developing next generation immunotherapies. We leverage our expertise with stem cells to develop therapies to treat solid tumor cancers. Our platform technology isolates and propagates tumor-initiating cells (or cancer stem cells), responsible for metastases of cancers, to target the full patient-specific antigenic profile of that patient's tumor. When presented by the patient's dendritic cells, these antigens are recognized by the immune system and targeted for termination. Exposing the full antigenic load of the tumor means the immune system may be able to identify mutated or dormant tumor-initiating cells, improving the patient's ability to fight the disease. In addition to two phase 2 studies in the US, we have a pivotal trial in Japan in metastatic melanoma starting Q1 2019. Our platform technology is autologous cell therapy. We have robust data in efficacy and mechanism of action and a low-cost, efficient manufacturing process. Company Description/Mission Statement Time Wednesday, Mar 6 9:30AM - 9:45AM Location Drawing Room Speakers Hans Keirstead AIVITA Biomedical
9:45am Cellerant Therapeutics, Inc. Ram Mandalam, Cellerant Therapeutics, Inc. show more Description Cellerant Therapeutics is a clinical-stage biotech company focused on AML and other blood-related disorders. Our lead product, romyelocel-L, is a Phase 3-ready universal cell therapy intended to prevent infection in patients with prolonged neutropenia. In a randomized controlled Phase 2 trial in AML patients, romyelocel-L decreased the incidence of infections, days in hospital and use of antimicrobial drugs compared to G-CSF. The FDA has granted romyelocel-L Regenerative Medicine Advanced Therapy (RMAT) designation and we plan to initiate a pivotal Phase 3 trial in 2019. We are also developing CLT030, an antibody-drug conjugate to treat AML. CLT030 targets CLL1, a target highly expressed on leukemic stem cells, but not on normal hematopoietic stem cells. We believe this expression profile gives CLL1 a potential safety advantage over other common AML targets such as CD33 and CD123. Company Description/Mission Statement Time Wednesday, Mar 6 9:45AM - 10:00AM Location Drawing Room Speakers Ram Mandalam Cellerant Therapeutics, Inc.
10:00am Biotech Incubator Business Models: Lessons and Needed Improvements Eugene Jiang, American BriVision Holding Corporation; Ryo Kubota, MD, PhD, Kubota Pharmaceutical Holdings Co., Ltd.; Robert Keller, JD, MD, MPH, University of Tokyo & Ikegami Incubator; Yujiro Maeda, DDS, PhD, The University of Tokyo; Japan Biodesign; Aillis Inc.; Ken Fujimura, Open Innovation Center Japan, Bayer Yakuhin; Toru James Seo, Pfizer Inc show more Description Corporate biopharmas have decades of experience with university collaborations and open incubator models that produce research and pre-clinical data, but disappointingly few new medicines. What features of incubators create value and where should incubator business model innovation go next? Time Wednesday, Mar 6 10:00AM - 10:55AM Location Coriander Speakers Eugene Jiang American BriVision Holding Corporation Ryo Kubota, MD, PhD Kubota Pharmaceutical Holdings Co., Ltd. Robert Keller, JD, MD, MPH University of Tokyo & Ikegami Incubator Yujiro Maeda, DDS, PhD The University of Tokyo; Japan Biodesign; Aillis Inc. Ken Fujimura Open Innovation Center Japan, Bayer Yakuhin Toru James Seo Pfizer Inc Delta-Fly Pharma, Inc. Kiyoshi Eshima, Delta-Fly Pharma, Inc. show more Description Delta-Fly has been focusing on oncology drug discovery and clinical development from hematologic cancer to solid tumors. We apply a unique technology called “Module Technology” for oncology drug discovery. The company was founded in 2010, and became a public company on October 12. We already have been developing 6 products and 4 of them, DFP-10917, 14323, 11207 and 14927, have been working on clinical studies in USA (MD Anderson Cancer Center in Texas) and Japan. DFP-10917 is on-going Phase III, DFP-11207 is on-going Phase II, DFP-11207 is preparation for Phase II and DFP-14927 is preparation for Phase I. Company Description/Mission Statement Time Wednesday, Mar 6 10:00AM - 10:15AM Location Drawing Room Speakers Kiyoshi Eshima Delta-Fly Pharma, Inc.
10:15am InveniAI Mansi Joshi, InveniAI show more Description InveniAI has pioneered the application of artificial intelligence (AI) and machine learning (ML) to transform innovation across biopharma and adjacencies. Our sister company, BioXcel Therapeutics, is the first AI powered drug company listed on NASDAQ (March, 2018). Our platform – AlphaMeldTM, monitors millions of data points in real time with industry-aware scoring algorithms that are customized by incorporating continuous feedback through machine learning. AlphaMeld Platform Capabilities Include: First Mover Advantage to Access Emerging Innovation - Fully automated AI/ML based signal detection platform. • Access, monitor, predict breakthrough events – targets, drugs, technologies, and therapeutic areas with break-out diseases Drug Discovery Analytics - Machine based clinical hypothesis generation for decoding hidden connections between targets and MoAs with diseases. • Generate clinical hypotheses, Optimize therapeutic value of drugs, modalities and platforms Company Description/Mission Statement Time Wednesday, Mar 6 10:15AM - 10:30AM Location Drawing Room Speakers Mansi Joshi InveniAI
10:30am HanaVax Pohsing Ng, HanaVax show more Description HanaVax is developing vaccines administered by small painless sprays into the nose. Our formulations retain the antigens on respiratory mucosal surfaces long time and initiate antigen-specific immune responses via the mucosal immune system. This results in more effective uptake, processing and presentation of the antigens by immune cells (e.g., nasal dendritic cells), which in turn results in strong antigen-specific T cell and B cell immune responses at both mucosal surfaces and in the systemic circulation for the protective immunity. This vaccination method has been shown to induce protective immunity against pneumococcal pneumonia in nonhuman primates. Develop nasal vaccine against infectious diseases is our company business focus. Pneumococcal vaccine is our lead product. Our pipelines include HPV therapeutic vaccine, HSV vaccine, Non-typeable Haemophilus influenzae (NTHi) vaccine, RSV vaccine and TB vaccine. Company Description/Mission Statement Time Wednesday, Mar 6 10:30AM - 10:45AM Location Drawing Room Speakers Pohsing Ng HanaVax
10:45am M Bio Technology Inc. Kazuhiro Matsuda, M Bio Technology Inc. show more Description M Bio Thechnology is a world leading company focused on the discovery and development of innovative therapeutic strategy for Mycoplasma Infectous Diseases (MID). M Bio Technology develops innovative vaccine, diagnostics, precision therapy for MID. Company Description/Mission Statement Time Wednesday, Mar 6 10:45AM - 11:00AM Location Drawing Room Speakers Kazuhiro Matsuda M Bio Technology Inc.
11:00am Cerecin Charles Stacey, Cerecin show more Description Cerecin is a global healthcare company with almost 20 years of innovation and leadership in brain health. We develop novel, evidence-based solutions across pharmaceuticals, medical foods, diagnostics, medical devices and e-health products. These solutions target conditions ranging from memory impairment to some of the most devastating neurological diseases. Headquartered in Singapore and Colorado, USA, we develop therapies for people around the world. Company Description/Mission Statement Time Wednesday, Mar 6 11:00AM - 11:15AM Location Drawing Room Speakers Charles Stacey Cerecin Using M&A for Data Advantages Beyond Product Pipelines Sridhar Gopal Mandapati, AbbVie; Neil Abdollahian, Cidara Therapeutics show more Description The “datafication” of health care means traditional life sciences companies must examine how they position themselves for the future. “Datafication” is particularly important for generating the knowledge to enable precision medicine for patients and the clear economic evidence for reimbursement discussions. EY research suggests that among the topics that should be at the top of the C-suite agenda are which kinds of deals – and which partners – position life sciences companies for maximum growth in 2019 and the future. Time Wednesday, Mar 6 11:00AM - 11:55AM Location Coriander Speakers Sridhar Gopal Mandapati AbbVie Neil Abdollahian Cidara Therapeutics
11:30am Biomere Tech Cora Lo, Biomere Tech show more Description Biomere Tech will advance the treatment of osteoarthritis (OA) with its innovative therapy- silk protein based knee patch with microsurgery insertion. OA currently impacts 27 million US adults. The disease occurs when cartilage breaks down in the joint space causing pain, inflammation and immobility. Biomere Tech’s technology is silk- a novel biomaterial known for its strength, lubrication, and drug-delivery capabilities which can be applied directly into the joint to provide long lasting pain relief and increased local bone density, and further prevent the progression of disease. Silk technology is an extension work of previous DARPA project when Tim was the leader of a DARPA projects back in 2005. Tim is the pioneer with years of experience and various patents in silk technology. Founded by Tim Lo and his team, has diverse expertise necessary to commercialize this product. Company Description/Mission Statement Time Wednesday, Mar 6 11:30AM - 11:45AM Location Drawing Room Speakers Cora Lo Biomere Tech
11:45am Synthetic Biologics, Inc. Steven Shallcross, Synthetic Biologics, Inc. show more Description Synthetic Biologics, Inc. (NYSE American: SYN) is a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients. The Company's lead late-stage candidates are: (1) SYN-004 (ribaxamase) which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) beta-lactam antibiotics to prevent microbiome damage, C. difficile infection (CDI), overgrowth of pathogenic organisms and the emergence of antimicrobial resistance (AMR), and (2) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C). The Company’s preclinical pursuits include an oral formulation of the enzyme intestinal alkaline phosphatase (IAP) to treat both local GI and systemic diseases as well as monoclonal antibody therapies for the prevention and treatment of pertussis. Company Description/Mission Statement Time Wednesday, Mar 6 11:45AM - 12:00PM Location Drawing Room Speakers Steven Shallcross Synthetic Biologics, Inc.
12:35pm Keynote Chat: BT Slingsby, MD, PhD, MPH, CEO & Executive Director, Global Health Innovative Technology (GHIT) Fund BT Slingsby, Global Health Innovative Technology (GHIT) Fund; Hayato Watanabe, Locust Walk show more Description Keynote Chat: BT Slingsby, MD, PhD, MPH, CEO & Executive Director, Global Health Innovative Technology (GHIT) Fund Time Wednesday, Mar 6 12:35PM - 1:25PM Location Grand Ballroom, West Speakers BT Slingsby Global Health Innovative Technology (GHIT) Fund Hayato Watanabe Locust Walk
1:45pm Boston Pharmaceuticals Ed Zhang, Boston Pharmaceuticals show more Description Boston Pharma is a translational drug development company. It was founded in 2016 by Chris Viehbacher, ex-CEO of Sanofi and Rob Armstrong, ex-R&D Executive from Eli Lilly. With $600M committed capital from Gurnet Point Capital, Boston Pharma’s business model is focused on partnering and developing therapeutics from late pre-clinical to clinical POC. In the past 3 years, we have built an experienced clinical development team and acquired a diverse portfolio of fifteen programs in oncology, autoimmune, cardiovascular, dermatology, anti-infective, gastrointestinal, and metabolic, including recent deals with GSK, Novartis, and other Pharma and biotech partners. In principle, we are agnostic with regards to indication or molecular modality. During this conference, we are seeking in licensing and out licensing partnering discussions. Company Description/Mission Statement Time Wednesday, Mar 6 1:45PM - 2:00PM Location Drawing Room Speakers Ed Zhang Boston Pharmaceuticals
2:00pm Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd William Dongfang Shi, Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd. show more Description Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd (Atom Bioscience) founded in 2012 in China and mainly focused on new drug discovery and development on metabolic diseases and anti-cancer. The management team members are mainly from the US and have extensive experiences on pharmaceutical industry. Atom Bioscience develops several pipelines. Among them, ABP-671 for gout treatment is currently under phase 1 clinical trials in US. It has shown superior reductions in serum uric acid in recent first human study, which is significantly better than market gout drugs. Besides ABP-671, ABP-6016 showed remarkable potency for treatment of NASH with excellent safety profile. ABP-431, a first-in-class novel drug, which greatly inhibited three types of cancers in nude mice, is under investigation. Atom Bioscience has completed over 10 million USD financing at Round Angel, A and A+. Investors are KAITAI Capital, YouChoose Capital, Ch-gemstone Capital, etc. Company Description/Mission Statement Time Wednesday, Mar 6 2:00PM - 2:15PM Location Drawing Room Speakers William Dongfang Shi Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd.
2:15pm ARTham Therapeutics Inc Sham Nikam, ARTham Therapeutics show more Description ARTham Therapeutics was launched in Yokohama, Japan in July 2018 with four projects in-licensed from Takeda Pharmaceuticals Company. Series A investors are Takeda, Miyako Capital, SMBC Capital, Mizuho Capital and Oita Venture Capital. Of the four projects, two are clinical candidates. The first clinical candidate, ART-648, for the treatment of NASH, and second, ART-001, for Venous Malformations, that includes orphan indication such as, Klippel Trenaunay syndrome. ART-648 Ph1 was initiated on Jan 8th 2019 and data will be available end of 2Q2019 and expected start for Ph2a is 2H2019. ART-001, Ph1 will be initiated in 1Q2020 post preclinical development activities that involve development of new formulation. We are seeking series B investment and/or strategic partnerships to advance the clinical candidates through later stages of development. Using repositioning strategies and virtual R&D model, ARTham’s leadership team drives the projects to deliver candidates in clinic for human POC studies. The leadership team has worked together in Takeda for more than 6 years and delivered several clinical candidates in diverse therapeutic areas. Company Description/Mission Statement Time Wednesday, Mar 6 2:15PM - 2:30PM Location Drawing Room Speakers Sham Nikam ARTham Therapeutics
2:30pm SANSHO Co.,Ltd Toshiro Morohoshi, SANSHO Co.,Ltd show more Description SANSHO is a bio venture company and was established on January 2008. We are developing a new treating drug of osteoarthritis(OA) which is low molecule compound. W got IND from US FDA and Taiwanese FDA and now conducting clinical trial phase 1/b including patients of OA. Phase 1/b trial consist of 32 OA patients and four groups for dose escalating method. The lowest dose is 50ug/body for injection in the knee and the first group (8 patients)are completed and now is stepping next dose (200ug/body). The trial will be completed at the middle of this year and going next step after phase 1/b. Company Description/Mission Statement Time Wednesday, Mar 6 2:30PM - 2:45PM Location Drawing Room Speakers Toshiro Morohoshi SANSHO Co.,Ltd
2:45pm Aspect Biosystems Tamer Mohamed, Aspect Biosystems show more Description Aspect Biosystems Ltd. is a privately held biotechnology company operating at the leading edge of 3D bioprinting and tissue engineering. The company’s proprietary microfluidic 3D bioprinting technology is enabling advances in understanding fundamental biology, disease research, development of novel therapeutics, and regenerative medicine. In addition to its internal programs, Aspect is focused on strategically partnering with pharmaceutical and biotechnology companies, as well as academic researchers, to enable the creation of living, human tissues for medical research, therapeutic discovery, and regenerative medicine products. Company Description/Mission Statement Time Wednesday, Mar 6 2:45PM - 3:00PM Location Drawing Room Speakers Tamer Mohamed Aspect Biosystems
3:00pm GEXVal Inc. Lili Mao, GEXVal Inc. show more Description GEXVal Inc. is a Japanese-based spinoff company from Takeda Pharmaceutical Company Limited, established since April 2018. We focus on rare/intractable diseases to help patients and families who need better treatment options fighting against debilitating diseases. Our mission is to execute late-stage research and early development projects with agility and taking risks in true spirit of entrepreneurship to deliver medicines in areas of high medical need. We are loaded with 2 development candidate and 3 discovery projects. Our strategy is to Generate EXtra Value by creative repositioning and extensive external partnership to accelerate R&D process: 1) by multi-platform drug repositioning research of novel development candidate molecules to aim high R&D productivity, 2) by focusing on rare/intractable diseases, and 3) by focusing on GPCR modulators, known as drugs with higher chance of success. This is GEXVal Inc., who always consider patients first and are committed to deliver. Company Description/Mission Statement Time Wednesday, Mar 6 3:00PM - 3:15PM Location Drawing Room Speakers Lili Mao GEXVal Inc.
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Development Phase of Primary Product