Ask the Experts: Advice on Academic Partners, IP and Regulatory Hurdles
for Life Science Start-Ups:
June 8, 11 a.m. to 1 p.m. 
Waller Lansden Dortch & Davis, LLP
511 Union Street, Suite 2700, Nashville, Tenn. 

The "Ask the Experts" panel series is an educational panel discussion for early stage entrepreneurs and researchers who want to pursue the process of commercialization of life science technologies. This discussion will be targeted to life science entrepreneurs and potential entrepreneurs.  

 

The “Ask the Experts” series mirrors the programmatic process of the Life Science Tennessee Statewide Mentor Network.  The Network will lead select entrepreneurs through a series of panel reviews discussing business model, regulatory hurdles, intellectual property, technology assessment, market assessment, strategic partnerships, product development, marketing and communications, and financing.  

 

Jim Monsor – Director, LifeSciTN Statewide Mentor Network
Jim served as the head of operations for BioMimetic Therapeutics for more than 13 years. He built and led the entire scope of operations and quality functions, and led the Life Sciences Center Construction Project. He is the fourth employee and was instrumental in leading BMTI through critical growth to a 100 person operation. He led multiple product development and commercialization teams and was a core leader in  completing clinical development and trial execution; manufacturing process development and qualification; filing development, submission, and approval in less than four years for a combination PMA product with a team of less than ten people. Previously, Jim spent fifteen years at Abbott Laboratories, and more recently was Director of Product Supply for ALK-Abello, where he was responsible for the entire product supply chain for US operations. He has very broad experience in supply chain management, quality, regulatory, commercial operations, IT, and facilities management for drug, device, biologics, combination products as well as bulk drug products. His experience spans early stage research through all phases of development, product launches, and routine commercial operations in US and international markets.

Eric Fugett – Associate, Waller Lansden Dortch & Davis, LLP
A registered patent attorney with an advanced degree in the life sciences, Eric Fugett represents clients in a variety of intellectual property-related legal matters. Leveraging his technical background and research experience in microbiology and molecular biology, Eric’s practice emphasizes patent drafting, prosecution, enforcement, and litigation for the biotechnology, pharmaceutical and food industries.  He also regularly advises on patent validity and infringement issues, including Freedom to Operate opinions, and provides trademark and copyright registration and IP portfolio management and licensing services.

Dr. Kenneth Holroyd – Medical Director, Vanderbilt CTTC
Kenneth J. Holroyd, M.D., MBA is Medical Director for the Center for Technology Transfer and Commercialization at Vanderbilt University. He also holds appointments as Assistant Vice Chancellor for Research, and Associate Professor of Anesthesiology and Medicine. At Vanderbilt, his clinical practice of medicine is in Anesthesiology. Ken was in the biopharmaceutical industry for seven years at Magainin Pharmaceuticals and Genaera Corporation, where he served as Executive Vice President and Chief Operating Officer, respectively