Thermo Fisher Scientific is the world leader in serving science. We understand that cell therapy is a dynamic industry with rapidly evolving technologies and processes. We help our cell therapy customers transition from discovery to clinical research and commercial manufacturing, with the breadth and depth of our portfolio of trusted and recognized products and services. Regardless of the type and source of your cells, we offer tools to help with every step of your cell therapy workflow. www.thermofisher.com
Interested in Sponsoring the Meeting?
Sponsorship opportunities for the 2016 Cell & Gene Meeting on the Mesa are now available. Please email Laura Parsons at email@example.com for further details. We look forward to working with you!
Celyad 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
Irvine 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 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
The 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 is part-funded by Innovate UK, formerly the Technology Strategy Board – the UK’s innovation agency. www.ct.catapult.org.uk | www.gov.uk/innovate-uk
CCRM, 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 is a premium supplier of high-quality reagents and tools for cell therapy and regenerative medicine applications. As the first company to obtain a GMP manufacturing authorization for cell processing in Europe, we have more than 20 years of expertise in GMP manufacturing and development of cell therapy products.
We offer a comprehensive product portfolio in combination with expert regulatory and technical support to ensure a seamless transition from research to commercialization. Our products combine a maximum of quality and safety due to the state-of-the-art production, stringent in-house quality control and comprehensive documentation. www.cellgenix.com
HemaCare 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 was incorporated in 2000 with an initial focus of developing products that meaningfully improve the lives of patients with defects in cartilage and joints. In May 2011, the Company acquired ProChon Biotech, a privately-owned biotechnology company based in Israel, which enabled a synthesis of products, technology and materials science by establishing a robust scientific and technology platform targeting tissue repair solutions. Histogenics’ goal is to become a leading regenerative medicine company developing, marketing and commercializing products in the musculoskeletal segment of the marketplace. The Company is building its core technology platform and plans to expand its clinical products’ therapeutic applications to develop new and innovative solutions for musculoskeletal conditions. Histogenics leverages a combination of the latest advances in molecular biology and proprietary materials sciences to create products designed to help improve patient outcomes. www.histogenics.com
Lonza 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 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
Medpace is a global full-service Clinical Research Organization (CRO) providing comprehensive development services for drug, biologic and device programs. 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 and direct global operations in over 40 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
MiMedx® 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 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 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
A critical factor facing the industry is choosing technologies and partners that can deliver scale. The challenges inherent in translating early clinical trials to a reproducible and robust process suitable for scalable commercial production are very significant. Each personalized drug product ultimately depends on a sustainable and consistent supply chain with lots of moving parts. Configured to your exact demands, using an industry-standard framework, TrakCel’s comprehensive supply chain platform ensures every resource is managed, monitored, recorded and is ultimately performed exactly as required. From sample collection through logistics, manufacturing and final transplantation, with comprehensive chain of custody, chain of identity and traceability, TrakCel’s proven technology integrates and orchestrates every aspect of your autologous and allogeneic supply chains in a scalable, compliant and validated technology platform. www.trakcel.com
Voyager 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
Akron 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
Cognate Bioservices is a fully-integrated contract bioservices organization providing the highest level of scientific and management expertise. Cognate provides full development and cGMP manufacturing services to companies and institutions engaged in the development of cell-based products. The combination of highly experienced staff, cGMP facilities and an international track record makes Cognate one of the most experienced contract manufacturers of cell-based products in the world today. www.cognatebioservices.com
CTI 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 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, Medtech 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
The International Institute for the Advancement of Medicine (IIAM) is the 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 14,000 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 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.
MEDIPOST’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 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
SCM 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 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 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/II trial in rheumatoid arthritis, as well as a Phase I sepsis challenge trial. Effective as of 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). Finally, TiGenix also developed ChondroCelect, an autologous cell therapy product for cartilage repair of the knee, which was the first Advanced Therapy Medicinal Product (ATMP) to be approved by the European Medicines Agency (EMA). From June 2014, the marketing and distribution rights of ChondroCelect were exclusively licensed to Sobi. www.tigenix.com
Edison is one of the largest investment intelligence and access firms globally, staffed by over 120 professionals. Equity research is a key area of expertise, and our team of 80+ analysts produce research on over 700 companies. We also specialise in running non-deal roadshows throughout Europe and North America, arranging over 2,000 investor meetings last year, as well as a range of other services including perception surveys, EdisonTV and Commercial Due Diligence. Our client base consists of approximately 100 leading institutional investors and 500 corporate clients. We have a globally recognised research brand supported by offices in North America, Continental Europe and Asia Pacific, and a particular strength in healthcare with one of the largest and most respected team of healthcare analysts worldwide. www.edisongroup.com
“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.”