Debra Robertson, Ph.D., Consulting Affiliate, Technology Assessment, Strategic IP Development
Debbie is an experienced business analyst serving SI's strategic consulting practices by focusing on key issues that small start up companies face in their growth cycle, ranging from product development issues, to proper positioning of emerging technologies in the market place, to development of a strong defensive and offensive intellectual property portfolio. Debbie has significant expertise in technical, clinical and market risk analysis of medical device opportunities, specialty pharmaceuticals, life science products and new chemical entities, and she serves as a specialist in global market evaluation including competitive assessment of technologies and products for startup, high growth and established corporate environments. Debbie has served as Executive Director of Intellectual Property at Epicyte Pharmaceuticals, Inc., Director of Intellectual Property at Sequenom, a scientific advisor for Lyon & Lyon, LLP, and as a freelance biotechnology writer for Nature Biotechnology. With over 15 years of experience in strategic corporate and business development in the biotechnology industry, Debbie was recognized as an "outstanding woman in business" by San Diego Business Journal.
Debbie holds a doctoral degree in microbiology from University of California at Los Angeles, a BA in Biology from University of California at San Diego, and she completed her postdoctoral training in the Departments of Molecular Biology and Chemistry at The Scripps Research Institute.
Roger Guidi, Principal Consulting Affiliate, Strategic Assessment and Planning, Commercialization
Roger has over 30 years of experience in the pharmaceutical and medical device/diagnostics area focused on the building significant new businesses in the global healthcare market. He has had hands-on experience across the entire spectrum of business creation from conceptualization through business formation, commercialization and successful exits. He has successfully operated in organizations ranging from raw start-ups to senior executive levels of Fortune 50 companies. Roger started his career at J&J in pharmaceutical sales and marketing, and soon focused on the introduction of new products and procedures into the global medical community. While at J&J he launched the Monistat™ franchise in the US. Roger then moved on to more entrepreneurial opportunities in drug delivery systems (ALZA) and the global development of surgical laser systems (Coherent Medical).
The next stage of his career involved the formation and management of several successful start-ups including: Advanced Interventional Systems, Inc. which addressed challenging vascular restenosis issues; VISX, Inc. developed and introduced laser refractive surgery (LASIK). Both achieved IPOs and a combined market value of $1.6B. He was also President of IntelliWire, Inc., a novel nitinol guide wire for improved vascular access which was acquired by a Japanese medical device company.
He was then recruited back to J&J as Vice President of Johnson & Johnson Development Corporation, the J&J venture capital subsidiary. In 9 years Roger invested in and sat on the Boards of Directors of over 20 early stage companies, guiding 9 of them to successful exits during his tenure.
Roger holds 3 medical device patents. He served on the Board of Directors of the American Society lasers in Medicine and Surgery. He currently serves on the Board of Mangers of Ascension Ventures, a strategic venture capital fund with $550M under management. He has a Bachelors degree in Biology from San Jose State University and a Certificate in Pharmaceutical Marketing from the Tuck School of Business, Dartmouth College.
Nicole Boramanand, Senior Consulting Affiliate, Market Research, Technology Assessment, and Corporate Development
Nicole Boramanand brings twenty years of experience that integrate clinical practice, technology innovation, and business development across medical device, biotechnology, and wireless health sectors. Her professional experience includes her role as Vice President for Clinical Systems Innovation at the West Health Institute, creating a translational clinical network for early stage innovation.
Prior to this, she was at Medtronic Incorporated in Corporate Development where she helped execute domestic and international strategic investments, acquisitions, and divestitures. Nicole practiced clinically for ten years as a pediatric nurse practitioner with a focus on cardiac electrophysiology and adult congenital heart disease. She spent her early career in biotechnology at Hybritech (acquired by Eli Lilly, Co.), Amylin Pharmaceuticals, and The Scripps Research Institute. Nicole has been an invited speaker in cardiology, electrophysiology, pediatric primary care, healthcare innovation and mobile health, and has served on the Advisory Board for 360 Fresh, a clinical analytics company, and CareSpeak, a mobile medication adherence company.
Nicole has a BS in Biochemistry & Cell Biology from University of California, San Diego, MSN from the Yale School of Nursing, and MBA from the Yale School of Management.
David L. Rosen
Stephen M. Lane, Senior Consulting Affiliate, Technology Assessment and Management
Steve has worked in the field of biophotonics as a research manager and researcher for the last 20 years, first in the Medical Technology Program at Lawrence Livermore National Laboratory, then for the last 5 years as an Adjunct Professor at the University of California, Davis. At UCD he has been a member of the Departments of Radiology and Neurological Surgery. Steve currently serves as the Chief Scientific Officer and Associate Director of the NSF funded Center for Biophotonics Science and Technology headquartered at UCD.
For most of his career, Steve has been involved in both applied research and the development of instrumentation for physics, biology, and medicine. His technical interests include medical sensors, x-ray and optical spectroscopy, imaging and microscopy, computer simulations of photon interaction and transport in tissue, and the development and commercialization of medical devices.
He completed M.S. and Ph.D. degrees in Applied Science Engineering from UCD, holds 15 patents, has over 100 peer reviewed publications, received two R&D 100 Awards, a DoE Award for Excellence in Technology Transfer and, at a White House ceremony, received the Department of Energy Bright Light Award for work on the development of an optical glucose sensor. Steve has led or participated in projects funded by DoE, DoD, DARPA, NIST, NIH, NSF, LLNL, and UC. He was the founder and executive officer of a start-up company that performed technical consulting and produced products for radiation detection and protection for research and for the radiopharmaceutical industry. He is currently or has formerly been a member of numerous boards and review panels including the Executive Committee of the UCD Cancer Center Biotechnology Program, the Research Advisory Committee of the UCD McClelland Nuclear Radiation Center, the Scientific Advisory Board for the Australian Research Council’s Centre of Excellence for Coherent X-Ray Science, the NSF Biophotonics Advanced Imaging and Sensing for Human Health (BISH) proposal review panel, the Special NIBIB Director's Optical Imaging Program Progress Review Committee, and the DoE Committee on New Frontiers in Characterizing Biological Systems. He has taught graduate classes in biomedical imaging and is currently an instructor for the Super-Resolution Microscopy short course at the annual Conference on Lasers and Electro Optics, Optical Society of America.
Dwight Duston, Senior Consulting Affiliate, Technology Assessment and Management
Dwight Duston has pursued a diversified 35-year professional career as a research scientist, technology manager, university professor, inventor and entrepreneur. He has managerial and technical expertise in a wide range of technologies in multiple industries, including defense, aerospace, bio-medical lasers, medical imaging, displays and ophthalmics.
He started as a research scientist at the US Naval Research Laboratory in the area of plasma physics, radiation, laser fusion and nuclear weapons simulation, and has more than 25 technical publications in peer-reviewed scientific journals. Advancing to technology management mid-career, Dr. Duston is former director of the Technology Division for the U.S. Strategic Defense Initiative Organization (now, the US Missile Defense Agency), popularly known as the “Star Wars” program. At the Pentagon, he managed research and development programs in structural and electronic materials, optics, lasers, particle beams, high-speed processing, imaging sensors, power, and propulsion. His office launched over 15 space missions during his tenure, including Clementine, the first space probe to discover ice on the moon. While at SDIO, he also managed the Congressionally-mandated Free Electron Laser Medical Program, the Small Business Innovation Research program, and SDI’s Technology Transfer Office. He has served on advisory panels to several other agencies, including the National Institutes of Health (digital mammography), NASA, DARPA and the Departments of Energy and Commerce.
Dwight retired from government service in 1998 to pursue a career in in the private sector. He joined The Egg Factory, a high-tech start-up, as CTO, in 1999 and worked on several inventions in a number of industries, including ophthalmics, information displays, solar photo-voltaic energy, adaptive optics, and electro-optics. He helped spin off PixelOptics Inc., the first company to commercialize electronic spectacle lenses, and served as Senior VP for Research & Technology until 2009. At another Egg Factory spin-off, eVision LLC, he managed the development of tunable electronic lenses for camera optics and cell phones, an electro-optic ophthalmic refractometer, and sun steering electro-optics for solar concentrators. He is listed as an inventor on 35 U.S. patents, with dozens more overseas. He taught physics as a US Peace Corps Volunteer in Malaysia, and was Associate Professor of Management & Technology at the University of Maryland.
Presently, he consults for aerospace companies, the U.S. Department of Defense and assists start-up companies in the biomedical industry. He received his B.S., M.S., and Ph.D. in physics from the University of Michigan.
David L. Rosen, B.S. Pharm, J.D., Consulting Affiliate, Regulatory Strategy
David Rosen is lead outside counsel to Strategic Intelligence on regulatory strategy matters, and he is also a partner and co-chair of Foley & Lardner's Life Sciences Industry Team. He is also a member of the firm's Public Affairs Practice and the Health Care, Nanotechnology and Food Industry Teams.
David has extensive experience in health law, life sciences, and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics. David was formerly a partner with several international the law firms. He was also employed by the FDA for 14 years, progressing to various supervisory positions involving virtually all aspects related to the drug approval process and related compliance activity.
David is a frequent speaker on medical device and drug issues. He has spoken before national and international audiences on how to expedite product clearance and approval; combination products; clinical trial issues; follow on biologics; the ANDA submission and review process and on the IND and expedited drug development, review, and approval processes. He has made presentations before investment analysts and managers of venture capital on the impact of FDA on the medical device, drug and biotech industry. David earned his J.D. at The Catholic University of America, Columbus School of Law (1991). He also holds a Bachelor of Science degree from the University of Connecticut School of Pharmacy (1978). David is admitted to practice in the District of Columbia and Maryland.
David Stroup, Consulting Affiliate, Design and Manufacturing Automation
Mr. Stroup has vast experience in automated manufacturing and processing systems for the medical device, bio-diagnostic and pharmaceutical fields. David is an expert in the conceptualization and design of complex automated process and manufacturing systems and has extensive knowledge and know how in product and process development with an emphasis on automated manufacturability. In recent years David has focused on product development and generated a portfolio of proprietary designs in the field of disposable medical and bio-diagnostic devices. Previously, David founded and served as the Chief Executive Officer for Prodosyst Automation. David grew and diversified customer list to include several Fortune 500 companies. An exemplary list of client companies include Johnson & Johnson, Abbott Laboratories, Guidant Corporation, Cardinal Health, Tyco Electronics, Welch Allyn, and C R Bard. David applies his expertise at the foundation level of development producing designs with a strong emphasis on manufacturability. David leads engineering project management, design, and manufacturing engagements for our clients.
David holds a BS in Mechanical Engineering from San Diego State University, and has invented, developed, and engineered multiple disposable medical and bio-diagnostic devices.
Kory Razaghi MS, MBA, Advisor, Corporate and Financial Strategy
Kory has 15 years of transactional and executive management experience including operations, strategic planning, turnarounds and financial management for a variety of healthcare organizations including medical device, pharmaceutical, biotechnology and hospitals. Kory has extensive experience in conducting due diligence, market assessment, valuation analysis, and advising on transaction structure, including securing licensing agreements. He has also advised clients to successfully drive their capital formation and fund raising activities.
As the Managing Director of Attentus, a boutique advisory firm providing management, operational turnaround and corporate finance services, Kory advised clients in various healthcare industries including hospitals and clinics, provider groups, medical devices, pharmaceutical, biotechnology, and sector-focused private equity firms. He has functioned in various roles including Chief Financial Officer, Chief Operating Officer, and various Vice President and Director positions. He has a demonstrated track record of turning around for profit, and not-for-profit, healthcare organizations through the design and implementation of critical initiatives.
Kory was a healthcare associate with Waveland Capital Group, an investment banking firm focused on funding and developing companies, mergers and acquisition advisory. He managed the transaction life cycle including sourcing, screening, structuring and execution of equity, debt, merger and acquisition transactions. Prior to that, Kory was a healthcare consultant providing financial analysis, financial and operational due diligence, valuation analyses, transaction management, post-merger integration planning, and market assessment for hospitals, medical device, pharmaceutical, and healthcare-focused financial services companies.
Kory is a member of the Healthcare Financial Management Association (HFMA) and Society of Competitive Intelligence Professionals (SCIP). Additionally, he has published articles on innovative medical devices and has lectured at UC Irvine on securing private equity investment.
Kory holds an MBA from the University of California at Irvine, an MS in Biomedical Sciences from University of New Mexico School of Medicine, and a BS in Chemistry from the University of Utah.