Affiliates – Click the Link to the Left to Return to our Staff ClinReg Consulting Services, Inc./Judy F. Gordon, D.V.M.—is Founder and President of ClinReg Consulting Services, Inc. (http://www.clinregconsulting.com) Dr. Gordon brings almost 20 years of experience in pharmaceuticals, biologics, and medical devices to her consulting practice a clinical and regulatory consultant since 1998. Dr. Gordon was with Chiron Vision, a division of Chiron Corporation, from the company’s founding in 1986 through its successful acquisition by Bausch & Lomb in 1997. At Chiron Vision, Dr. Gordon served most recently as Sr. Vice President of R&D and as V.P. of Scientific Affairs, with responsibility for product development, clinical research, regulatory affairs, and regulatory compliance. In her consulting practice, Dr. Gordon has been involved in the development, clinical and regulatory activities for a broad range of products including injectable polymers for tissue bulking, refractive surgery devices, CAD systems for tumor detection, coils for aneurysm treatment, intracranial stents for stroke prevention, breast biopsy devices, intraocular drug delivery systems for treatment of macular degeneration and diabetic retinopathy, coronary atherectomy systems, and multiple other products representing novel technology. Dr. Gordon has taken multiple PMAs and NDAs through the FDA review process, and has directed large-scale clinical trials of both devices and pharmaceutical products. In total, Dr. Gordon has prepared all or part of 16 successful PMA applications for novel devices. She served as the industry representative to FDA’s Ophthalmic Devices Advisory Panel, chaired an industry-FDA working group on guidance documents for clinical trials of refractive surgery lasers, and as the industry representative to the Mediation Dispute Panel of the Center for Devices and Radiologic Health (CDRH). Janet L Conway, Ph. D., Scientific Consultant—is head of Wyoming Pharmaceutical Consulting, providing R&D guidance to ophthalmic start-up organizations and due-diligence, risk assessment, and strategic planning for more developed companies. Dr. Conway brings 25 years of experience in the ophthalmic pharmaceutical, drug delivery and device sector, serving in a variety of roles from R&D, to product development to licensing. Dr. Conway provides scientific, pre-clinical and clinical assistance and analysis to The Magnum Group. Previously, Dr. Conway was Director of Licensing and Development at Pfizer, Executive Director of Ophthalmology Licensing at Pharmacia, Director of Global Business Development for Johnson & Johnson’s Vision Care Franchise, Vice President of Product Development and one of four founders of M6 Pharmaceuticals. She held similar positions at VimRx Pharmaceuticals, Olympus Corporation (Medical Device Division), and at Johnson & Johnson’s ophthalmic pharmaceutical and medical device company, IOLAB. Prior to J & J, Dr. Conway was a Senior Scientist in Allergan’s Discovery Research organization, Dr. Conway received BA and MA degrees from Northeastern University, earned a Ph. D. from the Massachusetts Institute of Technology in visual neurophysiology and completed a post-doctoral fellowship in neurochemistry at The University of California, Irvine. She serves on the Board of Directors of Aerie Pharmaceuticals, and is Chief Technical Officer of Encore Vision. She and her husband, ophthalmologist K. Buol Heslin, MD, live on a ranch in Alta, Wyoming raising organic grass-fed lamb. Lachman Consulting, LLC/Michael Lachman—is Founder and President of Lachman Consulting, LLC (http://www.lachmanconsulting.com/). He brings 25 years of experience to investment research and analysis, new business development, marketing, and engineering for corporate clients. Previously Mr. Lachaman was a Partner, Managing Director, and equity research analyst with Think Equity Partners, a growth-focused investment bank based in San Francisco. At Think Equity, Mr. Lachman’s research was focused primarily on ophthalmology, orthopedics, and specialty cardiology. Before that, Mr. Lachman was a healthcare analyst on the buy-side with SAC Capital Advisors and Jurika & Voyles. His first experience in equity research was as a medical device analyst with Hambrecht & Quist, where he received a #1 ranking in medical industry stock picking in the Wall Street Journal All-Star Analyst Survey. Mr. Lachman also brings 12 years of medical device industry experience. He worked for five years in business development for the Ethicon Endo-Surgery division of Johnson & Johnson. Previously, Mr. Lachman spent seven years with Baxter Healthcare Corporation, working in both research & development and product management, with a focus on implantable surgical products. Mr. Lachman holds an M.B.A. (with concentrations in marketing and finance) from Northwestern University's Kellogg School of Management. He also holds an M.S. in Mechanical Engineering from Stanford University, and a B.S. in Aeronautical Engineering with highest honors from the University of Illinois. Market Scope/Dave Harmon—is the Founder and President of Market Scope, LLC (http://www.mktsc.com), the leading source of market information on the ophthalmic surgical industry. Market Scope follows companies, technologies, regulatory issues, patents, providers, surgeons, procedure volumes, market share, and pricing. Because the Company focuses its efforts on the ophthalmic market, they are able to bring perspective and context to the latest industry information. The Company’s products include newsletters, reports, surveys, geographic analysis, custom research and analysis. Market Scope’s clients include the leading companies in the industry, investment analysts, surgeons, and optometrists Mr. Harmon has almost 25 years’ experience in the ophthalmic industry and has been writing and publishing newsletters and reports on the refractive industry since 1996. Through his extensive industry experience and his contacts in the business of refractive surgery, Mr. Harmon has become a leading expert in all business and technical aspects of the refractive industry. Mr. Harmon’s ophthalmology experience began in 1984 at Alcon Laboratories, where he served in several capacities including three years as Manager of Business Planning and Acquisitions for the Surgical Division and five years as General Manager of the Alcon Systems Division. His education background includes a Bachelors of Science in Business Administration with an Accounting major from Texas Tech University and a Masters of Science in Finance from the University of Texas at Dallas. SM2 Strategic/Shareef Mahdavi—is the Founder and President of SM2 Strategic (www.sm2strategic.com), is based in the San Francisco Bay Area. Mr. Mahdavi has over 20 years of experience in medical devices and has held senior marketing and sales roles with Advanced Medical Optics, Carl Zeiss-Meditec, and Glaxo SmithKline; he led the marketing team at VISX during the launch of the laser used in LASIK, which today is the top elective surgical procedure performed in the US. Mr. Mahdavi provides expertise in increasing consumer demand for new medical technologies in elective (self-pay) procedures. He works with leading manufacturers, VC/Incubators, and physicians. He is a sought after lecturer for medical conferences and manufacturer user group events. His clients are innovators in refractive surgery, aesthetics, eye disease, sleep/snoring, and cosmetic dentistry. Mr. Mahdavi is also a certified expert on the Experience Economy, one of only ten individuals to earn that designation under the tutelage of authors Pine and Gilmore.