Sponsors

Platinum Sponsor

PCT_350PCT is a leading development and manufacturing partner to the global cell therapy industry. For more than 18 years, PCT has provided preclinical and clinical cGMP development and manufacturing services to more than 100 clients, advancing cell therapy and immunotherapy product candidates from the development stage all the way through to commercialization. PCT offers manufacturing of cell therapy products, engineering and innovation services, process and analytical development, cell and tissue processing, collection and storage, logistics solutions and consulting. These services enable clients to focus on quality, cost of goods, scalability and sustainability as the foundational elements of commercial viability. PCT is a Hitachi Group Company. www.pctcelltherapy.com

Sponsor the Meeting!

cell-icon-hiresInterested in gaining extensive exposure to 850+ the leading stakeholders in the cell and gene therapy field? Sponsorship opportunities for this meeting are now available! Contact Laura Parsons for more information at lparsons@alliancerm.org

Program Partners

FIRM_155x68The Forum for Innovative Regenerative Medicine (FIRM) is the Japanese industry organization whose mission is to promote regenerative medicine. FIRM’s goal is to establish a stable and welcoming business environment to benefit patients in Japan and the world. FIRM works closely with the government to establish legislative, regulatory and business environments most suitable for the practice of regenerative medicine. FIRM works with academia to accelerate the transfer of research into commercialization. FIRM is comprised of member companies with diverse expertise in various technologies such as biotechnology, manufacturing and ancillary equipment. The organization is confident these group will foster biotechnology in the medical industry, along with the new regulatory and business environment established in Japan. FIRM was formed in 2011 and has grown to include more than 200 Japanese member companies in five years. As the first and only industry organization in this field in Japan, FIRM organizes ISO/TC 276 (Biotechnology) in Japan. Its main office is located in Tokyo. https://firm.or.jp/en

Sanford-Consortium_250The Sanford Consortium for Regenerative Medicine is a non-profit organization that marshals the intellectual resources of five world-leaders in life sciences research: the La Jolla Institute for Allergy and Immunology, the Salk Institute for Biological Studies, the Sanford-Burnham Medical Research Institute, The Scripps Research Institute and the University of California, San Diego. Using the collective strength of its members, the Consortium is creating tools and technologies to accelerate advances in stem cell research and developing diagnostics, therapies and cures for a wide range of chronic 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

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

ClearView_177x68Founded in 2007, ClearView Healthcare Partners is a global strategy consulting firm serving the life science sector. The firm combines international industry knowledge and deep scientific expertise across a range of therapeutic areas with an extensive network of external stakeholders to deliver practical and actionable recommendations to our clients’ most complex challenges. The firm’s projects include cross-functional support at the corporate, franchise and product levels for pharmaceutical, biotech, medical device and diagnostics companies worldwide. Pharma and biotech capabilities include: corporate growth strategy; corporate and business development strategy; franchise and therapeutic area assessment; new product planning; product and brand strategy; and pricing and market access strategy. www.clearviewhcp.com

Cryoport_185Cryoport is the premier provider of cold chain logistics solutions to the life sciences industry through our purpose-built proprietary packaging, information technology and specialized logistics expertise. We provide leading-edge cold chain 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 SmartpakII™ Condition Monitoring System, which provides visibility of the location and the key aspects of critical shipments. The SmartpakII™ 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

Dohmen_210Dohmen Life Science Services (DLSS) provides intelligent outsourcing to biopharma and medical device companies. With the broadest suite of services in the industry, DLSS has helped more than 600 companies connect more closely with their customers, grow their business and realize their vision. Whether it’s navigating regulatory requirements during development, commercializing products, managing daily operations or providing patient-centric care for the rare disease community, DLSS helps our clients advance with speed, scale and certainty. A member of the Dohmen family of companies. www.dlss.com

QuintilesIMS_210x68QuintilesIMS is a leading global healthcare provider of integrated information and technology-enabled services. QI is dedicated to helping its clients improve their clinical, scientific and commercial results. Formed through the merger of Quintiles and IMS Health, QuintilesIMS’s approximately 50,000 employees conduct operations in more than 100 countries. QuintilesIMS develops and implements solutions to help its clients maximize innovation and drive healthcare forward. www.quintilesims.com

Sangamo_185Sangamo Therapeutics, Inc. is focused on translating ground-breaking 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 advancing Phase 1/2 clinical programs in hemophilia A and hemophilia B, and lysosomal storage disorders MPS I and MPS II. Sangamo has a strategic collaboration with Bioverativ Inc. for hemoglobinopathies, including beta thalassemia and sickle cell disease, and with Shire International GmbH 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 Corporation and Dow AgroSciences. www.sangamo.com

Terumo_210Terumo BCT, a global leader in blood component, therapeutic apheresis and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing and pathogen reduction technologies. We believe in the potential of blood to do even more for patients than it does today. This belief inspires our innovation and strengthens our collaboration with customers. 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

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

Aldevron_150x63Aldevron is a recognized leader in contract manufacturing and development services for nucleic acids, proteins and antibodies. Founded in 1998, we provide companies with essential components for research, clinical and commercial applications. Our products have supported numerous programs in gene therapy, cell therapy and regenerative medicine from the bench to the bedside. Aldevron’s services include GMP-Source™ and GMP plasmid manufacturing, linear DNA and mRNA production, gene synthesis, RNA synthesis enzymes and fully human and recombinant antibody generation. Our collaborative approach and commitment to providing quality materials allow us to meet precise client requirements and provide innovative solutions to advance science. Aldevron’s headquarters is in Fargo, North Dakota and has facilities in Madison, Wisconsin and Freiburg, Germany. www.aldevron.com

Audentes_165Audentes Therapeutics (Nasdaq: BOLD) is a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases. We have 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). We are a focused, experienced and passionate team committed to forging strong, global relationships with the patient, research and medical communities. www.audentestx.com

Brammer-Bio_165Brammer 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

Catapult_160The Cell and Gene Therapy Catapult was established in 2012 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 100 employees focusing on cell and gene therapy technologies, we work with our partners in academia and industry to ensure these life-changing therapies can be developed for use in health services throughout the world. We offer 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. We aim to make the UK the most compelling and logical choice for UK and international partners to develop and commercialise these advanced therapies. Regenerative medicine is one of the UK government’s “eight great technologies” that support UK science strengths and business capabilities. The Cell and Gene Therapy Catapult works with Innovate UK. www.ct.catapult.org.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

CellGenix_170_websiteCellGenix is a leading global supplier of high quality raw materials in the expanding market of cell and gene therapy and regenerative medicine. We develop, manufacture and market recombinant human cytokines and serum-free media according to GMP. Our products combine a maximum of quality and safety due to state-of-the-art production, stringent in-house quality control and comprehensive documentation. In addition, we have more than 20 years of experience and offer expert regulatory and technical support. To ensure a seamless transition from research to commercialization we offer our products in preclinical and GMP grade. www.cellgenix.com

Cell-Therapies_170x63Cell 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

CDI_135_updatedCellular Dynamics International (CDI), a FUJIFILM company, is the leading developer and manufacturer of iPSC-derived human cells used in drug discovery, toxicity testing, stem cell banking and cell therapy development. Leveraging technology that can be used to create induced pluripotent stem cells (iPSCs) and differentiated tissue-specific cells from any individual, CDI is committed to advancing life science research and transforming the therapeutic development process to fundamentally improve human health. In addition to the commercially available iCell® and MyCell® Products, the company has four internal cell therapy programs in preclinical development (ocular, cardiac, Parkinson’s disease and CAR-T/NK). With our expanding cGMP resources, CDI employs our industry leading process development and manufacturing capabilities to also offer contract development and manufacturing services for partner cell therapy programs. www.cellulardynamics.com

Cognate_130x63Cognate 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

Draper_170x63Draper is a non-profit research and development company focused on the design, development and deployment of advanced technological solutions for the world’s most challenging problems. Draper’s Biomedical Solutions encompass organ-on-chip systems, cell therapy bioprocessing, rapid diagnostics and neurotechnology. Draper works closely with commercial partners to transition our technology into their hands, ensuring that our solutions provide enduring value. www.draper.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

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 more than 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

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. We are Janssen. We collaborate with the world for the health of everyone in it. Follow us at https://twitter.com/janssenglobal | www.janssen.com

Lonza_135_websiteLonza is one of the world’s leading suppliers to the pharmaceutical, healthcare and life science industries. Its products and services span its customers’ needs from research to final product manufacture. Lonza is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts, which play an important role in the development of novel medicines and healthcare products. Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. www.lonza.com

MaxCyte_180MaxCyte’s non-viral delivery platform allows for engineering of nearly all cell types, including human primary cells, with any molecule, at any scale for use in drug discovery and development, biomanufacturing, gene editing, cell therapy and immuno-oncology. Its consistency and minimal cell disturbance facilitate rapid, clinical and commercial grade cell engineering. www.maxcyte.com

Medpace_170_websiteMedpace is a global full-service Clinical Research Organization (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 a world leader in developing cellular therapies for patients with high, unmet medical needs. Harnessing the regenerative qualities found in its proprietary mesenchymal lineage adult stem cells (MLCs), Mesoblast is advancing a broad portfolio of product candidates in diseases including advanced heart failure, chronic low back pain due to disc degeneration and inflammatory conditions such as rheumatoid arthritis. Mesoblast’s leadership in cell-based medicine is evidenced by the recent launch by its Japan licensee of an MLC-based product for the treatment of life-threatening acute graft versus host disease (aGVHD). TEMCELL® HS. Inj. is the first allogeneic, regenerative medicine to receive full approval in Japan. Mesoblast expects its aGVHD product candidate, MSC-100-IV, to be the first “off-the-shelf”, allogeneic cell-based product launched in North America. Mesoblast has amassed critical intellectual property, manufacturing expertise and clinical experience that position the Company for success and support its efforts to improve patients’ lives worldwide. www.mesoblast.com

Millipore-Sigma_150MilliporeSigma, a life science leader, is a business of Merck KGaA, Darmstadt, Germany. We offer solutions that enable scientists to conduct life science research efficiently and economically. Our novel cell culture systems and characterization tools will meet your needs from stem cell research to cGMP manufacturing. Our highly validated, optimized products provide convenient solutions to many scientific challenges, so you have the time to focus on your research and clinical goals. www.emdmillipore.com

MiMedx_160MiMedx® is the premier processor of regenerative biomaterial products and implants from human amniotic membrane. MiMedx has distributed hundreds of thousands of amniotic tissue grafts worldwide. Profound clinical outcomes have been achieved in therapeutic areas including ophthalmology, spine, wounds, dental, orthopedic, surgery, sports medicine and urology. With this innovative allograft that promotes bioactive healing, MiMedx believes its intellectual property and proprietary processing technique strategically positions the Company as the leader in this area of regenerative medicine. www.mimedx.com

Oxford-BioMedica_170x63Oxford BioMedica has 20 years of experience in the field of gene and cell therapy and we were the first organization to treat humans in vivo lentiviral based vectors. Today, we have built our LentiVector® platform of exclusive cutting-edge technologies and capabilities with which we design, develop and produce gene and cell-based medicines for ourselves and for our partners. We already have product-related partnerships with Novartis, Immune Design, Orchard Therapeutics, licensed products and technology rights to Sanofi and GSK, and a research and development collaboration with Green Cross LabCell. Finally, we have our own proprietary pipeline of gene and cell therapy products addressing neurodegenerative and ocular diseases and a range of cancers for which there are either no treatments, or where therapy remains inadequate. www.oxfordbiomedica.co.uk

StemBioSys_190_websiteStemBioSys is a privately-held biomedical company focused on enabling optimized isolation, growth and delivery of adult stem cells for research, therapeutic or drug discovery applications. Its patented technology platforms – licensed from the University of Texas Board of Regents – overcome key obstacles to creating clinically useful stem cell therapies. The centerpiece of these enabling technologies is the HPME (High Performance Micro Environment) platform. This cell derived 3-dimensional microenvironment allows a variety of stem cells to replicate more rapidly, maintain a small cell size and express markers indicative of retained stem cell potency beyond that seen with more traditional tissue culture substrates. StemBioSys’ first commercial product BM-HPME®, is currently available to the stem cell research market. With directed collaborations and further research we hope to extend the disruptive technology presented by our HPME® platform to drug discovery and therapeutic applications. www.stembiosys.com

Stemonix_140Our mission is to accelerate the discovery of new medicines with physiologically-relevant, structured human cells in high density plates. We develop and manufacture human induced pluripotent stem cell (iPSC) derived cardiac and neural platforms for high throughput drug toxicity and efficacy screening. Predictive, accurate and consistent, our human models enable scientists to quickly and economically conduct research in a simplified workflow. Our microHeart® products provide researchers with structurally aligned cardiac cells resembling native human heart tissue with accelerated features of cell maturity, essential in predicting drug toxicity and efficacy. Our microBrain® products are physiologically mature with relevant biology and functionality that mimic human brain tissue. We also collaborate with organizations to test their compounds with our in-house screening capabilities, create new cell models and operationalize their human cells for high throughput screening. With leading-edge iPSC technologies, we are helping global institutions bring the most promising medicines to patients. www.stemonix.com

Synpromics_155x63Synpromics 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

TrakCel_150x63A 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

Bronze Sponsors

ACF_120x57ACF Bioservices (an Absorption Systems company) has the expertise and relevant experience needed to provide analytical support for gene and cell therapy products through every stage of development. Potency assays are on the critical path and ACF offers de novo development, optimization, qualification, validation and GMP compliant final product and product release testing services for both allogenic and autologous therapies. We have the capability to develop both in vitro and in vivo models to better predict human outcomes and correlations between animal studies and in vitro cell-based assays. Our fully compliant facilities and studies have been inspected by the FDA, USDA and AAALAC. ACF has over 20 years of business operating expertise developing proprietary assays, combining our skills in cell and molecular biology, assay development and validation, bioanalytical and immunochemical quantitation, statistical analysis and regulatory affairs in a single-source collaboration. www.absorption.com/potency

AGTC_90AGTC is a clinical-stage biotechnology company that uses its proprietary gene therapy platform to develop products designed to transform the lives of patients with severe diseases, with an initial focus in ophthalmology. AGTC’s lead product candidates are designed to treat inherited orphan diseases of the eye, caused by mutations in single genes that significantly affect visual function and currently lack effective medical treatments. AGTC’s pipeline includes six ophthalmology development programs across five targets (XLRS, XLRP, achromatopsia, wet age-related macular degeneration and blue cone monochromacy), two non-ophthalmology programs (alpha-1 antitrypsin deficiency and adrenoleukodystrophy) and AGTC is continuing to develop early research studies in additional indications. The company is also exploring genetic defects in cells in the inner ear that lead to deafness and expects to advance several product candidates into development within the next few years. 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 (AMI), acute respiratory distress syndrome (ARDS) 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

Be-the-Match_140x57Be 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 technology platform. Our experience in cell sourcing and collection allows us to provide cells consented for research, clinical or commercial use. Researchers have access to CRO services through our research program CIBMTR® (Center for International Blood and Marrow Transplant Research®). And, we have the infrastructure in place to collect, store and analyze patient samples post-cell or gene therapy treatment at the time points required by regulatory authorities. Discover how Be The Match BioTherapies can provide the solutions you need. www.bethematchbiotherapies.com

Bioreclamation_150x57_websiteBioreclamationIVT is a worldwide provider of biological and in vitro products to pharmaceutical and biotechnology organizations. We specialize in control and disease state matrices derived from human and animal blood, plasma, serum and other tissue types, which are used in drug discovery, compound development, clinical research and diagnostics and regenerative medicine. We have access to over 100 IRB-approved collection sites to source tissue and primary cells from healthy, normal or disease state donors. Utilization of our cell processing services affords researchers consistent, high quality cell products for use in their assays. Our products include whole blood, leukopaks, buffy coat, bone marrow and CPT collections, which can be further processed into PBMCs or other purified cell populations like B Cells, Monocytes, NK Cells, T Cells and more. Look to BioreclamationIVT for catalog and custom cell preparations to eliminate upstream variability and put your research on the fast-track to success. www.bioreclamationivt.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

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

EBD_60_websiteEBD Group is the leading partnering firm for the global life science industry. Since 1993, biotech, pharma and medical device companies have leveraged EBD Group’s partnering conferences, technology and services to identify business opportunities and develop strategic relationships essential to their success. Our conferences, run with the support of leading corporations and international trade associations, include BIO-Europe®, BIO-Europe Spring®, BioPharm America™, BioEquity Europe, ChinaBio® Partnering Forum, Biolatam® and Biotech Showcase™. EBD Group’s sophisticated web-based partnering service, partneringONE®, is used as the partnering engine at numerous third-party events around the world, and partnering360® is the open online community of life science dealmakers that enhances partnering experiences throughout the year. EBD Group is an Informa company. Informa is the largest publicly-owned organizer of exhibitions, conferences and training in the world. www.ebdgroup.com

Evidera_100x57Evidera, Evidence, Value & Access by PPD is a leading provider of evidence-based solutions to demonstrate the real-world effectiveness, safety and value of biopharmaceutical and biotechnology products. We leverage expert knowledge of the global payer and regulatory landscape to help biopharmaceutical and biotechnology companies generate the evidence needed to optimize the market access and commercial potential of their products. 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

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. We focus on oncology, orthopedics and dental support through our cord blood bank, our National Marrow Donor Program apheresis center and our deceased donor tissue bank. Leveraging these core resources and in-house skills including GMP manufacturing, 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

Informa_110_websiteInforma is one of the world’s leading knowledge providers. We create and deliver highly specialized information through publishing, events, training, market intelligence and expertise, providing valuable knowledge to individuals, businesses and organizations around the world. Informa provides authoritative research and analysis and up-to-the-minute business news, comment and events for all sectors of the healthcare, medical and life sciences communities. Informa Business Information (IBI) is one of the world’s leading providers of industry and drug news, analysis and data to the global pharmaceutical industry.
www.informa.com

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

jCyte_80x57jCyte is a clinical-stage company focused on the application of patented progenitor cell-based technology in retinal diseases. The allogeneic jCell product can be delivered by simple intravitreal injection, without the need for surgery or immune suppression. A phase I/IIa trial in retinitis pigmentosa (RP) has enrolled 28 patients and completion is expected in August, 2017. Initial data indicate that jCell is well tolerated without immune suppression. Preliminary indications of activity have been sufficient to apply to the FDA for RMAT designation, which was granted in April, 2017. An extension trial is underway that includes dosing of the fellow eye and a follow-on trial is in place to demonstrate clinical proof-of-concept. jCyte is in the process of defining an efficient path to approval in partnership with the FDA and additional retinal disease indications for jCell are currently under investigation. www.jcyte.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; Reliable traceability. With our system you can reduce the initial investment in your cell processing facility (CPF) 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 provide 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

MEDIPOST_72x57MEDIPOST’s R&D 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 E.U. 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

Organovo_130Organovo designs and creates functional, three-dimensional (3D) human tissues for use in medical research, cosmetic and therapeutic applications. The Company develops 3D human tissue models through internal development and in collaboration with pharmaceutical, cosmetic and academic partners. Organovo’s 3D human tissues have the potential to accelerate the discovery process, enabling drug treatments and active agents to be developed faster and at lower cost. The Company recently launched its exVive3D™ Liver for use in toxicology and other preclinical drug testing. We work across a number of disease areas in multiple tissue types with market leaders in the pharmaceutical and cosmetic industries. www.organovo.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

SCM_110SCM Lifescience was established in 2014 with the vision of developing treatment options for difficult to treat diseases to provide a new source of hope for patients and contribute to the welfare of humanity as a whole using proprietary stem cell isolation and production technologies. Through over 10 years of R&D, 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) and high-purity stem cell production technology (U.S. registered patent, 2014). Based on these technical breakthroughs, high-purity stem cell therapy shall be provided to treat various immunological conditions such as graft-versus-host disease, acute pancreatitis, liver cirrhosis, atopic dermatitis, diabetes and asthma. With our proprietary technology, SCM will continue to pursue excellence in the fields of stem cells and regenerative medicine to become an internationally recognized leader in these fields. www.scmlifescience.com

SERVA_110x57SERVA offers enzymes for high-yield isolation of viable cells, including the world’s first animal-free GMP grade products, Collagenase AF-1 GMP Grade and Neutral Protease AF GMP Grade. The product portfolio also includes SERVA’s Collagenase NB 6 GMP Grade, particularly suitable for isolation and passaging of stem cells destined for clinical applications. The pharmaceutical manufacturing standard guarantees stringent quality control, reliable lot-to-lot consistency and low endotoxin levels. Supporting documentation and access to Drug Master Files are available for GMP grade users. More affordable research grade collagenases can be used for protocol development before transitioning to the GMP grade alternatives with similar enzymatic activities for clinical cell isolation applications. SERVA translational enzymes: research and GMP grade collagenase and neutral protease enzymes – from research to the clinic. Don’t get lost in translation. Take the direct route with SERVA. www.serva.de

TiGenix_110_websiteTiGenix NV (Euronext Brussels [and NASDAQ]: TIG) is a biopharmaceutical company developing and commercializing novel therapeutics which exploit the anti-inflammatory properties of allogeneic, or donor-derived, stem cells generated by its proprietary platform technologies. TiGenix’s lead product, Cx601, has successfully completed a European Phase III for the treatment of complex perianal fistulas – a severe, debilitating complication of Crohn’s disease. Cx601 has been filed for regulatory approval in Europe and a global Phase III trial intended to support a future U.S. Biologic License Application (BLA) is expected to start in 2017. TiGenix has entered into a licensing agreement with Takeda, a large pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to commercialize Cx601 for complex perianal fistulas outside the U.S. Our second adipose-derived product, Cx611, is undergoing a Phase I/II trial in severe sepsis – a major cause of mortality in Western world hospitals. Finally, AlloCSC-01, targeting acute ischemic heart disease, has demonstrated positive results in a Phase I/II trial in acute myocardial infarction (AMI). TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain). www.tigenix.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, Massachusetts. www.voyagertherapeutics.com

Marketing Partner

Antenna_80x57Antenna is a leading communications agency working in life sciences, helping entrepreneurial companies achieve breakthrough velocity. Our unrivaled domain expertise means we hit the ground running on day one, and our genuine passion for the industry yields better results across the board. From landing on the front page of The Wall Street Journal to strategically targeting the medical or investor communities, Antenna’s clients earn unparalleled opportunities to tell their stories to global audiences. www.antennagroup.com