Organized By

The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory, and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, D.C. to specifically represent the interests of the companies, research institutions, investors, and patient groups that comprise the entire regenerative medicine community. Today, ARM has more than 350 members and is the leading global advocacy organization in this field. www.alliancerm.org

Platinum Sponsors

Audentes Therapeutics is a leading AAV-based genetic medicines company focused on developing and commercializing innovative products for serious rare neuromuscular diseases. The company is leveraging its AAV gene therapy technology platform and proprietary manufacturing expertise to develop programs across three modalities: gene replacement, vectorized exon skipping, and vectorized RNA knockdown. The company’s product candidates are showing promising therapeutic profiles in clinical and preclinical studies across a range of neuromuscular diseases. Audentes is a focused, experienced, and passionate team driven by the goal of improving the lives of patients. www.audentestx.com

At Lonza Pharma & Biotech, we provide contract development and manufacturing services that enable pharma and biotech companies to bring medicines to patients in need. From the building blocks of life to the final drug product, our solutions are created to simplify your outsourcing experience and provide a reliable outcome when you expect it. Our extensive track record includes commercialization of pioneering therapies and manufacturing of a wide variety of biological and chemical drugs. We continuously invest to solve not just the current, but also the future challenges. Together, let’s bring your next medicine to life. www.lonza.com

Program Partner

FIRM_155x68The Forum for Innovative Regenerative Medicine (FIRM) is a Japanese industrial association, with the mission to promote the expedition of regenerative medicine and cell and gene therapy industrialization. FIRM works closely with the Japanese government to develop regulatory legislation and systems to establish business environments that are most suitable for the practice of regenerative medicine and cell and gene therapy. FIRM also collaborates with academia to accelerate the translation of basic research into commercial products. Established in 2011 with merely 14 companies, FIRM currently has over 250 members comprising Japan-registered companies from diverse business sectors that are vital to regenerative medicine and cell and gene therapy industrialization, e.g. the pharmaceuticals, biotechnology, chemicals, engineering, equipment, transportation, and insurance sectors. FIRM chairs ISO/TC 276 (Biotechnology) committee and leads a working team in Japan, which is the first and sole case for industrial association of this kind in the country. FIRM’s main office is located in Tokyo. https://firm.or.jp/en

Gold Sponsors

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

Atara Biotherapeutics is a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune, and viral diseases. Atara’s technology platform leverages research collaborations with leading academic institutions with the company’s scientific, clinical, regulatory, and manufacturing expertise. Atara’s pipeline includes tab-cel® (tabelecleucel), which is in Phase III development for patients with Epstein-Barr virus-associated post-transplant lymphoproliferative disorder (EBV+ PTLD) as well as other EBV-associated hematologic malignancies and solid tumors, including nasopharyngeal carcinoma (NPC); T-cell immunotherapies targeting EBV antigens believed to be important for the potential treatment of multiple sclerosis; and next-generation chimeric antigen receptor T-cell (CAR T) immunotherapies for cancer as well as targets in other therapeutic areas. The company was founded in 2012 and is co-located in South San Francisco and Southern California. Our Southern California hub is anchored by the state-of-the-art Atara T-Cell Operations and Manufacturing (ATOM) facility in Thousand Oaks, California. www.atarabio.com

BioLife Solutions is a leading supplier of cell and gene therapy biopreservation tools. Our proprietary CryoStor® freeze media and HypoThermosol® shipping and storage media are highly valued in the regenerative medicine, biobanking, and drug discovery markets. These biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death. Our recently acquired ThawStar® family of automated cell thawing devices reduce therapeutic and economic risk for cell and gene therapy developers by reducing the potential of administering a non-viable dose. www.biolifesolutions.com

BlueRock_220BlueRock Therapeutics is an engineered cell therapy company with a mission to develop regenerative medicines for intractable diseases. BlueRock’s Cell+Gene platform harnesses the power of cells for new medicines across neurology, cardiology, and autoimmune indications. BlueRock’s cell differentiation technology recapitulates the cell’s developmental biology to produce native cell therapies which are further engineered for additional function. Utilizing these cell therapies to replace damaged or degenerated tissue brings the potential to restore or regenerate lost function. BlueRock was founded in 2016 by Versant Ventures and capitalized with one of the largest-ever Series A financings in biotech history by Bayer AG and Versant. BlueRock’s culture is defined by scientific innovation, the highest ethical standards, and an urgency to bring transformative treatments to all who would benefit. www.bluerocktx.com

Brammer Bio, part of Thermo Fisher Scientific, is a leading viral vector CDMO for companies developing gene-modified cell therapies and in vivo gene therapies. Brammer provides process and analytical development, clinical and commercial supply of viral vector drug substance and drug product, and regulatory support, enabling our clients to bring novel medicines to market. Brammer is flexible to support every client’s unique product needs, timelines, and regulatory pathways. Through recent investments in our world-class facilities and planned expansion, we are strategically positioned to support your immediate and long-term viral vector manufacturing needs. www.brammerbio.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

Covance, headquartered in Princeton, New Jersey, is the drug development business of Laboratory Corporation of America Holdings (LabCorp). Covance and LabCorp are at the forefront of the development of cell and gene therapies based on its well-established, unique expertise and coordinated capabilities in scientific, regulatory, and commercial areas across preclinical, clinical, and post-approval phases. COVANCE is a registered trademark and the marketing name for Covance Inc. and its subsidiaries around the world. www.covance.com

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

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

Hitachi Chemical Advanced Therapeutics Solutions (HCATS) is a wholly owned subsidiary of Hitachi Chemical Company, Ltd. representing Hitachi Chemical’s Regenerative Medicine Business Sector in the U.S. For the last 20 years, HCATS has exclusively focused on the cell therapy industry to provide contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. www.pctcelltherapy.com

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

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

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 and 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. www.medpace.com

For 30 years, Miltenyi Biotec has been a leader in the design, development, manufacture, and integration of products that enable cell and gene therapy (CGT), leading to new treatment options for patients with unmet medical needs. With technologies ranging from clinical-grade cell separation platforms to tailored cell processing protocols for the fully automated and enclosed, GMP-compliant CliniMACS Prodigy®, we offer comprehensive CGT support, including contract development and manufacturing of CGT products and tailored GMP lentiviral vectors. Today, our products have been used in more than 50,000 cell therapy procedures. In addition, the automated CliniMACS® Cell Separation System, in combination with high-quality MACS GMP and CryoMACS® products, has been used for the consistent generation of cellular products that are used in a wide range of clinical applications. www.miltenyibiotec.com

Rare disease includes some of the most serious of all illnesses and impacts millions of patients worldwide, representing an opportunity to apply our knowledge and expertise to help make a significant impact on addressing unmet medical needs. The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including hematology, neuroscience, and inherited metabolic disorders. Pfizer Rare Disease combines pioneering science and deep understanding of how diseases work with insights from innovative strategic collaborations with academic researchers, patients, and other companies to deliver transformative treatments and solutions. We innovate every day, leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures. www.pfizer.com/science/rare-diseases

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

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

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

World_Courier_220World Courier provides unparalleled specialty logistics services to drive the commercial success of our partners around the globe. For 50 years, we’ve delivered peace of mind through world-class supply chain programs, transportation services, and storage of time and temperature sensitive products. We are redefining what’s possible by providing dedicated solutions for innovative, cutting-edge medicines including cell and gene therapies and through our daily work, we are united in our responsibility to create healthier futures. With a presence in over 50 countries and powered by our 2,700+ associates, World Courier is driven by a commitment to excellence and provides customized solutions with global reach to increase access to healthcare; making us the most trusted specialty logistics company in the world. www.worldcourier.com

Yposkesi is one of the largest contract development and manufacturing organizations (CDMO) in Europe for AAV and lentiviral vector production. A spin-off from the world-class gene therapy pioneer Genethon, Yposkesi capitalizes on more than 20 years of expertise in biotherapeutic research to offer customers fully integrated services; bioprocess development (USP and DSP), from small/pilot to large production scale, analytical development, GMP manufacturing of clinical batches of lentiviral and AAV vectors, and regulatory support. Its current 50,000 square foot (approx. 5,000 square meter) state-of-the-art facility designed for high efficiency houses four independent manufacturing suites for bulk drug substance and two Fill and Finish suites. Yposkesi is extending this capacity. By 2021, it will double its global footprint to 100,000 square feet (approx. 10,000 square meters) with a second large-scale facility designed for commercial production and EMA and FDA compliance. Yposkesi invests significantly in innovation and bioprocessing to deliver on high quality projects, cost-effectively. www.yposkesi.com

Silver Sponsors

Abeona Therapeutics is a fully-integrated gene and cell therapy company at the forefront of the rapidly-advancing field of genetic medicine. The company’s multi-platform expertise across research, development, manufacturing, and discovery uniquely positions us to bring novel medicines to patients with life-threatening rare diseases. www.abeonatherapeutics.com

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases. www.amicusrx.com

Be The Match BioTherapies is the only cell and gene therapy solutions provider with customizable services to support the end-to-end cell therapy supply chain. Backed by the industry-leading experience of the National Marrow Donor Program®/Be The Match®, and a research partnership with the CIBMTR® (Center for International Blood and Marrow Transplant Research®), the organization designs solutions that advance cell and gene therapies in any stage of development. Be The Match BioTherapies is dedicated to providing high-quality cellular starting material consented for research, clinical, and commercial use, developing and managing expansive cell collection networks, and navigating cell therapy regulatory compliance. Using proven infrastructure to successfully manage cell therapy supply chains, including MatchSource® Supply Chain Software, personalized case managers and logistics experts, the organization has a history of compliance managing the chain of identity. The collaboration with CIBMTR extends services to include long-term follow-up tracking for the first two FDA-approved CAR T therapies. www.bethematchbiotherapies.com

Bio-Rad is a global leader with a team of over 7,800 employees and a global network of operations that serves life science research and clinical diagnostics customers, helping people live longer, healthier lives. Driven by the desire to be your partner in the cell and gene therapy industry, we are here to support your product stability and expression, protein purification, antibody development and selection, cell phenotyping, on/off-target effects, and predictive biomarker applications. Understanding the importance of quality in manufacturing, we offer platforms to simplify your workflow for viral titer, vector copy number, residual DNA, and protein expression profiling. www.bio-rad.com

Paragon Gene Therapy, a unit of Catalent Biologics, is an industry leader focusing on transformative technologies, including gene therapies (AAV), next-generation vaccines, and oncology immunotherapies. Paragon Gene Therapy has two facilities in Baltimore, Maryland dedicated to process development through commercial manufacturing of most scalable AAV platforms across multiple serotypes. Since 2016, Paragon Gene Therapy has completed over 100 clinical cGMP AAV batches across 40 programs. www.paragonbioservices.com

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

CCRM_135CCRM, a Canadian not-for-profit organization 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 new companies and 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 research facility used to both evaluate and advance technologies, a Centre for Advanced Therapeutic Cell Technologies, and a 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

Ce3 is a full-service CRO with a focus in oncology, providing support and services exclusively to biotech companies. We specialize in early phase development, managing studies from FIH (first in human) to accelerated approval. Having a therapeutic concentration promotes refinement of our expertise, skills, and tools throughout the organization. We leverage best practices and sharpen efficiencies across each service area to support our clients in the most cost-effective manner. We deliver quality data faster, easier, and better to facilitate timely decision making. Our team is energized by the complexities and challenges of the ever-changing landscape that defines oncology research. Our name, Ce3, represents our core values and serves as the foundation of our operations: a collaborative approach in managing studies with experience, efficiency, and excellence! www.ce3inc.com

CJ Partners (CJP) is a Tokyo-based life science consultancy that provides regulatory and financial advisory services, as well as consulting services, to biotechs looking to enter the Japanese market. Founded in 2012, CJP has been a leader in the regenerative medicine space following the 2014 regulatory reforms that opened the door to new development opportunities in Japan. According to publicly released data, CJP has conducted a sizable portion of all official regenerative medicine consultations with the PMDA, making CJP the most experienced advisory firm in the field. CJP maintains strong relationships with numerous doctors, clinics, and hospitals around the nation as well as with the many banks, VCs, and other investment funds in Japan that are actively looking to invest in the right opportunities. CJP additionally maintains several proprietary databases regarding regen med clinical trials and products in development in Japan and around the globe. www.cj-partners.com/en

Cryoport is the life sciences industry’s most trusted global provider of temperature-controlled logistics solutions for temperature-sensitive life sciences commodities, serving the biopharmaceutical market with leading-edge logistics solutions for biologic materials, such as regenerative medicine, including immunotherapies, stem cells and CAR T-cells. Cryoport’s solutions are used by points-of-care, CROs, central laboratories, pharmaceutical companies, manufacturers, university researchers; as well as the reproductive medicine market, primarily in IVF and surrogacy; and the animal health market, primarily in the areas of vaccines and reproduction. Cryoport’s proprietary Cryoport Express® Shippers, Cryoportal® Logistics Management Platform, leading-edge SmartPak II™ Condition Monitoring System, and geo-sensing technology, paired with unparalleled cold chain logistics expertise and 24/7 client support, make Cryoport the end-to-end cold chain logistics partner that the industry trusts. www.cryoport.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, Ohio, with operations across North America, Europe, Latin America, and Asia-Pacific. www.ctifacts.com

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

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

EVERSANA is the leading independent provider of global services to the life science industry. From industry-leading patient service and adherence support to global pricing and revenue management, EVERSANA creates value across the life cycle for patients, prescribers, channel partners, and payers. www.eversana.com

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

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

Fresenius Kabi is a leading global health company that focuses on pharmaceuticals and medical devices used to care for critically and chronically ill patients. We bring over 60 years of experience advancing the fields of cell collection and separation with expertise in closed-system processing. Our Lovo Cell Processing System is the only cell processing system that washes and concentrates white blood cells using filtration technology, specifically to serve the needs of the cellular therapies community. www.chooselovo.com

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

FUJIFILM Diosynth Biotechnologies is a world leading cGMP contract development and manufacturing organization (CDMO) supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines, and advanced therapies. With over 25 years of experience in process development and cGMP manufacturing, a dedicated staff of over 2,000, and a reputation for excellent customer service, flexibility, and responsiveness, we’ve become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry. Our process development experience includes the development of processes for molecules expressed via fermentation (E. coli, P. pastoris), cell culture systems including CHO, HEK, Vero, MDCK, EB66 and insect cells, and from transgenic sources. Our network expands within four development and manufacturing facilities located in Billingham, UK; Hillerød, Denmark; Research Triangle Park, North Carolina, and College Station, Texas.

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

Innoforce Pharmaceuticals is located in Hangzhou Airport Economic Demonstration Area. With an investment of $300 million, the first phase of Innoforce’s campus covers an area of about 21 acres, with a total construction area of nearly 170,000 square meters. Innoforce’s founders Dr. Guoliang-Yu and Dr. Yuling Li are both former CBA presidents. The campus includes biologic process development laboratories, scale-up lab and pilot facility, and several sets of 2000L antibody production line with commercial CMP production capacities, plus gene therapy manufacturing suites. Innoforce’s goal is to establish top tier global development and biomanufacturing capabilities to facilitate development and commercialization of innovative medicines. www.innoforce.com.cn

InVitria develops and commercializes high performance excipients, supplements, and media formulations that are used in cell therapy, CAR-T, gene therapy, cell-based vaccines, diagnostics, medical devices, biomanufacturing, and biopharmaceutical formulation. InVitria also offers custom media formulation services to cell therapy, vaccine, and gene therapy customers who seek blood-free and defined manufacturing systems. InVitria’s product portfolio includes recombinant albumin including optibumin, exbumin, and cellastim S as well as recombinant transferrin (Optiferrin), insulin, and transferrin supplements. InVitria’s blood-free and defined media products are optimized for specific cell types including: OptiVERO (VERO), OptiPEAK T Lymphocyte (CAR-T), and OptiPEAK HEK293t (HEK293t). www.invitria.com

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

L7 Informatics provides software and services that enable synchronized solutions for life science and health organizations. L7’s Enterprise Science Platform (ESP) is a scientific information management (SIM) solution that enables cell and gene therapy companies to manage and automate the capture of clinical, operational, and quality data by connecting people, lab instrumentation, robotics, environmental monitoring, and bioprocess equipment to optimize biologics research processes, clinical trials, manufacturing, and treatment. Organizations such as Gradalis, USDA, and AstraZeneca have implemented the platform and have seen excellent results. www.l7informatics.com

Lovelace Biomedical is a contract research organization that helps pharmaceutical and biotechnology companies advance their complex drug development studies from the preclinical stage and on to clinical trials. For over 70 years, our organization has leveraged its multidisciplinary expertise in toxicology, gene and cell therapy, regenerative medicine, and more, to provide excellence in preclinical research and fully understand the behavior of its clients’ investigational products. www.lovelacebiomedical.org

MaSTherCell S.A. is a dynamic and global contract development and manufacturing organization (CDMO) on a mission to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. MaSTherCell is a subsidiary of MaSTherCell Global Inc. – a gathering of MaSTherCell in Belgium, Atvio Biotech, an Israel-based CDMO, and MaSTherCell Korea, a Korea-based CDMO. MaSTherCell Global is majority-owned by Orgenesis, a cell therapy and regenerative medicine company that is committed to developing a cure for type 1 diabetes. At the heart of MaSTherCell is a team of highly dedicated experts combining strong experience in cGMP cell therapy manufacturing with a technology-focused approach and a substantial knowledge of the industry. From technology selection to business modeling, GMP manufacturing, process development, quality management, and assay development, MaSTherCell’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients. www.masthercell.com

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

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

Novasep is a CDMO specialized in viruses and viral vector production for tox, clinical, and commercial phases. Novasep offers global and integrated services from process development to commercial manufacturing. For 20 years, Novasep has acquired experience in manufacturing a wide range of viral vectors: AAV, lentivirus, adenovirus, HSV, VEEV, VSV for gene therapy, immunotherapy, and vaccination. We also offer Fill and Finish services to complete the manufacture of your biologic. Our recent investments in new commercial assets, addressing both drug substance and drug product manufacturing processes, will help to contribute to your project’s success. www.novasep.com

Ology Bioservices is a biologics-focused contract development manufacturing organization (CDMO) serving both government and commercial clients from early-stage through commercial product. The company has 183,000 square feet of manufacturing, process development, and quality assurance/quality control space in its state-of-the-art facility in Alachua, Florida; and an analytical, bioanalytical, and cell-line development and testing laboratory in Berkeley, California. The experienced team at Ology Bio provides support in upstream and downstream process development, formulation and analytical development, and cGMP manufacturing of monoclonal antibodies, recombinant proteins, live viral products, nucleic acids, and cell and gene therapies up to BioSafety Level 3 (BSL-3). The company also offers full regulatory support from preclinical through licensure from its Frederick, Maryland office. www.ologybio.com

Orchard Therapeutics is a leading global fully integrated commercial stage company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies. Orchard’s portfolio of ex vivo autologous gene therapy programs has demonstrated sustained clinical benefit in over 150 patients across five disease areas. These programs include Strimvelis®, the first ex vivo autologous gene therapy approved by the EMA in 2016, three advanced registrational studies for metachromatic leukodystrophy (MLD), ADA-SCID and Wiskott-Aldrich syndrome (WAS), clinical programs for X-linked chronic granulomatous disease (X-CGD), transfusion-dependent beta-thalassemia (TDT), and mucopolysaccharidosis type I (MPS-I), as well as an extensive preclinical pipeline. The company is partnered with world-leading institutions in gene therapy, including University College London, Great Ormond Street Hospital, the University of Manchester, Central Manchester University Hospitals, the University of California Los Angeles, Boston Children’s Hospital, and Telethon Institute of Gene Therapy/Ospedale San Raffaele. www.orchard-tx.com/

Using our unique LentiVector® delivery platform, Oxford Biomedica has created a valuable portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology, and CNS disorders. We have strong partnerships with Novartis, Bioverativ (part of the Sanofi Group), Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium and Imperial Innovations, Immune Design, and Orchard Therapeutics, providing them with access to our intellectual property, state-of-the-art production facilities, and expertise. In addition, we have licensed products and technology rights to Boehringer Ingelheim, Sanofi, and Axovant. These partnerships provide the company with multiple income streams, consisting of upfront milestone payments, development and production fees, and potential royalties on future product sales. We plan to progress our wholly-owned products via spin-outs and out-licensing opportunities, while continuing to invest in our LentiVector® platform and our preclinical R&D to discover new potential products. www.oxfordbiomedica.co.uk

Pall Biotech is a leading global provider of filtration, purification, and separation technologies to the diverse and rapidly expanding life sciences market. Its products are used from the earliest stages of discovery and development of new drugs, through production and delivery of therapies for the prevention, diagnosis, and treatment of disease. In pharmaceutical and bioprocess manufacturing, Pall offers full capability in upstream, chromatography, and filtration. Pall offers a complete range of products for viral manufacturing in the gene therapy market. www.biotech.pall.com

PeproTech creates the building blocks of your life science research by manufacturing high-quality products that advance scientific discovery and human health. Since 1988, PeproTech has grown into a global enterprise, manufacturing an extensive line of recombinant human, murine and rat cytokines, animal-free recombinant cytokines, monoclonal antibodies, affinity purified polyclonal antibodies, affinity purified biotinylated polyclonal antibodies, ELISA development kits, cell culture media products, and GMP cytokines. www.peprotech.com

Polyplus-transfection applies its 15+ years of expertise to the development of novel transfection solutions for mammalian cells. We provide reagents for high yield transient protein and antibody production in CHO and HEK-293 cells, as well as for viral vector production for gene and cell therapy (PEIpro product range). Our products meet the quality requirements for use in bioprocesses up to GMP grade. www.polyplus-transfection.com

POMS Corporation provides comprehensive 100% web based (cloud proven) manufacturing execution system (MES) and enterprise manufacturing intelligence (EMI) products for biopharmaceutical, medical device, and consumer packaged goods manufacturers to meet regulatory requirements while reducing risk, lowering costs, improving efficiency, and speed to market. The POMSnet MES product is a GAMP5, Category 4 (configurable software) standard product that has over 30 years of built-in industry experience. Core capabilities include electronic batch records, review/release by exception, real-time quality metrics, regulatory compliance, material management, weigh and dispense operations, genealogy, equipment management/use logs, personnel management, ISA S88/S95 compliance, business system, and plant floor integration. www.poms.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, North Carolina, we are excited to lead the next wave of medical and scientific possibilities through continuous gene editing innovation. www.precisionbiosciences.com

PTC is a science-led, global biopharmaceutical company focused on the discovery, development and commercialization of clinically-differentiated medicines that provide benefits to patients with rare disorders. PTC’s ability to globally commercialize products is the foundation that drives investment in a robust pipeline of transformative medicines and our mission to provide access to best-in-class treatments for patients who have an unmet medical need. www.ptcbio.com

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

SCM Lifescience was established with the vision of developing treatment options for difficult to treat diseases, to provide a new source of hope for patients, and to contribute to the welfare of humanity as a whole using proprietary stem cell isolation technology and stem cell production technology. Through over 10 years of 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; high-purity stem cell manufacturing technology – U.S. patent in 2014; and treatment of graft-versus-host disease – patents from Japan in 2014, U.S. in 2015, and the EU in 2016. Based on these technical breakthroughs, high-purity stem cell therapy shall be provided to treat various immune diseases such as graft-versus-host disease, acute pancreatitis, atopic dermatitis, and type 1 diabetes. SCM’s research will also focus on the field of regenerative medicine for technological breakthroughs including the regeneration of skin, cartilage, bone, hair growth, and other tissues and organs. www.scmlifescience.com/en

Syneos Health™ is the only fully integrated biopharmaceutical solutions organization. Our company, including a contract research organization (CRO) and contract commercial organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together approximately 24,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies, and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Learn more about how we are shortening the distance from lab to life®. www.syneoshealth.com

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

TriLink BioTechnologies specializes in the synthesis and production of complex and highly-modified nucleic acids for research, diagnostics, preclinical therapeutic, and pharmaceutical applications. Since 1996, TriLink has been developing and manufacturing custom oligonucleotides, mRNA transcripts, nucleotides, PCR and RT-PCR reagents, NGS library preparation kits, bioconjugation, custom chemistry, and other small molecules. www.trilinkbiotech.com

United Cargo® delivers superior shipping solutions via the cargo capacity of the world’s most comprehensive route network – an average of 4,900 flights a day to 355 airports across five continents. The United Cargo suite of specialty products is designed to accommodate patients’ diverse needs, including LifeGuard service for lifesaving cell therapy and human tissue shipments and TempControl for biopharmaceuticals. With certified handling stations located in key pharma markets around the world, customers benefit from the expansive global network and expertise of specially trained personnel. And with more than 200 domestic destinations also available on United® and United Express®, customers can quickly connect small package priority medical shipments to patients in destinations beyond major U.S. markets. www.unitedcargo.com

VGXI is a leading contract manufacturer of DNA-based pharmaceuticals with over 15 years of experience providing exceptional quality GMP products to clinical trials worldwide. The company’s skilled team has an outstanding track record of success in manufacturing challenging plasmid products under GMP conditions with exceptional yield, quality, and prompt delivery. Production services include high purity plasmid DNA preparations for preclinical research, highly documented (HD) plasmid DNA manufacturing for use in GMP viral vector production or pharmacology/toxicology studies, and GMP plasmid DNA for clinical through commercial supply. In addition to standard DNA manufacturing services, VGXI announced the addition of clinical-grade mRNA production services starting in 2020. www.vgxii.com

Werum IT Solutions is the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Our out-of-the-box PAS-X software product is run by the majority of the world’s top 30 pharmaceutical and biotech companies but also by many mid-sized manufacturers. Founded in 1969, Werum has many locations in the U.S., Latin America, Asia, and Europe and is headquartered in Lüneburg, Germany. www.werum.com/en

Bronze Sponsors

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

Significant breakthroughs in cell biology, biofabrication and materials science in the last decade have laid the foundation for large-scale manufacturing and commercialization of engineered tissues and tissue-related technologies, including tissues- and organs-on-chip. However, the tissue engineering field is fragmented and lacks a mechanism with which to turn laboratory breakthroughs into manufactured products. The ARMI | BioFabUSA mission is to make practical the large-scale manufacturing of engineered tissues and tissue-related technologies, to benefit existing industries and grow new ones. www.armiusa.org

Astellas is a Tokyo-based pharmaceutical company that is committed to turning innovative science into medical solutions that bring value and hope to patients worldwide. Keeping our focus on addressing unmet medical needs and conducting our business with openness, integrity, and a collaborative approach enables us to improve the health of people around the world. Astellas continues to enhance capabilities to deliver innovative medical solutions in oncology, urology, immunology, nephrology, and neuroscience as core therapeutic areas for research. Additionally, we have advanced new therapeutic areas including muscle disease, ophthalmology, and new technologies and modalities, such as regenerative medicine and next-generation vaccines. www.astellas.com/us

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

BioBridge Global (BBG) is a nonprofit organization committed to saving and enhancing lives through the healing power of human cells and tissue. BBG enables advances in the field of regenerative medicine by providing access to a variety of blood products and donated tissue, testing services, and biomanufacturing capabilities. www.biobridgeglobal.org

Blood Centers of America (BCA) is a national network of over 50 independent blood centers with over 500 fixed collection and testing sites positioned throughout the country. BCA connects with over 4 million donors each year and its members provide a variety of human blood products, cells, and tissues to the therapeutic, diagnostic, and cell therapy industries. We offer research or clinical grade materials, blood or tissue derived products, inventoried or custom collections. In addition to product collection and testing, the network can provide cell separation, isolation, transduction, expansion, qualification, cryopreservation, storage, and distribution with facilities close to the patient/subject/participant. FDA registered facilities include manufacturing and ISO certified and validated cleanroom environments and FDA registered tissue establishments with mature quality systems. www.bca.coop

bluebird-bio_150x57bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Massachusetts headquarters, we’re developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, we’re working to positively disrupt the healthcare system to create access, transparency, and education so that gene therapy can become accessible to all those that can benefit. bluebird bio is a human company powered by human stories. We are putting our care and expertise to work across a spectrum of disorders by researching cerebral adrenoleukodystrophy, sickle cell disease, transfusion-dependent β-thalassemia, and multiple myeloma, using three gene therapy technologies: gene addition, cell therapy, and (megaTAL-enabled) gene editing. bluebird bio has nests in Cambridge, Massachusetts; Seattle, Washington; Durham, North Carolina and Zug, Switzerland. www.bluebirdbio.com

CARISMA Therapeutics is developing a novel platform technology based on ex vivo engineered macrophages. Initial applications are autologous CAR-macrophages, an approach that combines powerful chimeric antigen receptor technology and adoptive cell transfer, two techniques with an established clinical track record in cancer therapy, to macrophages, cells known to infiltrate the solid tumor microenvironment. Ample in vitro and in vivo data demonstrate the ability of CAR-macrophages to traffic to solid tumors and to selectively eliminate tumor cells via phagocytosis. CAR-macrophages will also leverage macrophage’s natural antigen presenting capability to stimulate an adaptive immune response. The first product under development is a HER2 targeted CAR-macrophage with an anticipated IND filing in Q4 2019. Additional CAR-macrophages targeting other solid tumor antigens are under development. www.carismatx.com

CellGenix is a leading global supplier of high-quality reagents and tools for cell and gene therapy and regenerative medicine applications. As the first company to obtain a GMP manufacturing authorization for cell processing in Europe, we have more than 25 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

Founded in 2005 and based in Pittsburgh, PA, Celsense, Inc. is a clinical stage company offering novel tracer agents used to non-invasively visualize and measure the trafficking of transplanted cells in vivo using magnetic resonance imaging (MRI) techniques. The company’s customers include more the 100 leading pharmaceutical, biotechnology, and academic organizations in 14 countries. In early clinical trials, pharmacokinetic data regarding the delivery, migration, and persistence of transplanted cells can accelerate product development by supporting fundamental hypotheses regarding the mechanism of action and off target delivery. Cell trafficking data can also be used to evaluate dosing strategies, different routes of administration, co-therapy options, and conditioning regimens. The company’s lead product Cell Sense is the subject of Drug Master Files at FDA and Health Canada, and available for use in human clinical trials. All of the company’s products are further described in whitepapers available on the Celsense website. www.celsense.com

Founded in 2002 and headquartered in New York, Chardan is an independent, global investment bank focused on addressing the capital markets needs of public and private genetic medicines companies. Chardan focuses on companies that offer superior investment return prospects, based on the potential to create real value for society. In following vector gene therapy, small RNA therapy, and gene editing companies, Chardan covers more genetic medicines names than any other bank globally. Chardan is known for its market impact, communicating on fundamental sector value drivers (e.g. via the predictive Chardan Gene Therapy Framework), and has successfully raised more than $2.75 billion for public and private genetic medicines companies since 2015. www.chardan.com

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

Healios is a Tokyo-based, clinical-stage world leader in regenerative medicine and cell therapy. After its founding in 2011, Healios listed on the Tokyo Stock Exchange in 2015 and currently has more than 130 people based in its Japan and U.S. offices. Healios leverages the attractive Japanese regulatory framework for regenerative medicine to rapidly and efficiently deliver results for patients, its partners, and stakeholders. It is currently running clinical trials for ischemic stroke (Phase II/III) and acute respiratory distress syndrome (Phase II) using bone marrow-derived allogeneic adult stem cells. At the same time, Healios is developing a next generation gene edited iPSC platform to remove the need for immunosuppressants, improve scalability, and enhance effectiveness. Its iPSC programs seek to address multiple areas of unmet medical need in the ophthalmology, liver disease, and immuno-oncology fields, and are supported by manufacturing platform development undertaken by Healios and its industry and academic partners. www.healios.co.jp/en

Invetech provides tailored manufacturing automation to the global cell and advanced therapy market. Invetech works with clients to translate clinical processes into commercially successful products, from stepwise platforms to turnkey automation. Robust therapy production systems are configured to client processes using a combination of off-the-shelf solutions, proprietary technology platforms, and custom in-house engineering. Invetech and client teams work collaboratively to meet commercial, quality, and therapeutic objectives. Invetech has over 16 years of experience developing automated closed processing for regenerative medicine products, with over 50 projects delivered worldwide, powered by 300 technical personnel across Melbourne, San Diego, and Boston facilities. www.invetechgroup.com

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

IVERIC bio is a biotechnology company with a focus on the discovery and development of novel gene therapy solutions to treat orphan inherited retinal diseases with unmet medical needs. For more information on the company’s gene therapy and other programs, please visit the website. www.ivericbio.com

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

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

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

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

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

Nordmark is a pharmaceutical company which develops and produces ingredients and drug products through all stages of the value chain. As the world’s largest manufacturer of pharmaceutical collagenase, we are able to provide translational enzymes – research and GMP Grade collagenase and neutral protease products – to simplify the path from research to clinic. Our Nordmark Biochemicals division offers products for nearly every cell isolation application, including our highly-purified, animal-free Collagenase AF-1 GMP Grade and our excellent Collagenase NB 6 GMP Grade for stem cell isolation. Supporting documentation and access to Drug Master Files are available. New in 2019: Clostripain NB – an enzyme to fine-tune your cell isolation. www.nordmark-biochemicals.com

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

ReNeuron is a global leader in cell-based therapeutics, harnessing its unique stem cell technologies to develop off-the-shelf stem cell treatments, without the need for immunosuppressive drugs. The company’s lead clinical-stage candidates are in development for the blindness-causing disease, retinitis pigmentosa, and for disability as a result of stroke. ReNeuron is also advancing its proprietary exosome technology platform as a potential delivery system for drugs that would otherwise be unable to reach their site of action. ReNeuron’s shares are traded on the London AIM market under the symbol RENE.L. www.reneuron.com

Senti Biosciences is a Series A next-generation biotechnology company that designs gene circuits and programs cells for tremendous therapeutic value. Senti’s mission is to engineer an entirely new class of medicine that will transform people’s lives by curing the most complex diseases. Backed by a syndicate of leading biotech and tech investors including NEA, 8VC, Lux, Pear, Menlo Ventures, and Amgen Ventures, and led by an experienced team with deep translational knowledge of advanced cell therapies, the company is leveraging its proprietary gene circuit repertoire to solve the most pressing unmet needs in oncology and other difficult disease areas. www.sentibio.com

The Standards Coordinating Body for Gene, Cell, and Regenerative Medicines, and Cell-based Drug Discovery (SCB) is an unbiased, not-for-profit organization dedicated to ensuring that all stakeholders across the regenerative medicine community have input in the advancement of standards. Through the coordination of standards activities, engagement with a broader stakeholder community, and educational outreach, SCB promotes the acceleration of innovation and the improvement of quality manufacturing in the advanced therapeutics arena. As a coordinating body, SCB works to streamline the standards advancement process by driving momentum, aligning stakeholder efforts, and helping projects overcome obstacles. We encourage individuals to provide feedback to SCB on needed standards or to join SCB-coordinated projects by visiting our website. www.standardscoordinatingbody.org

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

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

Vineti creates the essential software solution to drive and scale personalized therapies. Our leading Personalized Therapy Management (PTM) platform delivers simplicity, compliance, and patient safety to medicine’s most complex supply chain, providing the next-generation technology that advanced therapies need. Today’s personalized therapies require new technology strategies. Vineti combines leading software expertise with deep, first-hand personalized therapeutics experience to develop a cloud-based “platform of record” that ensures quality, scale, security, efficiency, traceability, and patient safety for personalized therapies. The Vineti platform also provides actionable insights to continually optimize the therapy process, accelerating time to revenue and decreasing costs. Vineti partners with a range of small and large pharmaceutical developers, and offers the only independent platform to have been part of a successful, expedited cell therapy approval. Vineti supports hundreds of medical centers worldwide and was named a World Economic Forum Technology Pioneer in 2019. Vineti is based in San Francisco, California. www.vineti.com

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

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

Event Supporters

ASEBIO is the Spanish Bioindustry Association. ASEBIO brings together companies, associations, foundations, universities, research and technology centers that carry out activities directly or indirectly related to biotechnology in Spain. Since 1999, ASEBIO has been acting as a meeting and promotion platform for those organizations interested in stimulating the national biotechnology scene. In order to do this, ASEBIO works closely with regional, national, and European governments as well as all the social organizations interested in using biotechnology to improve quality of life, the environment, and generating skilled employment. www.asebio.com/en

BioPartner UK is the accredited trade organisation that provides practical support and international promotion to UK Life Sciences companies, who wish to grow their business overseas. BioPartner signposts to UK expertise and leads delegations to promote the UK presence at major international biopharma conferences. By operating in partnership with the UK government and event organisers, BioPartner assists all UK companies with access to government grants and heavily discounted entry fees. Members of the BioPartner Programme receive extra benefits and support to effectively trade overseas. www.biopartner.co.uk

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

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

The Maryland Stem Cell Research Fund (MSCRF) is focused on identifying and fostering cutting-edge research and innovation in the field of regenerative medicine in MD. Our Accelerating Cures initiative comprises programs that help transition human stem cell-based technologies from the bench to the bedside as well as mechanisms to build and grow stem cell companies in Maryland. MSCRF has invested over $155 million in accelerating stem cell research, cures and commercialization, in addition to building a collaborative stem cell community in our region. Learn more about our mission and our funding opportunities for any US-based stem cell/cell therapy company.

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