150 Years of Combined Life Science Experience
Rick has 24 years of experience in pharma, biotech, and medical devices. Rick led the US Treasury group for Glaxo Inc, Glaxo Wellcome, and later became head of the US Business Development function for GlaxoSmithKline. He eventually assumed marketing responsibility for a lifecycle product portfolio with sales exceeding $400 million, including brands such as Zantac®, Flolan®, and Ceftin®. Rick and his team revitalized a number of these brands utilizing novel lifecycle extension strategies, as well as closed 20+ transactions for the Company. In 2005, became the CEO and the first employee of Glenveigh Pharmaceuticals, a drug development company focused on obstetrics. Glenveigh licensed its lead therapeutic to a British biotech for an upfront and milestones in excess of $25 million. Glenveigh subsequently acquired the rights to multiple early-stage devices, leading development, FDA clearance, commercialization, and divestment for a multiple of revenues.
Mike’s clinical development and regulatory affairs capabilities have been honed during 25 years in the pharmaceutical and biotech industries. Through his work at Burroughs Wellcome, GlaxoWellcome, PharmaResearch, Triangle/Gilead and now at The Gnomon Group, he has had a leadership role in at least 15 NDA approvals for NCEs and many other important supplemental NDAs. He has also helped file more than 50 INDs and served as the FDA contact and liaison.
Neil started his career as an anesthesiologist practicing in the U.K. before moving to industry. He has played a leading role in successful NDA applications for 10 new chemical entities in multiple therapeutic areas (CNS, cardiovascular, oncology, vaccines, renal, GI), and over 20 applications for line extensions. His clinical and market perspective from both the medical and business side is invaluable in driving project success for clients.
Ron has 30+ years of diverse experience within the pharmaceutical industry, beginning at Glaxo Inc. where he set up its 1st research lab in North America. Ron’s global business development network for transactions is legendary. His proficiency covers regulatory, quality systems, clinical study management, manufacturing transfer, analytical method validation, FDA, EMEA and Health Canada audit interactions, CAPA development & implementation, DEA regulations, product stability and release.
Penny has 28 years of medical device experience in regulatory, clinical affairs, and quality systems (RAC, CQA) including direct interaction with FDA at federal and state levels in 8 different companies. She has prepared and closed over 100 regulatory submissions and registration/device approvals. Penny specializes in creative regulatory strategies to successfully navigate complex issues and achieve expedient product registrations.
Bill has 29 years of industrial experience in drug development, from early research projects to full commercialization. His understanding of total development process includes drug formulation, delivery, device testing, process development, technology transfer and manufacturing scale-up, quality control, clinical trial supply packaging, cold-chain distribution, regulatory, and toxicology. Bill has led the preparation of CMC sections of regulatory submissions for drugs, biologicals and devices, and served on numerous NIH grant and SBIR review panels.
Jeff is a seasoned expert with over 25 years of global medical device experience in product development, start-ups, turnarounds, bankruptcy, mergers/ acquisitions, business integration, process improvement, quality/regulatory and project management. Held numerous operational positions with Baxter Healthcare, C.R.Bard, InterVascular Inc., Horizon Medical Products, Graham-Field, Windstone Medical, Norwood EyeCare and Glenveigh Medical.