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 traction or enterprise customer engagement is also high. Both of these are frequently seen in the clinical research space.All these reasons will lengthen the timeline to exit or profitability as well as increase the likelihood that speculating investors will fail to get the expected return on investment.Health Enovation is addressing these issues by -Providing Incubator and investor funding for health tech, wellness, and patient data analytics. -Helping startup entrepreneurs design the business and build engaging technology to aggregate and facilitate health data management. We aim to help startups realize the missing components of their business that will determine if they succeed or fail.-Facilitating angel investors from Pharma, Insurance, and Healthcare in finding, evaluating, and conducting due diligence to invest in health & wellness tech startups. We aim to minimize your regulatory, clinical, legal, and financial risk.

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 technology enables the tracking of future purchases while protecting personal buyer identity, consequently converting sales faster and easier in global marketplaces. WishPoints technology has been recognized in competitions and featured by Salesforce.com, Entrepreneur magazine, EBay, Women@Forbes, Creative Startups, Startup Cup, InnovateHer, Propelify, and Survive and Thrive.

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 Business Women in Tech (Oct 2017): moderatorMeet Pipeline Angels (June 2017): moderator/panelistHarlem Tech Summit (May 2017): moderator of Founders' panel & VCs' panelStartup Weekend Travel Tech (Apr 2017): speaker & mentorPitch Lab: Female-Founded Health Tech (April 2017): sponsor & advisorColumbia Business Women's Leadership Conf (Feb 2017): Digital Innovation panelistQatar National Diabetes Strategy Vision Workshop: presenter (2015)Biomedical Research Council Conf on ”D2D: Data to Drugs & Diagnostics” (2014): --”Smart Glasses, Smart Vision: Seeing Beyond the Innovation Chasm”: panelist-- “Partnering to Build Big Data Platforms for your Real World Solutions": presenter Big Data in Pharma Conf in Boston (2013) & London (2014) on "Partnering to Build a Real World Platform for Your Big Data Solutions": presenter Orthotec Conf (2013) "Optimizing Strategic Clinical Research Outsourcing Partnerships & Ensuring Compliance in Asia": presenterHealthcare Businesswomen's Assoc:(2013) "Change Epidemic: Proactively managing responses to change": presenterPharma, Life Sciences, & Healthcare Industry Summit on “Ensuring Compliance and Optimizing Strategic Partnerships in China” (2012): presenterScientific Presenter:Efficacy and Tolerability of Memantine in Nursing Home Patients with Moderate-to-Severe Dementia. Europ Col of NeuropharmacolCharacterization of Murine D1Pas1 as a Nuclear Protein in Spermatogenic Cells. Soc for Gynecol Investig MtgOverexpression of Cyclin E in Ovarian Cancer. Columbia College of Physicians & Surgeons Biomed SympAmerican Assoc for Advancement of Science: Honorary Member

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 people think about travel in Africa with the launch of Tastemakers Africa a mobile app and content site that lets users find and buy hip experiences on the continent.

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 international best practices.• 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• Designed new PV business design, roadmap & enterprise architecture to meet the new Good Pharmacovigilance Practice guidelines for signal detection, monitoring, & analytics as well as automating case processing• Helped pharma improve capabilities to manage strategic partnerships Presentations• Qatar National Diabetes Strategy Vision, options analysis, customer engagement and international opinion leader meetings• Big Data in Pharma Conference: "Partnering to Build a Real World Platform for Your Big Data Solutions"• Orthotec Conference: "Optimizing Strategic Clinical Research Outsourcing Partnerships and Ensuring Compliance in Asia"• Healthcare Businesswomen's Association: "Change Epidemic: Proactively managing responses to change"Publications• Healthcare Financial Management Association: "HIPAA and Cloud Computing" • Corporate Compliance Insights: "Compliance Risks to Consider When Outsourcing Clinical Research to CROs in China"

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• Generated process efficiencies to provide >$200K in cost savings as a Six Sigma trained Green Belt • Develop technology, standards, templates, and SOPs

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• Liaised with licensing partner companies in Europe and Asia on global communication plan, data collection from investigator initiated trials, and clinical development strategies for new products • Collaborated with external thought-leaders in the writing of medical journal articles • Managed budget and team of writers for pre-launch and post-launch publications and presentations • Generated data for presentations at medical and scientific meetings US (48 posters at 20 meetings) and international (24 presentations at 7 meetings)• Recruited and collaborated with investigators and key thought leaders on innovated assessment tool development, study design, data analysis, and investigator initiated studies • Evaluated clinical data of new drug entities or new indications for possible licensing partnership • Strategically designed study protocols, clinical development plans and target product profiles for new products and in lifecycle management • Managed matrix teams in clinical site identification/feasibility, data management, and statistics • Supervise and negotiate the work of efficacy evaluation tool development, patient recruitment, and investigator meeting management companies

• 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