Company

About

AAVnerGene

AAVnerGene

North Bethesda, Maryland, US

AAVnerGene Inc is an innovative company specialized in AAV technologies. It is founded by a group of AAV gene therapy enthusiasts who dream to serve the community, promote and lead the future of gene therapy. Our passion is to solve the bottleneck problems in AAV gene therapy and find more and better cures for all the patients. We believe that hard core technologies are the key to achieve it. With 20 years of frontline gene therapy experience, our team develops novel AAV vectors, methods and strategies that can efficiently produce, deliver and express high quality vectors into specific cells. Our goal is to increase AAV gene therapy efficacy and decrease the cost, making it accessible and affordable to patients. Our highly complex AAV capsid libraries allow us to efficiently select the best AAV capsid for each cell type in a high-throughput manner.

AAVogen

AAVogen

Rockville, Maryland, United States of America

Our mission is to make you stronger. The company was founded by a family directly impacted by three muscle wasting diseases: Duchenne muscular dystrophy, cancer cachexia and COPD. Our fight is personal and our commitment to developing better and more effective therapies is undaunted. AVGN7 prevents muscle wasting in different animal models and can restore muscle mass and strength even after wasting has already occurred. It works when injected directly into muscle or when administered systemically to all muscles. It was also designed to avoid the potentially serious side-effects of other "myostatin attenuating" therapies. AVGN7 for the durable maintenance of muscle mass and function.

AbelZeta

AbelZeta

Rockville, Maryland, United States

AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T and TIL therapies.

ABL

ABL

9800 Medical Center Drive, Building D, Rockville, MD 20850, US

With a 60+ year history as a service provider to the life sciences industry, Advanced BioScience Laboratories (ABL) provides a strong core of product development expertise, GMP manufacturing, and analytical testing capabilities. Founded in 1961 as a biomedical research contractor for the federal government, ABL has made major contributions to the development and evaluation of a wide range of life-saving diagnostics, vaccines, and therapeutics designed to combat the world's most challenging diseases. We partner with our clients to support advancement of their candidate vaccines and therapeutics through preclinical and clinical development. With facilities located in the United States, ABL aims to be a seamless extension of our clients' team – helping them advance today's ideas into tomorrow's medicines. ABL's CDMO service division specializes in the development and manufacturing of GMP cell banks and viral vectors from the bench to Phase I/II clinical trials. We aim to contributes to the success of our clients' ground-breaking innovations, including gene therapies, immunotherapies, viral vaccines, oncolytic viruses, and more. ABL's CDMO services include bulk drug substance production, fill/finish of drug products, process development, assay development and release testing.

Advanced Bioscience Laboratories (ABL)

Advanced Bioscience Laboratories (ABL)

Rockville, Maryland, United States

With a 60+ year history as a service provider to the life sciences industry, Advanced BioScience Laboratories (ABL) provides a strong core of product development expertise, GMP manufacturing, and analytical testing capabilities. Founded in 1961 as a biomedical research contractor for the federal government, ABL has made major contributions to the development and evaluation of a wide range of life-saving diagnostics, vaccines, and therapeutics designed to combat the world’s most challenging diseases. We partner with our clients to support advancement of their candidate vaccines and therapeutics through preclinical and clinical development. With facilities located in the United States, ABL aims to be a seamless extension of our clients’ team – helping them advance today’s ideas into tomorrow’s medicines. ABL's CDMO service division specializes in the development and manufacturing of GMP cell banks and viral vectors from the bench to Phase I/II clinical trials. We aim to contributes to the success of our clients' ground-breaking innovations, including gene therapies, immunotherapies, viral vaccines, oncolytic viruses, and more. ABL's CDMO services include bulk drug substance production, fill/finish of drug products, process development, assay development and release testing.

Aloe Therapeutics

Aloe Therapeutics

Maryland

Aloe Therapeutics is a biotech start-up aimed at delivering cancer cures. We have designed a therapy, termed Allo-Immunotherapy (AIM), to trigger an influx of activated immune cells to traffic to the tumor microenvironment - turning "cold" tumors "hot" and "hot" tumors "hotter." INFLAME WITH AIM.

American Gene Technologies

American Gene Technologies

Rockville, Maryland

American Gene Technologies® International Inc. (AGT™) is a private biotechnology company pursuing cures and treatments for infectious diseases, cancers, and monogenic disorders. AGT™'s emerging gene and cell therapeutics programs are designed to: ✅ Create immunotherapy for HIV disease with gene-modified T cells ✅ Activate innate T cell immunity capable of killing all tumor cells with its vector used in immuno-oncology ✅ Treat PKU by bringing a functional gene into cells that express a dysfunctional gene due to mutation ✅ Advance clinically to provide human proof of concept For over a decade, AGT™ has developed, tested, and banked thousands of lentiviral vectors that can be adapted to the specific needs of new target diseases. AGT™ has developed gene therapy for diseases using this rapid gene delivery platform. GENE THERAPIES AGT™’s platform allows it to pursue clinical “cures” for complex diseases. The company has developed patent-protected gene therapeutics that are breakthroughs in medicine. *** See our extensive award winning patents on our website *** HIV/AIDS Immunotherapy for HIV disease with gene-modified T cells IMMUNO-ONCOLOGY Activates innate T cell immunity capable of killing all tumor cells with its vector used in immuno-oncology PHENYLKETONURIA (PKU) Treats PKU by bringing a functional gene into cells that express a dysfunctional gene due to mutation AGT™'s Core Objectives ✔️ Leverage our lentivirus platform to create highly-effective targeted genetic medicines ✔️ Create solutions for patients across a spectrum of infectious diseases, cancers and inherited disorders ✔️ Collaborate with leading medical researchers from around the globe To learn more and get in touch with American Gene Technologies® Inc., contact us today at https://www.americangene.com/contact-us/

American Society of Human Genetics

American Society of Human Genetics

Bethesda, Maryland, US

The American Society of Human Genetics (ASHG), founded in 1948, is the primary professional membership organization for human genetics specialists worldwide. The Society’s nearly 8,000 members include researchers, academicians, clinicians, laboratory practice professionals, genetic counselors, nurses and others who have a special interest in the field of human genetics. Our members work in a wide range of settings, including universities, hospitals, institutes, and medical and research laboratories. Our mission is to advance human genetics in science, health, and society through excellence in research, education, and advocacy. ASHG serves research scientists, health professionals, and the public by providing forums to: -- Share research results at annual meetings and in The American Journal of Human Genetics -- Advance genetic research by advocating for research support -- Enhance genetics education by preparing future professionals and informing the public -- Promote genetic services and support responsible social and scientific policies Connect with ASHG members and the broader human genetics community in our LinkedIn Group: https://www.linkedin.com/groups/142742

Arcellx Inc

Arcellx Inc

Gaithersburg, Maryland, United States

Arcellx, Inc., a clinical-stage biotechnology company, engages in the development of various immunotherapies for patients with cancer and other incurable diseases. The company’s lead ddCAR product candidate is CART-ddBCMA, which is in phase 1 clinical trial for the treatment of patients with relapsed or refractory (r/r) multiple myeloma (MM). It is also developing ACLX-001, an immunotherapeutic combination composed of ARC-T cells and bi-valent SparX proteins targeting BCMA to treat r/r MM; ACLX-002 and ACLX-003 for treating r/r acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS); and other AML/MDS product candidates, as well as solid tumor programs. The company was formerly known as Encarta Therapeutics, Inc. and changed its name to Arcellx, Inc. in January 2016. Arcellx, Inc. was incorporated in 2014 and is headquartered in Gaithersburg, Maryland.

Cartesian Therapeutics

Cartesian Therapeutics

Gaithersburg, Maryland, United States

Cartesian Therapeutics is a fully integrated, clinical-stage biopharmaceutical company developing novel cell and gene immunotherapies to treat cancer and autoimmune diseases.

Cellomics

Cellomics

Halethorpe, Maryland, United States

Cellomics Technology, LLC is dedicated in developing more efficient and powerful tools to enhance and accelerate life science researches. Top scientific excellence is the goal and focus of our scientists.

Cellphire Therapeutics

Cellphire Therapeutics

Rockville, Maryland, United States

Cellphire Therapeutics, Inc. is a Rockville, Maryland-based biotechnology company developing next-generation therapeutics. The company is applying its proprietary cell stabilization technology to all cell types, including platelets, to develop lifesaving products. Its lead product, Thrombosomes®, a freeze-dried hemostatic agent derived from human platelets, is currently in a Phase I clinical trial. Cellphire’s technology has potential applications across a wide range of medical applications from trauma to wound care, imaging, targeted drug delivery, and regenerative medicine.

Cognate Bioservices

Cognate Bioservices

Baltimore, Maryland, United States

Cognate BioServices is a leading contract development and manufacturing organization specialized in cell and cell-mediated gene therapies. We pride ourselves in the level of quality and experience we bring to the table. Cognate is a dynamic, results-driven, organization focused on providing the broadest range of commercialization services to regenerative medicine, cellular immunotherapy and advance cell therapy companies, organizations and institutions. Cognate provides a unique combination of custom services to companies across all points of clinical and commercial development ranging from early preclinical studies, to mid phase trials and product scale-up though later stage clinical trials and bridging into commercial manufacturing. Cognate applies the know-how 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.

Cystic Fibrosis Foundation

Cystic Fibrosis Foundation

Bethesda, Maryland, US

The Cystic Fibrosis Foundation is the world’s leader in the search for a cure for people with cystic fibrosis, a rare, genetic disease in which a defective gene causes a thick buildup of mucus in the lungs, pancreas, and other organs. The buildup of mucus can lead to extensive lung damage, respiratory failure, malnutrition, liver disease, and gastrointestinal issues, among many other complications. Recognized globally, the Cystic Fibrosis Foundation has led the way in the fight against cystic fibrosis, fueling extraordinary medical and scientific progress. Working alongside the CF community, the CF Foundation has fostered the development of more than a dozen CF treatments — an unprecedented number in a short span of time — and helped add decades of life for people with CF. Thanks to this work, the life expectancy of someone born with CF has doubled in the last 30 years. We are driven by a dream that one day every person with cystic fibrosis will have the chance to live a long, healthy life. Our vision is a cure for every person with cystic fibrosis and a life free from the burden of this disease. While our headquarters are in Bethesda, Maryland, we have additional offices in more than 60 locations across the country with positions in fundraising, marketing, digital, information technology, legal, finance and more – all supporting our mission to cure cystic fibrosis. At the Foundation, we are committed to creating an environment that is free from discrimination and provides a rewarding experience for all members of our team. We strive to be an organization where everyone is welcomed and where talented individuals from all backgrounds have the opportunity to thrive. The CF Foundation is a nonprofit, donor-supported organization and an accredited charity of the Better Business Bureau's Wise Giving Alliance. Please visit us at www.cff.org.

Elixirgen Scientific

Elixirgen Scientific

Baltimore, Maryland, US

Elixirgen Scientific is a global leader in regenerative medicine and biotechnology, headquartered in the Science + Technology Park at the Johns Hopkins Medical Campus in Baltimore, MD. Our mission is to advance science and medicine with fast, functional, and scalable induced pluripotent stem cell (iPSC) differentiation products and services. Our state-of-the-art, transcription-factor-based technology allows you to overcome the high cost and inefficiencies associated with lengthy cell differentiation periods. We empower research institutions, pharmaceutical organizations, and biomedical enterprises worldwide, even those with no previous iPSC experience, by increasing access to relevant cells for modeling human biology and accelerating the path to drug discovery and development. This commitment to innovation and efficiency underpins our goal to revolutionize regenerative medicine. We are the partner of choice for supplying high-quality, reliable iPSC-derived cells and kits and conducting customized research services. Connect with Elixirgen Scientific today to discover how we can accelerate your research!

Elixirgen Therapeutics

Elixirgen Therapeutics

Baltimore, Maryland, United States

Elixirgen Therapeutics is a biotechnology company advancing its controllable self-replicating RNA technology to develop therapies for a broad spectrum of diseases, including rare diseases, aging-related disorders, and cancer. Elixirgen Therapeutics is located in the Science + Technology Park at Johns Hopkins in Baltimore.

EMIT Imaging

EMIT Imaging

Baltimore, Maryland, US

EMIT Imaging is the leading manufacturer of CFT systems and provider of CFT fee-for-service research for the global life sciences market. CFT was created to better visualize drug distribution and protein expression (pharmacokinetics/PK, and pharmacodynamics/PD) in whole animals at high resolution and sensitivity. CFT applications span drug discovery and delivery, oncology and immunotherapy, gene and cell therapy, neuroscience, and beyond. The company is based in Baltimore, MD, and Boston, MA.

Emmes

Emmes

Rockville, Maryland, US

Foundation for the Institutes of Health (FNIH)

Foundation for the Institutes of Health (FNIH)

North Bethesda, Maryland, US

Howard Hughes Medical Institute

Howard Hughes Medical Institute

Chevy Chase, Maryland, US

Howard Hughes Medical Institute is a biomedical research organization focusing on advancing medical and life sciences research.

Hypoxygen

Hypoxygen

Frederick, Maryland, US

HypOxygen® was founded to provide technology with the level of precision and accuracy necessary for scientific study and research. We specialize in hypoxic chambers (or low oxygen incubators) for scientists focusing on cell research applications requiring precise atmospheric conditions that can be accurately controlled. Unlike a commonly used CO2 incubator, our hypoxia workstations can achieve these precise conditions.

Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc.

Rockville, MD

Immunomic Therapeutics, Inc. (ITI) is a privately-held clinical stage biotechnology company pioneering the study of the Universal Intracellular Targeted Expression (UNITE) nucleic acid immunotherapy platform. This investigational technology has the potential to alter how we use immunotherapy for a number of diseases, including cancer, allergy and infectious diseases.

Innovative Cellular Therapeutics (ICT)

Innovative Cellular Therapeutics (ICT)

Rockville, Maryland, US

Innovative Cellular Therapeutics (ICT) is a clinical-stage, VC-backed cell therapy company based in Rockville, MD. ICT has established a broad portfolio of CAR-T products to treat cancer patients. Some highlights of the company are provided below: Leading clinical data in solid tumor CAR-T Colorectal cancer: 3rd line treatment, ~50% PR/PMR (8/16) in dose escalation trial Activity in additional solid tumor indication including thyroid and pancreas Significant market opportunity in colorectal cancer and other solid tumor cancers Lead program in colorectal cancer: Estimated 53,2001 deaths (#2 cancer death) in the U.S. in 2020 Platform technology for solid tumors, which comprise 91% of new cancer cases Strong global IP protection CoupledCAR®, ArmoredCAR®, and other ICT technologies protected by ~200 patents/patent applications globally, including for U.S., Europe, China and Japan

Johns Hopkins Medicine

Johns Hopkins Medicine

Baltimore, Maryland, US

Johns Hopkins Medicine is a governing structure for the University’s School of Medicine and the health system, coordinating their research, teaching, patient care, and related enterprises. The Johns Hopkins Hospital opened in 1889, followed four years later by the university’s School of Medicine, revolutionizing medical practice, teaching, and research in the United States. The hospital is now part of the Johns Hopkins Health System, which includes two other acute-care hospitals and additional integrated health-care delivery components, with a network of primary and specialty care practices throughout Maryland, outpatient care, long-term care, and home care. The Johns Hopkins University opened in 1876 as America’s first research university, founded for the express purpose of expanding knowledge and putting that knowledge to work for the good of humanity. Two Interconnected Institutions: Over the years, the University and Hospital have grown, and—sometimes jointly, sometimes separately—they have created affiliated organizations. The Johns Hopkins Institutions is a collective name for the University and the Johns Hopkins Health System. The Johns Hopkins University includes nine academic and research divisions, and numerous centers, institutes, and affiliated entities. Johns Hopkins Medicine is a governing structure for the University’s School of Medicine and the health system, coordinating their research, teaching, patient care, and related enterprises.

Johns Hopkins University

Johns Hopkins University

Baltimore, Maryland, US

Johns Hopkins University is a higher education institution known for its research initiatives and academic programs.

Kennedy Krieger Institute

Kennedy Krieger Institute

Baltimore, Maryland, US

Kennedy Krieger Institute is a healthcare organization that specializes in pediatric care, medical research, and rehabilitation services.

Lieber Institute for Brain Development

Lieber Institute for Brain Development

Baltimore, Maryland, US

Lieber Institute for Brain Development is a research institute focused on advancing understanding of brain development and disorders.

MagBio Genomics Inc

MagBio Genomics Inc

Gaithersburg, Maryland, US

At Magbio Genomics, we are dedicated to advancing genetic research with cutting-edge products designed to safeguard the integrity of bio-samples while efficiently isolating circulating biomarkers. Specializing in human genetic research, including cancer studies and non-invasive prenatal testing (NIPT), our innovative solutions empower researchers to unlock invaluable insights. At the heart of our operations lies our core platform, enabling seamless nucleic acid sequencing methods such as Sanger and Next Generation Sequencing (NGS) across both manual and automated workflows. Our commitment extends beyond product development; it's about facilitating quality data generation at an accelerated pace and an accessible cost. Driven by our corporate mission, we strive to empower our customers to achieve their research goals efficiently and effectively, propelling scientific discoveries forward with Magbio Genomics by their side.

MaxCyte

MaxCyte

Rockville, Maryland, United States

At MaxCyte, we pursue cell engineering excellence to maximize the potential of cells to improve patients’ lives. We have spent more than 20 years honing our expertise by building best-in-class platforms, perfecting the art of the transfection workflow, and venturing beyond today’s processes to innovate tomorrow’s solutions. Our ExPERT™ platform, which is based on our Flow Electroporation technology, has been designed to support the rapidly expanding cell therapy market and can be utilized across the continuum of the high-growth cell therapy sector, from discovery and development through commercialization of next-generation, cell-based medicines. The ExPERT family of products includes: three instruments, the ATx™, STx™, GTx™ and VLx ™; a portfolio of proprietary related processing assemblies or disposables; and software protocols, all supported by a robust worldwide intellectual property portfolio. By providing our partners with the right technology, as well as technical and regulatory support, we aim to guide them on their journey to transform human health.

Meso Scale Diagnostics

Meso Scale Diagnostics

Rockville, Maryland, US

Founded in 1995, Meso Scale Discovery (MSD) is a global leader in the development, manufacture, and commercialization of innovative assays and instruments for the measurement of molecules in biological samples. MSD’s proprietary MULTI ARRAY technology enhances medical research and drug development by enabling researchers to profile many biomarkers simultaneously in a single sample without compromising assay performance. MSD’s technology has been widely adopted by researchers in pharmaceutical companies, government institutions, universities, and clinical laboratories worldwide for its high sensitivity, excellent reproducibility, and wide dynamic range. Throughout its history, MSD has continued to evolve its technology platform to enable researchers to solve complex biological questions and, as the Company looks toward the future, it is expanding into clinical applications and the emerging fields of personalized medicine and companion diagnostics.

National Institute of Standards and Technology

National Institute of Standards and Technology

Gaithersburg, Maryland, US

National Institute of Standards and Technology is a government agency that sets standards, conducts research, and promotes innovation in technology and measurement.

NexImmune Inc

NexImmune Inc

Gaithersburg, Maryland, United States of America

NexImmune, Inc., a clinical-stage biotechnology company, engages in developing therapies with curative potential for patients with cancer and other life-threatening immune-mediated diseases. It develops approaches to T cell immunotherapies based on its proprietary Artificial Immune Modulation (AIM) technology. The company has two product candidates in human trials, including NEXI-001 in acute myeloid leukemia, or AML; and NEXI-002 in multiple myeloma, or MM. NexImmune, Inc. was founded in 2011 and is headquartered in Gaithersburg, Maryland.

NextCure Inc

NextCure Inc

Beltsville, Maryland, United States of America

NextCure, Inc., a clinical-stage biopharmaceutical company, engages in discovering and developing novel immunomedicines to treat cancer and other immune-related diseases by restoring normal immune function. Its lead product candidate is NC318, which is in Phase II clinical trials for the treatment of advanced or metastatic solid tumors. The company is also developing NC410, which is in Phase I for novel immunomedicine designed to block immune suppression mediated by an immune modulator called Leukocyte-Associated Immunoglobulin-like Receptor 1; and NC762, an immunomedicine targeting a molecule called human B7 homolog 4 protein, or B7-H4. Its discovery and research programs include an antibody in preclinical evaluation of other potential novel immunomodulatory molecules. NextCure, Inc. has a license agreement with Yale University. The company was incorporated in 2015 and is headquartered in Beltsville, Maryland.

Northwest Biotherapeutics

Northwest Biotherapeutics

Bethesda, Maryland, United States of America

Northwest Biotherapeutics, Inc. is a development stage biotechnology company focused on discovering, developing and commercializing immunotherapy products that generate and enhance immune system responses to treat cancer. Currently approved cancer treatments are frequently ineffective, can cause undesirable side effects and provide marginal clinical benefits. The Company’s approach in developing cancer therapies utilizes its expertise in the biology of dendritic cells, which are a type of white blood cell that activate the immune system. The Company’s cancer therapies have been demonstrated in clinical trials to significantly extend both time to recurrence and survival, whilst providing a superior quality of life with no debilitating side effects when compared with current therapies. The Company’s platform technology, DCVax®, uses a patient’s own dendritic cells, the starter engine of the immune system. The dendritic cells are extracted from the body, loaded with tumor biomarkers or ‘‘antigens’’, thereby creating a personalized therapeutic vaccine. Injection of these cells back into the patient initiates a potent immune response against cancer cells, resulting in delayed time to progression and prolonged survival. The Company’s lead product candidate is DCVax®-Brain which targets Glioblastoma Multiforme (‘‘GBM’’), the most lethal form of brain cancer. DCVax®-Brain has entered a Phase II FDA-allowed clinical trial, which is designed and powered as a pivotal trial (i.e. a trial from which a company may go directly to product approval). Following this trial, the Company anticipates filing a biologic license application (or ‘‘BLA’’) with the FDA for DCVax®-Brain. DCVax®-Prostate, which targets hormone independent (i.e. late stage) prostate cancer, has also been cleared by the FDA to commence a Phase III clinical trial, which is also designed and powered as a pivotal trial.

Orgenesis

Orgenesis

Germantown, Maryland, United States

Orgenesis is a global biotech company that has been committed to unlocking the potential of decentralized cell and gene therapies (CGTs) since 2012. Orgenesis established the POCare Network in 2020 to bring academia, hospitals, and Industry together to make these innovations more affordable and accessible to patients. In 2022, the POCare Services business unit responsible for developing and managing the decentralized POCare Centers and proprietary OMPULs was formed. Orgenesis will continue to focus on advancing to market through various partnerships its CGTs to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, and decentralized production.

OspreyBio

OspreyBio

Frederick, Maryland

OspreyBio is a newly launched and first gene-and-cell-therapy-centric biotools company. Our core principle is to "Think Multigenic". From tools to make multi-effector AAVs to 8-gene (or more) constructs, Osprey is expanding its portfolio of products related to building multigenes, delivering large DNA, and reducing manufacturing costs to bring us all into the future of gene and cell therapy.

Precigen

Precigen

Germantown, Maryland, United States of America

Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization.

Primera Therapeutics

Primera Therapeutics

Rockville, Maryland, United States

Primera Therapeutics is a company that provides patient-centric gene therapies targeting the causes of mitochondrial disorders. The company focuses on developing treatments for rare mitochondrial diseases for which there are no approved therapies. Primera Therapeutics is pioneering a first-in-class gene editing platform to cure genetic diseases.

RareMoon Consulting Inc.

RareMoon Consulting Inc.

Baltimore, Maryland, US

We work exclusively on orphan drugs and advanced therapies providing biotech partners with an integrated suite of strategic and operational regulatory services. Our regulatory team brings over 100 combined years of industry and consulting experience in orphan drug regulations and development. Made up entirely of Ph.D./MS-level/MD, senior regulatory strategists and mechanics, and all the passion in the world, they lead programs to success. Our Clients are those looking for strategic and operational support; someone who can be eyes-on and hands-on their program as and when needed; someone to help them navigate this complex regulatory pathway, and help them to decide when and how to submit their orphan applications, applications for accelerated approvals, and interactions with the Agencies. We plan, formulate questions, write, review, and/or submit. ­ - Regulatory operations ­ - Strategy & Development ­- Medical Writing ­- Publishing

Regenxbio

Regenxbio

Rockville, Maryland, United States

REGENXBIO is a leading biotechnology company focused on the development, commercialization and licensing of recombinant adeno‐associated virus (AAV) gene therapy. REGENXBIO's NAV® Technology Platform, a proprietary AAV gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO's mission is to transform the lives of patients suffering from severe diseases with significant unmet medical need by developing and commercializing in vivo gene therapy products based on REGENXBIO's NAV Technology Platform. REGENXBIO seeks to accomplish this mission through a combination of internal development efforts and third‐party NAV Technology Platform licensees.

Secretome Therapeutics

Secretome Therapeutics

Baltimore, Maryland, United States

Revolutionizing cell therapy to address inflammatory diseases driven via neonatal cardiac progenitor cells and their secretomes.

Seraxis

Seraxis

Germantown, Maryland, United States

Seraxis is a privately owned biotechnology company. Our GMP lab is located in Germantown, Maryland, in the heart of the vibrant BioHealth Capital Region. Launched in early 2013, Seraxis used proprietary technologies to develop a cell replacement therapy, SR-01, that is more effective and safer than embryonic stem cell-derived therapies. Our highly pure insulin-producing cells are micro-encapsulated through a proprietary technology that enables the function of human pancreas cells in type-1 diabetes models without the need for immuno-suppression. Seraxis intends to bring SR-01 to the clinic in order to provide a cure for the devastating disease of diabetes.

Uniformed Services University

Uniformed Services University

Bethesda, Maryland, US

Uniformed Services University is a medical education institution that specializes in training healthcare professionals for military service.

United Therapeutics

United Therapeutics

Silver Spring, Maryland, United States

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions. We currently have five approved products on the market, and a long-term mission of providing an unlimited supply of transplantable organs for those who need them! Our employees can be found collaborating across the United States, Europe and Asia. As a group, we are relentless in our pursuit of “medicines for life” and continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers, and other orphan diseases.

Vector BioMed, Inc.

Vector BioMed, Inc.

Gaithersburg, Maryland, US

Vita Therapeutics

Vita Therapeutics

Baltimore, United States

Vita Therapeutics - We are a team of dedicated scientists striving to advance treatments in multiple indications in our cell therapy platform. Our mission is to utilize the power of genetics to deliver life-transformative cell therapies by unlocking the potential of engineered cellular medicine.