Grace S. Lee Email & Phone Number

Health tech is in a bubble at the moment and is quite regulated with data being quite difficult to integrate from various systems or to acquire from hospitals, doctors, patients, caregivers, or insurers.The frequency of entrepreneurs not knowing the intricacies of the regulatory landscape is quite common and the risk of the company failing to achieve user.

WishPoints Blockchain + AI technology platform tokenizes personal intent-to-buy ledger to enable high volume consensus negotiations in loyalty contracts with brands. WishPoints is changing how customers connect with companies by building a global intent aggregator system that brings transparency and consensus to expedite sales pipeline conversion. This.

Sharenett Investor Conference Speaker (Jan 2019)AI Tech Summit Speaker (Nov 2018)IBM Startup Bus (May 2018): Women in Blockchain speaker and judgeStartup 52 Diversity Panel (Apr 2018): panelistColumbia Venture Competition (Apr 2018): judgeColumbia Ignite Entrepreneurship (Feb 2018): Ideation workshop presenterWomen@Forbes Live (Dev 2017): panelistColumbia.

Irvine, CA, US

Contributing Columnist focused on startups, women in business, travel, healthcare/health tech, business design, technology innovations, and designing your life and health strategy.

Houston, Texas, US

Angel Investor in health tech, fintech, traveltech, edtech, and businesses for social impact.Angel Investor in exited company: Agora for Good is the first cloud-based, digital manager of charitable capital. We allow smart social investors to easily make high impact donations.Angel Investor in emerging travel tech: Rare Customs is revolutionizing what.

London, London, GB

• Business Design & Enterprise Architect, Strategist & Advisor to National Health Agencies, Pharma & Biotech companies
• Lead strategy, technology, and management consultant teams to develop innovative health technology data platforms and business solutions for national healthcare governance and expediting drug/biotech development
• Designed the National Diabetes Strategy for the Qatar Supreme Council of Health and National Diabetes Committee to improve health technologies, public health, education, research and clinical care based on.
• Developed predictive models for diagnosing diabetes using unstructured comments from patient records
• Developed CLASS: Clinical and Safety Signal big data cloud platform: to aggregate, analyze, and assemble real world data for competitive intelligence, pharmacovigilance (PV), HEOR, and business development
• Designed the business model for an industry-wide platform for Clinical Site Evaluations for Institute of Medicine, FDA, and NIH

Summit, New Jersey, US

• Lead the strategic planning on regulatory submissions and clinical data analysis and reporting in oncology and inflammatory indications
• Supervise and advise global teams responsible for preparing regulatory eCTD submissions, INDs, IBs, CSRs, Briefing Books, Article 20, pediatric investigational plans, and Clinical Trial Disclosures
• Lead Six Sigma Process Improvement projects and integrated processes from acquired biotechnology company
• Develop resourcing, departmental restructuring, budgeting, and submissions plan

New York, NY, US

• Provide consulting services for venture capital firms and equity research analysts at Fortune 100 financial investment companies on industry trends, emerging business models, and competitive intelligence

• Provide regulatory strategy for NDA submissions
• Liaise with Senior leaders on the Governance Committee to integrate processes, manage portfolio, and influence change in strategic partner companies (Merck/Schering, Lilly, Roche, J&J, Otsuka, and Bayer)
• Advise clinical development and peri-approval commercialization teams on developing services of interest to pharmaceutical development executives
• Provide consultation services on clinical development, study design, and eCTD/NDA preparation
• Supervise a global teams responsible for >300 client projects
• Create new technology and service capabilities

US

• Achieved unanimous FDA Advisory Board support and full marketing approval on action date of Namenda, the first in class of NMDA receptor antagonists for Alzheimer’s disease
• Met with FDA on clinical safety and study design issues at Pre-IND meetings
• Led the Safety Team for the FDA Advisory Committee Meeting to evaluate the global safety data accumulated over 20 years’ of drug exposure
• Supervised a matrix team of medical writers in study report writing and electronic regulatory publishing;
• Developed company standards for protocols, study reports, narratives, and clinical trial disclosure
• Provided strategic input for customization of Documentum and guided the publishing of the first electronic regulatory submission

• Collaborated with thought-leaders in cancer, involuntary weight loss, and atrial fibrillation and with pharmaceutical marketing/product managers at Biotechnology General, Ortho Biotech and Pfizer
• Strategically designed large-scaled CME initiatives for new oncology products
• Researched pre-launch scientific development of competitive products
• Supervised internal online interactive CME division (CMEacademy.com), analyze website usership, and insure adherence to ACCME guidelines

• Collaborated with key opinion leaders in lipid management, cardiology, epilepsy, pain management, and psychiatry
• Managed Parke-Davis’ Lipitor/Rezulin/Neurontin and Forest's Celexa & Lexapro medical communication and education programs
• Developed CME and promotional programs, including regional symposia, speakers bureau programs, advisory board meetings and dinner series
• Edited The Treatment of Epilepsy: Principles and Practices textbook (92 chapters)

New York, NY, US

• Developed and taught chemistry laboratory curriculum to incoming undergraduate students.
• Instructed undergraduate & post-baccalaureate students concepts in cell biology, physiology, immunology, and developmental biology.

New York, NY, US

• Studied the role of p75 and Trk receptors in signal transduction during neuronal stem cell differentiation
• Investigated Cyclin E expression in Ovarian cancer
• Evaluated clinical data on pain tolerance during sonohysterosalpingography

• Founded non-profit organization and secured start-up funding
• Coordinated, designed and implemented community outreach agenda and activities to promote health education in the minority low-income population
• Managed, recruited and trained volunteer doctors, medical students and pre-medical students

Masters, Biotechnology

Bachelor'S Degree, Biological And Biomedical Sciences

Business Design & Enterprise Architecture