Mally Arad, PMP
Manager, Project Planning and Execution at Integrated Project Management
Mally Arad is a Manager at Integrated Project Management Company (IPM), a nationally based company focused to providing outsourced project management services to companies ranging from start-up ventures to fortune 100 companies. She has thirteen years of experience in project management and business process optimization with both domestic and international companies in the biotech and high-tech industries. Working directly with life sciences organizations based on the West Coast, Ms. Arad has helped medical device, diagnostic and drug delivery companies improve and right-size their Product Development Processes to meet project objectives, and instilling a discipline project management approach to their project. Ms. Arad has been involved in several successful product development projects that resulted in product commercial launch. Ms. Arad graduated from the University of California at Berkeley with a degree in Business Administration and received an MBA in Marketing and Entrepreneurship from the California State University, Hayward. She is a certified Project Management Professional (PMP) with the Project Management Institute.

John Howard
Vice President of Research & Development
John Howard has over 20 years of progressive design and leadership experience in product development. Prior to joining Intuity Medical, Mr. Howard held roles as Vice President of Device Manufacturing and Principal Fellow of Delivery Systems at Nektar, where he helped develop a proprietary drug delivery system for Pfizer's Exubera™ inhaled insulin. Before Nektar, Mr. Howard led multiple Product Design teams in the development of desktop and notebook computers at Apple. He received his Bachelor's Degree in Mechanical Engineering and a Master's Degree in Engineering from Stanford University, where he has been a lecturer in the Mechanical Engineering Design Division since 1989.

Liz Lison
Advocea LLC.
Ms. Lison is an independent regulatory affairs and compliance consultant. She has over 20 years experience in the IVD industry, most recently working with early stage companies on cutting-edge diagnostics. These assignments have included working with and advising teams on the development of assay and instruments for SNP, gene expression and protein biomarker assays, including IVDMIAs. She is experienced in developing early stage regulatory strategy and quality system implementation for startup companies allowing them to build compliant operations and to shorten time to commercialization of their first product. Ms. Lison has experience in implementation and compliance with ISO 13485, QSR and CLIA Quality Systems and has focused on how to integrate these various requirements into manageable systems for small companies. Prior to setting up her own consultancy company, she was VP of Regulatory Affairs at Aviir, Director of Regulatory Affairs at XDx, VP of Operations at Naxcor and VP of Customer Service Operations at PharmChem. Ms. Lison has a BS in Medical Science from Bradford University, UK.

Dennis F. Marr, Ph.D., PMP
Sr. Director of Research and Development, Thoratec Corporation
Dr. Marr currently serves as Senior Director of R&D at Thoratec Corporation, a world leader in products to treat cardiovascular disease. He has over seventeen years of product development, program management and engineering design experience in the medical device and biotechnology industries. Prior to joining Thoratec, he was Vice President of R&D at ThermoGenesis Corporation. Dr. Marr began his career at Baxter Healthcare Corporation as a Senior Principal Engineer and was promoted to roles of increasing product development and program management responsibilities during his twelve-year tenure there. He had management responsibility for contract manufacturing and development partnerships with both Baxter internal divisions and external non-Baxter partners, and he finished his career at Baxter in the role of Director of Device Development & Engineering for the BioScience/BioSurgery Division before joining ThermoGenesis. Prior to Baxter, he worked in various research and engineering capacities at Argonne National Laboratory. Dr. Marr holds a Doctorate Degree in Chemical Engineering from the University of Wisconsin-Madison and a Bachelors Degree in Chemical Engineering from the University of Illinois Champaign-Urbana. He is also a certified Project Management Professional.

Jonathan Morris, Ph.D.
QA Director, Endovascular Innovations, Medtronic CardioVascular
Jonathan Morris currently serves as QA Director for the Medtronic Endovascular Innovations business with pre- and post-market quality responsibilities for endovascular stent grafts used to treat aortic disease. He has fifteen years experience in the implantable medical device field in the areas of reliability, field performance management, and product development. Dr. Morris began his career at Sulzer Intermedics as a reliability engineer for pacemaker leads and expanded that role at St. Jude Medical managing the returned product analysis labs for pacemakers, leads, and implantable cardioverter defibrillators. He joined Medtronic Vascular in Santa Rosa in 2001 and has held various leadership positions in R&D and Quality during which time endovascular stent grafts have become the standard of care in treating aortic aneurysms. Dr. Morris holds Bachelors, Masters and Doctoral degrees in Materials Science and Engineering from Rice University.

Denise Zarins
Vice President of Research and Development, Ardian Inc.
Denise Zarins brings with her more than 14 years of experience in medical device product development from concept to commercialization. She is a co-founder and current employee of Ardian, Inc., a clinical stage medical device company focused on developing a safe and minimally invasive system designed to block hyperactivity of renal sympathetic nerves, lower blood pressure and therefore, improve management of hypertension. Prior to co-founding Ardian, Inc., Ms. Zarins held an Entrepreneur in Residence position at The Foundry, a medical device company incubator working to rapidly transform concepts into companies. Denise’s previous experience includes AneuRx, which was acquired by Medtronic, followed by Bacchus Vascular, which was recently acquired by Covidien. Ms. Zarins holds a Master of Science (Biomedical Engineering) degree from Marquette University.