Enhancing Public Health
At Athari BioSciences, we are proud to stand at the forefront of Research and Product Development, delivering innovative, cutting-edge biomedical advancements that enhance overall public health, such as diagnostic tools for infectious and degenerative diseases, cancer medicines, and biopharmaceutical products. We utilize decades of expertise to navigate regulatory requirements in the research and development process efficiently and effectively, accelerating the delivery of new products to market. With expert level Diagnostics Development, Clinical Trial Support, and Lab Testing & Consulting, our team works diligently every day to deliver real solutions to the most significant challenges facing public health and advance critically needed research to bring products to market.
Diagnostic Development Consulting: FDA-approved Companion Diagnostics
As an end-to-end, full-service contract diagnostics organization (CDO), we support clients leveraging our scientific and medical expertise in all areas of diagnostics with comprehensive data analysis to ensure projects are designed, implemented, and compliant with established priorities and schedules. We also provide clients the flexibility to add new lines of testing and modify workflows with agility as conditions evolve. Our reports close the data and diagnosis gap securely using HIPAA-compliant connectivity and cloud-based ordering. In our Biosafety level 2 (BSL2) Clinical Laboratory Improvement Amendments (CLIA) certified laboratory, our diagnostic development capabilities play a crucial role in enhancing public health through:
- Pathogenic Viral Immunosurveillance: Driving accurate, timely disease detection, advancing the way viral infections are detected, and shaping the way vaccines and therapeutic responses are evaluated to inform public health strategies and rapidly scale and respond to current and future outbreaks.
- Specialized Testing & Routine Health Screenings: Conducting genetic testing for hereditary disorders, molecular diagnostics for personalized medicine, advanced tests not available in traditional healthcare settings, along with tests for common health conditions (e.g. cholesterol, diabetes, etc.) and prenatal screening to support preventive healthcare and assure healthy future generations.
- Integrated Development of a Drug and Companion Diagnostic: Integrating and synchronizing all in vitro diagnostics (IVD) and biopharma development activities to serve as a single start-to-finish partner that can simplify and successfully expedite navigation of the companion diagnostic regulatory process.
Clinical Trial Support
Our team leverages decades of collective expertise in research, manufacturing, consulting, and data analysis to simplify and navigate the clinical trial process. We support client needs in bioinformatics and statistical programming, data management, regulatory and medical writing, and consulting to diversify clinical trials. Adaptive trial support capacity enables the rapid turnaround of results to support evolving trial needs and the flexibility to adjust testing needs as trials progress. The result for clients is significantly reduced time-to-market for new therapies and improved overall success rate of clinical trials to accelerate product commercialization through:
- Expert Level Research Support: Collaborating on clinical trials and research studies, providing data for epidemiological research, and supporting the development of new diagnostic methods to bring research into commercial reality.
- Biomarker Testing & Validation: Conducting tests to identify and validate biomarkers for drug efficacy and safety, measuring drug levels and metabolites to assess dosing, and collaborating with sponsors to optimize assays for specific requirements and effective testing protocols.
- Specialized Clinical Capabilities: Supporting Pharmacokinetic/Pharmacodynamic (PK/PD) analyses through precise measurement of drug concentrations and effects, providing immunoassays, flow cytometry, and other specialized analyses, as well as developing and validating custom assays for novel drugs or biomarkers to meet public research needs from broad to hyper-niche.
- Patient Recruitment & Quality Control Support: Supporting genetic screening for targeted therapies, assisting in identifying eligible patients, and implementing rigorous quality control measures including Good Clinical Laboratory Practice (GCLP) standards to assure valid trial results.
Lab Testing & Consulting
Our BSL2 CLIA-certified laboratory is at the forefront of enhancing public health through comprehensive, expert-level laboratory testing and consulting services. This translational research bridges the gap between science and clinical application, ensuring the development of effective bench-to-bedside solutions. Athari Bio opens our doors to this laboratory for good, enhancing STEMM workforce development through:
- Hands-on training and continuing education: Providing the next generation of STEMM professionals with real-world experience in a laboratory setting otherwise inaccessible, particularly for women, underrepresented groups, and neurodivergent individuals. We take immense pride in providing these opportunities to any and all individuals who seek to join the STEMM workforce, regardless of their background. We emphasize quality management, strong leadership, and equitable treatment to foster a culture of continuous improvement and mutual respect that is essential for success.
- Internship Programs & Technical Skill Development: Offering internships paired with experienced staff in a state-of-the-art laboratory setting, training in specialized equipment and lab developed tests, and expertise in emerging fields like genomics, viral pathology, and proteomics.
- Industry-Academia Partnerships: Facilitating knowledge transfer between academic researchers and industry professionals, assisting aspiring STEMM professionals in identifying and pursuing career goals within the field, and hosting visiting scholars and researchers.
