Doug is a 30 year veteran of the medical devices industry, with a diverse background in research and development, marketing, finance and general management roles. He was an executive at Becton Dickinson & Company for 15 years, where among other roles he served as Vice President for the company’s >$1bn global Insulin Injection business and led launches of a number of insulin delivery innovations. Following his time at BD, Doug served for 3 years as CEO at CeQur S.A. a Swiss/US company building simple insulin patch pumps for Type 2 diabetes, and has served as CEO, Interim CEO and Board member of a number of diabetes and diagnostic med tech startups.
Doug’s background includes medical device and pharmaceutical industry experience at leading companies including Procter & Gamble and The BOC Group plc. Prior to his work at BD Diabetes Care, he was responsible for the development and marketing of innovative products in ophthalmology, infusion therapy, critical care and consumer health including BD insulin needles and catheters, Crest, Pampers, White Cloud, Pepto Bismol and Peridex. He has a degree in Systems Engineering from the University of Pennsylvania, and business degrees from the University of Pennsylvania’s Wharton School and Northwestern University’s Kellogg School. He is the appointed Chair of the Economic Development Industrial Corporation of the City of Framingham, and Chair Emeritas of MassMEDIC.
Linda is an experienced technical program manager and business development professional with a broad background in biochemical/biomedical engineering. As the Director of Biomedical R&D at Giner, Inc. since 2001, she led the development of the oxygenated cell implant technology, and is leading the effort to seek investors and strategic partners to accelerate the path to the clinic. She is also leading the development of the Portable Pancreas Preservation System (P3S™ System), a transportation device for a donated pancreas organ, which incorporates a portable oxygen generator. Previously, Linda led the development and launch of the Giner transdermal alcohol sensor into criminal justice markets in 2010. Previously, she was a scientist at CytoTherapeutics where she modified the cellular environment for their pain management cell encapsulation technology. Linda is a named inventor on 6 issued and pending U.S. patents, as well as additional international patents. Linda received her PhD in Chemical Engineering with a minor in Biochemistry from Cornell University in the area of mammalian cell adhesion.
After receiving an MBA from the Harvard Graduate School of Business, Andy worked at Bain and Company in London for 5 years. He was then a co-founder of an innovative, venture backed and successful packaged foods business in London, followed by co-founding a technology consulting firm in Boston, which grew to a professional staff of over 250. Andy was appointed to the Giner Board in 2009 with responsibility for the commercial development of Giner’s technology portfolio, including the oxygenated cell therapy area. He became President and CEO of Giner Inc. in 2014. On the formation of Giner ELX in April 2017 Andy became President and CEO of Giner ELX and also serves as President for Giner Life Sciences.
Simon is a seasoned design engineer and inventor with over 18 years’ experience developing products which leverage electrochemistry in energy conversion and commodity production applications. With special focus in direct methanol fuel cells and medical oxygen generation, Simon applies strengths in chemistry, mechanical engineering and systems to deliver innovative prototypes and enabling products to a range of customers, applications and scales. He leads the engineering and technology development efforts for the Portable Pancreas Preservation System (P3S) and the oxygenated cell implant technology. He also led the development of an external oxygen concentrator on behalf of a client pursuing a wound healing application, and he current manages the associated OEM product portfolio. Simon is a named inventor on 13 issued and pending patents and is a key innovator in the bioartificial pancreas system. Simon received his M.S. in Chemistry from Arizona State University.
Theresa has over 15 years of Finance and Accounting experience in start-up and fast growth companies. She has held positions at Ulvac Technologies, FusionStorm, Open Mile, and ZipCar. As Controller for the Giner companies (Giner, Inc; Giner ELX; Giner Life Science), she oversees, among other areas, strategic financial planning, organizational development, process definition and improvement, and project planning and execution. Theresa has a bachelor’s degree, Magna Cum Laude, in Business Administration with an Accounting concentration from Fitchburg State University.
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Darlene brings extensive financial leadership experience to the Giner Life Sciences Board of Directors, as she has been serving on public and private for-profit company Boards of Directors since 2006. She currently serves as the Chief Financial Officer of F-Star Therapeutics and Northern Biologics, Inc. and prior for T2 Biosystems, Inc. (NASDAQ:TTOO) a public medical diagnostics company. Other recent roles include Senior Vice President and Chief Financial Officer, of Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), from 2014 to 2017 and Executive Vice President and Chief Financial Officer of Microline Surgical, Inc. from 2011 to 2014. Within these roles, she provides strategic financial and business direction and leadership on long-term strategies and decisions affecting the future financial performance of the company including capital formation, commercialization, strategy and M&A. Darlene holds a B.A. from Southern New Hampshire University and an M.B.A. from Rivier College. She also completed the executive education program at Dartmouth's Tuck School of Business.
Christopher is a Director at Broadview Ventures where he leverages over 25 years of experience in biopharmaceutical R&D, business development and strategy to help meet Broadview Ventures’ cardiometabolic focused investment mission.
Prior to Broadview, Christopher was at Novartis and SkyePharma. He has an MBA from Rutgers University and a PhD in endocrine physiology from Louisiana State University with post-doctoral training at “The Upjohn Company” and the Joslin Diabetes Center/Harvard Medical School.
Christopher currently serves on multiple Broadview Ventures portfolio company boards, the board of MassBio and several not for profit boards. He chairs the British Heart Foundation’s Translation Grant Committee and serves on several other grant review committees.
Nan Giner is a partner in Choate’s Wealth Management Group. She delivers comprehensive counsel targeted to clients’ personal planning objectives, with an emphasis on sophisticated wealth transfer strategies. Her clients include company founders and other entrepreneurs, as well as domestic and international families.
Nan has been named a “Trust and Estates Trailblazer” by The National Law Journal and is annually listed in Best Lawyers in America. She is also listed as a leading individual in Chambers HNW Guide 2019, a 2014 “Top Woman of Law” by Massachusetts Lawyers Weekly, and has been ranked among the top 50 women Massachusetts Super Lawyers. She is proficient in Spanish and German.
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Giner has partnered with Proven Process Medical Devices (PPMD), a leading designer and manufacturer of Class II and Class III medical devices to move its oxygenated cell implant technology and its organ preservation technologies to the clinic. PPMD provides the partnership with broad experience bringing medical devices to the clinic with expertise in design, quality and regulatory, and manufacturing. PPMD’s quality system is 21 CFR 820 FDA Quality System Regulation compliant and EN ISO 13485:2012/AC:2012 certified.
Giner is working with CBSET to perform preclinical studies in support of the oxygenated cell implant effort. CBSET is a not-for-profit pre-clinical research organization dedicated to the advancement of novel therapeutic technologies. Their AAALAC-certified, GLP-compliant institute has a long history of executing trials with expertise in medical device testing, including surgical and minimally invasive methods. CBSET’s staff includes recognized experts in regulatory consulting, veterinary medicine, as well as board-certified pathologists and a comprehensive histology laboratory.
M Squared Associates provides a full range of regulatory, quality and clinical consulting services to US and international medical technology firms. The M Squared Associates team has experience with devices reviewed by every Division within FDA Center for Devices and Radiological Health (CDRH) Office of Device Evaluation (ODE), by the Office of In Vitro Diagnostics and Radiological Health (OIR), and by the Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT).