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.

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 Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer’s disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, immunology, neurocognitive disorders, acute neurology and pain. www.biogen.com

Cytiva is a global provider of technologies and services that help advance and accelerate the development and manufacture of therapeutics. Previously GE Healthcare Life Sciences, Cytiva’s diverse portfolio includes well-recognized brands such as ÄKTA, Amersham, Biacore, FlexFactory, HyClone, MabSelect, Whatman and Xcellerex. Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the delivery of transformative medicines to patients. www.cytiva.com

IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. Formed through the merger of IMS Health and Quintiles, IQVIA has approximately 67,000 employees worldwide. www.iqvia.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 diseases include some of the most serious of all illnesses and impact 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 rare hematologic, neurologic, cardiac 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. Learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness. 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 have made significant investments in GMP raw material manufacturing and drug product manufacturing capabilities to provide innovative end-to-end solutions – from the acquisition of Brammer Bio to investing to expand our critical raw material manufacturing facilities. Partner with us to access the high-quality materials, services, and support you need from discovery to clinical research and commercial cell and gene therapy manufacturing. Through our Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and Gibco brands, we offer an unmatched combination of innovative technologies, manufacturing, and distribution capabilities. www.thermofisher.com/cellandgenetherapy

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

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

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

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

At Dark Horse Consulting Group, 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, preclinical development, quality, regulatory, program management, business development, strategy, intellectual property, 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 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.darkhorseconsultinggroup.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

ICON plc is a global, full service CRO with dedicated centers of excellence for both cell and gene therapy (CGT) and rare disease. Over the last six years, ICON has worked on over 63 CGT trials across multiple therapeutic areas including hematology-oncology, CNS, ophthalmology, thalassemia, hemophilia and sickle cell. Our oncology portfolio has 36 trials in both allogeneic and autologous programs – taking five from early phase to BLA filing. With 400+ colleagues dedicated to cell and gene therapy – supported by another 250+ in our Rare Disease COE – our teams can support preclinical, regulatory and commercial positioning, as well as translational and clinical development. ICON understands that CGT trials must be delivered differently. Because there are no handbooks and few standards – experience matters in CGT. www.iconplc.com

Silver 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) and achromatopsia (ACHM CNGB3 & ACHM CNGA3). In addition to its clinical trials, AGTC has preclinical programs in optogenetics, other ophthalmology, CNS and otology indications. The optogenetics program is being developed in collaboration with Bionic Sight and the otology program is partnered with Otonomy. 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

Akron Biotech is an innovative biotechnology company with a strategic focus on supplying GMP-qualified ancillary materials and services to the regenerative medicine industry. Akron manufactures a range of products for cell therapy discovery, development and commercialization. These products include growth factors, sera and purified proteins, custom-made cell culture media, tailored scaffolds with biomaterials and proprietary cryopreservation formulations. In addition, our services and capabilities such as raw materials qualification, logistics and packaging optimization, bioassay design, validation and regulatory services are one of the many opportunities for Akron to provide our customers with unique knowledge and expertise. As a regulatory compliant company (ISO certified), Akron supports clients with rigorous documentation and quality standards to fulfill their regulatory demands. Our unique capabilities allow us to seamlessly transition from R&D to preclinical and clinical development with minimal change control, and thus drive the emerging regenerative medicine sector to unmet clinical needs through affordable and seamless manufacturing options. www.akronbiotech.com

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering novel high-quality medicines for people living with rare metabolic diseases. With extraordinary patient focus, Amicus Therapeutics is committed to advancing and expanding a robust pipeline of cutting-edge, first- or best-in-class medicines for rare metabolic diseases, including an industry leading rare disease gene therapy portfolio. www.amicusrx.com

We partner with cell and gene therapy companies to save lives through autologous and allogeneic cellular therapy. We are the only cell and gene therapy solutions provider with customizable services to support the entire end-to-end cell therapy supply chain. As part of the National Marrow Donor Program®/Be The Match®, our organization has sourced, collected and delivered cells from more than 100,000 volunteer allogeneic donors around the world for time-critical cellular therapies. We have extensive experience providing cellular source material consented for research, clinical and commercial use. Throughout the past 30+ years, we’ve developed and continually enhanced our cell collection network and proven cell therapy supply chain infrastructure. Our teams are responsible for more than 6,500 time-sensitive cell therapy shipments per year. Through the CIBMTR®, we provide long-term follow-up tracking for the first two FDA-approved CAR-T therapies. www.bethematchbiotherapies.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

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, gene therapies and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable global clinical and commercial product supply. www.catalent.com

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

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

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

Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule active pharmaceutical ingredients (APIs) from both mammalian cell culture and microbial fermentation such as monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines and other biological products including plasmid DNA and cell-based therapeutics. In addition to its clinical and commercial CGMP API manufacturing services, Cytovance offers well-integrated development services supporting the entire product lifecycle including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization. A centralized, responsive program management team coordinates all critical chemistry manufacturing and controls (CMC) activities for each client program around raw materials management, QC testing, ICH stability studies, and regulatory support. Our 140,000 sq. ft. state-of-the-art facilities in Oklahoma City are designed to meet U.S., EU, and other global regulatory standards. www.cytovance.com

Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Bringing more than 60 years’ experience in cell collection and separation, our team is focused on serving the needs for the cell and gene therapy industry with the Lovo Cell Processing System. Lovo is the only cell processing system that can wash, concentrate, and volume reduce cells using spinning membrane filtration technology.

Based in St. Paul, Minnesota, Wilson Wolf was founded in 1998 to pioneer the development of innovative cell culture technologies and has created patented products and protocols for numerous applications including monoclonal antibody production, corneal transplants, porcine heart valve testing, mesenchymal cell production, and islet transplants for type 1 diabetes. Over the last 5 years, its G-Rex product line with a focus on production needs in the cell therapy industry, has experienced an average annual sales growth rate of nearly 100%. www.chooselovo.com | www.wilsonwolf.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

Hitachi Chemical Company, Ltd (HCC) is the parent company to Hitachi Chemical’s Regenerative Medicine Business Sector, which provides contract development and manufacturing organization (CDMO) services at current Good Manufacturing Practices (cGMP) standards, including clinical manufacturing, commercial manufacturing, and manufacturing development. Facilities to deliver these services under a global harmonized service platform have been established in Japan (Yokohama City, Kanagawa Prefecture), Europe (Munich, Germany), and in the United States (New Jersey and California). www.pctcelltherapy.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

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. www.janssen.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

At MaxCyte, a clinical-stage global cell-based therapies and life sciences company, we believe in the power of next-generation cell and gene therapies to revolutionize medical treatment and ultimately save lives. As the inventors of the premier cell engineering enabling platform, we help bring the promise of cell and gene-editing therapies to life. Our Flow Electroporation® technology and next-generation ExPERT® platform enable our partners to accelerate, streamline, and improve the drug development process from the early stages of research to commercialization. We have placed our technology with leading drug developers worldwide, including all of the top ten global biopharmaceutical companies. In addition, MaxCyte has 120+ programs licensed and more than 90 of those are licensed for clinical use. 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

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

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. 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

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

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

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

Founded in 1996, Teknova has established itself as a leader in providing critical reagents for bioprocessing, bioproduction, and molecular diagnostics. Product offerings include cell culture media and supplements, protein purification buffers, and molecular biology reagents for the life sciences and healthcare communities. Teknova prides itself on its agility and customer centricity, allowing the company to meet the most complex formulation and packaging requirements at unprecedented delivery times. The company supports customers in the research, clinical, and applied markets with custom and specialty products beyond standard catalog offerings, delivering cost savings for research and development, diagnostics, and production of vaccines and therapeutics. www.teknova.com

With decades of expertise in cellular technologies and a reputation for outstanding support and collaboration, Terumo Blood and Cell Technologies 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/cell-therapy

TriLink BioTechnologies, part of Maravai LifeSciences, is a CDMO for overcoming challenges in the synthesis and scale-up of nucleic acids, NTPs and mRNA, including its proprietary CleanCap® mRNA capping technology. TriLink offers cGMP and general mRNA, oligonucleotide and plasmid manufacturing to support therapeutic, vaccine and diagnostic customers. www.trilinkbiotech.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

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

Cambridge Consultants develops breakthrough products and processes, and provides business consultancy in technology-critical issues for clients worldwide. For more than 50 years, the company has been helping its clients in a wide range of sectors turn business opportunities into commercial successes, whether they are launching first-to-market products, entering new markets or expanding existing markets through the introduction of new technologies. With a team of more than 850 engineers, scientists, mathematicians and designers, in offices across the USA, Europe and Asia, Cambridge Consultants are uniquely placed to help you close, automate and analyse your development and manufacturing platforms for the therapies of the future. We’d love to talk with you about how we can help solve your technical challenges in cell and gene therapy and regenerative medicine, and let you know a little more about the work we’ve already been doing for clients in this space. www.cambridgeconsultants.com/expertise/bioinnovation

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin and numerous breakthrough cancer drugs are based on technology developed at the institution. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope has been ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report for 14 consecutive years. Its main campus is located near Los Angeles, with additional locations throughout Southern California. www.cityofhope.org

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 helps solve commercial manufacturing challenges for the global cell and gene therapy market. With dozens of successful collaborations with the world’s leading regenerative medicine companies over the past 20 years, we’re a proven partner committed to helping you successfully transition from clinical to commercial-scale manufacturing. Our automation platforms and manufacturing systems provide Assured Pathways™ to integrated commercial manufacturing, from pre-clinical phase to large-scale manufacturing, without any substantive process changes. We configure solutions and provide the systems and resources you need to achieve large-scale, end-to-end cell and gene therapy manufacturing with a single point of accountability. www.invetechgroup.com

With decades of biopharmaceutical industry experience in facility design, quality operations, and engineering, Lykan Bioscience provides the first true end-to-end solution for cell-based therapies. Formed in early 2019, Lykan Bioscience is a privately held Manufacturing Services Organization™ (MSO) located in Hopkinton, MA. Lykan Bioscience offers a 64,000 square-foot, purpose-built facility that has been uniquely designed to fully integrate CGMP principles and advanced software solutions. Developed with their clients in mind, their proprietary software application platform allows for timely access to data, logistics, and expertise in driving treatments from clinical production through to commercial manufacturing. Lykan Bioscience and its clients are Transforming the Future Together™, as we work collaboratively to provide new life-saving therapies to patients worldwide. www.lykanbio.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

Ology Bioservices is a biologics-focused contract development manufacturing organization (CDMO) serving both commercial and government clients from early-stage through commercial product. The company has two state-of-the-art facilities, a 183,000 ft2, Biosafety Level 3 (BSL-3) capable, facility in Alachua, FL for tech transfer, process development/optimization, CGMP manufacturing, and analytical development and testing; and a 35,500 ft2 facility in Alameda, CA for cell-line development, bioanalytical development and testing, and CGMP manufacturing of personalized medicines. The experienced team at Ology Bio provides support in upstream and downstream process development, formulation and analytical development, and CGMP manufacturing of cell and gene therapies, oncolytic viruses, live viral vaccines and vectors, monoclonal antibodies, and recombinant proteins. The company also offers full regulatory support from preclinical through licensure from its Frederick, MD office. bd@ologybio.com | www.ologybio.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

A critical factor facing the industry is choosing technologies and partners that can deliver scale. The challenges inherent in translating early clinical trials to a reproducible and robust process suitable for scalable commercial production are very significant. Each personalized drug product ultimately depends on a sustainable and consistent supply chain with lots of moving parts. Configured to your exact demands, using an industry-standard framework, TrakCel’s comprehensive supply chain platform ensures every resource is managed, monitored, recorded, and is ultimately performed exactly as required. From sample collection through logistics, manufacturing, and final transplantation, with comprehensive chain of custody, chain of identity, and traceability, TrakCel’s proven technology integrates and orchestrates every aspect of your autologous and allogeneic supply chains in a scalable, compliant, and validated technology platform. www.trakcel.com

Voyager_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

Xcell Therapeutics is a cell culture media expert, HQ in Seoul, Korea. Our First-in-class CellCor CD MSC is successfully commercialized in the GMP facility. We are also doing work in the exosome/EV/secretome space using our CD media, as well as optimizing media for the production and collection of “cell-free” therapies with exosomes/EV/secretomes. Besides, we are doing some work in applications of our CellCor media for cosmetics/skin/dermatology, and have some interesting data that we are collecting. Thus, we are further in the development of culture media optimized for keratinocytes as well as DPCs utilizing our IP portfolio. We are a venture and young company, seeking meaningful collaborations and partnership opportunities. www.xcell.co.kr

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.
www.mscrf.org

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