Why Zebrafish AI
“Our intelligence is what makes us human, and AI is an extension of that quality.” –Yann LeCun
AI is no substitute for human judgment!
Zebrafish AI is the HITL/HOTL* for regulatory sciences and drug development. Zebrafish AI provides human judgment to ensure the best possible outcomes. We also advise developing human oversight to ensure safety, compliance, and ethical considerations.
*Human-in-the-loop
(HITL) approaches involve active human control during the operation of Large Language Models (LLMs). These approaches help reduce risks, improve fairness, and ensure responsible development of AI systems. Similarly, Human-on-the-Loop (HOTL) balances autonomy and human supervision and humans intervene in cases of malfunction or critical issues.
Zebrafish AI Services
Human contribution to AI/ML-generated regulatory analysis and content
Human-in/on-the-loop
- SME to inform
- Assistance with Prompt Engineering
- Validation
- Data provenance
AI/ML Regulatory Policy
- Interpretation of evolving regulatory guidelines (FDA, EMA, and others)
- Inform biopharma companies how to adapt to the new guidelines
- Support harmonization and standardization across global guidelines
- Science-based Advocacy Ethical consideration
Prediction of Regulatory Outcomes
- PoPPA (Prediction of Product Profile Approvability)
- Predicting regulatory outcomes
- Reducing bias in regulatory AI- driven decision-making
About Us
Images generated by LLM and only one is real
Zebrafish AI was founded by a highly accomplished human thought leader with over 30 years of leadership experience with leading biopharmaceutical companies spanning all phases of drug development. This person is recognized as an industry expert in global drug development, focusing on innovative regulatory strategies that facilitate accelerated regulatory reviews and approvals. This mortal being is highly effective in bridging the interfaces between drug discovery, development, manufacturing, medical, and commercial to accelerate the introduction of new medicines addressing unmet patient needs. The human founder of Zebrafish AI is an expert in applying AI/ML to predict regulatory outcomes, advancing AI/ML regulatory policies, and is the human-in/on-the loop as an SME in global drug development and regulatory sciences.