Our mission is to provide a forum for biospace professionals engaged in all segments of the industry to network, expand technical knowledge and connect our members with companies who can benefit from their expertise.

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Board of Directors

Jim Beebe, Ph.D.
Jim Beebe has managed US and EU regulatory support for 23 nuclear medicine, X-ray, CT, and PET imaging systems, from regulatory design specifications through post-market. Mr. Beebe developed excellent relationships with FDA such that when an issue arose, he got a faster response than normal and avoided weeks of delay in the approvals. When the backlog for California approval for new PET systems was 18 months, he negotiated an alternative approval from another state in 3 months that could be used in several states, including California. As a result of his efforts, the Company increased its PET sales by more than $30MM.

Audrey Erbes, Ph.D.
Audrey Erbes is a global life-science business development and marketing consultant, industry educator, organization leader and public speaker who originated several bioscience business development and marketing courses nationally at the UCB and UCSC Extensions in 2002. She has 25 years of managerial experience in the biopharmaceutical industry including Executive Vice President and Co-founder of Kowa Research Institute, a biopharmaceutical licensing and investment subsidiary of Kowa Company Ltd., Japan . Previously, she held both U.S. and international management positions at Syntex Corporation in market research, product management, strategic marketing, and business development, with a special emphasis on Europe and Asia/Pacific/Canada.

Audrey's industry involvements include the article “Face to Face with Investors,” Pharmaceutical Executive , (June 2003); chair for BIO 2004 panel “The Most Likely Successful Business Model for Personalized Medicine;” current Board member of the Bio2Device Group; and past Board member of the Syntex Syva Alumni Association. 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 Audrey is currently the Secretary of the Bio2Device Group.

Sudhi Gautam, M.D., Ph.D.
Dr. Sudhi Gautam  MBBS, DLO (ENT Surgery), Ph.D. (Biomedical Engineering), a surgeon-turned-Biomedical Engineer has over  15 years of experience in developing technological solutions to medical problems.  His 8 years of surgical practice motivated him into engineering after realizing the impact that technology could have in addressing clinically unmet needs.  He did a Ph.D. in Biomedical Engineering at the renowned IIT and followed it up with a Post-doctoral research at the University of Michigan, Ann Arbor.

As EIR/Adviser to technology incubators such as Girvan & TEN he assesses technologies and develops strategies for biomedical products. As a motivator, a cross-disciplinary biomedical educationist he trains entrepreneurs, physicians, non-medical personnel and provides leadership skills.  Areas of expertise include Artificial Organs/Implants, Breast Devices, Extracorporeal Devices, Blood Devices, Non-invasive Physiological Monitoring, Stem Cell-based technologies, Ear, Nose & Throat Technology, Medical/Clinical Info Systems and Engineering Solutions to Medical/Clinical problems.

Patrick Lee, P.E., RAC
Patrick Lee is currently a Regulatory Affairs professional at Micrus Endovascular Corp. in San Jose, CA where he is involved in regulatory activities worldwide. Prior to Micrus, he co-founded and was a director of iMedic Devices, Inc., in Sunnyvale, CA. At iMedic Devices, he was involved in the development of drug-delivery devices. Patrick has over 20 years of experience in the food, medical device, and other hi-tech industries including over 16 years at Fortune 500 companies. He has experience in food, nutrition, and medical 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. Patrick is currenlty the Treasurer of the B2DG.

Stan Levy
Mr. Levy has 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 two start-up companies, delivering several products to market. Mr. Levy is currently consulting to medical device companies.  Prior to this, he was Vice President of Research & Development at SURx, Inc. and Vice President of Manufacturing and Director of Instrumentation Research & Development at Cardiometrics, Inc. Mr. Levy is a graduate of Stanford University holding Bachelor and Master of Engineering degrees in Electrical Engineering.

Sharon Lewis
Sharon Lewis is the Founder and President of Strategic Impact, Inc. (www.strat-impact.com), a management consulting practice that provides global sales and marketing operations solutions. Ms. Lewis has 25 years of leadership experience within Life Science and software companies. Most recently, she was with Genentech, where she established a new commercial department and led a customer strategy initiative. Previously, she established a worldwide sales operations function at a company recently acquired by IBM. Ms. Lewis led Global Sales, Marketing, and Worldwide Operations and IT at CRM software company, Clarify. She also held leadership roles in sales, marketing, and IT operations at Parke-Davis, Warner-Lambert (Pfizer). She was a key contributor in the launches of Lipitor® and Accupril®. She holds an MBA from Fairleigh Dickinson University and a BS from Montclair State. Sharon is currently the Vice President of the Bio2Device Group.

Rajendra Rajpara
Raj Rajpara is a 15 year veteran of the high tech industry. More recently he has transformed his Fortune 100 experience of managing business application implementations into managing corrective and preventive actions for a major medical device manufacturer. Raj has a B.Sc. in Computer Information Systems from San Francisco State University and a Regulatory Affairs certificate form the UC Santa Cruz Extension.

Raj is committed to the B2DG mission of bringing the powerhouse communities of Pharma, Biotech and Medical Devices into an even greater collective of individuals dedicated to discovering and implementing solutions that better the human condition.

Harry Wachob , Ph.D.
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. He is currently the Managing Materials Scientist at Xoft, Inc.  Previously he was Director of Engineering for Aerogen, Inc., 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 engineering degrees in Materials Science & Engineering from Cornell University .