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 300 members and is the leading global advocacy organization in this field. www.alliancerm.org
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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
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
EBD 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
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
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 nearly 250 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. For more information please visit ct.catapult.org.uk or visit http://www.gov.uk/innovate-uk.
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
Cobra is a leading international contract development and manufacturing organization (CDMO) supporting the global cell and gene therapy industry in the development and manufacture of DNA and viral vectors from proof of concept through to clinical trials. We provide a comprehensive service offering, with multi-functional and experienced project teams nurturing customers’ products from preclinical through to clinical GMP manufacture. For cell and gene therapy products we are able to produce DNA (HQ and GMP) and viral vectors (Adenovirus, AAV and Lentiviral vectors). Cobra has also embarked on a £15M operations expansion to fast track our customers’ portfolios through to in-market supply. Check out our updated video on the current expansion. www.cobrabio.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
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
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
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-
At Synthace, we harness the power of the digital world to empower biologists to leverage the potential of research. Our software platform, Antha, brings digitisation and automation to facilitate complex experimental design and execution. Antha conducts experiments in a reproducible way, linking lab equipment, protocols and processes, thereby allowing vast and speedy development, enhancing productivity for research and manufacturing of cell and gene therapy. We have partnered with Microsoft, Merck, Oxford Biomedica, Cambridge Consultant and Cell Gene Therapy Catapult to optimise their research process and unleash the full potential of the hardware.https://synthace.
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
World 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 2022, 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.
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
G-CON Manufacturing designs, builds and installs prefabricated cleanrooms. G-CON’s POD portfolio provides cleanrooms in a number of dimensions for a variety of uses, from laboratory environments to personalized medicine and production process platforms. G-CON POD cleanrooms surpass traditional cleanroom structures in scalability, mobility and the possibility of repurposing once the production process reaches its lifecycle end. https://www.gconbio.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
With your need for rapid progress and vision for making a difference in the lives of patients, Merck is your trusted partner in cell and gene therapy. Whether you are in preclinical development or commercializing your therapy, we provide a spectrum of products and services to help solve the challenges in cell and gene therapy manufacturing. With over 20,000 employees and 72 manufacturing sites worldwide, Merck’s portfolio spans more than 300,000 products enabling scientific discovery. The company is committed to solving the toughest problems in life science by collaborating with the global scientific community. https://www.merck.com
OXGENE redefines possible in mammalian cell engineering. Our technology platforms and expert solutions accelerate the discovery, development and manufacture of cell and gene therapies. We address some of the most important and challenging questions in modern biology within gene therapy, antibody-based therapeutics and CRISPR / gene editing. Our technologies enable precise and robust mammalian cell engineering. Our automation and informatics driven approaches mean we solve the problems that no-one else can to advance the delivery of new therapeutics. https://www.oxgene.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
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
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