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Published: Aug 22, 2018 By Mark Terry (www.biospace.com) It has been noted repeatedly that during the Gold Rush, the most successful businesses were the ones that sold shovels, picks and sluices to the gold prospectors. In many ways, that’s true today in any number of industries, including biopharma. Inc. magazine collates an annual list of the fastest-growing private companies in America. This year, 15 of the top 5,000 were related to healthcare, medical devices and biopharma. Many of them were clinical research organizations (CROs) or consultancies that help biopharma companies move through the development, regulatory and commercial processes. Here’s a look. uBiome (#50). Headquartered in San Francisco, uBiome utilizes machine learning, artificial intelligence (AI), and advanced statistics to analyze the microbiome. The company was founded in 2012. It offers several sequencing-based clinical microbiome screening tests. ViGene Biosciences (#81). Based in Rockville, Maryland, Vigene offers AAV, lentivirus and adenovirus-based products and custom services for use in life science research, gene therapy and cell therapy. In April, Vigene announced a partnership with Virovek to use Virovek’s AAV Production Technology, BAC-to-AAV, in AAV GMP productions. Acuity Surgical (#201). Located in Dallas, Texas, Acuity Surgical offers tools and technology used in spinal surgeries. Products include natural bone void filler for spine surgery, AcuPac Allograft Tissue, and A-Link Z fusion systems. MedSource (#1363). With corporate headquarters in Houston, Texas and locations in San Diego, Boston, Raleigh, NC, and Newcastle, UK, MedSource is a full-service clinical research organization (CRO) focused on complex diseases and study designs. It provides services in oncology, neurology/CNS, rare/orphan diseases, and endocrinology, infectious diseases, transplant, respiratory/pulmonary, urology/nephrology, pain management and others. Novasyte (#1692). Headquartered in Carlsbad, California, Novasyte was founded by two former Medtronic executives and provides quick-to-market sales, clinical, field service and field correct teams for the healthcare industry in the U.S. and Canada. Its areas of expertise are medical device, diagnostic and pharmaceutical segments. This was the sixth year Novasyte made the 500 List of Fastest-Growing Private Companies in America, where it jumped from #2,428 in 2017 to its current position of #1692. BioAgilytix (#1833). Located in Durham, NC, BioAgilytix offers large molecule bioanalysis with tailored services for biomarker, immunogenicity, pharmacokinetics, and cell-based assays. On July 11, BioAgilytix announced a strategic collaboration with biOasis Technologies to develop and validate bioanalytical methods to support Bioasis’ lead candidate to treat HER2+ brain cancer. Steep Hill (#2387). With laboratories around the world, Steep Hill specializing in lab testing, research and development, licensing, genetics and remote testing for cannabis, to ensure recreational cannabis is compliant with public safety standards. It has labs in Alaska, California, Canada, France, Spain and other locations. In May, Steep Hill and Eybna Technologies launched Delta, which produces custom terpene formulation for incorporation into cannabis-derived products. Nuventra Pharma Sciences (#2819). Based in Durham, NC, Nuventra is a pharmaceutical consulting company. The company has more than 50 scientific consultants and focuses on clinical pharmacology and PK/PD, which can be used to inform drug development. In May, it announced it was opening a new office in Cambridge, Massachusetts. The FDA Group (#2959). Located in Westborough, MA, The FDA Group offers quality assurance consulting and auditing services for GMP, GCP, GLP, and PV. The company has more than 500 specialists worldwide, with more than 75 who were previously employed by the U.S. Food and Drug Administration (FDA). BioPoint (#3115). Headquartered in Wakefield, MA and Carlsbad, CA, BioPoint is a life sciences consulting company focused on accelerating all aspects of drug development, and ensuring compliance at a global level. Areas of expertise are pharmacovigilance, drug safety and risk management, regulatory affairs, market access, and clinical operations and biometrics. Caldera Medical (#3209). Located in Agoura Hills, CA, Caldera Medical develops and markets differentiated surgical implants specifically to treat Stress Urinary Incontinence and Pelvic Organ Prolapse. In June, Caldera teamed with the Foundation for International Urogynecological Assistance (FIUGA) to support urogynecological education, research and care worldwide. Atlantic Research Group (#3302). Based in Charlottesville, VA, Atlantic Research Group (ARG) is a rare disease-focused contract research organization (CRO). It provides a comprehensive clinical program development services that range from pre-launch consulting to commercialization. It was founded in 2004. DSP Clinical Research (#3500). Headquartered in Fairfield, NJ, DSP Clinical Research is a CRO focused on clinical trial management. Those services include study startup, ongoing study management, multi-vendor management, site monitoring, study rescue and cleanup, site and monitor training and auditing, data management, statistics and medical writing, and FDA submissions. ProPharma Group (#3733). With offices throughout the U.S., Europe, Asia and Australia, ProPharma Group partners with life science companies to provide expertise in pharmacovigilance, development lifecycle and other services. In July, ProPharma Group, which is a portfolio company of Linden Capital Partners, acquired Xendo Holding, a Netherlands-based provider of compliance consulting, engineering and technical support, regulatory affairs, and pharmacovigilance services. LabConnect (#3917). Headquartered in Seattle, WA, LabConnect provides global central laboratory services, including routine and esoteric laboratory testing, kit building, sample management, biorepository and scientific support services for biopharma, medical device and CROs.