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.
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.
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.
R. Michael Scarano Jr.
David L. Rosen
Joseph Sinkule, Ph.D., Consulting Affiliate, Clinical and Regulatory Development
Joe is a seasoned pharmaceutical executive with over 24 years of pharmaceutical and biotechnology management experience in the research, development, manufacturing, project management and commercialization of drugs, devices, and biologics. Joe is a prolific entrepreneur, with in-depth experience in having founded several early stage biotechnology companies in the past decade. He has been directly involved in the development and commercialization of five vaccine products submitted to FDA.
Previously, Joe was the Director of EER Medical Systems, Inc., a US-based clinical research organization (CRO) where his responsibilities, including advising the company's clients in all aspects of clinical and regulatory affairs and GMP manufacturing. Joe also founded and served as President/COO and Director of Iatros BioPharma Inc., a genetics vaccine company where, as President, he negotiated and licensed the company's technologies, obtained private funding, and advanced the technologies through Phase II clinical trials. Previously, he held senior management positions with Immunex Corporation as Director of Clinical Research and was a key team member on the product development team for the commercialization of recombinant GM-CSF and the clinical introduction of recombinant IL-3 and recombinant IL-1.
Earlier in his career, Joe was Senior Vice President of Research and Development at a NASDAQ-listed biotech company and contract GMP manufacturing organization called Techniclone International. Joe was instrumental in converting a public company that was making research-grade biological products (recombinant proteins and monoclonal antibodies) into a fully compliant GMP production facility for clinical-grade biologics. Joe provided pharmaceutical consulting services for nearly five years before joining EER in 1996. He has many years of executive management experience and is capable of managing several difficult projects simultaneously and taking them from planning and initiation to completion. Within Strategic Intelligence, Joe is actively involved in clinical and regulatory development consulting engagements.
R. Michael Scarano, Jr., Esq., Consulting Affiliate, Reimbursement Strategy
R. Michael Scarano, Jr. is lead outside counsel to SI on reimbursement strategy matters. He also serves as a partner and co-chair of Foley & Lardner's Life Sciences Industry Team and is a member of the firm's Health Care Industry Team.
In his legal practice with Foley & Lardner, Mike has represented a wide variety of health care clients, including medical device companies, private and governmental hospitals and their medical staffs, nursing homes, medical groups, independent practice associations (IPAs), management services organizations (MSOs), emergency medical services (EMS) providers, public EMS agencies, diagnostic test providers and professional associations. His primary areas of practice include reimbursement, fraud and abuse/compliance, managed care, allied health professions, EMS law, and general business transactions such as entity formation and sales/acquisitions.
Mike was selected for inclusion in the 2007 edition of The Best Lawyers in America®. He was also named a 2007 Southern California "Super Lawyer" in San Diego by Law & Politics Media, Inc. He is the co-chair of the Health Law Committee of the State Bar of California for 2006-2007.
Mike speaks regularly before health care professional organizations and has published numerous articles on a variety of health law topics. He is a member of the Healthcare Financial Management Association (HFMA) and former member of the board of directors of the San Diego/Imperial County Chapter of HFMA. Mike has also been an adjunct professor of health law in the Master of Business Administration programs at National University and Webster University and a guest lecturer in the Graduate Masters of Public Health Program at San Diego State University. He is a regular columnist for EMS Insider.
Mike is a 1984 graduate of Boalt Hall School of Law at the University of California at Berkeley, where he was an associate editor of the Ecology Law Quarterly. He received his Bachelor of Arts degree, with academic distinction, from the University of California at Berkeley in 1978.
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 over 10 years of investment banking, business development, sales and marketing, and R&D experience in various segments of the life science industry. Previously, Kory was leading business development, strategic consulting, and competitive intelligence gathering and analysis for xIQ Ventures. Prior to xIQ Ventures, Kory served as an Associate at Waveland Capital Group's private equity team. He was responsible for initial screening, due diligence, market assessment, valuation analysis, and advising on transaction structure, including securing licensing agreements for prospective clients and portfolio companies. Kory also played an integral role in the capital formation and fund raising activities on behalf of client companies. Kory has worked as a biochemist for public and private biotechnology companies. He has worked on a variety of projects including research and development of pre-clinical anti-hemorrhagic drugs, genetically enhanced agricultural products, and analytical chemistry products and services.
Kory holds an MBA in Finance and Marketing from the University of California at Irvine, an MS in Biomedical Sciences from University of New Mexico, and a BS in Chemistry from the University of Utah.