San Diego based, Therapeutics, Inc., The Dermatology CRO was founded in 1997. Approximately 90% of our activities are focused on developing dermatology products. TI is the only dermatology-focused CRO that provides all services required to move a product concept through non-clinical and clinical stages to FDA approval. During the last 5 years: TI managed >12,000 subjects in >80 clinical studies and filed 18 INDs and IDEs in a variety of drug, device and biologic programs.
Labskin’s pioneering approach for testing skincare products by cloning a patient’s skin microbiome and transplanting it on to Labskin Human Skin Equivalent, allows a wide range of testing that no longer requires invasive procedures on patients. Data from next generation sequencing of the Labskin and skin microbiome is coupled with AI processes to interpret and direct further development of skincare products in a controlled and efficient manner, reducing development time and costs.
Diversigen & DNA Genotek
DNA Genotek Inc. and Diversigen are subsidiaries of OraSure Technologies, Inc. working as a group to provide high-quality microbial sample collection products and comprehensive services for sample processing, sequencing, and bioinformatic analysis.
DNA Genotek’s OMNIgene product line immediately stabilizes microbiota samples at the point of collection, ensuring an unbiased ‘snapshot’ of the microbial community.
Diversigen, who has sequenced more than 170,000 microbial samples, offers the best analytical science available to accelerate microbiome discovery for academic, pharmaceutical, biotechnology, agricultural and environmental applications.
Boston Analytical is a cGMP compliant, FDA/DEA registered, ISO/IEC-17025:2005 accredited world class pharmaceutical testing laboratory. We provide identity, purity, and potency analyses necessary to characterize microbiome products and we have a proven track record on a variety of Microbiome programs including Spore Fraction and Defined Drug Product manufacturing processes. Boston Analytical employs LabWare Inc.’s™ LIMS and ELN software to help ensure on-time and accurate results.