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 an portable oxygen generator. Previously, Linda led the commercialization of the Giner transdermal alcohol sensor in the criminal justice market which has generated $5M in revenues for the company; currently the company is leveraging that success to make medical and consumer market products. 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 Ph.D. 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.
Anthony is an R&D scientist and manager with more than 15 years of experience working at the interface of biology and engineering to develop instrumentation and assays for the life sciences and medical device markets. Since joining Giner, Inc. in 2015 Anthony has focused on program management, and development of additional IP for the oxygenated cellular implant technology which has resulted in two provisional patent applications with Simon Stone. Previously, at Physical Sciences Inc., he built and managed the Biological Sciences group which had peak revenues of $1.8 million. As Director of Life Science at Union Biometrica, Inc., Anthony led assay development and helped commercialize the COPAS technology for automation of small animal model research, and led assay development for an early prototype for a hematology analyzer currently sold as the IDEXX LaserCyte®. Anthony is a named inventor on 4 issued patents and 3 US patent applications in addition to the two provisional applications. Anthony received his Ph.D. in Microbiology from the University of Massachusetts.
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.
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.
TheraCyte is the pioneering developer of systems that enable long-term, human allogeneic cell transplant without immune suppression. Giner has partnered with TheraCyte to develop proprietary oxygen-enabled cell capsule technologies that, in combination with Giner’s implantable oxygen generator, will support long-term, effective cellular therapies in a small form factor without the need for immune suppression. Novel capsule technologies are protected by provisional and non-provisional patent applications as well as nearly two decades of know how.
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).
Barry is an experienced biomedical entrepreneur and technical expert. He instrumented a management buyout from parent W.R. Grace & Co. to form Circe Biomedical, which developed bioartificial organs including the PancreAssist System, an implantable, bioartificial pancreas for severe insulin-dependent diabetics. Barry is advising Giner on strategic business and technical issues.
Lisa is a dedicated technology licensing and ventures professional providing Giner with guidance relating to strategic planning, partner identification, license negotiation, and deal structure. Lisa has twenty five years of business development experience covering technology spinouts, therapeutics, clinical development, product launch, medical devices, academic licensure requirements and early stage technologies.