The studio

Human- and data‑centric AI design — a career-long practice, not a recent pivot.

Grace S. Lee is Founder & CEO of Health Enovation, Inc. For 30+ years in clinical research and drug development she has designed human‑ and data‑centric systems, and more recently AI systems, that put models and data next to the people accountable for decisions — safety physicians, regulators, clinicians, and national health leaders — rather than as stand-alone tools. Today, through Health Enovation, she advises pharma, health systems, and governments, including integrated Safety Intelligence Systems for Sanofi and Pfizer and real‑world data strategy for Pfizer and AbbVie. While at PA Consulting she built CLASS (Clinical and Safety Signal Intelligence System) on Google technology in 2013 — demonstrated on a CIO roadshow including the Gartner CIO conference and presented to the EMA, MHRA, NIHR and top 15 global pharma and biotech companies. Case narrative automation began while at a pharma company (2006–07), then at Covance (2008–10) for Bayer and more than 50 other pharma and biotech clients, including a 2008 Bayer language model that regulators accepted in NDA approvals. In 1999–2001 she led the launch of Lipitor, Viagra, Neurontin and Lexapro for Warner-Lambert, Pfizer and Forest via human‑ and data‑centric integration; her practice is rooted in academic research — cell-cycle and Alzheimer’s work — and earliest published presentations on cellular communication (National Academy of Sciences, 1992; AAAS Annual Meeting, San Francisco, 1993).

Credentials in the open

Living credentials stay on LinkedIn, where the record can be checked: linkedin.com/in/gracelee528.

Published research in cancer, Alzheimer’s, and epilepsy. Six Sigma practitioner. Advisor and Pipeline Angel on health-tech diligence; Pipeline Angels investments in Tastemakers Africa and Agora for Good. Google Partner of the Year, 2012 and 2013. American Association for the Advancement of Science (AAAS) Honorary Member. Most Innovative HealthTech CEO 2023 (USA), Acquisition International Influential Businesswoman Awards (Issue 9, 2023). Industry Era 10 Best Female Leaders, 2020.

Press & recognition

What the trade press has written.

Award profiles first, then more coverage, newest first. Select an image to view the full page.

Acquisition International magazine spread headlined “Most Innovative HealthTech CEO 2023 (USA): Grace Lee”, with a portrait of Grace Lee

Acquisition International Issue 9 · 2023 · Influential Businesswoman Awards

Most Innovative HealthTech CEO 2023 (USA): Grace Lee

The profile traces Grace’s career in health tech, biotech, and pharma, advising CEOs, CMOs, and CSOs as well as the FDA, NHS, EMA, and Ministries of Health. It covers AI and natural-language automation for regulatory filings and adverse-event processing, and the CLASS safety-signal platform, featured by Google and Gartner. It also notes a platform for the Qatar Supreme Council of Health and pandemic tracking across 50 US states and 3,000 counties.

Read the article  (opens in a new tab)
Industry Era profile page titled “A Pioneering Thought-leader & Mentor”, with a portrait of Grace Lee and the 10 Best Female Leaders of 2020 Certificate of Honour

Industry Era 2020 · 10 Best Female Leaders of 2020 · Certificate of Honour

A Pioneering Thought-leader & Mentor

Industry Era named Grace, Founder & CEO of Health Enovation, one of its 10 Best Female Leaders of 2020, with a profile and a Certificate of Honour. The profile notes she was a published scientific researcher before graduating high school and led a global expert team (November 2014 – June 2015) on Qatar’s national healthcare strategy for 2016–2022. It also covers Million Patients Cured (MPC), the COVID-19 platform built with 32+ experts and 15,000+ sources across all 50 states and 3,000+ counties, and her work mentoring women in leadership.

Read the article  (opens in a new tab)

More coverage

The path the work comes from

A timeline, not a myth.

15–

Health Enovation

Founder & CEO. Advises founders, life‑science executives, and governments on health technology and integrative AI. Since 2016, has advised and done due diligence for 700+ investors and startup founders, including PE/VC investors and C-level executives. Designed the Global Medical Epidemiology & Big Data Analytics (real‑world data) strategy and roadmap for Pfizer (2017–22) and AbbVie (2020), and built the integrated Safety Intelligence System for Pfizer (2017–22), which automates safety reporting, surveillance and analytics for regulatory filings.

2020

MillionPatientsCured.com

Grace S. Lee founded MillionPatientsCured.com, a human‑centric COVID-19 platform that integrates data from 15,000+ sources across all 50 states and 3,000 counties. The Epidemic Explorer map puts state and county information two clicks away, combining data exploration with AI and machine learning, and connecting the public, patients, testing sites, clinical trials, and scientists — with patient-controlled data privacy. Dr. Amanda Heron Parsons, MD, former deputy commissioner of the NYC Department of Health and Mental Hygiene, called Epidemic Explorer “a fantastic way to sift through a ton of information.” PR Newswire, Jul 2, 2020 (opens in a new tab).

MillionPatientsCured.com Epidemic Explorer: U.S. county map of relative COVID-19 cases with test-site and clinical-trial markers, legend, and June 15, 2020 timeline control. (opens the full-size Epidemic Explorer map in a new tab)
Epidemic Explorer on MillionPatientsCured.com (product screenshot from Grace’s July 2020 PRECIS MED / MPC deck; map dated Jun 15, 2020). County-level case intensity with test sites and clinical trials — the two-click public map described in the Jul 2, 2020 PR Newswire release. Select the image to open it full size.
11–16

PA Consulting

Managing Consultant, Life Sciences and Healthcare. Authored and designed Qatar’s National Diabetes Strategy for the Supreme Council of Health. CLASS (Clinical and Safety Signal Intelligence System), which she built on Google technology in 2013, was demonstrated on a roadshow with CIOs across the industry, including at the Gartner CIO conference, and presented to the EMA, MHRA, NIHR and top 15 global pharma and biotech companies. It is a pharma intelligence and compliance platform on Google Cloud (BigQuery) that integrated terabytes of real‑world data from 120+ sources, tracked 283 million patient cases and 587,000 serious adverse events, and answered questions in three clicks. Built with Google; regulators (FDA, EMA, MHRA) and patient advocacy groups were design partners. Language processing read 100,000 sentences in 17 seconds (2013). Clinical trial site performance tool covering 21,860+ sites. Co-presented with Google (Big Data in Pharma Europe 2014 with Rob Easton; BRC D2D 2014; with Thanikai Sokka). Google Partner of the Year, 2012 and 2013. Bayer narrative-automation results (built while at Covance, 2008) were presented at DIA 2012 (Lee et al., PA Consulting — presentation affiliation only). For Sanofi (2013–14), built the integrated Safety Intelligence System for safety reporting, surveillance and analytics for regulatory filings. In 2014, built an AI language model for early detection of diabetes in medical records, for J&J and the EU/EFPIA Innovative Medicines Initiative (IMI).*

Qatar National Strategy for Diabetes and integrated care system* Author and designer of Qatar’s National Strategy for Diabetes and its International Best Practices Analysis for the Qatar Supreme Council of Health, endorsed by contributors to the US, EU, UK, and Australian diabetes and obesity treatment guidelines. The strategy’s six-pillar national integrated diabetes care and data system connects screening, patient and clinician apps (including the integrated diabetes app Grace designed), the national registry, hospital records (Cerner, NHI/SEHA, Sidra), the biobank and wearables into one research and reporting platform.

Diagram of Qatar’s future national diabetes care system. Rows for awareness and prevention, patient empowerment, care delivery and capacity planning, information management, and research are linked by coordination, running from awareness campaigns and screening through patient and clinician apps, counseling and treatment, to the registry, tracking, service evaluation and clinical research. Below, a data-integration layer joins the screening registry, patient and clinician apps, appointments and referrals, wearables, Cerner, the Qatar Diabetes Registry, NHI/SEHA, the biobank and Sidra into a central database and a research platform and reporting portal. (opens the full-size diagram in a new tab)
Future national diabetes care system: Qatar National Diabetes Strategy, designed by Grace S. Lee (2015).* It is an integrated ecosystem built from the patient and provider experience, so people, data, technology, and processes work together. Six pillars (awareness and prevention, patient empowerment, care delivery and capacity, information management, research, and coordination) are integrated in data flow, from biobank to medical records to patient trackers, and in time, effort, and resources, with measurable, actionable outcomes. The vision map traces the patient–provider journey; the blue boxes in the middle are the strategy deliverables. Grace also designed the integrated diabetes app for patients and providers. Select the diagram to open it full size.
07–11

Covance / Labcorp and Celgene

Global head and senior director roles. Global Lead of Clinical Data and Regulatory Strategy at Covance (now Labcorp Drug Development); Global Lead of Medical Data Strategy & Submissions at Celgene. NDA strategy, portfolio governance, and the operating system behind submissions. Case narrative automation began while at a pharma company (2006–07), then at Covance (2008–10) for Bayer and more than 50 other pharma and biotech clients. The 2008 Bayer language model for case narrative automation (89.5% improvement, p<0.001; about 1.2 minutes per draft; accepted by regulators in Bayer NDA approvals; York, Covance, PhUSE 2009) was built while at Covance.

98–07

Sudler & Hennessey, then Forest Laboratories

1999–2001: Led the launch of Lipitor, Viagra, Neurontin and Lexapro for Warner-Lambert, Pfizer and Forest via human‑ and data‑centric integration. Medical communications at Sudler & Hennessey / IntraMed. Then clinical development at Forest Laboratories. Pivotal NDA documents for memantine (Namenda). Safety-team lead at the FDA Advisory Committee; unanimous support and full marketing approval on the action date.

97

H.E.A.L.

Founded the Health Education and Advocacy League, a nonprofit for health awareness and patient empowerment in low-income communities — the first company built before college was finished.

Early

Academic research

Academic research in cell-cycle characterization and potential therapies for cancer and gynecological malignancies, and in Alzheimer's disease mechanisms with proposed stem cell and other treatment options.

92–93

Cellular communication

1992–1993: Earliest published work and presentations on cellular communication: National Academy of Sciences (1992) and AAAS Annual Meeting, San Francisco (1993).

Work delivered while at PA Consulting.

Speaking

Talks, panels, and stages.

Grace S. Lee. Reverse-chronological within each group. LinkedIn speaker list integrated Oct 14, 2026 (deduped).

Investor & startup ecosystem

  • 2022

    ADAPT accelerator (Village Capital with MetLife Foundation)

    Advisory Board member.

  • 2021

    Investor Connect podcast · Ep. 490 with Hall Martin (opens in a new tab)

    Guest, “Grace Lee of Health Enovation,” Mar 1, 2021: user-first health-tech investing, finding the real payer, and regulatory diligence for investors.

  • 2021

    MUN Impact E3 Summit for the SDGs · Equity Forum

    Forum speaker on how the pandemic deepened gender inequality.

  • 2020

    Princeton University Keller Center

    Speaker, “How to Fund an Impactful Business Venture” (Friday Lunch & Learn), Feb 7, 2020.

  • 2019

    Sharenett Investor Conference

    Speaker (Jan 2019).

  • 2019

    4th WIN (Women in Innovation) Forum New York, Parsons School of Design

    Panelist, “Improving Diversity in the Life Sciences Industry,” May 22, 2019.

  • 2019

    5th Annual Global Women in Leadership Summit, New York

    Case study, “How Wonder Women Skip the Ladder and Rise Up Faster to Break Glass Ceilings,” Apr 12, 2019.

  • 2018

    AI Tech Summit

    Speaker (Nov 2018).

  • 2018

    NASA Innovation Challenge (C3 Alliance)

    Guest speaker, “Ideation & Innovation for Sustainable Startups.”

    “Excellent presentation… Grace provided some excellent tools to use to innovate NASA patents.”

    Alan White, C3 Alliance
  • 2018

    United Nations General Assembly · PGA72 Youth Dialogue (opens in a new tab)

    Speaker, May 30, 2018, on bridging education and skills with employment.

  • 2018

    IBM Startup Bus · Women in Blockchain

    Speaker and judge (May 2018).

  • 2018

    Startup 52 Diversity Panel

    Panelist (Apr 2018).

  • 2018

    Columbia Venture Competition

    Judge (Apr 2018).

  • 2018

    Columbia Ignite Entrepreneurship

    Ideation workshop presenter (Feb 2018).

  • 2017

    Women@Forbes Live

    Panelist (Dec 2017). Same event as Smart Money Live with Natalia Oberti Noguera (Pipeline Angels), hosted and filmed by Women@Forbes, Dec 4, 2017.

  • 2017

    Columbia Business Women in Tech

    Moderator (Oct 2017).

  • 2017

    Meet Pipeline Angels

    Moderator/panelist (June 2017).

  • 2017

    Harlem Tech Summit

    Moderator of Founders’ panel & VCs’ panel (May 2017).

  • 2017

    Startup Weekend Travel Tech

    Speaker & mentor (Apr 2017).

  • 2017

    Pitch Lab: Female-Founded Health Tech

    Sponsor & advisor (April 2017).

  • 2017

    Columbia Business Women’s Leadership Conf

    Digital Innovation panelist (Feb 2017).

Industry & regulatory

  • 2020

    KNOW:Identity Digital Forum: Healthcare (One World Identity)

    Panelist, May 7, 2020. Digital identity, patient record matching and healthcare credentialing in the COVID era.

  • 2015

    Qatar National Diabetes Strategy Vision Workshop

    Presenter (2015); also customer engagement and launch meetings.*

  • 2014

    Biomedical Research Council · “D2D: Data to Drugs & Diagnostics”

    Panelist, “Smart Glasses, Smart Vision: Seeing Beyond the Innovation Chasm”; presenter, “Partnering to Build Big Data Platforms for your Real World Solutions.” Videos: session 1 (opens in a new tab) · session 2 (opens in a new tab).

  • 2014

    Big Data in Pharma conference, London

    Presenter, “Partnering to Build a Real World Platform for Your Big Data Solutions” (Google partner and co-presenter).

  • 2013

    Big Data in Pharma conference, Boston

    Presenter, “Partnering to Build a Real World Platform for Your Big Data Solutions” (Google partner and co-presenter).

  • 2013

    Orthotec Conf

    Presenter, “Optimizing Strategic Clinical Research Outsourcing Partnerships & Ensuring Compliance in Asia.”

  • 2013

    Healthcare Businesswomen’s Association (HBA)

    Presenter, “Change Epidemic: Proactively managing responses to change.”

  • 2013

    Healthcare Financial Management Association (HFMA) · Regulatory and Legal Forum

    Presenter, “HIPAA and Cloud Computing.”

  • 2012

    Pharma, Life Sciences, & Healthcare Industry Summit

    Presenter, “Ensuring Compliance and Optimizing Strategic Partnerships in China.”

  • 2012

    Drug Information Association (DIA) Annual Meeting · Philadelphia

    Poster T22 on narrative automation (Lee et al., PA Consulting — presentation affiliation). Bayer language model results (built while at Covance, 2008; began while at a pharma company, 2006–07): 89.5% improvement (p<0.001); about 1.2 minutes per narrative draft.*

Scientific

  • Scientific

    Efficacy and Tolerability of Memantine in Nursing Home Patients with Moderate-to-Severe Dementia

    European College of Neuropsychopharmacology (and related US/international meetings, 2003–2004).

  • Scientific

    Characterization of Murine D1Pas1 as a Nuclear Protein in Spermatogenic Cells

    Society for Gynecologic Investigation Meeting (oral and poster).

  • Scientific

    Overexpression of Cyclin E in Ovarian Cancer

    Columbia College of Physicians & Surgeons Biomedical Symposium.

  • 1994

    Thigmomorphogenesis: The Growth Response of Beans to Mechanical Stimulation by Irrigation

    American Association for the Advancement of Science (AAAS) Annual Meeting (poster).

  • 1992–93

    Cellular communication

    Earliest published work and presentations: National Academy of Sciences (1992) and AAAS Annual Meeting, San Francisco (1993).

Plus memantine and escitalopram clinical data, co-authored, presented at additional US and international meetings in 2003–2004, including the American Academy of Neurology, the American Psychiatric Association, NIMH NCDEU, and CINP.

Work delivered while at PA Consulting.

Publications

Led by a 2017 National Academy of Medicine paper on harmonizing clinical trial site standards. 40+ publications and scientific presentations in all.

Show publications (14)Hide publications

Policy paper

  • It’s Time to Harmonize Clinical Trial Site Standards.Johnston SC, Lewis-Hall F, Bajpai A, Blumenfeld T, Goldschmidt P, Koski G, Lee G, Schneider R, Tenaerts P, Womack A. NAM Perspectives, National Academy of Medicine (formerly the Institute of Medicine), Oct 9, 2017. With Pfizer’s chief medical officer and a medical school dean; from the Clinical Trial Site Standards Harmonization Action Collaborative, National Academies Forum on Drug Discovery, Development, and Translation. Describes her human‑ and data‑centric system design for IOM and US industry-wide clinical trial changes. doi.org/10.31478/201710b (opens in a new tab) · Source: Grace’s Oct 10, 2017 post sharing the NAM article (opens in a new tab)

Peer-reviewed papers

  • Memantine treatment in patients with moderate to severe Alzheimer disease already receiving donepezil: a randomized controlled trial.Tariot PN, Farlow MR, Grossberg GT, Graham SM, McDonald S, Gergel I. JAMA. 2004;291:317-324. (acknowledged contributor)
  • Characterization of D1Pas1, a mouse autosomal homologue of the human AZFa region DBY, as a nuclear protein in spermatogenic cells.Session DR, Lee GS, Wolgemuth DJ. Fertility and Sterility, 2001;76(4):804–11.
  • Expression of Cyclin E in Gynecologic Malignancies.Session DR, Lee GS, Choi J, Wolgemuth DJ. Gynecologic Oncology, 1999;72:32–37.
  • A Comparison of Pain Tolerance During X-ray Hysterosalpingography and Sonohysterosalpingography.Session DR, Lee GS, Kelly A. Gynecologic & Obstetric Investigation, 1997;43(2):116–9.
  • Sonohysterosalpingography in the Evaluation of the Uterus and Fallopian Tubes.Session DR, Lerner J, Lee GS, Choi J, Kelly AC. Journal of Gynecologic Techniques, 1997;3:73–84.

Selected abstracts

  • Memantine is safe for short- and long-term treatment of dementia.Graham S, Jonas J, Lee G, et al. Neurobiology of Aging, 2004;25(S2):S195; also published in Neurology, J Am Geriatr Soc, J Manag Care Pharm, and Eur J Neurol, 2004.
  • Efficacy and Tolerability of Memantine in Nursing Home Patients with Moderate-to-Severe Dementia of the Alzheimer’s Type.Winblad B, Lee G, Möbius HJ, McDonald S, Graham S. Eur J Neurol, 2003;10(Suppl 1); Eur Neuropsychopharmacol, 2003;13(Suppl 4):S116.
  • The Effects of Escitalopram Administered Alone and With Alcohol on Cognition and Psychomotor Performance.Wilkinson CJ, Lee GS, Chang CC, Ventura D. Biological Psychiatry, 2003;53.
  • Safety and tolerability of memantine in the treatment of patients with vascular dementia.Lee G, Goetz M, Wirth Y, Graham S. Int Psychogeriatr, 2003;15(Suppl 2):260.
  • Thigmomorphogenesis: The Growth Response of Beans (Phaseolus vulgaris) to Mechanical Stimulation by Irrigation.Lee GS. AAAS Annual Meeting, February 1994.

Books and editorial

  • The Treatment of Epilepsy: Principles and Practice.Wyllie E, ed. 3rd ed. Philadelphia: Lippincott Williams & Wilkins; 2001. (92-chapter textbook) (acknowledged contributor)

Business articles

  • 4 Easy Ways to Help Women Succeed in Business.Lee GS. Entrepreneur, contributor column, Mar 8, 2017. Read the column (opens in a new tab)
  • Compliance Risks to Consider When Outsourcing Clinical Research to CROs in China.Lee GS. Corporate Compliance Insights, Mar 21, 2013; also Pharmaceutical Compliance Monitor, May 21, 2012.

How she works

Whole-system design, not human-in-the-loop as an afterthought.

The through-line is not a résumé of titles. It is the same design problem, at different scales: integrate AI, data, process, and human accountability so a decision can be explained and made in time to matter — case-level (narrative automation from 2006–07; Bayer narratives, 2008), enterprise (CLASS, 2013; Sanofi and Pfizer Safety Intelligence Systems), and national (Qatar’s National Strategy for Diabetes).*

Many approaches add a human-in-the-loop check to one workflow, such as case intake. Grace designs the human role into the architecture from the start — and did so with regulators as design partners on CLASS roughly a decade before CIOMS Working Group XIV’s responsible-AI and human-oversight guidance (2025–26). Integrate people, data, and process before you automate.

Health Enovation is that practice as a studio. No fabricated client list. No stock portrait. The work is the proof.

Education

Where the science started.

  • Columbia College, Columbia University — B.A. with honors, Biological Sciences
  • Columbia Graduate School of Arts and Sciences — M.A., Biotechnology
  • Henley Business School — Business and enterprise architecture certificate
  • American Association for the Advancement of Science (AAAS), 1994 — First scientific abstract, on thigmomorphogenesis, published at 14; named an honorary lifetime junior member
  • American Association for the Advancement of Science (AAAS) — Honorary Member