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 global voice of the sector, representing the interests of 370+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups. To learn more about ARM or to become a member, visit www.alliancerm.org.

Sponsor the Meeting

Interested in gaining extensive exposure to hundreds of stakeholders in the advanced therapies sector? Contact Laura Stringham at lstringham@alliancerm.org to learn more about supporting the conference.

Platinum Sponsors

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

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

Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focuses on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring a cell or gene therapy to market. Precision for Medicine – Accelerate Clinical Development: Delivering the global R&D services that are driving cell and gene therapy innovations; Project Farma – Optimize Next-Gen Manufacturing: Setting the manufacturing standard for cell and gene therapy success; Precision Value & Health – Drive Commercial Success: Charting the path to patient access for cell and gene therapy. www.precisionmedicinegrp.com

Gold Sponsors

Right. On Time. AGC Biologics is a leading global Contract Development and Manufacturing Organization (CDMO), providing world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast track projects for orphan drugs and rare diseases. www.agcbio.com

Aldevron serves the biotechnology industry with custom production of nucleic acids and proteins. 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 cGMP manufacturing and is known for inventing the GMP-Source® quality system. Aldevron operates the largest cGMP plasmid DNA manufacturing facility in the world at company headquarters in Fargo, North Dakota, with additional facilities in Madison, Wisconsin. www.aldevron.com

BlueRock 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

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

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

L7 Informatic’s Enterprise Science Platform (L7|ESP) is designed to solve today’s life science and biopharmaceutical industry challenges with cell therapy processes that have limited workflow automation and critical data compliance requirements. Siloed multi-vendor IT systems make it challenging to create an integrated and validated environment for biologics manufacturing with processes involving a mixture of paper, software systems, instruments, environmental monitoring systems, and bio-process equipment. L7|ESP is a unique regulatory compliant platform that provides an integrated software platform for digitizing the sample to drug process with features including equipment integration, Electronic Batch Records (EBR), MES, CPV, inventory, sample/ location management, and analytics/statistical processing with reports and dashboard and QC LIMS. www.l7informatics.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 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

Silver Sponsors

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

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 330 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. ct.catapult.org.uk | 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 Biologics, together with its parent company Cognate BioServices, is a leading international contract development and manufacturing organisation (CDMO) providing the highest quality development and manufacturing services for the cell and gene therapy fields, ranging from early stage development and pre-clinical services to clinical and commercial supply. Cobra and Cognate service an international customer base from its manufacturing and development facilities in the UK, Sweden, and the US. Each of the Company’s GMP approved facilities are tailored to serving our customers around the world. We offer a broad range of integrated and stand-alone contract development and manufacturing services for the clinical trial and the commercial markets. As a trusted provider and a key partner in the drug development and commercialisation process, we take pride in our manufacturing excellence and comprehensive range of services to the pharmaceutical and biotech industries. www.cobrabio.com

Cognate BioServices is the leading CDMO for the development and manufacturing of autologous and allogeneic cell and gene therapy products. We are a dynamic, results-driven, organization focused on providing the broadest range of commercialization services to regenerative medicine, cellular immunotherapy and advance cell therapy companies. Cognate provides a unique combination of custom services to companies across all points of clinical and commercial development specializing in mid to late stage clinical trials and supporting our clients through product scale-up into commercial manufacturing. Cognate applies the knowledge and expertise of its business, scientific and technical teams to successfully develop autologous and allogeneic products across multiple cell-based technology platforms from start to finish. Cognate’s business and expansion activities are supported by leading shareholder EW Healthcare Partners, as well as Medivate Partners, Blackrock, and a Middle East Sovereign Wealth Fund.
www.cognatebioservices.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

Exothera is a CDMO dedicated to virus and viral vector production. As a Univercells company, Exothera provides best-in-class bioprocessing expertise that capitalizes on novel manufacturing technologies. The company delivers accelerated process development/optimization to rapidly reach GMP clinical and commercial production of virus and viral vectors. Exothera has developed its expertise to support development and industrialization projects and can offer support during all phases of process development and manufacturing. Exothera’s DNA is to use innovative development principles such as highly concentrated and continuous processing to increase process performance and reduce operating costs. Our experienced team has conducted successful process development, optimization, scale-up and technology transfer projects while at Univercells, building a strong track record and know-how that drove the creation of a dedicated service company. www.exothera.world

Forge Biologics is a gene therapy manufacturing and development company helping clients achieve their cGMP program goals. Forge enables AAV vector production at 1-50L research and 50-500L cGMP grade scales, including process and analytical development. Our mission is to enable access to life changing gene therapies and help bring them from idea into reality. www.forgebiologics.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

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

Teknova is a partner to the biopharma sector that provides end-to-end solutions in the development of reagents and processes for a multitude of life sciences applications, including cell and gene therapy. We have a dedicated R&D laboratory that offers expertise from prototype product design to GMP manufacturing of media, buffers, and reagents for plasmid DNA production, fermentation, cell clone development, and bioreactor virus production scale-up. Our research services facility is ideally located at our headquarters near the San Francisco Bay area in Hollister, CA. 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

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

Asklepios BioPharmaceutical (AskBio), a wholly owned, independently operated subsidiary of Bayer AG acquired in 2020, is a fully integrated AAV gene therapy company dedicated to developing life-saving medicines. Using a broad portfolio of capsid, gene control and manufacturing technologies, AskBio is advancing therapeutics across a range of neuromuscular, CNS, cardiovascular and metabolic disease indications with a clinical-stage pipeline that includes Pompe disease, Parkinson’s disease and congestive heart failure. AskBio’s 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 field, AskBio holds more than 500 patents in AAV technology and manufacturing. Founded in 2001, AskBio is based in Research Triangle Park, North Carolina, with European headquarters in Edinburgh, UK. www.askbio.com

Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. Catalent recently acquired MaSTherCell, adding expertise in autologous and allogeneic cell therapy development and manufacturing to position Catalent as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global network of clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. Catalent Cell & Gene Therapy has produced more than 100 cGMP batches across 70+ clinical and commercial programs. www.catalent.com

Founded in 2002 and headquartered in New York, Chardan is an independent, global investment bank focused on addressing the capital markets needs of public and private cell & gene therapy companies. Chardan focuses on companies that offer superior investment return prospects, based on the potential to create real value for society. 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 $8.5 billion for biotech companies. www.chardan.com

CPC – Colder Products Company, is the leader in single-use connection technology offering a wide variety of cell and gene therapy connection solutions that ensure ease of use and a robust connection. Single-use technologies (SUT) saves time and labor during set-up and between cycles, by eliminating steps, costs of cleaning, sterilization; and eliminating cross-contaminations between batches. CPC connectors have been tested and validated to comply with accepted industry standards; for mechanical strength; extractables and leachables; bacterial ingress and others. Learn more about the AseptiQuik connectors and our entire portfolio to help you to connect with confidence. www.cpcworldwide.com/cgt

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. www.gconbio.com

GlobalData is a trusted and authoritative intelligence provider to the world’s largest industries. We cover a broad spectrum of the pharmaceutical, medical technology and healthcare value systems with in-depth analysis, forecasts, exclusive news, and robust databases all available through a fully integrated platform. Our Consulting team expands on the company’s intelligence offering and serves our clients as strategic advisors. The team combines a global presence with the extensive industry expertise required to ask the right questions and uncover strategic insights, thereby allowing our clients to anticipate and plan for the market events likely to impact their future success. www.globaldata.com

Cell and gene therapies hold the promise to change lives. Even as the path to patients accelerates, manufacturing and regulatory complexity remains a challenge. With limited process templates, evolving regulatory guidance, and urgent patient needs, finding a partner with experience is critical to success. Our company is giving shape to cell and gene therapy development every day. We bring 30+ years of expertise, and a global organization to integrate leading manufacturing technologies with process development, scale-up, safety testing, and regulatory knowledge to meet your therapy’s needs. We have more experience in this area than almost anyone else in the industry. We were the first gene therapy CDMO to produce commercial product following successful regulatory inspection. Our products and services include optimized manufacturing platforms, media and reagents; manufacturing, biosafety and characterization testing, and process development services. Draw on our experience to bring your cell and gene therapies to life. www.sigmaaldrich.com/genetherapymanufacturing | www.sigmaaldrich.com/celltherapymanufacturing

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 cell therapy candidate is in clinical development for the blindness-causing disease, retinitis pigmentosa. ReNeuron is also advancing its proprietary exosome technology platform as a potential delivery system for drugs that treat diseases of the brain. The Company also has the ability through its conditionally immortalised induced pluripotent stem cell (iPSC) platform to make any tissue cells of choice; in-house programmes are focused on treatments for blood cancers and diabetes. ReNeuron’s shares are traded on the London AIM market under the symbol RENE.L. www.reneuron.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

BioProcess Online is the leading source of technical information, industry knowledge, and content for the biotherapeutic community. From upstream to downstream processing through bioanalysis and biomanufacturing, our goal is to provide readers with the most up-to-date information about the issues, challenges, and news they care about most. BioProcess Online delivers the latest updates on the business and scientific information you need to succeed in the biotherapeutic industry. BioProcess Online reaches an audience of 32,000+ newsletter subscribers who seek the latest on bioprocessing and biomanufacturing.
www.bioprocessonline.com

Cell & Gene provides actionable information to professionals involved in the development and commercialization of cell and gene therapies. Through the original editorial published on the site, Cell & Gene facilitates the sharing of insights on challenges, trends, and best practices in this burgeoning field. Cell & Gene’s editorial scope spans the entire product lifecycle from basic research to commercialization. www.cellandgene.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

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