Board of Directors
Harry Wachob, Ph.D. - Founder & President
Harry Wachob is the Founder and President of the Bio2Device Group. He is an experienced engineering leader in materials science, biomedical device engineering and R&D. He has directed and mentored multidisciplinary teams in solving complex technical issues in order to improve the safety, reliability, and performance of medical devices. Most recently, he was the Managing Materials Scientist at Xoft. Previously he was Director of Engineering for Aerogen, a biopharmaceutical company specializing in novel aerosol drug delivery. Prior to that, Harry was Managing Engineer at Exponent/Failure Analysis Associates where he guided research and development, and product failure investigations covering a broad range of medical and industrial applications. He received his BS, MS and PhD engineering degrees in Materials Science & Engineering from Cornell University.
Patrick Lee, P.E., RAC - Treasurer
Patrick Lee is currently the Director of Regulatory Affairs at Iridex Corp in Mountain VIew, CA. Patrick is involved in regulatory activities worldwide in obtaining regulatory approvals and compliance. Prior to Iridex, Patrick served in various management positions in regulatory affairs at Bay area medical device companies. The product categories that he has worked in include neuro-implants, cardiovascular devices, cellular therapy device, laser and other electro-mechanical devices, blood processing, stem cell harvesting, drug-delivery devices, and others. Patrick has over 25 years of experience in FDA-regulated industries including health-care, medical device, and nutritional products. Patrick received his Chemical Engineering BS from Cornell, MS in engineering from Columbia, and MBA from the Anderson School at UCLA. He is a licensed Professional Engineer in the states of New Jersey and California and holds several patents. Patrick holds the US Regulatory Affairs RAC (US) designation and CQA.
Stan Levy - Board Member
Stan Levy has over twenty years of experience developing and manufacturing medical products including electro-surgical devices and generators, catheters and guide wires, and ultrasound instruments. He has directed R&D and manufacturing departments at three start-up companies, delivering several products to market. Stan is currently consulting to medical device companies. Prior to this, he was Director of Imaging Development at iScience Interventional, Inc., Vice President of Research & Development at SURx, Inc. and Vice President of Manufacturing and Director of Instrumentation Research & Development at Cardiometrics, Inc. Stan is a graduate of Stanford University holding Bachelor and Master of Engineering degrees in Electrical Engineering.
Jim Beebe, Ph.D - Board Member
Jim Beebe has managed US and EU regulatory compliance for 23 GE Healthcare nuclear medicine, X-ray, CT, and PET imaging systems, from regulatory design specifications through post-market product complaint reporting. His excellent relationships with FDA often saved weeks of delay during the regulatory approvals, decreasing time to market. In another circumstance, many states had backlogs of 18 months and longer to approve new PET systems. Jim negotiated an alternative approval in 3 months that could be used in several states. As a result, GE increased its PET sales by more than $30MM. Presently Jim consults with startups and small device companies about the impact of regulations on their business. Jim holds a Bachelor degree in Mathematics from Stanford University and Ph.D. in Biomedical Engineering from University of Virginia. His dissertation explored a novel non-invasive respiratory measurement as a clinical indicator of cardiac health.
Audrey Erbes, Ph.D. - Vice President
Audrey Erbes, Ph.D., Principal, Erbes & Associates, is a life-science business development and marketing consultant, organization leader, public speaker, and educator teaching courses to working professionals at University of California, Berkeley Extension. She has 30 years of managerial experience in biopharmaceuticals including Executive Vice President and Co-founder of Kowa Research Institute, a licensing and investment subsidiary of Kowa Company Ltd., Japan. Previously, she held U.S. and international management positions at Syntex Corporation in product management, strategic marketing, business development, and market research with a global emphasis, including Europe and Asia/Pacific/Canada. She writes an industry blog at www.audreysnetwork.com. Audrey was named the NCC—Association for Women in Science, “2006 Distinguished Professional” and Professional Women’s Healthcare Alliance (PWHA), “2006 Innovator of the Year”. She holds an M.A. and Ph.D. in political science from the University of Florida.
Darshana Nadkarni, Ph.D. - Chair Speaker Committee
Darshana Nadkarni, Ph.D., Principal, Winning Difference, does Recruitment for Medical Device and Biotech companies with her extensive network and an ability to match individuals with business requirements. Darshana offers total package of recruitment that includes initial screening, complete reference checks, and all required follow up discussions. Some of her past and present clients include Incube Labs, Spinal Modulation, Robodoc, Intrapace, NfocusNeuro, Guidant, Victhom, G-tech and so on. Darshana also facilitates trainings in areas of Diversity, Working Effectively with India, and a variety of other topics. Some of the companies she has facilitated training workshops for include, Medtronic, IBM, Michelin, United Illuminating, Xerox, Coca Cola, Rosche, Siemens, HP, SUN, NetApp, Inktomi and others. She writes blogs and contributes articles in Indian papers. Her blog is www.darshanavnadkarni.wordpress.com and Twitter Handle is @DarshanaN.
Gerri Smoluk, Ph.D., PMP® - Secretary
Gerri Smoluk is a PMP certified project and program management leader, with extensive cross-functional drug development R&D experience from pre-clinical through post-approval, alliance management, CMC leadership, clinical and process development, medical affairs, regulatory affairs, and medical writing. She has experience leading drug development teams and experience working in multiple therapeutic areas, including oncology, neurology, cardiovascular, metabolic disease, virology, and transplantation. She has worked in both small and large Pharma including Syntex, Roche, Scios, Pharmacyclics, Durect, Medivation, and MAP Pharmaceuticals. She is currently working as an independent consultant in the pharma and biotech industries. Gerri holds a B.Sc. in biochemistry from McGill University and a M.Sc. and Ph.D. in chemistry from the University of California at San Diego.
Denise Forkey, Speaker Committee
Denise Forkey, MS-BME, has been in the medical device industry since 1996, working in product development and preclinical contract research. Throughout her career she has gained an understanding of all aspects of preclinical research from operations, to regulatory compliance (GLPs, AAALAC, PHS, USDA), to business development and marketing. She has successfully established and nurtured client relationships for multimillion dollar accounts; set up quality systems for ISO 9001 and GLP compliance; led companies through corporate identity changes, and performed in vivo, in vitro, and bench testing for R&D and marketing for products generating revenue of nearly $1 billion. Denise started her career as an engineer working at Maven Laboratories, performing risk assessments and failure mode testing of TENS devices and later joined Ergomed where she developed protocols for assessing ergonomic workload for laparoscopic instruments. In 1998 Denise joined Guidant where she held multiple engineering positions in R&D performing marketing claims testing and overseeing preclinical studies in the areas of interventional cardiology and peripheral radiology devices. From there Denise joined LyChron, a preclinical contract research organization which was eventually purchased by Surpass, where she held senior management positions in regulatory, operations, business development and marketing. Denise regularly provides lectures on preclinical research at Biomedical/Bioengineering Programs such as San Jose State and Santa Clara University. She holds an MS degree in Biomedical Engineering from California State University, Sacramento and a BS degree in Physics from California Lutheran University.