Sponsors

Organized By

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

Sponsor the Meeting

Interested in gaining extensive exposure to 1,200+ stakeholders in the cell and gene therapy sector? Contact Laura Stringham to learn more about the benefits of supporting the 2020 conference.

Platinum Sponsor

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

Program Partner

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

Gold Sponsor

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

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

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

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

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

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

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

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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