Please see full descriptions below
Biomarker Discovery and Development
Our skills and experience deliver strategies for identifying genomic biomarkers and roadmaps for their development as tools to support clinical drug development. We assist with the technical aspects of biomarker-assay development and validation. If appropriate, Cabernet Pharmaceuticals also provides expertise in translating biomarkers to companion diagnostics.
Genetic/Genomic Lab Management
Cabernet has strategic alliances with genomic-service providers that produce high-quality sequence, genotype, gene-expression, and epigenetic data under strict QA/QC requirements. Services include nucleic-acid isolation, sample QC, and biobanking.
Genetic/Genomic Data Management, Bioinformatics, Analysis
Our strategic partners are experts in data management (harmonization and synthesis from multiple assays/vendors), statistical strategies employing novel algorithms for analysis, and superior data reporting and visualization tools.
ADME PGx Analysis
Drug absorption, distribution, metabolism, and excretion (ADME) can be profoundly affected by genetic polymorphisms in ADME genes. Genetic variants are major determinants of pharmacokinetics, pharmacodynamics, clinical response, adverse events, and ultimately drug risk/benefit. Our consultants will devise a strategy to address ADME genetic variation in clinical trials, evaluate its effect on treatment risk/benefit, incorporate findings into development strategies, and report this information to global regulators.
Biomarker Enrichment in Clinical Trials
Creating and implementing clinical-trial designs incorporating biomarkers to identify patients with specific disease risk or potential drug responses (therapeutic or adverse) are a distinctive skill of Cabernet consultants. Our optimized biomarker-enriched trial designs decrease patient heterogeneity, save cost and time, and increase the probability of trial success.
Enabling Tactics to Reduce Study Start-up Timelines
In the neuroscience therapeutic area, Cabernet uses our global network of pre-identified, experienced clinical centers and study-specific patient registries to reduce study start-up timelines, accelerate recruitment, and significantly reduce cycle time between clinical-study phases.
Clinical Protocol Development/Management
Cabernet works closely with clients to understand their needs and goals and then deliver timely, executable clinical protocols that provide actionable answers for the key scientific, regulatory, and payer questions in all phases of drug development. We also develop study documentation, such as study-procedure manuals, informed consents, and clinicaltrials.gov summaries. We can create and manage external clinical-study committees including advisory, adjudication, and drug-safety monitoring boards.
Combination Drug/Device Product Development
Cabernet can create a drug/device development strategy that includes device classification and qualification advice and identifies device-specific data requirements. We can identify and evaluate appropriate diagnostic-assay vendors. We will prepare drug/device co-development registration strategy and prepare and conduct regulatory meetings.
Regulatory Strategies for Fast-track, Breakthrough, Orphan Designations
Cabernet can help identify suitable regulatory opportunities, frameworks, and timelines, especially for expedited drug development. We can help clients devise innovative regulatory strategies to guide product development and optimize development time. These services include drafting briefing documents, facilitating meetings, and responding to regulators' requests.
Management of Regulatory Operations
Through our network of strategic alliances, Cabernet can provide:
- Document/report templates
- Report-writing support
- Quality-assurance support
- Document publishing
- Submission-compilation support
- Secure electronic regulatory submissions
- Support of regulatory maintenance activities (e.g. annual/periodic reports)
Patients, physicians, payers, and regulators all desire more precise guidance about drug-related risks. PGx-guided pharmacovigilance informs adverse-event reporting by determining whether risk is limited to genetically defined subpopulations and thus enabling precision-medicine strategies that enhance life-cycle management.