Platinum Sponsor

Thermo_234_websiteThermo Fisher Scientific is the world leader in serving science which uniquely positions us to partner with our customers to provide end-to-end cell therapy solutions. We understand that cell therapy is a dynamic industry with rapidly evolving technologies and processes and we are committed to helping our cell therapy customers 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 knowledge and experience allow us to provide comprehensive solutions to support every step of the cell 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

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

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

Gold Sponsors

Celyad_180_websiteCelyad is a leader in engineered cell therapy with clinical programs in regenerative medicine and oncology. Founded in 2007 with offices in the Walloon region of Belgium, Celyad is growing to become an international biotech having opened an office in Boston, Massachusetts. Celyad is developing a portfolio of assets through research collaborations with renowned scientific institutions in the U.S. and Europe. The Company’s lead product candidate in cardiology is C-Cure®, an autologous stem cell therapeutic using adult guided stem cells for the condition of ischemic heart failure. In oncology, NKR-2 is an autologous T cell product candidate using the natural killer receptor NKG2D, to target ligands present on both hematological and solid cancers, including ovarian, bladder, breast, lung and liver cancers, as well as leukemia, lymphoma and myeloma. This unique approach weaponizes a T cell to direct a robust immune response against cancer cells. www.celyad.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

Irvine-Scientific_220Irvine 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

Mesoblast_210_no-tagMesoblast 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

PCT_155_websitePCT, a Caladrius Company (PCT), a subsidiary of Caladrius Biosciences, is a leading contract development and manufacturing organization working to provide its clients with high quality, scalable, innovative, reliable and cost-efficient manufacturing platforms and services to advance commercialization of cellular therapies. PCT and Hitachi Chemical Co. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise. For more than 17 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. www.pctcaladrius.com

Quintiles_210_secondQuintiles (NYSE: Q) helps biopharma and other healthcare companies improve their probability of success by connecting insights from our deep scientific, therapeutic and analytics expertise with superior delivery for better outcomes. From advisory through operations, Quintiles is the world’s largest provider of product development and integrated healthcare services, including commercial and observational solutions. Conducting operations in approximately 100 countries, Quintiles is a member of the FORTUNE 500 and has been named to FORTUNE’s list of the “World’s Most Admired Companies.” www.quintiles.com

Sangamo_220_websiteSangamo BioSciences is a clinical-stage genome editing company focused on Engineering Genetic Cures™ for monogenic and infectious diseases. Sangamo is developing novel ZFP Therapeutics® for therapeutic genome editing and gene regulation based on its proprietary zinc finger DNA-binding protein (ZFP) technology platform. The Company has an ongoing Phase II clinical study to evaluate the safety and efficacy of a novel T cell based ZFP Therapeutic for the treatment of HIV/AIDS (SB-728), and an ongoing Phase I clinical trial of this same approach in hematopoietic stem cells (HSCs). Both strategies are designed to genetically engineer an HIV-resistant immune system that can achieve functional control of the virus. Sangamo is developing additional stem cell applications for monogenic diseases such as sickle cell disease and beta-thalassemia, and in vivo approaches for indications including hemophilia A and B, lysosomal storage disorders and Huntington’s disease. www.sangamo.com

SDI_210_websiteScottish Development International (SDI) has a proven track record of helping companies succeed in business in Scotland. SDI is the international arm of Scotland’s enterprise agencies. We can offer significant financial incentives and other assistance to help establish and grow your business in Scotland and worldwide. Scotland’s stem cell and regenerative medicine cluster delivers a “one-stop” solution for companies developing applications at preclinical, clinical or commercial stages of development. This dynamic commercial and academic landscape provides unique solutions across the whole supply chain including cell line supplies, screening, characterization, GMP manufacturing, QA/QC and a range of enabling technologies and other supporting services. Scotland has a proven track record in implementing cell therapy clinical trials using the world-class MHRA-accredited GMP ATMP manufacturing facilities. All of this expertise is in close proximity across Scotland with excellent connections to the rest of Europe. This makes Scotland the ideal location for academic research collaborations, stem cell technology research and development, clinical/translational research and cell line manufacturing. www.sdi.co.uk

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

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 2,000+ 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

AllCells_140Founded in 1998, AllCells is a biotechnology company dedicated to providing global researchers and biomanufacturing organizations with a dependable supply of biologically relevant, high quality primary cells that enable drug discovery, development and manufacturing of cell therapies. Leveraging its expertise in hematology and immunology cell isolations, combined with on-site whole blood and bone marrow clinical collection operations, AllCells maintains direct access to a large repository of diverse donor profiles that can be further screened and qualified for biomedical applications. Utilizing its contiguous cell processing facilities, freshly collected tissue is immediately processed into purified cell types with unparalleled quality consistency. This optimal work-flow provides for the highest viability, purity and cell count available. Fresh or frozen cells are shipped worldwide, or fresh cells can be immediately utilized in fee-for-service cell-based assays (“bioservices”) designed according to customer criteria – delivering cell culture results/data to meet client project timelines. www.allcells.com

Brammer-Bio_165Brammer Bio is a CDMO focused on process development and clinical and commercial supply of viral vector and cell and gene therapy products. We enable the delivery of novel medicines to improve patient health. Our highly skilled team of scientists with development, cGMP manufacturing and analytical experience, gained from over 100 client projects, enables us to tackle the challenges posed by these novel technologies and to accelerate their transition from the clinic to patients in need. Brammer Bio has the expertise and capabilities to support your gene and cell therapy projects to Phase III and beyond. www.brammerbio.com

Capricor_157x63Los Angeles-based Capricor Therapeutics is a clinical-stage biotechnology company focused on the development and commercialization of regenerative medicine and large molecule products for the treatment of diseases. Capricor’s lead product candidate, an allogeneic cardiosphere-derived cell (CDC) product, CAP-1002, aims to attenuate and potentially improve damage to the heart caused by a heart attack, and is currently under evaluation in the Phase I/II ALLSTAR clinical trial of patients 30-days to 1-year after a heart attack. Additionally, Capricor plans to explore development of exosome technology as a next generation regenerative medicine platform in a variety of cardiovascular and non-cardiovascular areas. Groundbreaking preclinical research has demonstrated that exosomes extracted from Capricor’s CDCs reduced scar tissue caused by a heart attack and prompted myocardial regeneration in preclinical models of ischemic heart disease. www.capricor.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 and 40,000 square feet in development for advanced cell manufacturing. 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

CDI_135_updatedCellular Dynamics International (CDI), a FUJIFILM company, is a leading developer and manufacturer of human cells used in drug discovery, toxicity testing, stem cell banking and cell therapy development. The Company partners with innovators worldwide to combine biologically relevant human cells with the newest technologies to drive advancements in medicine. CDI’s technology offers the potential to create induced pluripotent stem cells (iPSCs) from anyone, starting with a standard blood draw, and followed by the powerful capability to develop into any cell type in the human body. The Company’s proprietary manufacturing system produces billions of cells daily, resulting in inventoried iCell® products and donor-specific MyCell® Products in the quantity, quality, purity and reproducibility required for drug and cell therapy development. Founded in 2004 by Dr. James Thomson, a pioneer in human pluripotent stem cell research, Cellular Dynamics is based in Madison, Wisconsin, with a second facility in Novato, California. www.cellulardynamics.com

Cryoport_165Cryoport is the premier provider of cryogenic logistics solutions to the life sciences industry through its purpose-built proprietary packaging, information technology and specialized cold chain logistics expertise. We provide leading edge 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. Our packaging is built around our proprietary Cryoport Express® liquid nitrogen dry vapor shippers, which are validated to maintain a constant -150°C temperature for a 10 day dynamic shipment duration. Our information technology centers around our Cryoportal™ Logistics Management Platform, which facilitates management of the entire shipment process. Cryoport is the preferred cryogenic logistics solutions partner to the world’s largest shipping companies controlling more than 85% of the world’s air shipments. www.cryoport.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

GE_165_websiteGE Healthcare’s $4B Life Sciences business is on a mission is to accelerate an age of molecular and precision medicine by providing expertise, tools and solutions for a wide range of applications, including basic research of cells and proteins, drug discovery, cell therapy and regenerative medicine, as well as tools and technology to support large-scale manufacturing of biopharmaceuticals, vaccines and biologics such as insulin. It also supplies leading contrast, PET and nuclear medicine agents for diagnostic imaging to help doctors make more informed diagnoses for better patient outcomes. The company’s mission is to help enable a new era of molecular and precision medicine by providing customers with the tools, insight and knowledge to guide them ever more quickly from better biological understanding to better clinical therapies. www.gelifesciences.com

HemaCare_165x63HemaCare is a leading blood products and services company. HemaCare provides human-derived primary blood cells and tissues for advanced biomedical and preclinical research. Additionally, through its 38 years of apheresis collections experience, HemaCare supports autologous and allogeneic cell therapy ranging from process development, clinical trials and ultimately commercialized patient collections. www.hemacare.com

Histogenics_170_websiteHistogenics (NASDAQ: HSGX) is a leading regenerative medicine company developing and commercializing products in the musculoskeletal segment of the marketplace. Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions to treat musculoskeletal-related conditions. Histogenics’ first investigational product candidate, NeoCart®, is currently in Phase III clinical development. NeoCart is an autologous cell therapy designed to treat cartilage defects in the knee using the patient’s own cells. Knee cartilage defects represent a significant opportunity in the U.S., with an estimated 500,000 or more applicable procedures each year. 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, characteristics not exhibited in other current treatment options. The Company is also developing next-generation allogeneic therapies with Intrexon Corporation (NASDAQ: XON). www.histogenics.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

MaSTherCell_170MaSTherCell is a leading CDMO dedicated to cell therapy and located in Belgium, the European cluster for cell therapy. We provide manufacturing services for clinical Phase I, II, III and commercialization. We also help companies in their process and assay development based on our extensive expertise in cell types, bioprocessing and cGMP standards. Our 80 experts operate for worldwide customers in a state-of-the-art facility. MaSTherCell will double its production capabilities by Q1 2017. www.masthercell.com

MaxCyte_180MaxCyte’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

Medpace_170_websiteMedpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its physician-led, high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. With extensive medical expertise, a renowned regulatory affairs department and direct global operations in over 35 countries, 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. www.medpace.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

Organovo_160Organovo 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

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

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

Voyager_150Voyager Therapeutics is a clinical-stage gene therapy company developing life-changing treatments for severe diseases of the central nervous system. 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 CNS diseases in need of effective new therapies, including advanced Parkinson’s disease, a monogenic form of amyotrophic lateral sclerosis (ALS), Friedreich’s ataxia and Huntington’s disease. 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

Bronze Sponsors

Akron_100_websiteAkron Biotech is an innovative biotechnology company with a strategic focus on supplying GMP-qualified raw 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 an ISO-compliant company, 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

Aldevron_125Aldevron 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

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 six 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

Audentes_130Audentes Therapeutics is a biotechnology company committed to the development and commercialization of innovative new gene therapy treatments for people with serious rare diseases. We have four programs in our pipeline for the treatment of X-Linked Myotubular Myopathy (XLMTM), Pompe disease, CASQ2-related Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) and Crigler-Najjar Syndrome Type 1 (CN Type 1). We are a focused, experienced and passionate team driven by the goal of improving the lives of patients. www.audentestx.com

BioLife_165BioLife Solutions develops, manufactures and markets biopreservation media products and smart shipping containers connected to a cloud hosted cold chain management app to improve the quality of delivery logistics for cells, tissues and organs. BioLife also performs contract aseptic media formulation, fill and finish services. The company’s proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the biobanking, drug discovery and regenerative medicine markets. BioLife’s biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. BioLife’s enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues and organs. www.biolifesolutions.com | www.twitter.com/biolifesol

Biological-Industries_130x57For over 30 years, Biological Industries (BI) – a global leader in cell culture media development, molecular and diagnostic tools and stem cell research products – has been serving the life sciences industry in more than 50 countries worldwide. Today, we are excited to announce Biological Industries USA, a new division headquartered in the United States. Researchers around the country will have easy, direct access to BI’s entire product portfolio as well as access to our dedicated technical support and R&D scientists. Our stem cell culture media includes NutriStem® – a serum-free; xeno-free stem cell media for the growth and expansion of pluripotent stem cells and mesenchymal stem cells. Our product portfolio also includes MSCgo™ Differentiation Kits, CryoStem™ Freezing Media and many other serum-free, xeno-free custom media formulations designed for stem cell research. www.bioind.com

Brace-Pharma-Capital_100Brace Pharma Capital is a strategic investment firm formed by EMS S/A, the largest pharmaceutical company in Brazil. We invest in innovative, life changing therapies for diseases with a high degree of unmet medical need and insufficient treatment options. www.bracepharma.com

Cognate-updated_100_websiteCognate 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

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

GenVec_140_websiteGenVec is a clinical-stage gene delivery company focused on developing a pipeline of cutting-edge therapeutics and vaccines using its proprietary AdenoVerse™ gene delivery platform. The company is a pioneer in the design, testing and manufacture of adenoviral-based product candidates that can deliver on the promise of gene-based medicine. GenVec’s lead product candidate, CGF166, is licensed to Novartis and is currently in a Phase I/II clinical study for the treatment of hearing loss and balance disorders. In addition to its internal and partnered pipeline, the company is also focused on opportunities to license its proprietary technology platform, including vectors and production cell lines, for the development and manufacture of therapeutics and vaccines to the biopharmaceutical industry. www.genvec.com

IIAM_100_websiteThe International Institute for the Advancement of Medicine, IIAM, is a world-leading provider of healthy and diseased human organs and tissues for medical research, education and development. These tissues are recovered with minimal ischemia from organ transplant donors who have authorized use of the non-transplantable organs for research. Stored in preservation solution, the organs are shipped directly from the recovery suite and delivered to the researcher’s lab in 12-24 hours. Human tissues in research enable the faster development of more efficacious drugs with improved safety profiles and enhanced understanding of basic disease processes that directly affect humans. With access to over 15,000 organs for research each year, IIAM enables qualified researchers, scientists, healthcare and biotech professionals to obtain fresh, human tissues to explore cures for disease, and to develop new drugs, therapies and medical devices to advance medicine. www.iiam.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.

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

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.

Lattice-Point_110LatticePoint is a boutique consulting firm that focuses on pricing and market access for novel approaches to treating disease and on traditional pharmaceuticals. We specialize in technologies that are used to treat rare diseases in Europe and the U.S. We have offices in Geneva, Switzerland and New York City. 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 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

NuTech_90_websiteNuTech is a leading regenerative medicine company that provides an integrated portfolio of innovative products. They offer a wide range of allograft tissue products, and a complete line of innovative products taking advantage of the unique properties of the amniotic tissues and fluids. NuTech is dedicated to providing new technologies that will benefit surgeons, hospitals and most importantly, patients. www.nutechmedical.com

Pluristem_84Pluristem Therapeutics is a leading developer of placenta-based cell therapy products. The company has reported robust clinical trial data in multiple indications for its patented PLX (P Lacental eXpanded) cells. The cells release a range of therapeutic proteins in response to inflammation, ischemia, hematological disorders and radiation damage. PLX cell products are grown using the company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration. Pluristem has a strong intellectual property position; company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team. www.pluristem.com

Regeneus_125Regeneus is an ASX-listed clinical stage regenerative medicine company developing a portfolio of innovative cellular therapies for the human and animal health markets. Regeneus’ clinical focus is on osteoarthritis (OA), cancer, inflammatory skin conditions and wound care. The company’s product portfolio is underpinned by proprietary stem cell and immunotherapy technologies comprising: allogeneic off-the-shelf adipose derived mesenchymal stem cells (MSCs) for OA and other inflammatory conditions (Progenza for humans and CryoShot for animals); allogeneic off-the-shelf bioactive secretions from adipose derived MSCs for inflammatory skin conditions and wound care (for humans only); and autologous cancer immunotherapy that uses the patients’ own tumor cells and a bacterial adjuvant for immune recognition. www.regeneus.com.au

Sanofi_150Sanofi Genzyme, the specialty care business unit of Sanofi, focuses on rare diseases, multiple sclerosis, oncology and immunology. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. Our approach is shaped by our experience developing highly specialized treatments and forging close relationships with physician and patient communities. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world. www.sanofigenzyme.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

TiGenix_110_websiteTiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Two products from the adipose-derived stem cell technology platform are currently in clinical development. Cx601 is in Phase III for the treatment of complex perianal fistulas in Crohn’s disease patients. Cx611 has completed a Phase I sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product, AlloCSC-01, is currently in a Phase II clinical trial in acute myocardial infarction (AMI). In addition, the second product candidate from the cardiac stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being developed in a chronic indication. On July 4, 2016, we 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 United States. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain). www.tigenix.com

Wuxi_140_updatedWuXi AppTec U.S. Biologics Manufacturing and Testing provides a comprehensive range of integrated programs – along with expert technical and regulatory guidance – to help take biologic products from preclinical development all the way through to commercialization. Flexible, high-capacity (including commercial) cGMP manufacturing is offered for cell therapies, gene therapies and gene-mediated cell therapies. Testing services – including lot release, viral clearance and sterility assurance – utilize cutting-edge in vitro, in vivo, molecular and analytical methodologies. Our facilities – in St. Paul, Philadelphia and Atlanta – are FDA registered/ISO certified and dedicated to meeting the unique needs of our customers. www.wuxiapptec.com

Event Supporters

Edison_120_websiteEdison, founded in 2003, is a strategic advisory and investment research company. We service 450 corporate clients with investor relations, investment research and strategic consulting from our offices in North America, Europe and Asia. Edison’s renowned international investment research platform enables us to provide a highly differentiated approach to strategic advisory work based on deep multi-sector knowledge and extensive networks of investors, advisors and companies. www.edisongroup.com


    “Overall the Cell & Gene Meeting on the Mesa is one of our favorite meetings in the space. The combination of quality attendees, discussions, partnering software and venue are fantastic.”

    – Chris Moore, Terumo BCT