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Tuesday, March 5
9:00am Welcome and Opening Remarks show more Description Remarks from the event organizers to set the themes for the conference. Time Tuesday, Mar 5 9:00AM - 9:20AM
9:20am How is the Drug Pricing Reform Initiative Affecting Patient Access, Investment, and Innovation in Japan? show more Description TBD Time Tuesday, Mar 5 9:20AM - 9:55AM
10:15am 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 - 11:00AM
11:00am Turning RNA Interference Research into Medicines 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 - 11:45AM
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 - 1:30PM Speakers Tatsuya Kondo Pharmaceuticals and Medical Devices Agency (PMDA), Japan
2:00pm Bridging External Innovation and Internal R&D for New Patient Therapies 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
3:00pm Explaining CFIUS and New Investment Regulations in the United States 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
4:00pm Access as a Policy Choice: Measuring Openness to Innovation & Creativity 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
4:30pm Market Outlook—Finding Opportunities During Global Trade Downturns 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
Wednesday, March 6
9:00am Deploying Artificial Intelligence (AI) to Improve R&D Productivity 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 - 9:30AM
10:00am Biotech Incubator Business Models: Lessons and Needed Improvements 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
11:00am Using M&A for Data Advantages Beyond Product Pipelines 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
12:00pm Keynote Chat: BT Slingsby, MD, PhD, MPH, CEO & Executive Director, Global Health Innovative Technology (GHIT) Fund BT Slingsby, Global Health Innovative Technology (GHIT) Fund show more Description Keynote Chat: BT Slingsby, MD, PhD, MPH, CEO & Executive Director, Global Health Innovative Technology (GHIT) Fund Time Wednesday, Mar 6 12:00PM - 1:25PM Speakers BT Slingsby Global Health Innovative Technology (GHIT) Fund
2:00pm Crafting a Global Clinical Trials Strategy: Partner Selection and Regulatory Risk show more Description The market for global clinical trials is projected to grow to $65 billion by 2025. Companies can accelerate innovation by considering the opportunities to expand trials around the globe. Data from patients representing different disease areas and across different locations provide a diverse set of information that can lead to approvals of more medicines faster, such as the recent first-in-world approval by China for a medicine from a non-Chinese company. The panel will discuss the operational priorities for successful global clinical trials and the strategic considerations for selecting partners to reduce regulatory risks across different markets. Time Wednesday, Mar 6 2:00PM - 2:55PM
No time slot
Abcuro, Inc. Stefano Gulla, Abcuro show more Description Abcuro is developing a new generation of immunomodulatory therapeutics for treating both autoimmunity and cancer. The company uses proprietary analysis of transcriptome data from human disease to target key compartments of the immune system. Abcuro was launched in 2016 and to date it has raised over $12M to advance two functionally differentiated therapeutic programs that target KLRG1, an inhibitory receptor on T and NK cells. Abcuro’s autoimmunity program is under development for inclusion body myositis (IBM), primary biliary cholangitis (PBC) and other T cell driven autoimmunity indications. Abcuro's immuno-oncology program is being developed for solid tumors via a biomarker based indication selection strategy. Both programs have completed candidate selection and are now in pre-clinical development. Speakers Stefano Gulla Abcuro 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. Speakers Angus Wu ACT Genomics 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. Speakers John Womelsdorf AIMM Therapeutics BV 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. Speakers Hans Keirstead AIVITA Biomedical 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. Speakers Larry Green AlivaMab Discovery Services and Ablexis 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. Speakers Yochi Slonim Anima Biotech Inc. 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 University. Of the four projects, two are clinical candidates. The first clinical candidate, ART-648, for the treatment of NASH will enter Ph1 in Jan 2019 and second, ART-001, for Venous Malformations, that includes orphan indication such as, Klippel Trenaunay syndrome. ART-648 Ph1 was initiated in Jan 2019 and Ph2a in 2H2019 and ART-001, Ph1 will be initiated in 4Q2019. We are seeking series B investment and/or strategic partnerships to advance the clinical candidates through later stages of development. Using a 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. Speakers Sham Nikam ARTham Therapeutics 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. Speakers Tamer Mohamed Aspect Biosystems 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. Speakers Vishal Doshi AUM Biosciences 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. Speakers Martin Welschof BioInvent International 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. Speakers Cora Lo Biomere Tech 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. Speakers Vikas Sharma Bioxcel Therapeutics 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. Speakers Ed Zhang Boston Pharmaceuticals BRAINCURES Krzysztof Potempa, BRAINCURES show more Description BRAINCURES is a biology-based platform company with a unique in silico approach to de-risk and accelerate drug discovery and repurposing for brain diseases. Their biology-powered Discovery Engine can be exploited to turn data on compounds, diseases, drugs, patients and pipelines into opportunities for precision medicine without data-training associated with artificial intelligence (AI)-powered approaches. Other applications include Companion Diagnostics, Biomarkers and Novel Treatment identification. www.braincures.com https://www.linkedin.com/company/braincures Speakers Krzysztof Potempa BRAINCURES 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. Speakers Takumi Kawabe CanBas Co., Ltd. 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. Speakers Ram Mandalam Cellerant Therapeutics, Inc. 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. Speakers Shinya Kojima Chitose Biologics 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. Speakers Neil Abdollahian Cidara Therapeutics 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. Speakers Sabrina Johnson Daré Bioscience, Inc. 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. Speakers Yuki Tanabe EditForce Inc. enterome Pierre BELICHARD, ENTEROME show more Description Enterome is a clinical-stage company pioneering the development of novel pharmaceuticals based on its leading knowledge of the interaction between the immune system and the gut microbiome. Enterome is advancing a pipeline of small molecule and peptide candidates to treat microbiome-associated diseases with a focus on auto-immune disease and cancer: these include EB8018, a selective FimH blocker, in a Phase 1b clinical trial for Crohn’s disease (partnered with Takeda); and EO2401, an innovative Microbiome antigen-based therapeutic (“onco-mimic”), which is expected to enter clinical trial in glioblastoma patients in 2019. The Company’s strategic drug discovery is driven by its proprietary metagenomics platform enabling the identification of new targets and therapeutic candidates derived from the microbiome. The Company’s approach is based on a “drugs from bugs” philosophy and is expected to facilitate the use of recognised development and regulatory pathways for its candidates. Speakers Pierre BELICHARD ENTEROME Gene Therapy Center Austria (GTCA) | Takeda Roman Necina, Shire 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. Speakers Roman Necina Shire 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. Speakers Lili Mao GEXVal Inc. 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. Speakers Pohsing Ng HanaVax 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. Speakers Kenji Kakuta iHeart Japan Corporation 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 Speakers Mansi Joshi InveniAI 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. Speakers William Dongfang Shi Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd. 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. Speakers Doug Manion Kleo Pharmaceuticals 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. Speakers Kazuhiro Matsuda M Bio Technology Inc. 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. Speakers Steven Lin Merck Life Science/BioReliance End-to-End Solutions 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. Speakers Kiyoshi Takayama NB Health Laboratory Co., Ltd 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. Speakers Anton Buzdin Omicsway 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. Speakers Yirang Kim Oncocross PhysioCue Simon Yi, PhysioCue show more Description PhysioCue targets the most prevailing and common health issues; hypertension, migraine, and headache. Furthermore, the company is equipped with essential eHealth and mobile health technology ingredients, such as bio-sensors, to cope with its exponential growth in demand due to the aging and proactively health-conscious generation of the world. PhysioCue Product lines are in 3 major categories; 1. Hypertension therapy device 2. Migraine headache therapy device 3. Bio-sensor blood pressure monitors The device generates a certain range of cold temperature with vibration in the mix to stimulate the baroreceptor of the carotid artery. Baroreceptors are the part of the principle parasympathetic system, regulating the blood pressure. PhysioCue technology enables to stimulate and condition the baroreceptor, and eventually balance autonomic system to gain the blood pressure control of the body. It is recommended to use 5 mins per day. Speakers Simon Yi PhysioCue 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. Speakers James Taylor Precision NanoSystems Inc. 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. Speakers Toshiro Morohoshi SANSHO Co.,Ltd SciMed Ltd. George Sakellaris, SciMed Ltd. show more Description Scimed Biotechnologies is a Czech biotechnological company focusing on the development of cell-based medicinal products. Utilising the natural healing and regenerative properties of cells, we offer our patients effective and personalized methods of treatment. Our laboratories are equipped for aseptic production of cell and tissue-based products with clean room facilities that meet strict criteria for tissue establishments and GMP accreditation. Scimed Biotechnologies also offers CRO services in the fields of regenerative medicine, cell therapy and stem cell application. Scimed Biotechnologies was established in 2018. The company is located in the Prague Innovation Center Innocrystal within a dynamically evolving region comprised of many biotechnological institutes. The company team is composed of scientists with rich knowledge in the cell therapy field, as well as specialists experienced in leading companies within the private sector. Speakers George Sakellaris SciMed Ltd. 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. Speakers Jeong Tae Kim Shaperon 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. Speakers Shintaro Morizane Susmed, Inc. 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. Speakers Steven Shallcross Synthetic Biologics, Inc. 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. Speakers Linda Masat Trianni, Inc TriSalus Life Sciences Mary Szela, TriSalus Life Sciences show more Description Effective delivery remains one of the challenges in solid tumors, which has hampered the development of cell therapy and other novel IO agents in solid tumors. TriSalus Life Sciences has developed Pressure Enabled Drug Delivery™ (PEDD) technology that can overcome the high intratumoral pressure to improve distribution and penetration of therapy in solid tumors. The FDA-approved intratumoral delivery device has been used in over 11,000 procedures for liver tumors, and have demonstrated positive pre-clinical and clinical data with CAR-T in liver mets and pancreatic cancer. The company is now seeking additional funding and clinical collaborations with therapy manufacturers to continue developing its pre-clinical and clinical data in pancreatic cancer and liver mets. Speakers Mary Szela TriSalus Life Sciences 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 Speakers Jaeyoung Ahn VORONOI Inc.
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Development Phase of Primary Product