| Xaira Therapeutics | Bay Area | AI-driven drug discovery, generative biology | Preclinical, raising $1B Series A | Gene therapy, AI/ML models, IP protection | Robust, auditable cloud infrastructure for high-compliance AI model training and validation; Secure data pipelines for proprietary biological data; Strong data integrity (ALCOA+) controls. |
| EvolutionaryScale | San Francisco, CA | AI-designed therapeutic proteins | Seed stage, raising $142M | Protein sequence data, AI/ML validation | Secure computational infrastructure for LLM training on protein data; Validated systems for managing and storing massive datasets; Adherence to GxP data integrity principles. |
| Mammoth Biosciences | Brisbane, CA | CRISPR diagnostics | Preclinical / Early Clinical | FDA-cleared diagnostic tests, genetic data | GxP-compliant ELN and LIMS for CRISPR assay development; Secure management of sensitive patient genetic data; 21 CFR Part 11 compliance for electronic records/signatures. |
| Allogene Therapeutics | South San Francisco, CA | Allogeneic CAR-T cell therapies | Clinical | Cell therapy manufacturing (cGMP), clinical trials (GCP), data traceability | Full GxP alignment including 21 CFR Part 11 and Annex 11; Computerized System Validation (CSV) for manufacturing and clinical data systems; Audit-ready data for FDA submissions. |
| Akero Therapeutics | South San Francisco, CA | Liver disease therapeutics | Clinical (Phase 3) | Active Phase 3 clinical trials for MASH | GxP-compliant EDC, LIMS, and ePRO systems for clinical trial data management; Secure and validated systems for imaging and biomarker data; Real-time monitoring capabilities. |
| Denali Therapeutics | South San Francisco, CA | Neurodegenerative diseases (Alzheimer’s, Parkinson’s) | Clinical | CNS-targeted therapies, nonclinical data (GLP), clinical data (GCP) | GxP-compliant EDC and LIMS for clinical trials; GLP-compliant systems for nonclinical study data; Secure data handling for sensitive neurological data. |
| Azaan Pharma | Not Specified | Not Specified | Not Specified | Not Specified | Not Specified |
| Endpoint | Not Specified | Interactive Response Technology (IRT®) | Not Specified | Clinical trial supply chain, patient dosing, operational compliance | 21 CFR Part 11 and Annex 11–aligned IT infrastructure for IRT platforms; Secure and compliant systems for managing clinical trial logistics and patient data. |
| Arterys | San Francisco, CA | Cloud-based AI platform for radiology | Commercial | FDA-cleared medical device, HIPAA | HIPAA/GxP-aligned IT infrastructure for cloud platform; Cybersecurity controls for handling protected health information (PHI); Full GxP software lifecycle management for the AI platform. |
| Verily Life Sciences | South San Francisco, CA | Digital health tools, remote monitoring, AI analytics | Established | Regulated as SaMD (Software as a Medical Device) | Full GxP-aligned software development lifecycle management; Automated version control and audit trails; Robust cybersecurity controls for connected health data. |
| GRAIL | South San Francisco, CA | Multi-cancer early detection blood test | Commercial | CLIA, CAP, FDA authorization | Strict GxP-aligned IT infrastructure for validated LIMS; Secure ePRO systems; 21 CFR Part 11-compliant systems for analytical pipelines and regulatory submissions. |
| Genentech | South San Francisco, CA | Oncology, immunology, neuroscience drugs | Large Enterprise | >60 investigational molecules, >19,000 employees | Extensive GxP-compliant IT for clinical pipeline, manufacturing, and post-marketing surveillance; Complex system integration and validation needs. |