Human‑ and data‑centric AI design · Health systems
We design AI, data, and the people accountable for decisions as one system, so outputs can be explained, audited, and used in regulated settings.
CURRENT PAINPOINTS
Who we serve
The offer is concrete: diagnose the system, design the shared brain, and stand it up so people can actually decide with it.
Turn an idea into a company that can survive diligence — business model, data architecture, regulatory path, and the first product that is not another silo.
Founder diagnostic →Redesign how clinical, safety, medical, and commercial share a brain, so integrative AI is infrastructure — not a chatbot parked in a corner.
Life-science offers →Give ministers and agencies one picture of the population: strategy, shared dataset, and decision rights in the same architecture.
Government, payer & non‑profit offers →The problem we exist to fix
Departments collect data they cannot see together. Vendors sell another platform. AI arrives as a pilot or a human-in-the-loop check on one intake step. The patient, the molecule, and the minister still wait on PDFs.
We design whole systems: AI, multi‑source data, process, and human accountability together — so safety physicians, regulators, clinicians, and leaders can explain, audit, and act. Oversight is built into the architecture, not bolted on after the model.
The founder
Founder & CEO since 2015 · 30+ years in drug development, regulatory data, and health strategy
Founder & CEO Grace S. Lee: 30+ years designing AI, data, and human‑centric systems in clinical research and drug development — from case narrative automation that began while at a pharma company (2006–07) and a 2008 Bayer language model at Covance, through CLASS on Google technology in 2013, to Safety Intelligence Systems for Sanofi and Pfizer.
Grace S. Lee founded Health Enovation, Inc. in 2015 to continue a career-long practice: designing integrated AI, data, and human‑centric systems so decisions in drug development, safety, and health strategy can be explained and used. She published her first scientific abstract at 14, on thigmomorphogenesis, with the American Association for the Advancement of Science (1994), and was named an honorary lifetime junior member.
She went on to gynecology research at Columbia University, where she earned a BA in biological sciences and an MA in biotechnology. At Forest Laboratories she worked on memantine for Alzheimer’s disease and led the safety team before an FDA advisory committee. She later held global head and senior director roles in medical data and submissions at Covance and Celgene, then led healthcare strategy work at PA Consulting — including CLASS on Google technology and Qatar’s National Strategy for Diabetes (author and designer). She advises pharma, biotech, and government health leaders.
Author and designer of Qatar’s National Strategy for Diabetes and its International Best Practices Analysis, endorsed by contributors to the US, EU, UK, and Australian diabetes and obesity treatment guidelines.
Written for the Qatar Supreme Council of Health.* The Ministry of Health launched it in November 2015, as part of national healthcare strategy work covering 2016–2022.
At Forest Laboratories she helped prepare the regulatory documents for memantine in Alzheimer’s disease and led the safety team for the FDA Advisory Committee review of 20 years of global safety data.
At Celgene she built a global team of 50 authors and publishers and planned submissions for more than 25 products, including more than 5 simultaneous electronic submissions to the FDA and EMA.
She developed CLASS on Google technology in 2013 — multi‑source safety and clinical intelligence with regulators and patient advocacy as design partners, demonstrated on a CIO roadshow including Gartner CIO, and featured by Google and Gartner at their conferences. Google Partner of the Year, 2012 and 2013. The pattern is whole-system design: AI, data, and human accountability together — not a human-in-the-loop check bolted onto one workflow.
She designed the Global Medical Epidemiology & Big Data Analytics (real‑world data) strategy and roadmap for Pfizer (2017–22) and AbbVie (2020), along with Pfizer’s institutional customer strategy. She has worked with 500+ biotech and pharma companies and 400+ C-level and VP executives, and has a network of 800 high-net-worth investors.
Health Enovation’s integrated-data AI in practice: MPC brought 15,000+ sources across all 50 US states and 3,000+ counties into one picture of COVID-19 mandates, case trends, and testing sites.
Work delivered while at PA Consulting.
Named work
Since 2016, Health Enovation has advised and done due diligence for 700+ investors and startup founders — PE/VC investors, C-level executives, and founders. The work covers clinical and AI strategy, regulatory and safety readiness, and technical due diligence. More on investor and startup work
500+ drug and biotech companies helped, saving them hundreds of millions of dollars. Helped get 300+ drugs, biologics and medical devices approved by the FDA, EMA, MHRA and SFDA. Clients include CEOs, CMOs, and CSOs, the FDA, NHS, EMA, the Academy of Medicine, and Ministries of Health. The named systems are below. All corporate and public-health work
Current-state analysis, international best practice, and epidemiology used to design a national strategy and implementation plan (2016–2022) — prevention, care, workforce, information, and research as one system.
Qatar National Strategy for Diabetes* Author and designer of Qatar’s National Strategy for Diabetes and its International Best Practices Analysis, endorsed by contributors to the US, EU, UK, and Australian diabetes and obesity treatment guidelines.
Clinical and Safety Signal Intelligence System built on Google technology in 2013, featured by Google and Gartner: multi‑source real‑world data for pharmacovigilance, HEOR, and competitive intelligence, with regulators as design partners. Whole-system AI + data + human accountability — the pattern Health Enovation still uses.
Early language-generation for safety: case narrative automation began while at a pharma company (2006–07), then at Covance (2008–10) for Bayer and 50+ other pharma and biotech clients. The 2008 Bayer language model automated case narratives (89.5% improvement, p<0.001; about 1.2 minutes per draft), accepted by regulators in Bayer NDA approvals. The through-line starts here — AI next to the people accountable for safety decisions.
An integrated Safety Intelligence System that automates safety reporting, surveillance and analytics for regulatory filings, built for Sanofi (2013–14)* and Pfizer (2017–22).
An AI language model for early detection of diabetes in medical records, built for J&J and the EU/EFPIA Innovative Medicines Initiative (IMI) in 2014.*
1999–2001: Led the launch of Lipitor, Viagra, Neurontin and Lexapro for Warner-Lambert, Pfizer and Forest via human‑ and data‑centric integration. Pivotal NDA work for memantine (Namenda), first‑in-class NMDA receptor antagonist for moderate-to-severe Alzheimer’s. Safety-team lead at the FDA Advisory Committee that voted unanimous support; full marketing approval on the action date.
Health Enovation’s integrated data and AI platform: data from 15,000+ sources across all 50 states, 3,000+ counties, and African countries with limited technology resources — mandates, cases, testing, and research — brought into one picture that people and agencies can share. The studio’s living proof of a shared brain at population scale.
Work delivered while at PA Consulting.
Begin
Say who you are — founder, life‑science operator, or government — and what has to be true in 90 days. Grace reads the mail.
grace.lee@healthenovation.com