The 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
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Dohmen 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
Audentes 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 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
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 works with Innovate UK. www.ct.catapult.org.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, 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 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
Cellular 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
Cognate Bioservices is a fully-integrated contract bioservices organization providing the highest level of scientific and management expertise. Cognate provides full development and cGMP manufacturing services to companies and institutions engaged in the development of cell-based products. The combination of highly experienced staff, cGMP facilities and an international track record makes Cognate one of the most experienced contract manufacturers of cell-based products in the world today. www.cognatebioservices.com
Cryoport is the premier provider of 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
At 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 (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
At 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 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’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 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.
MilliporeSigma, 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
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
Akron 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 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
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, 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
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.
Kawasaki 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.
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
Precision 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 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 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
“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.”