Partners, Associates and Panel Members form the Angel Plus team. Each person on the team brings a specific skill set to our activities. The Partners (operating and silent) have broad backgrounds in entrepreneurship and investor relations and are accredited investors themselves. They lead the teams and bring unique perspectives helpful to entrepreneurs as they manage their funding rounds. A team is formed once a contract is signed and industry experts are collected to vet the company in multiple topic areas.
Our Associates and Team Members are experts in their technical fields worldwide and vary depending on the project at hand. Customized teams are regularly put together based on industry sector needs and requirements. The Associates and Team Members combine sector expertise, business acumen, and ethical behavior in both our due diligence activities and our educational efforts with entrepreneurs and investors. Collectively they have decades of experience in all of the industry sectors. Their reports not only validate the strengths and weaknesses of startup's, they cover concerns and questions that investors typically take into consideration before investing.
Shirley Gee, Founder and Managing Partner
Shirley Gee has extensive executive-level experience driving increased efficiency and performance across organizational tiers. She has a strong track record of achievements and in building relationships with academic community, executive peers, users, business partners, and external partners both within the United States and internationally (Feature Shanghai Story): http://mp.weixin.qq.com/s/Ehc2XQpke_XJlT6OlKM6vQ). Her expertise includes technology transfer from academia to commercialization; vetting start-up companies (formal due diligence process), evaluating corporate business and strategic plans, establishing operation infrastructures, and helping companies navigate through their business development journey and the venture capital eco-systems.
She is currently the Managing Partner at Angel Plus, LCC, (www.angelplusllc.com) a trusted validation firm of latter stage, start-up corporations in anticipation of capitalization. The firm performs deep dive due diligence reviews on emerging corporations including assessments in the following areas: management teams, product, addressable market, financials, capitalization history, manufacturing end, pricing, regulatory needs and timetable, patents, competitors, quality assurance program, risk and mitigation, and exit strategy. Other services include making assessment of private equity and venture opportunities for oversea investor, negotiating term sheets (between companies and investors), managing investor pool, assisting companies with follow up fund raises, and educational workshops, seminars, and lectures in areas of expertise. She is a highly sought after consultant with a reputation for integrity and high ethical standards and comes with stellar recommendations from the investor community.
She is a Senior Venture Partner with YStrategies, Inc., (www.ystrategies.com) a publicly traded Venture Capital firm (YSTR) operating in Silicon Valley and San Francisco, CA. YStrategies is a Venture Capital (VC)/Business Development Company (BDC) and will be focused on early stage, advanced technology companies that has been market validated and can be expeditiously positioned in the marketplace. As venture partner, she is responsible for sourcing early stage technology companies coming out of the Silicon Valley eco-system and U.S. National Laboratories and for evaluating prospective start-up companies with disruptive technology for the YStrategies' portfolio. She is also providing detailed guidance on business strategy, organization operation and structure, and will assist in building YStrategies' capital runway domestically and overseas.
Ms. Gee is a member of the Technical Advisory Committee with CalSEED, (http://www.calseed.fund/) managed by CalFund with funding from the California Energy Commission. The California Sustainable Energy Entrepreneur Development Initiative—CalSEED—is a funding and professional development program for innovators and entrepreneurs working to bring early-stage clean energy concepts to market. CalSEED is tasked with helping to distribute $24M over next five years in early stage funding for the clean tech sector. Members of the CalSEED Technical Advisory Committee (TAC) are responsible for evaluating and scoring applications and providing counsel on process design and ongoing process improvements.
As a Mentor and Advisor for the National Lab Accelerator program at the Lawrence Livermore National Laboratory (LLNL), Ms. Gee is working one-on-one with scientists to help increase their business knowledge so they can move technology from academia to the marketplace. This program is designed to help scientists understand the nexus between basic, fundamental research and development process and the commercialization of national laboratory technology. It is a program to further develop business concepts, business models and plans, the product development process, market validation and value proposition for investor community. She is also a mentor and lecturer for the UC/Davis Entrepreneurial Academy for Lawrence Livermore National Laboratory LLNL and Sandia National Laboratory and works regularly with scientists pursuing entrepreneurial aspirations and assisting them in advancing technology in the commercial market place.
She is currently a Board of Trustee with St. Mary’s College of California where she is serving on the Investment Committee.
Ms. Gee was the Chief Strategy Officer and Board of Director at DeltaTrak, Inc. (www.deltatrak.com), a privately held, innovative company in the cold chain business for over 20+ years. Deltatrak serves the Life Science, Aerospace, Industrial, and Food industries. The company has over 65 products including thermometers, reusable data loggers, chart recorders, software, and in-transit data loggers, shelf life monitors, labels, and time-temperature indicators. Their services include validation, qualification and certification; calibration, and software and drivers. Ms. Gee is providing company with a deep dive, due diligence review and strategic direction and plans to take company to its next level of growth. Focus is on innovation and new products; blockchain participation and integration; establishment of digital data services; white board acquisition and pursuit of additional revenue streams.
She was the Chief Operating Officer for an international firm with aspirations to manage an incubator/accelerator complex for science, technology, and health start-up's from Latin America including Brazil, Peru, Venezuela, Columbia, and Mexico. Her role was to set up the operation for the incubator and to facilitate strategic partnerships for the incubator/accelerator; particularly, with respect to educational content and capitalization. This project was originally designed to include a consortium of universities and capital funders to provide educational support and capital liftoff, respectively to start-up's from Latin America coming to Silicon Valley. While the political and economic conditions of the host country (Venezuela) prevented the project from moving forward, she continues to work with entrepreneurs from Latin America looking for a "soft landing" in the United States for their companies and products.
She was a long standing member and contributor with the Keiretsu Forum, an international investor group with chapters all over the world. She has been an Accredited Investor for over eight years investing in CleanTech, Renewable Energy, Technology, IoT, life science, medical device, and health-related companies. She served as the Chair of the Life Science and Medical Device Committee and served on numerous Due Diligence reviews as Team Lead. As Team Lead, she lead due diligence teams (8-20 team members) to assess corporation in following topics: management team, product review, business strategy, capitalization, manufacturing and pricing, alignment of systems and processes to strategy, financial forecast and budgets, quality control, patent review, market validation, marketing strategy, exit strategy, and regulatory requirements. She also negotiated term sheets and purchase agreements on behalf of investors and put together syndicated investment deals and performed Series A-C fund-raising rounds for start-up's from $3M to $11M at angel level. She has served on a number of corporate Boards in the Investor seat overseeing the interest of investors.
Ms. Gee also worked for 20+ years at Stanford University's $450M international research laboratory, SLAC National Accelerator Laboratory, as an Executive Senior Member and Department Head working at the pleasure of the President of the University and under the direction and guidance of the Laboratory Director. She worked for three Directors, in turn, including the Founder, a Nobel Laureate, and a Senior Faculty Member during her tenure at Stanford. As a Department Head, she provided administrative, technical guidance to 200+ senior managers, in her areas of expertise. She managed STEM-related programs; worked on special projects for the laboratory, as assigned (e.g., State-certified Apprenticeship Program, National Science and Engineering Programs, etc.); performed pre-litigation investigations and other sensitive reviews; developed laboratory wide training programs, and served as a member of or Chair of salary review committees, layoff committees and laboratory-wide federal compliance audits.
Her earlier career was with the Department of Energy as Compliance Officer auditing West Coast national laboratories. During her career, she worked in the following departments: Contracts, Security, Special Projects, and Personnel and Management Directives and has deep experience in technology transfer, R&D at U.S. National Laboratories, and governmental directive and regulations.
Board Member, DeltaTrak, Inc. (Cold Chain MonitoringTools)
Board Member, Dapicon, Inc. (Big Data/Blockchain)
Board Member, InfoBionic, Inc. (Medical Device)
Board Member, Savara Pharmaceutical Inc. (Pharmaceutical Products)
Board of Trustees, Investment Committee, St. Mary’s College of California (Education)
Board Member, Equal Rights Advocates (Public Policy)
President and Chairperson, IDBA, (Economic and Community Development)
Board Member, League of Women Voters (Public Policy and Governance)
Board Member, Oakland Asian Cultural Center (Art and Culture)
Board Member, Aquatic Park (Aquatics for Youth)
Board Member, Pot Luck (Food Security & Recovery)
Sean Fong, Associate
Sean is an MBA graduate with an emphasis in finance and entrepreneurship. He has expertise in the due diligence process and has been on multiple teams vetting start-up companies. Professionally, he is a management professional with in-depth experience managing high-volume, multi-million dollar construction projects in the government, education, and commercial sectors (e.g., Project Engineer for the Knight Business Campus project at Stanford University).
He spent five years working with Turner Construction, an subsidiary of an international German Construction firm, as a Project Engineer managing their complex projects. He is experienced in working with high-profile clients involving multiple stakeholders and end-users with proven leadership ability to operate at both macro and micro levels. He possess strong business analytical abilities and can prioritize multiple tasks and meet targeted objectives on time and within budget. In the last 5 years, he has been in the solar development industry, first as a Project Manager, and then as Director, Financial Transactions for major solar development projects (upwards of $100M) on both buy and sell side.
Sean’s strength lies in his ability to resolve issues, which may affect the critical path, in a diplomatic and constructive manner. He has specialty in renewable energy; particularly the solar development and construction industry. Sean is very passionate about innovation generally and in the renewable energy industry and enjoys helping entrepreneurs with their strategic planning and moving them towards capitalization so they can successfully execute their business plans. He is also an enthusiastic traveler, domestic and international, and enjoys the experience of meeting people and learning about their customs and exploring their business perspectives.
Past Team Members and Their Bios (Sampling and for Illustrative Purposes Only)
Rita Kelly, Topic Lead, Management Review & Exit Strategy
Rita Kelley is the Principal Director of Shoreline Consulting, LLC, spearheading advisory services and consulting to companies seeking early commercial and product development expertise across business sectors. Ms. Kelley has more than 20 years of senior management experience in large and small Biotech and Pharmaceutical companies including EpiCept and Oncogenerix, both of which were novel start up drug development organizations, and Fortune 50 firms such as Pfizer and Novartis. Her most recent role was VP of Global Product Strategy.
Rita's expertise crosses all functional areas such as Commercialization, Development, Business Development, Regulatory, and Operations. She has specific expertise in the fields of Oncology, Hematology and Immunology. She has been responsible for overseeing the successful launches of 5 products in the above categories, and has helped drive these products to revenues in excess of $1B annually, on a global scale.
Rita received her Bachelors degree from the University of Mississippi, and attended Wharton and Harvard for advanced management programs.
Richard Samuelson, Contributor, Financials
Mr. Samuelson spent the bulk of his career in investment banking, virtually all of it located in Asia. As an investment banker he specialized in equity and equity derivatives at both UBS and BNP Paribas. Mr. Samuelson began his career as an analyst and in his final position he served as global head of equity and equity derivatives for both Asia and Japan at BNP Paribas.
Since settling in Gig Harbor, Washington in 2008, he has focused on angel investing, primarily through the Keiretsu forum. This angel investor organization boasts about 300 members in the Seattle office but continues to open offices both around the world and across North America. He also remains active in the CFA Society of Seattle, helping to find speakers for their many events.
Mr. Samuelson holds a BA from Yale, an MA from the Fletcher School at Tufts and an MBA in finance from Wharton. His professional accreditations include the CFA, FRM and CAIA designations.
Paul Twombly, Topic Lead, Product Review
Paul Twombly has over 40 years of global technology experience in entrepreneurship, executive management, business development, product management, manufacturing, operations, M & A, venture investing and board membership.
He began his entrepreneurial career in his early 20’s, when he and a partner started, built and sold a successful telecommunications interconnect company. He’s held executive and senior executive positions with both large and small, private and public companies including ROLM Corporation (acquired by IBM), IBM Corporation, Voysys Corporation, WarpSpeed Communications (acquired by Enron), NICE Systems and Foundry Networks (aquired by Brocade Communications).
Currently, Mr. Twombly is an active angel investor and member of several prominent angel groups including the Keiretsu Forum, The Band of Angels and The Angels Forum. In addition, he is an advisor and board member to a number of early stage companies.
Neal Strickberger, Contributor, Product Review
Neal Strickberger is a consultant, entrepreneur and investor with more than 30 years of expertise in software development, operations and business roles. As a management consultant, his focus is on operations and execution, helping companies scale and deliver product. He has held engineering, management and executive positions at Xerox Corporation, Adobe Systems and most recently ebrary. At ebrary, he helped scale the company from start-up to disruptive top player in the academic e-book space, up to an exit by acquisition in 2011.
Neal also maintains active participation in visual arts both as a collector and an artist, creating large-scale public art using billion-candlepower searchlights.
Jennifer Marks, Topic Lead, Marketing
Jennifer Marks brings over 15 years experience in strategy development and execution within high growth public corporations and private ventures in the US and internationally. Jennifer partners with Core Management and CEO’s to design and deliver valued products and services and create profitable high growth businesses positioned for market leadership.
Ms Marks is a recognized senior executive-entrepreneur with Bay Area and Australasian growth companies. Expert at business planning, product and market development, strategic partnering, operational execution, and exit strategies, Jennifer has worked in multiple industries including healthcare, therapeutics and devices, technology, telecommunications, media, consumer products, retail, financial services, and energy.
Most recently Jennifer has been working with Fortune 200 and emerging private growth companies on leveraging technology for improved business outcomes and customer experience. These include leveraging connected health technology for improved healthcare delivery and outcomes, social media engagement for self health management, and customer experience strategy across physical, human and digital touch-points, aligning business, brand and delivery for measurable results in multiple industries. Previously, at Pure Markets, a Silicon Valley VC-backed financial services venture, Ms. Marks headed Business Development, working across product development, marketing, sales, and operations, while growing the company from 2 to 70 personnel. Prior global strategy development and execution experience spans both consulting - with Strategic Decisions Group (SDG) of Menlo Park, CA, Accenture Asia Pacific Strategy Practice, and Towers Perrin’s Bay Area Strategy & Organization Practice, assisting Corporations with growth and strategy decisions - and prior in-house roles with responsibilities spanning general management, marketing, IT systems and finance.
Ms. Marks holds an MBA from Canterbury University, NZ, completed at Stanford University Graduate School of Business. She completed Postgraduate Studies in Systemic Innovation and Sustainable Enterprises (Dominican University of California, Exec Green MBA), Energy and Policy Design (Berkeley), Leadership in Healthcare (Teleosis Institute. Berkeley), and BioEntrepreneurship (UC Berkeley & Salk Institute). She contributes on a wide range of healthcare, technology, entrepreneurial, design innovation, angel investing and social enterprise groups within the bay area and holds an EIR role with the ICEHOUSE incubator in Auckland, New Zealand.
Rob Gemmell, Contributor, Marketing
Rob has been CEO, CMO or a founder of businesses in building intelligence, commercial lighting, social media, marketing platform and marketing consulting categories with multiple positive financial exits. He has also designed or been responsible for the design of award-winning computer products and marketing programs for Apple, retail catalogs for lovers of high design, user interfaces for a wide variety of digital media and dozens of websites and apps for businesses and brands of all sizes. He’s created go-to-market strategies and ad campaigns in print, outdoor, point-of-purchase, radio, video, online and 3D media.
His expertise spans marketing strategy and operations, startups and turnarounds, process improvement, project management, ROI optimization, forecasting, internet marketing and tools, business development, eCommerce, validation-based innovation, brand building & revitalization, and relationship-based marketing for organizations ranging from start-ups to large corporations.
Brad Winegar, Topic Lead, Financials
Brad is Managing Director with Pacific Mezzanine Fund, a licensed Small Business Investment Company formed to invest growth capital in middle-market companies which are primarily in western United States. Fund has financial resources upwards of $82M with access to funding guarantees via the Small Business Administration and a history of investment over $125M in 38 companies.
Professional history includes positions as: Senior Vice President at Prudential Capital Group; Senior Vice President at Prudential Asia Infrastructure Investors; and Associate to Senior Vice President at Prudential Capital Group. BA, Economics and Accounting, Brigham Young University and MBA, Finance, New York University.
Ryan Roe, Contributor, Financials, (Forecasting)
Ryan is an experienced attorney with background as corporate counsel in the financial services industry. He is currently corporate counsel for PMI Mortgage Insurance Co. He served in similar capacities for Washington Mutual Bank, Providian Bank, and State Farm Insurance. Before his corporate counsel positions, Ryan was a partner in a San Francisco-based law firm and was actively engaged in insurance-related litigation.
Keith Zachow, Contributor, Financials (Capitalization and Valuation)
Mr. Zachow is President of Omega Valuation, DPA/ABV, CVA, and has specialty in Early-Stage Technology and Life Sciences Companies. He has worked with firms in all stages of development (Concept, Startup, Product Development, Product Shipping and Revenue Generating) and nearly every stage of financing (Friends and Family, Angel, Seed, First-Third, Mezzanine/Bridge, and IPO). He has performed valuation analysis of early stage companies in a wide variety of industries.
In addition to helping early stage companies, he periodically engages with mature companies with consistent cash flow in assignments related to ESOP, Gift taxation and Fairness opinions.
Ted Kucklick, Lead, Manufacturing and Pricing and Market Review
Ted Kucklck has extensive experience in the hands-on design and commercial development of medical devices, including radio frequency ablation devices, microwave catheters for minimally invasive therapy, in-home diagnostics devic4s, surgical closure devices, battery-powered devices, disposable, gene therapy manufacturing equipment, and general surgery tools. Ted has been involved in the early stages and development and productization of devices for companies such as Vidamed, Oratec, Neomend, Somnus, Curon, Starion Instruments, Sleep Solutions, RITA Meical, AfX (now Guidant), and Cannuflow. He is the former senior deigner for RITA medical Systems and Advanced Closure Systems (now Neomend).
Ted is currently the Co-founder, Vice President of Engineering and CTO for Cannuflow, Inc., an arthroscopic instrument start-up company, and design director for TRKD Medical Device R&D, a medical device design and development company. Ted has a bachelor’s degree in product design and is the inventor of several issued and pending patents; he is a member of the IEEE/Engineering in Medicine and Biology Society, the Industrial Designers Society of America, and the Association of Medical Illustrators. Ted is also a founding member of the Keiretsu Forum angel investment group of Silicon Valley; a graduate of the University of California, Berkeley Haas School of Business Bio-Entrepreneurship certificate program, and a member of the Eureka Medical advisory board.
Scott Thielman, Contributor, Product Review
Scott is Co-founder and Vice President of Product Creation Studio, a multidisciplinary design firm specializing in medical, consumer and industrial equipment. He leads the embedded systems group and is charged with bringing products to life through integrated electronics and embedded software. Products with batteries, keypads, displays, motors, sensors and network connections are tailored by Scott and his team.
An accomplished mechanical engineer, Scott has extensive R&D experience including mechanism design, enclosure design, system modeling, embedded software, electronic circuits and board layout. Scott’s expertise in these disciplines, as well as regulatory compliance, allows him to create effective solutions and manage medical projects through production both domestically and overseas. Career highlights include leading a R&D team dedicated to improving the performance of a dental hand piece, designing a low flow-rate chiller system for a body contouring ultrasound device, and integrating a ZigBee chipset in a wireless networked product. Scott holds a Ph.D. in mechanical engineering for work on an automated manufacturing system from the University of Washington and he is a Washington State licensed professional engineer.
Stan Dong, Contributor, Product and Market Review (Adoption, Ease of Installation)
Stan Dong is currently a consultant in business development, fund raising, cross-border trade (with China/Hong Kong) and bioinformatics services. He has over 10 years of R&D experiences in biomedicine at Stanford and SRI. Recently, he served as Associate Director for the private equity fund at CCB international in Hong Kong, where he led several late-stage PE investments with exit as IPO at SEHK. Mr. Dong holds M.D. from Peking University, Ph.D. in molecular biology from University of Kentucky and M.S. in computer sciences from California State University.
Mark Kraus, Topic Lead, Key Milestones and Exit Strategy
Mr. Kraus has more than 20 years’ experience in biomedical device product development. He has provided consultation for medical device companies and for the University of Washing-ton’s Center for Commercialization. Previously, he served as VP of Technology Commercialization at The University Funds. At Medtronic/ Physio Control, he established a new R&D group and formed a major business unit team. At InstruMed, he managed R&D and operations, adding several new products and business partnerships leading to its successful acquisition by Stryker Instruments. In addition to other biomedical companies for which he has worked, Mark is actively involved with several leading angel and medical device investment groups, and is the chairman for the Life Sciences at Keiretsu NW chapter.
Christine Bo Lee, Topic Lead, Risk Management and Corporate Document Validation
Bo Yang is the founder of Wingo International, a consumer product company with global sales channels and network. She’s on the Board of Baicaoji Charity Foundation and a member of China CEO Association in Shanghai. She was a fellow of Pipeline Fellowship 2011, an organization that supports philanthropists to invest in women-led social impact ventures worldwide. Bo completed a BA from Nanjing University of Aeronautics and Astronautics, and holds an MBA from Washington University in St. Louis. She also studied in the VC Executive program at UC-Berkeley. Born and raised in China (Wuxi), Bo now lives in Bay Area.
Yun Deng, Topic Lead, Insurance and Risk
Co-founder of HL Investment Group LLC, a real estate company specializing in foreclosed residential homes in the greater San Jose area. Current MBA student at Santa Clara University. Received his B.A. from Santa Cruz University.
Thomas Loker, Topic Lead, Management Review
Tom Loker is an author and was the founder and senior partner of Wild Tiger Holding Company and Thomas Loker Consulting. He is an active member of the Board of Directors of a number of companies ranging from health care to technology, from sanitary and wastewater to robotics. He is a Senior Advisor to Venture-Med - an angel investment community. He also continues to advise and mentor startup companies and entrepreneurs in both healthcare, hit-tech and non-tech business. As a champion for those most in need of health care and related services, Mr. Loker has traveled to Washington D.C. extensively over the past several years where he met with legislators, helping them shape the recently passed health care bill. Speaking on a range of topics related to his areas of expertise,
With over 30 years’ experience in sales, marketing, finance and operations, Mr. Loker’s background has not only included serving the needs of health care companies, he has also offered his expertise to other industries including technology, biotech, consumer retail, telecom services, and education.
Mr. Loker currently serves on the board of directors or as an adviser to the board of ForeFront Telecare, Prime Genomics, Mojalink. Commensurate with Tom's strong concern over the increasing risk of highly drug-resistant pathogenic organisms Tom is also a member of the Board of Directors of the Staphylococcus Educational Leadership Foundation (SELF). SELF is dedicated to research and education on the recognition, treatment and prevention of staphylococcus with a particular interest in community-associated infections. SELF's goal is to improve clinical and patient education and outcomes while raising awareness about community associated Staphylococcal infections on a global scale. He has also served on the boards of Safebridge Consultants, Inc., Sybersay Corporation, ICOMMM, Inc., Redzone Robotics, The Oakland School for the Arts, Flowers Heritage Foundation, and Ramsell Corporation among others.
He has been involved in a number of philanthropic and charitable activities The Oakland School for the Arts, the Children’s Hospital of Oakland, and the Easter Seals program.
David Paul, Topic Lead, Financials
David is a veteran of Silicon Valley high technology manufacturing companies in operations finance roles. His most recent companies include Intuitive Surgical, Omnicell and Fusion-io where he participated in the initial public offerings for both Intuitive Surgical and Fusion-io and assisted in the turnaround activities for Omnicell after a public restatement. He has led ERP system implementations and likes to create efficient, scalable infrastructure for growing organizations.
Mr. Paul joined the Keiretsu Forum Silicon Valley Chapter in early 2014 and has participated and led a variety of due diligence teams.
Mr. Paul received a BA from Lawrence University in Appleton, Wisconsin and an MBA from Santa Clara University. He is also a Certified Six Sigma Black Belt. He lives in Sunnyvale, CA where he enjoys an omni-directional reverse commute.
Cindy Du, Contributor, Financials (History and Present)
Cindy Du has over 15 years of corporate finance and accounting experience in a variety of commercial settings, ranging from start-ups to Fortune 500 companies. Currently she is serving as the Treasurer and a member of the Board of Directors for RotaCare Bay Area, Inc., a 501(c)3 health care organization. Previously she worked as Corporate Controller at Intematix Corp., an LED material manufacturing company. Ms. Du received her MBA from the University of South Alabama and is also a licensed California CPA.
Michele Nikoloff , Topic Lead, Product Review
Dr. Michele Nikoloff is an intuitive scientist and leading expert in the area of in vitro diagnostic (IVD) development for personalized healthcare. Dr. Nikoloff understands product development from prototype to commercialization and has vast expertise resolving issues ranging from manufacturing and product safety to regulatory and customer concerns. Currently, Dr. Nikoloff evaluates emerging molecular diagnostic technologies as commercialization opportunities for academic, start-up and venture capital clients. Dr. Nikoloff identifies risks, gaps and unmet needs and provides guidance regarding the competitive landscape, potential applications and diagnostic markets for early detection, treatment prediction or disease monitoring. Dr. Nikoloff previously worked at Roche Molecular Diagnostics in the Research group, where she led a number of critical initiatives and built strategic alliances with academic and pharmaceutical groups to establish clinical utility and drive adoption of companion diagnostics in oncology. Dr. Nikoloff received her Ph.D. in Biological Sciences from Carnegie Mellon University and A.B. in Biochemistry from UC Berkeley.
Mary Vincent, Topic Lead, Manufacturing and Pricing
Mary Vincent is Co-Founder and CTO of a new stealth wearable health startup, LifeTimeMD. She was also Co-Founder and Head of Product Engineering for Sensilk, a smart fabric wearables company, providing leadership in global wearable computing hardware and software architecture innovation, integration, testing, quality and technical engagement. Sensilk was accepted into the Intel Make it Wearable Semifinals, two Startup Incubators, and she was chosen to present at Google Developer Group Silicon Valley, Keiretsu Womens Forum, Draper University, Silicon Valley China Wireless, and was selected as a Delta Techcrunch Disrupt Innovator
Ms. Vincent's background includes work in Sun Microsystems Java Engineering, Data Center Energy Efficiency, and Mobile Health Application development with Stanford and Government Projects. Ms. Vincent’s has a unique understanding of the software and hardware worlds and how they work together and often speaks about the future of wearables and the internet of things (IoT), and how we can use technology to improve lives.
Roberta Lee, Topic Lead, Addressable Market, Adoption and Competition
Roberta Lee has been a medical device entrepreneur for over fifteen years and is an accredited investor with the Keiretsu Forum of last two years. She has served on a number of panels vetting start-up companies and is a Board-certified general surgeon.
Nandini Murthy, Topic Lead, Regulatory
Nandini Murthy has over 20 years of work experience in regulatory affairs, clinical and quality assurance functions with multiple device specialties. She has authored numerous, successful FDA submissions including a de novo, a modular PMA, a HDE, original PMAs, several original IDEs, pre-Submissions, PMA and IDE Supplements and 510(k)s for novel products including implantable devices, sensor/monitoring tools and diagnostic devices, including IVDs. She has led projects with complex submissions, where she has both managed a team and where necessary, written or executed on the various document deliverables in a hands-on manner. Ms. Murthy has a successful track record of on-time execution and FDA approvals. She has a demonstrated ability to map strategy and execute on the same.
In addition to her core expertise in regulatory affairs, Ms. Murthy has designed and executed complex clinical trials and established quality systems to ISO 13485 and FDA Quality System requirements. This complementary work experience helps Ms. Murthy provide comprehensive regulatory support, aligning the engineering and clinical support documentation with overall regulatory strategy.
As a Consultant, Ms. Murthy has worked on projects for clients with novel Class II and Class III IVD, diagnostic, therapeutic devices and drug-device combination products, including: Trans-cranial Magnetic Stimulation and neurological devices, Dental devices, Implantable reabsorbable restorative gel (therapeutic indication), Orthopedic devices, Peripheral stent, Mobile monitoring applications for hearing, cardiovascular and glucose monitoring, Ventricular Assist Devices (VADs), Intravascular imaging device, Diagnostic software devices,Non-radiological breast cancer screening device, Cervical cancer screening device, ECG and Optical monitoring devices, Esophageal cancer detection device, Surgical tools, Robotic surgical system, Aberrometer, NIBP monitoring system, Device-Food combination product
Prior to establishing ENEM Consulting LLC in 2007, Ms. Murthy served on the Management team of several companies, providing leadership to regulatory efforts, blending a strategic solution-oriented approach with strong tactical abilities. Her work experience includes mergers and acquisitions support, and a tenure at the USCI Division of C.R. Bard, supporting the company's efforts to address the FDA Consent Decree.
Anna Katz, Topic Lead, Patent Review
Anna Katz is a transactions attorney and business consultant who enjoys working with investors and entrepreneurs alike. Ms. Katz leverages operational experience with her background in corporate transactions and intellectual property to provide comprehensive risk assessment profiles to members of the investment community and counsel on the formation and operation of startup enterprises. Most recently, Ms. Katz consulted on the establishment of a community of entrepreneurs, where she worked intimately with member-companies and external partners to identify unmet needs and provide access to resources, financing opportunities, and partnerships. By adopting a community-based approach to support the growth and strategic positioning of early stage companies, Anna drove a 300% growth of the community in less than ninety days. Prior to establishing her practice, Anna was an Associate with Cole-Frieman & Mallon LLP, where she spearheaded the launch of investment companies and their associated funds, in addition to advising on all aspects of ongoing transactional, compliance, and operational matters. Anna received her J.D. from Boston University School of Law and B.A., with honors, in Anthropology and Religious Studies from the University of Virginia.