Sponsors

Program Organizers

The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 300 members and is the leading global advocacy organization in this field. www.alliancerm.org

SSSCC-Logo_220The Sanford Stem Cell Clinical Center at UC San Diego Health exists to transform the enormous potential of stem cell science into real therapies for patients. Our goal is to advance therapies and cures by supporting ethically conducted clinical trials that result from scientific discoveries. The Sanford Stem Cell Clinical Center was created to protect and counsel patients, and accelerate innovative stem cell research into patient diagnostics and therapy. As the center’s clinical arm, the CIRM Alpha Stem Cell Clinic at UC San Diego Health works to accelerate the design of innovative stem cell research to advance the testing and delivery of safe and effective stem cell-based therapies in regenerative medicine. Our current clinical trials focus on diabetes, spinal cord injuries, heart problems and cancer. https://health.ucsd.edu/clinicaltrials/sanford/Pages/default.aspx

Platinum Sponsor

PCT is the global cell therapy manufacturing and development service platform of the Hitachi Chemical Regenerative Medicine Business Sector, leveraging nearly two decades of PCT platform experience exclusively focused on the cell therapy industry. The PCT service platform includes contract development and manufacturing organization (CDMO) services, at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing and manufacturing development.

Hitachi Chemical Advanced Therapeutics Solutions (HCATS), is a wholly owned subsidiary of Hitachi Chemical Company, Ltd. (Hitachi Chemical) representing Hitachi Chemical’s Regenerative Medicine Business Sector in the U.S. HCATS’ vision is a world in which transformative cell-based therapeutics are accessible to all, and its mission is to provide its clients with high-quality, scalable, innovative, reliable and cost-efficient manufacturing platforms and services, such as the PCT platform, to advance commercialization of cellular therapies. Robert Preti, Ph.D., the CEO and President of HCATS is the General Manager of the Hitachi Chemical Regenerative Medicine Business Sector. www.pctcelltherapy.com

Program Partners

FIRM_155x68The Forum for Innovative Regenerative Medicine (FIRM) is a Japanese incorporated association whose mission is to promote regenerative medicine. FIRM’s goal is to establish a stable and welcoming business environment to benefit patients both in Japan and the rest of the world. FIRM works closely with the government to establish legislative, regulatory and business environments that are the most suitable for the practice of regenerative medicine. FIRM also works with academia to accelerate the transfer of basic research into commercialization. The organization is confident that these groups will foster biotechnology in the medical industry, along with the new regulatory and business environments established in Japan. FIRM was formed in 2011 and has more than 220 members of Japanese companies with expertise in diverse fields such as pharmaceutics, biotechnology, manufacturing, transportation, insurance and related supporting areas for regenerative medicine. FIRM organizes ISO/TC 276 (Biotechnology) in Japan, as the first and only incorporated association in this field in Japan. Further, newly established FIRM-CoNCEPT (Committee for Non-Clinical Safety Evaluation of Pluripotent Stem Cell-derived ProducT) and MEASURE (Multisite Evaluation Study on Analytical Methods for Non-Clinical Safety Assessment of HUman-Derived REgenerative Medical Products) define a roadmap and best practices for internationally acceptable concepts/consensus, and the testing methods for reduction of tumorigenicity risk of cell-based products with a particular focus on pluripotent stem cell-derived products. These attempts are expected to propel Japan several steps ahead of the rest of the world in regenerative medicine. FIRM’s main office is located in Tokyo. https://firm.or.jp/en

Sanford-Consortium_250The mission of the Sanford Consortium for Regenerative Medicine is to advance stem cell research through collaborative, multi-disciplinary interactions. This collaboratory enables scientists from the La Jolla Institute for Allergy and Immunology, the Salk Institute for Biological Studies, the Sanford Burnham Prebys Medical Discovery Institute, The Scripps Research Institute, and the University of California, San Diego to work side-by-side in a facility specifically designed to achieve breakthrough discoveries. Consistent with the objectives of the California Institute for Regenerative Medicine (CIRM), Sanford Consortium for Regenerative Medicine researchers are applying the powers of stem cells to promote diagnoses, treatments and cures for degenerative diseases and injuries. Originally assembled in March 2006 as the San Diego Consortium for Regenerative Medicine, the organization was renamed in September 2008 in recognition of an extraordinary gift from T. Denny Sanford. www.sanfordconsortium.org

Gold Sponsors

Aldevron is a recognized leader in contract manufacturing and development services for nucleic acids, proteins and antibodies. Founded in 1998, we have provided thousands of clients with plasmid DNA, RNA, customized proteins, therapeutic antibodies and gene editing enzymes for research, clinical and commercial applications. These products and services have supported revolutionary treatments in many fields including oncology, neuroscience and regenerative medicine. Our services incorporate research grade through GMP manufacturing, and include Aldevron’s proprietary GMP-Source quality system. Our collaborative approach and commitment to quality allow us to meet precise client requirements and provide the basis for breakthroughs in medicine. Aldevron has headquarters in Fargo, North Dakota and facilities in Madison, Wisconsin and Freiburg, Germany. www.aldevron.com

Audentes Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases. The company has four product candidates in development, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), AT342 for the treatment of Crigler-Najjar syndrome, AT982 for the treatment of Pompe disease, and AT307 for the treatment of the CASQ2 subtype of catecholaminergic polymorphic ventricular tachycardia (CASQ2-CPVT). Audentes is a focused, experienced and passionate team committed to forging strong, global relationships with the patient, research and medical communities. www.audentestx.com

BlueRock_220Driven by a vision to liberate patients from the burden of degenerative disease, BlueRock Therapeutics is ushering in a new era of cell-based medicine that repairs the body when it cannot repair itself. Founded in 2016 through one of the largest Series A financings in biotech history, BlueRock and its team of preeminent scientists are pioneering cell therapies that replace dead, damaged or dysfunctional cells to restore critical natural functions in the body. Using an approach that can be applied to multiple diseases with great unmet need, BlueRock is initially targeting severe brain and heart conditions, with the goal of altering the course of disease and drastically improving quality of life. BlueRock’s culture is defined by scientific innovation, highest ethical standards and an urgency to bring transformative treatments to all who would benefit. www.bluerocktx.com

Brammer Bio is an experienced cell and gene therapy CDMO focused on process and analytical development, clinical supply and now commercial supply. With more than a decade of experience, our 240-strong, highly skilled team has managed over 100 client projects delivering first-in-human clinical materials to enable us to accelerate our client’s products from the laboratory to patients in need. We work in close collaboration with each client’s team to deliver successful programs. We are Manufacturing Personalized. Through this, we enable the delivery of novel medicines to improve patient health Helping to Cure. www.brammerbio.com

IQVIA (NYSE:IQV) is a leading global provider of information, innovative technology solutions and contract research services dedicated to using analytics and science to help healthcare stakeholders find better solutions for their patients. Solutions are powered by the IQVIA CORE™, which combines big data, advanced technology, analytics and extensive industry knowledge. Formed through the merger of IMS Health and Quintiles, IQVIA has approximately 55,000 employees worldwide. www.iqvia.com

Lonza_180x68Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life. The company is organized into two market-focused segments: Pharma and Biotech and Specialty Ingredients. The core competencies that span these segments are advanced manufacturing and quality-control systems, superior regulatory expertise, in-depth market knowledge and extensive technical customer-support and research and development capabilities. www.lonza.com

MaxCyte’s flow electroporation is driving the next generation of cell-based medicines. Used in the discovery, development and manufacture of cell-based therapeutics, the MaxCyte GT® Flow Transfection System, MaxCyte STX® Scalable Transfection System, and MaxCyte VLX® Large Scale Transfection System enable the development of transfected cells for a range of applications. www.maxcyte.com

Terumo_210With decades of expertise in cellular technologies and a reputation for outstanding support and collaboration, Terumo BCT is proud to be a leader in cell collection, separation and expansion technologies used in the production of cellular therapies. Our scientists, engineers and cell processing specialists are united in their commitment to helping customers address challenges, find solutions and refine processes within the development process from start to finish serving the entire spectrum: hospitals to research centers to manufacturers in cGMP environments. www.terumobct.com

Thermo_210x68As the world leader in serving science, Thermo Fisher Scientific is uniquely positioned to provide the quality materials, services and support needed to accelerate the pace of advanced therapy development. We understand the complexity of this rapidly evolving industry and partner with our customers as they transition from discovery to clinical research and commercial manufacturing. Our portfolio of trusted and recognized products and services, combined with over 50 years of cell culture expertise, enables us to provide comprehensive solutions to support every step of the advanced therapy process from cell collection through manufacture to clinical site delivery. Through our Thermo Scientific, Applied BioSystems, Invitrogen, Fisher Scientific, Fisher BioServices, Unity Lab Services, and Gibco Cell Therapy Systems (CTS) brands, we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. www.thermofisher.com

Vineti_180x68Vineti builds 21st century technology to drive the production and delivery of 21st century medicine. The company combines leading software expertise with deep, first-hand industry experience in commercializing personalized medicines to develop a cloud-based platform that ensures quality, scale, security, efficiency, traceability and safety. The Vineti platform provides actionable insights to continually optimize the cell and gene therapy process, accelerating time to revenue and decreasing costs. Caregivers and pharmaceutical pioneers are empowered to help more patients more effectively and safely, treatments are better understood and improved over time and most importantly, there’s an opportunity to provide greater health outcomes – and cures – to patients in need. Vineti was co-founded by GE and the Mayo Clinic and is based in San Francisco, CA. www.vineti.com

World_Courier_220World Courier is a global specialty logistics company that designs world-class logistics and supply chain programs in complete alignment with our customers’ business goals. Pharmaceutical companies rely on us because they value the peace of mind that comes with our unsurpassed knowledge, global reach and flawless supply chain execution. Each trusted partnership we form with a customer is deeply rooted in our shared vision of improving global health. With 2,500+ associates in more than 140 offices across the globe, we offer solutions that instill confidence in the on-time, on-temperature delivery of critical products. When trust is absolutely essential, there’s only one choice: World Courier. www.worldcourier.com

Silver Sponsors

Alira Health simplifies the complicated journey that is the healthcare and life science product and corporate lifecycle. With us, you get a full spectrum of advisory support to help you overcome your strategy, execution and innovation challenges from one dedicated partner committed to your best outcomes. We respect the journey that life science and healthcare innovators and market leaders must take. We’re committed to helping our clients arrive at their destination with confidence and a competitive advantage. We’re on a mission to grow healthcare and life science innovation companies. Alira Health partners with clients to identify the best roadmap for advancement and goal realization. We provide the right financial, scientific, clinical and marketing tools to empower their ideas, implement their strategies and succeed at every turn. www.alirahealth.com

Be The Match BioTherapies® partners with organizations pursuing life-saving cellular therapies in every stage of development – from discovery through commercialization. Built on the foundation established over the last 30 years by the National Marrow Donor Program® (NMDP)/Be The Match®, we have unparalleled experience managing cellular therapies. Our cell therapy supply chain delivery for autologous or allogeneic therapies is enabled by high-touch, personalized case management and a robust, customizable software platform, MatchSource®. Our experience in cell sourcing and collection allows us to provide cells consented for research, clinical or commercial use. Researchers have access to clinical trial services through our research program CIBMTR® (Center for International Blood and Marrow Transplant Research®). In addition, we have the infrastructure in place to collect and analyze patient outcomes post-cell or gene therapy treatment at the time points required by regulatory authorities. www.bethematchbiotherapies.com

BioLife Solutions is the leading developer, manufacturer and supplier of proprietary, clinical-grade biopreservation media for cells and tissues. Our HypoThermosol® hypothermic storage and CryoStor® cryopreservation freeze media are highly valued in the regenerative medicine, biobanking and drug discovery markets. These novel biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death; offering commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function. www.biolifesolutions.com

Catapult_160The Cell and Gene Therapy Catapult was established as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation. With more than 180 experts focusing on cell and gene therapy technologies, it works with partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. It offers leading-edge capability, technology and innovation to enable companies to take products into clinical trials and provide clinical, process development, manufacturing, regulatory, health economics and market access expertise. Its aim is to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies. The Cell and Gene Therapy Catapult works with Innovate UK. www.ct.catapult.org.uk | www.gov.uk/innovate-uk

CCRM_135CCRM, a Canadian not-for-profit funded by the Government of Canada, the Province of Ontario and leading academic and industry partners, supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. A network of academic researchers, leading companies, strategic investors and entrepreneurs, CCRM aims to accelerate the translation of scientific discovery into marketable products for patients with specialized teams, funding and infrastructure. CCRM sources and evaluates intellectual property from around the globe, offers various consulting services, conducts development projects with partners and establishes new companies built around strategic bundles of intellectual property. CCRM has a fully resourced 6,000 square foot development facility used to both evaluate and advance technologies, a Centre for Advanced Therapeutic Cell Technologies and a (coming soon!) GMP facility within a 40,000 square foot office designed for advanced cell manufacturing. CCRM is the commercialization partner of the Ontario Institute for Regenerative Medicine and the University of Toronto’s Medicine by Design. CCRM is hosted by the University of Toronto and was launched in Toronto’s Discovery District on June 14, 2011. www.ccrm.ca

Cell Therapies Pty Ltd (CTPL) is the leading provider of manufacturing and deployment infrastructure for cell based therapies in Australasia and SE Asia. CTPL provides contract process development and GMP manufacturing and delivery services to product development companies across all cell types. Our expertise is needle-to-needle ensuring complete product security and control and includes collection management (especially apheresis), cryopreservation, cell processing and distribution. Our home base at The Peter MacCallum Cancer Institute (our parent) in Melbourne’s Parkville biomedical precinct provides unparalleled access to clinical and research resources to enable rapid start-up or extension of clinical trials and centres of excellence for commercial deployment, all supported by Australia’s efficient Clinical Trial Notification scheme. CTPL holds numerous cGMP manufacturing licenses with Australia’s Therapeutic Goods Administration and is proud to be working with some of the world’s leading stem cell companies. An alliance with Pharmabio in Japan enables us to project our capabilities under a common quality management system and project governance structure into this important market. We welcome enquiries from new contract customers. www.celltherapies.com.au

Chardan is a global boutique investment bank focused on companies that offer superior investment return prospects, based on the potential to create real value for society. In following vector gene therapy, small RNA therapy, and gene editing companies, Chardan covers more genetic medicines names than any other bank globally. Chardan is known for its market impact, communicating on fundamental sector value drivers (e.g. via the predictive Chardan Gene Therapy Framework), and has successfully raised more than $1.4 billion for genetic medicines companies since 2015. www.chardan.com | info@chardan.com | 646-465-9018

ChemoMetec is a Danish founded company which specializes in the development, manufacturing and sales of high-quality automated Cell Counters, Advanced Cell Analyzers and Image Cytometers to help streamline research and production processes for maximum efficiency. Our instruments are based on a patented, unique technology platform that ensures a high quality of analysis results and reliability. The instruments are known for their robustness and high precision as well as the ease of use yet advanced analysis capabilities. Our primary focus is on cell counting and cell analysis, especially for use in life sciences research, clinical diagnostics and in production and quality control within the pharmaceutical industry. www.chemometec.com

Cognate Bioservices is a fully-integrated contract bioservices organization providing the highest level of scientific and management expertise. Cognate provides full development and cGMP manufacturing services to companies and institutions engaged in the development of cell-based products. The combination of highly experienced staff, cGMP facilities and an international track record makes Cognate one of the most experienced contract manufacturers of cell-based products in the world today. www.cognatebioservices.com

Cryoport is the premier provider of temperature controlled logistics solutions to the life sciences industry through our purpose-built proprietary packaging, information technology and specialized logistics expertise. We provide leading-edge temperature controlled logistics solutions for biologic materials such as immunotherapies, stem cells, CAR-T cells and reproductive cells for clients worldwide including points-of-care, CROs, central laboratories, pharmaceutical companies, contract manufacturers and university researchers. Cryoport’s unparalleled information technology centers around our proprietary Cryoportal™ Logistics Management Platform, which facilitates management of the entire shipment process. Our state-of-the-art technology also includes our innovative Smartpak II™ Condition Monitoring System, which provides visibility of the location and the key aspects of critical shipments. The Smartpak II™ works in conjunction with our Cryoportal™ to provide real-time information reporting about shipments, integrated condition monitoring, logistics and shipper qualification performance in a single data steam. Cryoport also has a dedicated 24/7/365 customer service team to proactively monitor each shipment, allowing for invention when necessary. www.cryoport.com

At Dark Horse Consulting, we specialize in the development of Cell and Gene Therapy products. All of our consultants have deep Cell and Gene Therapy industry experience, spanning diverse functions including process development, device development, manufacturing, quality, regulatory, program management, business development, strategy, and financing/investor relations. Many of our consultants also bring experience from adjacent more mature sectors, including traditional biologics, small molecules, medical devices, and management consulting. As a result, we deeply understand the unique challenges faced by Cell and Gene Therapy developers and are able to apply best practices from other industries to address the needs of our clients. Our team of Cell and Gene Therapy professionals bring deep technical expertise to help you tackle the unique challenges of our exciting young field. www.darkhorseconsulting.us

Evidera_200x63_updated-2018Evidera, PPD’s peri- and post-approval business unit, is a leading provider of evidence-based solutions to demonstrate the real-world effectiveness, safety and value of biopharmaceutical and biotechnology products. We help biopharmaceutical and biotechnology companies generate the evidence needed to optimize the market access and commercial potential of their products. We provide integrated and tailored scientific expertise and global operational capabilities. Our offerings include interventional studies, real-world observational research and data analytics, patient-centered outcomes studies, epidemiological studies, modeling and simulation, meta-analysis, literature reviews, market access consulting and communications and medical writing. Evidera has approximately 500 employees representing over 35 nationalities in locations around the world, with major offices across North America and Europe. Our scientific and consulting staff are methodological and thought leaders with an average of 15 years of experience, contributing to hundreds of submissions to payers and regulators, and publishing over 2,200 peer-reviewed articles dating back nearly 30 years. www.evidera.com

Founded in 2010, FloDesign Sonics develops acoustic technologies for the separation, concentration and purification of materials in an active fluid. Our key focus area is cell therapy, helping to address manufacturing challenges related to the processing, separation and purification of CAR T cells. Our goal is to help industrialize cell therapies by driving down costs, and creating a scalable platform for preclinical through production. We apply this acoustic cell processing technology to key applications such as concentrate and washing steps, affinity separation and cell harvest. www.fdsonics.com

FHCC_180At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, and Hutch scientists continue to be thought leaders and innovators in the field. Fred Hutch’s robust pipeline of translational therapies is cultivated and supported by over 300 faculty members, onsite vector manufacturing and cell processing facilities, stellar clinical care partners and a commitment to innovation. www.fredhutch.org

FUJIFILM Cellular Dynamics (FCDI) is a leading developer and supplier of human cells used in basic and translational research, drug discovery, toxicity testing and regenerative medicine applications. Leveraging technology that can be used to create induced pluripotent stem cells (iPSCs) and differentiated tissue-specific cells from any individual, FCDI is committed to advancing life science research and transforming the therapeutic development process in order to fundamentally improve human health. www.fujifilmcdi.com

At GE Healthcare Life Sciences, we accelerate precision medicine by helping researchers, pharmaceutical companies and clinicians discover and make new medicines and therapies. We provide expertise, technology and services for a wide range of areas within the life sciences industry, including the manufacture of contrast agents for diagnostic imaging, basic research of cells and proteins and technologies that enable large-scale manufacturing of vaccines, biologics and cell therapy. The emergence of cell therapy as a frontline treatment for challenging diseases, including cancer, is rapidly changing the healthcare landscape. Our Cell Therapy business provides the tools, technology and processes to enable customers from pharmaceutical manufacturing as part of our Cell Processing segment, to clinicians and technicians in our Cell Banking and Point of Care business segments. We are investing in the field for the long-term, and partnering with pharma, biotech and clinical researchers. GE brings expertise in quality, global distribution, research and development and regulatory that will transform cell therapy from small-scale treatment to a globally-accessible personalized medicine. www.gelifesciences.com

Histogenics_170_websiteHistogenics is a leading regenerative medicine company developing and commercializing novel tissue therapies that may offer more rapid and durable recoveries for patients with pain and loss of function due to musculoskeletal conditions. Histogenics regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering and bioadhesives to create tissue ex-vivo. Histogenics first investigational product candidate, NeoCart is designed to treat cartilage defects in the knee and is currently in Phase III clinical development. NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage. As a result, NeoCart is the only product in development or on the market with a one-year primary superiority endpoint as compared to the standard of care. There are 500,000 or more knee cartilage procedures in the U.S. each year, with many healthy active adults avoiding treatment as they seek other alternatives. Left untreated, even a small cartilage defect can expand in size and progress to debilitating osteoarthritis, ultimately necessitating a joint replacement procedure. Osteoarthritis is more common in adults over the age of 50, but the condition and precursors of the condition can be observed much earlier, and cartilage damage is believed to be one of the leading contributors of this disease. www.histogenics.com

Homology Medicines is a genetic medicines company dedicated to transforming the lives of patients suffering from rare genetic diseases with significant unmet medical needs by curing the underlying cause of the disease. Homology’s proprietary platform is designed to utilize its human hematopoietic stem cell-derived adeno-associated virus vectors (AAVHSCs) to precisely and efficiently deliver genetic medicines in vivo either through a gene therapy or nuclease-free gene editing modality across a broad range of genetic disorders. Homology has a management team with a successful track record of discovering, developing and commercializing therapeutics with a particular focus on rare diseases, and intellectual property covering its suite of 15 AAVHSCs. Homology believes that its compelling preclinical data, scientific expertise, product development strategy, manufacturing capabilities and intellectual property position it as a leader in the development of genetic medicines. www.homologymedicines.com

Irvine-Scientific_180x63Irvine Scientific is a worldwide leader in the design and production of cell culture products for cell therapy, immunology, biopharmaceutical, cytogenetic and ART applications. Our extensive experience with rational media design, cGMP manufacturing and compliance with ISO and FDA regulations uniquely positions us to support cell therapy applications from basic research through scale-up, and to the later stages of clinical development. www.irvinesci.com

Janssen_140At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. www.janssen.com

KBI Biopharma is a biopharmaceutical contract development and manufacturing organization that accelerates the development of innovative discoveries into life-changing biological products. From early-stage to academic/non-profit organizations, to many of the world’s largest pharmaceutical companies, KBI has served 250+ clients globally to accelerate and optimize their drug development programs. KBI’s extensive track record of successful programs is a result of its unique approach: applying the insight gained from our advanced biophysical and analytical protein characterization techniques toward the development of robust and scalable processes. KBI delivers accelerated and integrated process development and cGMP manufacturing programs for a wide range of recombinant protein Active Pharmaceutical Ingredients (API) and cell therapy products for our clients. KBI was founded in 1996 and operates four facilities: Durham and Research Triangle Park, NC; Boulder, CO; and The Woodlands, TX. www.kbibiopharma.com

Founded in 2002, LabConnect provides global central laboratory and client-inspired support services including routine and specialized laboratory testing, kit building, sample management, data management, biorepository and scientific support services for biopharmaceutical and CRO clients. LabConnect’s unique combination of state-of-the-art technology, world-class laboratories, easy access to major and emerging markets and extensive specialized testing expertise means that drug development companies can rely on one provider for their central laboratory and preclinical through Phase IV clinical development needs. www.labconnectllc.com

MAK-SYSTEM_180x63Established in 1984, MAK-SYSTEM’s vision is to design, develop and deliver globally best-of-breed software to manage cell and gene therapy, blood bank and plasma centers from end-to-end using the best technologies and functionalities for the patient benefit. Our T.C.S. software provides unrivaled functionality, scalability and technology within the same application to support the traceability of your treatments across the complete supply chain. www.mak-system.com

As a global leader in healthcare services, McKesson helps our customers enhance their efficiency, improve their business health, and deliver better patient care. We bring together our customers and partners to expand care networks and access, leading the way to healthier communities and a healthier future. At McKesson, we’re defining better health. www.mckesson.com

Medpace_170_websiteMedpace is a global full-service clinical research 0rganization (CRO) providing comprehensive development services for drug, biologic and device programs with a specialized focus on advanced therapies including cell and gene therapies. Medpace has strong experience supporting development programs for regenerative medicine products across a number of therapeutic areas including cardiovascular, neuroscience, musculoskeletal and diabetes. With extensive medical expertise, a renowned regulatory affairs department, across six continents, Medpace conducts studies and navigates regulatory requirements worldwide. From feasibility, research site compatibility, safety and logistics, Medpace brings efficiencies and operational excellence to regenerative medicine development programs. In addition, Medpace offers integrated imaging and lab capabilities through its family of companies to provide cohesive, streamlined and standardized trial management. Learn more about Medpace’s focus on cellular, tissue and gene therapy medicines at www.medpace.com.

Mesoblast_180x63Mesoblast is building a leading franchise of cellular medicines to treat serious and life-threatening illnesses. The company has leveraged its proprietary disruptive technology platform, based on allogeneic off-the-shelf mesenchymal lineage adult stem cells, to target advanced stages of diseases with high, unmet medical needs including cardiovascular diseases, immune-mediated and inflammatory conditions, spine orthopedic disorders and oncology/hematology diseases. Each of these products has its own distinct technical characteristics, target indications, separate commercialization potential and unique partnering opportunities. In 2016, Mesoblast’s licensee in Japan, JCR Pharmaceuticals, received the first full approval for an allogeneic cellular medicine in Japan. www.mesoblast.com

Millipore-Sigma_150MilliporeSigma, a leader in life science, is a business of Merck KGaA, Darmstadt, Germany. Our purpose is to solve the toughest problems in life science by collaborating with the global scientific community- and through that, we aim to accelerate access to better health for people everywhere. We provide scientists and engineers with best-in-class lab materials, technologies and services. Our broad portfolio of 300,000 products along with our service offering, help tackle our customers scientific challenges. www.emdmillipore.com

MiMedx_160MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind the company’s mission to provide physicians products and tissues to help the body heal itself. The company processes the human placental tissue utilizing its proprietary PURION® process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million allografts to date for application in the wound care, burn, surgical, orthopedic, spine, sports medicine, ophthalmic and dental sectors of healthcare. www.mimedx.com

Novasep is a CDMO specialized in viruses & viral vectors production for tox, clinical and commercial phases. Novasep offers global and integrated services from process development to commercial manufacturing. For more than 15 years, Novasep has acquired experience in manufacturing viral vectors (lentivirus, AAV, ADV…) for gene therapy and vaccination. Our unique manufacturing capabilities and our strong track record can address all manufacturing needs thanks to a mastery of both cultivation and purification technologies as well as virus-dedicated process development methodology. Our ongoing investment in new commercial assets, addressing both drug substance and drug product manufacturing processes, will help to contribute to your project’s success. www.novasep.com

Paragon Bioservices is an industry-leading, private-equity backed contract development and manufacturing organization (CDMO) whose focus is the development and manufacturing of cutting-edge biopharmaceuticals. Paragon aims to build strong client partnerships with the world’s best biotech and pharma companies, focusing on transformative technologies such as recombinant viral vectors for gene therapy and providing scalable manufacturing solutions. Expanding to meet the needs of its clients, Paragon now provides complete manufacturing services from process development and clinical manufacturing through commercial launch at its new 150,000 ft2 facility. www.paragonbioservices.com

PeproTech creates the building blocks of your life science research by manufacturing high-quality products that advance scientific discovery and human health. Since 1988, PeproTech has grown into a global enterprise manufacturing an extensive line of Recombinant Human, Murine and Rat Cytokines, Animal-Free Recombinant Cytokines, Monoclonal Antibodies, Affinity Purified Polyclonal Antibodies, Affinity Purified Biotinylated Polyclonal Antibodies, ELISA Development Kits, Cell Culture Media Products and GMP Cytokines. www.peprotech.com

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare around the world. For more than 160 years, we have worked to make a difference for all who rely on us. www.pfizer.com

Polyplus-transfection applies its 15+ year expertise in transfection to the development of novel transfection reagents suitable for production of virus clinical batches and use in GMP processes, such as PEIpro-HQ, the unique PEI optimized for large scale virus production. PEIpro-HQ has proven to be the gold standard for production of various virus types, providing high, reliable and extremely reproducible virus titers, thanks to a very tight quality environment. Polyplus-transfection product range also covers in vivo delivery (in vivo-jetPEI and GMP grade reagents), CRISPR delivery reagents and R&D applications. www.polyplus-transfection.com

Sangamo Therapeutics is focused on translating groundbreaking science into genomic therapies that transform patients’ lives using the company’s industry leading platform technologies in genome editing, gene therapy, gene regulation and cell therapy. The company is conducting Phase I/II clinical trials in Hemophilia A and Hemophilia B, and lysosomal storage disorders MPS I and MPS II. Sangamo has an exclusive, global collaboration and license agreement with Pfizer for gene therapy programs for Hemophilia A, with Bioverativ for hemoglobinopathies, including beta thalassemia and sickle cell disease, and with Shire International to develop therapeutics for Huntington’s disease. In addition, it has established strategic partnerships with companies in non-therapeutic applications of its technology including Sigma-Aldrich and Dow AgroSciences. www.sangamo.com

SCM Lifescience was established with the vision of developing treatment options for difficult to treat diseases, to provide a new source of hope for patients and to contribute to the welfare of humanity as a whole using proprietary stem cell isolation technology and stem cell production technology. Through over 10 years of research and development, SCM Lifescience has obtained intellectual property protection for its high-purity stem cell isolation technology – registered patent in Korea in 2008, U.S. in 2010, Japan in 2012, China in 2013 and the EU in 2014; high-purity stem cell manufacturing technology – U.S. patent in 2014; and treatment of graft-versus-host disease – patents from Japan in 2014, U.S. in 2015 and the EU in 2016. Based on these technical breakthroughs, high-purity stem cell therapy shall be provided to treat various immune diseases such as graft-versus-host disease, acute pancreatitis, atopic dermatitis and Type I diabetes. SCM’s research will also focus on the field of regenerative medicine for technological breakthroughs including the regeneration of skin, cartilage, bone, hair growth and other tissues and organs. www.scmlifescience.com/en

StemBioSys_190_websiteStemBioSys, based in San Antonio, Texas, is a privately-held biomedical company focused on enhancing the growth and delivery of adult stem cells for research, therapeutic or drug discovery applications. Its patented and proprietary technology platforms – licensed from the UT Systems – overcome key obstacles to creating clinically useful stem cell therapies. Our technologies represent the next evolution in cell research and are branded to the research market under the CELLvo™ label. The centerpiece of these enabling technologies is our CELLvo™ Matrix. This cell derived 3-dimensional microenvironment allows a variety of stem cell types to replicate more rapidly, maintain a small cell size and express markers indicative of retained stem cell potency beyond that seen with traditional tissue culture substrates. Additionally the CELLvo™ Matrix has been shown to enhance tissue specific differentiation of various primary and iPS cell types. The company recently announced a Xeno Free version of its core cell expansion technology. The company also has several cell products available for the research market. The cell products are all isolated and expanded on our CELLvo™ Matrix. We are actively seeking collaboration partners interested in applying our matrix and/or cell technologies in a variety of applications. www.stembiosys.com

Syneos Health™ (NASDAQ: SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 23,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Learn more about how we are shortening the distance from lab to life®. www.syneoshealth.com

Synpromics is a synthetic biology company with IP and know-how in the design of synthetic promoters. Our synthetic promoters enable the controlled expression of genes at a specific place, in a specific environment, at a specific time or in response to a specific biological condition. PromPT is our proprietary technology engine to rapidly design, develop and validate novel promoter systems. Custom promoter design parameters typically include: expression level, tissue specificity, inducibility, size, kill-switch, environmental and pathologic response. We provide solutions to our customers across multiple fields of use including: Targeted gene therapies and DNA vaccines, where we have created tissue specific promoters with activity levels in excess of CMV and CBA and a size of less than 500bp; Enhanced functionality of cell therapies through creation of inducible and condition specific promoters; Viral vector bioprocessing, for which we have developed inducible promoters for the creation of stable producer cell lines for lentivirus, retrovirus and AAV manufacture; Biotherapeutic protein production, for which we have created CHO expression systems with activity levels in excess of 10X CMV. www.synpromics.com

As a recognized world leader in pluripotent stem cell banking and characterization, WiCell provides the stem cell community with high-quality cell lines as well as accurate and reliable cytogenetic testing. WiCell Stem Cell Bank offerings currently include human pluripotent cell lines (ES, iPS, disease model and modified) as well as differentiated progenitors. WiCell is continually looking to expand offerings, and cell line deposits are encouraged (contact deposits@WiCell.org for more information). Cytogenetic services available include karyotype, FISH, fastFISH, SKY and identity by STR. In addition, customizable services such as quality control testing and cell banking services are offered, allowing laboratories to fully optimize their limited resources. www.wicell.org

Bronze Sponsors

AGTC is a clinical-stage biotechnology company that uses a proprietary gene therapy platform to develop transformational genetic therapies for patients suffering from rare and debilitating diseases. Its initial focus is in the field of ophthalmology, where it has active clinical trials in X-linked retinoschisis (XLRS), X-linked retinitis pigmentosa (XLRP), and achromatopsia (ACHM CNGB3 and ACHM CNGA3). In addition to its clinical trials, AGTC has preclinical programs in optogenetics, adrenoleukodystrophy (ALD), which is a disease of the central nervous system (CNS), and otology. The clinical-stage XLRS and XLRP programs, the discovery program in ALD and two additional ophthalmology programs are being developed in collaboration with Biogen. In addition to its product pipeline, AGTC has a significant intellectual property portfolio and extensive expertise in the design of gene therapy products including capsids, promoters and expression cassettes, as well as expertise in the formulation, manufacture and physical delivery of gene therapy products. www.agtc.com

Akron_118x57Akron Biotech is an innovative biotechnology company with a strategic focus on supplying GMP-qualified ancillary materials and services to the regenerative medicine industry. Akron manufactures a range of products for cell therapy discovery, development and commercialization. These products include growth factors, sera and purified proteins, custom-made cell culture media, tailored scaffolds with biomaterials and proprietary cryopreservation formulations. In addition, our services and capabilities such as raw materials qualification, logistics and packaging optimization, bioassay design, validation and regulatory services are one of the many opportunities for Akron to provide our customers with unique knowledge and expertise. As a regulatory compliant company (ISO certified), Akron supports clients with rigorous documentation and quality standards to fulfill their regulatory demands. Our unique capabilities allow us to seamlessly transition from R&D to preclinical and clinical development with minimal change control, and thus drive the emerging regenerative medicine sector to unmet clinical needs through affordable and seamless manufacturing options. www.akronbiotech.com

Athersys_55Athersys is a clinical-stage biotechnology company developing novel and proprietary best-in-class therapies designed to extend and enhance the quality of human life. The company’s focus is on the treatment of medical conditions where there is significant unmet clinical need. Athersys is developing MultiStem®, a patented, adult-derived off-the-shelf stem cell product platform, for multiple disease indications in the areas of neurological, cardiovascular and inflammatory and immune disease. The company currently has clinical-stage programs including for the treatment of stroke, acute myocardial infarction, acute respiratory distress syndrome and other areas. Athersys has forged a network of strategic alliances and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research and clinical institutions in the U.S. and Europe to further develop its platform and products. www.athersys.com

Biological Industries USA (BI-USA) was established as a division of Biological Industries, a global leader in cell culture and stem cell media development with over 30 years of experience, by a group of highly experienced biotechnology professionals and scientists. Our vision is to collaborate, develop and provide innovative tools for stem cell and specialty cell applications to help accelerate discovery, clinical research and cell therapy. BI-USA offers a comprehensive portfolio of optimized cell culture media to achieve this vision, including products such as: Serum-free, xeno-free media, NutriStem® hPSC and MSC Media, CryoStem™ Freezing Media, Human Platelet Lysate, FBS, Mycoplasma Detection and Custom Media Manufacturing. We are founded on a culture that believes that quality must be at the forefront of everything we do. Our advanced manufacturing and quality-control systems, superior regulatory expertise, in-depth market knowledge, extensive technical customer-support and R&D capabilities all define our Culture of Excellence. www.bioind.com

bluebird-bio_150x57With its lentiviral-based gene therapies, T-cell immunotherapy expertise and gene editing capabilities, bluebird bio has built an integrated product platform with broad potential application to severe genetic diseases and cancer. bluebird bio’s gene therapy clinical programs include its Lenti-D product candidate for the treatment of cerebral adrenoleukodystrophy and its LentiGlobin BB305 product candidate for the treatment of transfusion-dependent β-thalassemia and severe sickle cell disease. bluebird bio’s oncology pipeline is built upon the company’s leadership in lentiviral gene delivery and T-cell engineering. bluebird bio’s lead oncology program, bb2121, is an anti-BCMA CAR-T program partnered with Celgene. bluebird bio also has discovery research programs utilizing megaTALs/homing endonuclease gene editing technologies with the potential for use across the company’s pipeline. www.bluebirdbio.com

CellGenix is a leading global supplier of high-quality reagents and tools for cell and gene therapy and regenerative medicine applications. As the first company to obtain a GMP manufacturing authorization for cell processing in Europe, we have more than 20 years of expertise in GMP manufacturing and development of cell therapy products. We offer a comprehensive product portfolio in combination with expert regulatory and technical support to ensure a seamless transition from research to commercialization. Our products combine a maximum of quality and safety due to the state-of-the-art production, stringent in-house quality control and comprehensive documentation. www.cellgenix.com

CTI_130_websiteCTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO), delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTI’s focused therapeutic approach provides pharmaceutical, biotechnology and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts Phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across six continents, CTI partners with research sites, patients and sponsors to fulfill unmet medical needs. CTI is headquartered in Cincinnati, OH, with operations across North America, Europe, Latin America and Asia-Pacific. www.ctifacts.com

DiscGenics_140x57DiscGenics is a biotechnology company developing and commercializing advanced spinal therapeutics to treat patients with diseases of the intervertebral disc. With back pain being such a significant problem globally and a burden on the healthcare system, DiscGenics technology has the potential to increase quality of life for patients and to reduce costs to the healthcare system, while providing a significant revenue opportunity. DiscGenics is the only company to utilize allogeneic therapeutic progenitor cells derived from intervertebral disc to treat the disc. The company’s first product, Injectable Discogenic Cell Therapy (IDCT), is starting clinical testing for the treatment of moderate degenerative disc disease (DDD). www.discgenics.com

EBD_60_websiteEBD Group’s overriding mission is to help collaborations get started across the life science value chain. Our range of partnering conferences has grown to become the largest and most productive conference platform in the industry. Each one of our seven landmark events held in key life science markets around the world is powered by our state-of-the-art partnering software, partneringONE, that enables delegates to efficiently identify and engage with new opportunities via one-to-one meetings. Today our events (BIO-Europe, BIO-Europe Spring, BioPharm America, Biotech Showcase, ChinaBio Partnering Forum, Cell & Gene Exchange, and BioEquity Europe) annually attract more than 12,000 senior life science executives who engage in over 43,000 one-to-one partnering meetings. These vital one-to-one engagements are the wellspring of deals that drive innovation in our industry. www.ebdgroup.com

Fresenius-Kabi_110x57Fresenius Kabi is a leading global healthcare company that focuses on pharmaceuticals and medical devices used to care for critically and chronically ill patients. We bring over 60 years of experience advancing the fields of cell collection and separation with a deep expertise in closed-system processing. We recently launched Lovo, the only cell processing system that washes and concentrates white blood cells using filtration technology, specifically to serve the needs of the cellular therapies community. Fresenius Kabi’s U.S. headquarters are located in Lake Zurich, Illinois. www.fresenius-kabi.us/lovo

GenCure_140x57GenCure is a regenerative medicine and cell therapy company using the power of human cells and tissues to inspire hope, enhance lives and enable clinical advancements. GenCure enables the development of cell and tissue based therapies and companies by providing access to source materials, biomanufacturing services and clinical research support. Leveraging our core resources and in-house expertise including GMP contract manufacturing, process development, quality management, compliance and testing, GenCure is expanding its focus and collaborating with outside partners to develop new approaches for cell expansion and manufacturing in the regenerative medicine field. www.gencure.org

Invetech_110For over 30 years, Invetech has been providing full-spectrum product realization services to create breakthrough products and custom automation systems for companies across the globe. Our experience spans a broad range of market sectors, including cell and advanced therapies, life sciences, laboratory diagnostics, point of care diagnostics, industrial and consumer products. Since 2004, Invetech’s Cell Therapy Group has helped realize clinical and commercial-scale cGMP manufacturing solutions for more than 25 cell and advanced therapy companies across the globe. We leverage our vast experience and deep understanding of the market, as well as the unique technology and business challenges our clients face, to design and deliver optimal cGMP manufacturing solutions that integrate off-the-shelf equipment and custom systems when needed. We have a proven process in which we work collaboratively with our clients to fully understand their therapy and current process, in order to propose cGMP manufacturing solutions that will not impact the therapy, compromise the cell performance or fundamentally alter the current process. We then develop a plan to successfully transition from the clinic to commercial-scale, and deliver scalable solutions that will ensure a consistent, repeatable product while also managing costs of goods and minimizing total cost of treatment. www.invetech.com.au

Invitrx Therapeutics is a leader in birth tissue research and pioneer in the field of regenerative stem cell therapies. Invitrx was established through wound healing funding in 2003 by CEO, Habib Torfi. In this time, Invitx has grown as an innovator of stem cell products and is developing therapies from amniotic stem cells, cord blood stem cells, placental stem cells and Wharton’s jelly stem cells. Our pursuit for innovation has led to a new $7 million facility being opened in Lake Forest, CA in July of 2018. This facility includes three clean rooms, a flow cytometry core and ultracentrifuges. These resources will push for exosomal research. Publishing in renowned journals has illuminated the age of exosomes and these minuscule molecules have the potential to attenuate diseases and possibly improve the quality of life for millions of people. Invitrx hopes to alleviate the symptoms of osteoarthritis and eliminate opioid dependency. www.invitrx.com

Kawasaki_120_websiteKawasaki is committed to providing customers unique business solutions with our innovative technologies to meet diverse societal needs worldwide. Our newly developed Automated Cell Processing System: AUTO CULTURE is intended for use in clinical research, practice and commercialization to support advances in regenerative medicine and cell therapy featuring the following capabilities: safe, stable and scalable automated production of cells; contamination control; high versatility and expandability; and reliable traceability. With our system you can reduce the initial investment in your cell processing facility as well as the running cost. Search “Kawasaki AUTO CULTURE” for more information.

LSCM_140x57Lake Street Capital Markets is a research-powered boutique investment bank focused on select, high-growth industries and companies. Our firm targets industry verticals that are undergoing structural changes or are at the front end of long-term secular growth cycles. Our research enables institutional investors to understand emerging secular trends and identify innovative companies best positioned to capitalize on them. We develop and deploy our intellectual capital to help institutional clients pursue opportunities and understand risk. Our investment banking team provides access to capital through equity underwriting, private placement, M&A and other corporate finance advisory services while helping build relationships to drive long-term growth. Since founding our firm in 2013, we have completed over 53 banking transactions and helped raise more than $1.9 billion of growth capital for our clients. At the core of everything we do is our commitment to providing informed advice and exceptional service to our clients. www.lakestreetcapitalmarkets.com

LatticePoint is a boutique consulting firm that works with various biopharma companies and investors to help define, establish and defend the value of their products in key markets around the world. LatticePoint is led by former industry market access leaders who understand how to plan for the political, scientific and financial realities that will be pivotal in negotiating product access. The output of our work product is used for product commercialization, valuations for investment decisions, licensing and M&A due diligence. Our clients consist of investors, start-ups, commercial-stage and post-LOE companies across a variety of therapeutic areas, for orphan and non-orphan indications, in oncology, genetic diseases, including cell and gene therapies and many others. LatticePoint has offices in Switzerland and the United States. www.latticepointconsulting.com

LMRI_150_websiteThe Lowy Medical Research Institute (LMRI) was established in 2005, with the goal of carrying out innovative research into human diseases. LMRI is currently focused on the study of a neuro-/vasculodegenerative disease of the retina, idiopathic juxtafoveal macular telangiectasia type 2, or MacTel. In addition to the Institute with a full time staff in La Jolla, California, LMRI supports multinational natural history and interventional clinical trials as well as international laboratory collaborations in North America, Europe, Asia and Australia. www.lmri.net

MEDIPOST_72x57MEDIPOST’s research and development is focused on novel off-the-shelf allogeneic stem cell therapeutics using umbilical cord blood-derived stem cells in the disease areas of Osteoarthritis (OA), Broncho-pulmonary Dysplasia (BPD) and Alzheimer’s disease (AD). MEDIPOST’s flagship product, CARTISTEM® for OA was approved by the regulatory agency in Korea as an allogeneic stem cell product in 2012 and to date, over 3,500 patients have been treated on the market with an excellent long-term safety and efficacy profile. CARTISTEM® has also successfully completed a Phase I/IIa trial in the U.S. PNEUMOSTEM® for the prevention of BPD in premature infants, completed Phase I and Phase II clinical trials in Korea, while currently undergoing a Phase I/II clinical trial in the U.S. PNEUMOSTEM® has received Orphan Drug Designation in Korea, the U.S. and EU. NEUROSTEM® for AD is in a Phase IIa clinical trial in Korea after successfully completing the first-in-human Phase I trial in Korea with patients suffering from AD. www.medipostamerica.com | www.medi-post.com

MeiraGTx is a vertically integrated, clinical stage gene therapy company with four ongoing clinical programs and a broad pipeline of preclinical and research programs. MeiraGTx has core capabilities in viral vector design and optimization and gene therapy manufacturing, as well as a potentially transformative gene regulation technology. Led by an experienced management team, MeiraGTx has taken a portfolio approach by licensing, acquiring and developing technologies that give depth across both product candidates and indications. MeiraGTx’s initial focus is on three distinct areas of unmet medical need: inherited retinal diseases, severe forms of xerostomia and neurodegenerative diseases. Though initially focusing on the eye, salivary gland and central nervous system, MeiraGTx intends to expand its focus in the future to develop additional gene therapy treatments for patients suffering from a range of serious diseases. www.meiragtx.com

Nordmark Biochemicals offers translational collagenases and other proteases used for tissue dissociation and cell isolation. The Collagenase NB products manufactured by Nordmark were previously marketed and distributed worldwide by SERVA. In 2018, Nordmark took over distribution in order to offer production, sales, marketing and support from one source. Our product portfolio includes Collagenase NB 6 GMP Grade for isolation of a variety of cells destined for clinical applications, and animal-free Collagenase AF-1 GMP Grade and Neutral Protease AF GMP Grade, the world’s first animal-free GMP grade products. Our pharmaceutical manufacturing standards result in high lot-to-lot consistency, safety and superior quality to guarantee cell viability and high yields. Supporting documentation and access to Drug Master Files are available for GMP grade users. More affordable research grade enzymes can be used for protocol development before transitioning to the GMP grades with similar enzymatic activities for an easy transition to the clinic. www.nordmark-biochemicals.com

OriGen Biomedical designs, manufactures and distributes a complete line of products for use in regenerative medicine applications including T-cell therapies and immunotherapies. Our products are FDA-approved, MDSAP-certified and CE-marked. The PermaLife Cell Culture Bag is an optimal way to protect critical cell cultures. PermaLife has a user inspired design including a sterile, needle-free, luer-actuated adapter which is self-sealing to make it easy to sample, feed and harvest sensitive cells. The PermaLife is also gas permeable and water impermeable which eliminates the need for a humidified incubator. The CryoStore Freezing Bag is the industry-preferred cryogenic freezing bag. The CryoStore Bag is available in a variety of configurations including a number of tubing and multi-bag options, allowing you to select the product that best fits your process. OriGen Biomedical supplies many complementary supplies to our bags such as product sampling syringes, tube sealers, overwraps, and cryopreservation solutions. www.origen.com

Informa Pharma Intelligence delivers the data and insights needed by the pharmaceutical and biomedical industry to make decisions and create real-world opportunities for growth. Its market leading products cover every perspective of key diseases, clinical trials, drug approvals or R&D projects and are supported by the breadth and depth its data and insights. www.pharmaintelligence.informa.com

Precision_130Precision BioSciences is a privately held biotechnology company dedicated to improving lives through its next generation gene editing technology, ARCUS. Precision’s approach is based on a proprietary synthetic enzyme, the ARC endonuclease, which features coordinated target site binding and DNA cutting to ensure precise editing outcomes. Uniquely small and monomeric, ARC nucleases are readily delivered to target sites throughout the genome and across cell types and tissues. The value of the ARCUS editing platform is enhanced by Precision’s extensive patent portfolio, established freedom to operate and deep collaborative relationships, positioning Precision to create products that solve significant problems in oncology, genetic disease, agriculture and beyond. Our team includes pioneers in genome engineering and a staff of experienced, committed Precisioneers. Working together in the vibrant innovation center of Durham, NC, we are excited to lead the next wave of medical and scientific possibilities through continuous gene editing innovation. www.precisionbiosciences.com

REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO’s NAV® Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology licensees are applying the NAV Technology Platform in the development of a broad pipeline of product candidates in multiple therapeutic areas. REGENXBIO is currently developing its own gene therapy product candidates in the retinal, metabolic and neurodegenerative therapeutic areas. Our gene therapy product candidates are designed to deliver genes to cells to address genetic defects or to enable cells in the body to produce therapeutic proteins that are intended to impact disease. Through a single administration, our gene therapy product candidates are designed to provide long-lasting effects, potentially significantly altering the course of disease and delivering improved patient outcomes. www.regenxbio.com

ReNeuron is a leading clinical-stage cell therapy development company. Based in the UK, ReNeuron has therapeutic candidates in clinical development for motor disability as a result of stroke, for critical limb ischemia and for the blindness-causing disease, retinitis pigmentosa. ReNeuron is also advancing its proprietary exosome technology platform as a potential new nanomedicine targeting cancer and as a potential delivery system for gene therapy treatments. ReNeuron’s shares are traded on the London AIM market under the symbol RENE.L. www.reneuron.com

time:matters is specialized in worldwide customized transportation of urgent and sensitive commodities like cells and tissues for regenerative medicine and cell and gene therapy in commercial state and clinical development. We provide an unique White Glove Airfreight Service being the handling partner for several airlines, maintaining access to your valuable shipments even beyond airport gates and ensuring special requirements like ‘do not x-ray’ and ‘upright loading first-hand’. Additionally, we offer solutions for temperature-controlled transports from cryo-preserved up until 37°C including return logistics of packaging. www.time-matters.com

A critical factor facing the industry is choosing technologies and partners that can deliver scale. The challenges inherent in translating early clinical trials to a reproducible and robust process suitable for scalable commercial production are very significant. Each personalized drug product ultimately depends on a sustainable and consistent supply chain with lots of moving parts. Configured to your exact demands, using an industry-standard framework, TrakCel’s comprehensive supply chain platform ensures every resource is managed, monitored, recorded and is ultimately performed exactly as required. From sample collection through logistics, manufacturing and final transplantation, with comprehensive chain of custody, chain of identity and traceability, TrakCel’s proven technology integrates and orchestrates every aspect of your autologous and allogeneic supply chains in a scalable, compliant and validated technology platform. www.trakcel.com

Headquartered in Research Triangle Park, Triangle Insights Group is a strategy consulting firm providing guidance on the most critical business issues to leaders in life sciences organizations. The firm’s approach combines deep knowledge of the industry across therapeutic areas and functional groups, with a dedication to creativity and disciplined critical thinking. Recommendations from Triangle Insights Group are original, relevant to the industry environment and supported by rigorous analytics. Clients of Triangle Insights Group include large pharmaceutical companies, emerging biotechnology firms, diagnostics manufacturers, medical device companies and private equity investors. www.triangleinsightsgroup.com

Universal Cells is developing stem cell therapies that overcome immune rejection and can be used to create truly off-the-shelf stem cell-based therapeutic products. Using the company’s proprietary genome editing approach, Universal Cells engineers stem cells to prevent expression of polymorphic human leukocyte antigen (HLA) molecules, removing the mechanism by which donor tissue rejection occurs and creating Universal Donor Stem Cells that are compatible with every patient. The company has established major strategic partnerships to help advance its Universal Donor Cell Program to the clinic. By combining the safest gene editing approach with a deep understanding of stem cell immunology, the company is positioned to play a central role in the commercialization of pluripotent cell-based therapies. www.universalcells.com

Voyager_110Voyager Therapeutics is a clinical-stage gene therapy company developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV (adeno-associated virus) gene therapy through innovation and investment in vector engineering and optimization, manufacturing and dosing and delivery techniques. The company’s pipeline is focused on severe neurological diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of amyotrophic lateral sclerosis (ALS), Huntington’s disease, Friedreich’s ataxia, frontotemporal dementia and Alzheimer’s disease and severe, chronic pain. Voyager has broad strategic collaborations with Sanofi Genzyme, the specialty care global business unit of Sanofi, and the University of Massachusetts Medical School. Founded by scientific and clinical leaders in the fields of AAV gene therapy, expressed RNA interference and neuroscience, Voyager Therapeutics is headquartered in Cambridge, MA. www.voyagertherapeutics.com

The Advanced Therapies business unit of WuXi AppTec is a Contract Development and Manufacturing Organization (CDMO) that reduces the complexities of the high-touch, multi-vendor biopharmaceutical production model by providing platforms that enable cell and gene therapies to be developed, manufactured and released faster and with greater predictability. Since 2004, WuXi AppTec has supported Advanced Therapy manufacturing programs from their Philadelphia, PA campus, which today includes over 220,000 square feet of GMP compliant manufacturing space. www.advancedtherapies.com

Yposkesi is the largest European CDMO for gene therapy vector manufacturing. Created in November 2016 in Corbeil Essonnes, France, as a spin-off from the world-class gene therapy pioneer Genethon, Yposkesi provides a full-service offer covering bioprocess development (USP and DSP), from small/pilot to large production scale, analytical development, GMP manufacturing of clinical lots of lentiviral vectors and regulatory support. Its current facility consists in a 50,000 sq. ft. building, operating four manufacturing suites for bulk drug substance and two Fill and Finish suites. This capacity will be expanded in 2021 with a large scale facility (50,000 sq. ft.) equipped with 2,000L bioreactors, designed for commercial production and compliant to EMA and FDA. Capitalizing on more than 25 years of expertise, Yposkesi significantly invests in innovation in bioprocessing to cost-effectively deliver on high quality projects. www.yposkesi.com

Event Supporters

Edison is one of the largest investment intelligence and access firms globally, staffed by over 120 professionals. Equity research is a key area of expertise, and our team of 80+ analysts produce research on over 700 companies. We also specialise in running non-deal roadshows throughout Europe and North America, arranging over 2,000 investor meetings last year, as well as a range of other services including perception surveys, EdisonTV and Commercial Due Diligence. Our client base consists of approximately 100 leading institutional investors and 500 corporate clients. We have a globally recognised research brand supported by offices in North America, Continental Europe and Asia Pacific, and a particular strength in healthcare with one of the largest and most respected team of healthcare analysts worldwide. www.edisongroup.com

The FreeMind Group is the premier international consulting firm specializing in assisting life science organizations to secure non-dilutive funding from U.S. federal agencies and private foundations. Founded in 1999, The FreeMind Group is the largest consulting group of its kind and works with a variety of life sciences organizations, from small startups to large pharmaceutical companies. FreeMind’s proven long-term strategic approach has garnered its clients over $1.5 billion to date in non-dilutive funding. The FreeMind team combines their extraordinary scientific understanding, innovative business and financial expertise and creative writing and presentation skills to cater to the specific and unique needs of academic and research institutions as well as the life science industry. www.freemindconsultants.com

The Maryland Stem Cell Research Fund was established by the Governor and the Maryland General Assembly during the 2006 legislative session. This fund is continued through an appropriation in the Governor’s annual budget. The purpose of the fund is to promote state-funded stem cell research and cures. To date, over $142 million and over 400 grants have been committed and for this year (FY2019) the program has a budget of $8.2 million. www.mscrf.org