List of Clinical Research Companies in Maryland - 9

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.

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.

BIOQUAL, Inc. is fully accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC) and has a long history of providing state-of-the-art facilities and trained, experienced research scientists, veterinarians and animal care personnel for clients involved in infectious disease investigations, cancer research, and a wide variety of other in vivo and in vitro studies.

CosmosID provides award-winning, end-to-end microbiome solutions. They offer NGS, Metabolomics, Bioinformatics, as well as the world's most advanced microbiome analysis software, CosmosID-HUB: Microbiome. The HUB relies on validated databases and algorithms specifically designed for maximum sensitivity, precision and lowest false positive rates. Unlike other solutions, CosmosID delivers strain-level results – we understand that the biologically informative and actionable unit in microbiology is not a genus or species, but ultimately a strain and its unique genetic and metabolic properties. CosmosID was founded in 2008 by Dr. Rita Colwell, former director of the National Science Foundation and currently Distinguished University Professor at the University of Maryland and Johns Hopkins University Bloomberg School of Public Health. To learn more please visit www.cosmosid.com.

CSSi LifeSciences™ Drug & Medical Device Commercialization & Medical Device CRO Our goal is to ensure a successful and expeditious pathway to commercialization for our clients’ drugs and medical devices by providing insight-driven analysis that saves time, development costs, and resources. We enable faster, more informed decision making to increase commercial success, while reducing the risk of late-stage failures and post-authorization action. Unparalleled Success from Discovery to Commercialization • Commercialized over 500 new drugs, biologics, medical devices, and in-vitro diagnostics • Over 250 medical device 510(k) Class 1-3 submissions with 100% success. • Extensive Orphan, “First in Class,” and “First In” Indication success. • Reduced time to approval by over 600 days. • Over 100 NDA, ANDA and BLA submissions, with 96% success. • Greater than 60 EMA CHMP Marketing Authorizations. • SmartStudyTM design and feasibility assessments enhanced study efficiency and success and reduced protocol amendments by over 50%. CSSi LifeSciences Medical Device CRO has experience navigating regulations in over 100 countries. Often companies struggle with the pathways for a medical device from design to commercialization because of the ambiguity and complexity of the process. Regulations and requirements change frequently and vary by notifying bodies, country, level of risk (i.e., Class 1-3), specific product claims, and intended use. Our diverse team has many years of medical device commercialization experience, with the knowledge that goes beyond published guidance, documents and initiatives. CSSi LifeSciences Medical Device CRO aims to impact the timeline of regulatory clearance and increase profitability.

DP Clinical, Inc. is a privately held Contract Research Organization (CRO) specializing in neurology/CNS (including spinal cord injury), oncology, ophthalmology, infectious disease/vaccines, and rare disease Phase I-IV clinical programs. DP Clinical provides a full complement of clinical trial services to pharmaceutical, biotech, and medical device companies including trial management, monitoring, data management, biostatistics, regulatory, safety monitoring and reporting, and medical writing. Since 1994, we have worked for clients of all sizes — small to large pharmaceutical and biotech companies, academic research institutions, and government sponsors. DP Clinical provides integrated trial solutions as well as specific service components based on sponsor need. Our comprehensive services include: • Project management • Clinical trial monitoring • Data management • Biostatistics • Pharmacovigilance and safety • Regulatory affairs • Quality assurance • Medical writing

Psomagen, Inc., formerly Macrogen Corp, delivers genomic sequencing services to the clinical, academic, and consumer markets. Psomagen's labs are US-based and CLIA and CAP certified. Not only is the company accredited to perform the highest quality Sanger sequencing, Next-Generation Sequencing and Microarray Gene Analysis, it is also networked with Macrogen's worldwide headquarters, stretching its capabilities and capacity across a diverse set of labs around the world. Learn more at psomagen.com.

Westat offers innovative professional services to help clients improve outcomes in health, education, social policy, and transportation. We are dedicated to improving lives through research. Expertise • Data Collection & Management • Clinical Trials • Statistical Research & Survey Methods • Evaluation • Communications & Social Marketing Staff and Locations Westat’s staff of more than 2,000 are located at our headquarters in Rockville, Maryland, near Washington, DC. Additional staff are located at Westat’s data collection survey processing facilities, at our Telephone Research Center facilities, and throughout our nationwide field operations. Westat also maintains research offices near our clients in Atlanta, Georgia; Cambridge, Massachusetts; Raleigh/Durham, North Carolina; Philadelphia, Pennsylvania; Houston, Texas; and San Antonio, Texas. We have international offices in Liberia, Costa Rica; Johannesburg, South Africa; and Bangkok, Thailand. Westat is committed to providing accessible media on LinkedIn. Should you experience difficulties with any posted media, please send us a message at Section508Coordinator@westat.com. An alternative format will be provided upon request.