Sponsors

Organized By

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory and reimbursement initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing regenerative medicines and advanced therapies. In its 11-year history, ARM has become the voice of the sector, representing the interests of 350+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups. To learn more about ARM or to become a member, visit www.alliancerm.org.

Sponsor the Meeting

Interested in gaining extensive exposure to hundreds of stakeholders in the cell and gene therapy sector? Contact Laura Stringham to learn more.

Platinum Sponsors

Audentes Therapeutics, an Astellas company, is developing genetic medicines with the potential to deliver transformative value for patients. Based on our innovative scientific approach and industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for the newly created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. 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 

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

As 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

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 serves the biotechnology industry with custom production of nucleic acids, proteins, and antibodies. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from research grade to clinical trials to commercial applications. Aldevron specializes in GMP manufacturing and is known for inventing the GMP-Source® quality system. Company headquarters are in Fargo, North Dakota, with additional facilities in Madison, Wisconsin, and Freiburg, Germany. www.aldevron.com

The 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 230 employees 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

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

Silver Sponsors

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

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

CRB is a leading provider of sustainable engineering, architecture, construction and consulting solutions to the global life sciences and advanced technology industries. Our more than 1,100 employees provide best-in-class solutions that drive success and positive change for our clients, our people and our communities. CRB is a privately held company with a rich 35-year history of serving clients throughout the world, consistently striving for the highest standard of technical knowledge, creativity and execution. www.crbusa.com

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

FUJIFILM Diosynth Biotechnologies is an industry 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 gene therapies. With over 30 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.g., 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 Teesside, United Kingdom; Research Triangle Park, North Carolina, USA; College Station, Texas, USA and Hillerød, Denmark. www.fujifilmdiosynth.com

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

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

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) is a public-private partnership whose mission is to accelerate biopharmaceutical innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry. NIIMBL is part of Manufacturing USA®, a diverse network of federally-sponsored manufacturing innovation institutes. NIIMBL is funded through a $70 million cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce and leverages additional commitments from our partners. www.niimbl.force.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 quality products for nearly every cell isolation and tissue dissociation application, including our highly-purified, animal-free Collagenase AF-1 GMP Grade and Neutral Protease AF GMP Grade and our excellent Collagenase NB 6 GMP Grade for stem cell isolation. Supporting documentation and access to Drug Master Files are available. www.nordmark-biochemicals.com

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

Polyplus-transfection applies its 18+ year expertise to the development of novel transfection solutions. Polyplus-transfection is the leading supplier of a key critical component for viral vectors manufacturing for Gene & Cell Therapy. We are proud to provide qualified and GMP-grade transfection reagents suitable from R&D to clinical trial and commercial scale, accompanied by a strong scientific and regulatory support. In addition, we provide a range of effective transfection reagents to deliver most nucleic acids, including DNA and siRNA in vitro and in vivo. www.polyplus-transfection.com

The Standards Coordinating Body (SCB) is a non-profit organization with a mission to “coordinate the accelerated advancement and improved awareness of the standards and best practices that address the rapidly evolving needs of the global regenerative medicine advanced therapy community.” SCB, through its FDA-funded work, looks to complement the current processes of standards organizations to ensure that new or revised standards provide the greatest benefits to the regenerative medicine community. SCB engages the broader community in the identification, prioritization, and advancement of potential standards; coordinates and communicates about standards activities across the regenerative medicine community; and educates the community about available standards, the standards development processes, and standards implementation. SCB was co-founded by the Alliance for Regenerative Medicine (ARM), and builds upon Section 3036 of the 21st Century Cures Act, which calls for the coordination and prioritization of standards creation to support the developmentv and review of regenerative advanced therapies. www.standardscoordinatingbody.org

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

Bronze Sponsors

Founded in 2001 by gene therapy pioneers, Asklepios BioPharmaceutical (AskBio) is a fully integrated, privately held gene therapy company with global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, UK. We are dedicated to developing treatments for children and adults living with a range of genetic disorders. Our clinical-stage programs include Pompe disease and congestive heart failure, as well as out-licensed clinical indications for hemophilia (Chatham Therapeutics acquired by Takeda) and Duchenne muscular dystrophy (Bamboo Therapeutics acquired by Pfizer). Our gene therapy platform includes Pro10™, an industry-leading, proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. An early innovator in the space, AskBio holds more than 500 patents in areas such as AAV production and chimeric and self-complementary capsids. www.askbio.com | LinkedIn

Athersys is a clinical-stage biotechnology company that is focused primarily on developing product candidates in the field of regenerative medicine. Athersys is committed to the discovery and development of therapies designed to extend and enhance the quality of human life and have established a portfolio of therapeutic product development programs to address significant unmet medical needs in multiple disease areas. MultiStem® cell therapy, a patented and proprietary allogeneic stem cell product candidate, is the Company’s lead platform product and is currently in clinical development. The most advanced program is focused on the treatment of ischemic stroke, which is currently being evaluated in a registrational trial in Japan, an ongoing Phase 3 clinical trial in North America under a Special Protocol Assessment and in Europe under a Final Scientific Advice positive opinion, as well as a pivotal Phase 2/3 study evaluating MultiStem cell therapy for COVID-19 induced acute respiratory distress syndrome (ARDS). Both of these programs have received Fast Track designation from the FDA. The current clinical development programs are focused on treating critical care and other conditions where current standard of care is limited or inadequate for many patients. 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

The mission of ARMI | BioFabUSA is to make practical the scalable, consistent, and cost-effective manufacturing of engineered tissues and tissue-related technologies to benefit existing industries and grow new ones. BioFabUSA is a 160+ member, public-private partnership throughout the US comprising companies, academic institutions, and not-for-profit organizations in the Tissue Engineered Medical Products (TEMP) ecosystem. Members include therapeutic products companies and participants in the manufacturing supply-chain. The ARMI | BioFabUSA ecosystem identifies technologies and trends that crosscut manufacturing areas by considering raw materials, automation, equipment, software, measurement tools, data management, preservation, processes, quality systems, and other pertinent elements of tissue engineered medical product manufacturing. www.armiusa.org/connect

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

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

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

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

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

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

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.
www.mscrf.org

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