INDIANAPOLIS — Jennifer L. Stotka, M.D., has joined B&D Consulting, a division of Baker & Daniels LLP, as a senior advisor on the health and life sciences team. She will practice from the firm's Indianapolis 96th Street Office.
Before joining B&D Consulting, Dr. Stotka spent almost 20 years in pharmaceutical and drug development at Eli Lilly and Company where she was involved with more than 20 major submissions, reviews and approvals. She most recently was Vice President of Global Regulatory Affairs with Lilly Research Laboratories.
"Jen is an outstanding addition to our health and life sciences team," said Timothy R. Franson, M.D., senior vice president with B&D Consulting. "Her vast experience in pharmaceutical development, approval and postmarketing processes — involving extensive interactions with FDA and other regulators — will provide a great asset to our clients as they navigate through regulatory planning, submission preparation and application review procedures. Her addition to our team further augments the scope and depth of regulatory and clinical consulting services available to biopharmaceutical companies and venture capital firms."
With eight years in clinical development and 11 years in regulatory affairs at Lilly, Dr. Stotka provided comprehensive regulatory due diligence oversight, pre-approval strategic guidance, advisory committee preparations and post-marketing regulatory advice across multiple therapeutic areas. She has extensive clinical and regulatory experience in all pre- and post-approval phases of pharmaceutical development (small and large molecules) relating to FDA interactions, policy and product-related issues. In addition, Dr. Stotka has served on many Pharmaceutical Research and Manufacturers (PhRMA) steering committees, working groups and dialogue sessions, including the industry's PDUFA V negotiation team with FDA.
Dr. Stotka earned a Doctor of Medicine degree in 1984 from Wake Forest University School of Medicine. She completed postgraduate training in Internal Medicine at Presbyterian University Hospital, University of Pittsburgh, from 1984-87 and served as staff physician in the primary care and emergency departments at the Veterans Administration Medical Center in Pittsburgh from 1987-88.
Dr. Stotka held a fellowship in Infectious Diseases at the Medical College of Virginia, affiliated with Virginia Commonwealth University from 1988-91. At the Indiana University School of Medicine in Indianapolis, she was an assistant professor of medicine from 1991-93.
With Lilly Research Laboratories, Dr. Stotka was presented the President's Award in 1994 and 1999. She was given a National Foundation for Infectious Diseases (NFID) Postdoctoral Fellowship Award for nosocomial research in 1988.
ABOUT B&D CONSULTING
B&D Consulting is a national advisory and advocacy firm based in Washington, D.C. since 1985. Whether developing a business or advancing a mission, the firm's professionals serve clients across key sectors of the U.S. economy, including local government, health and life sciences, energy, education, and financial services. For more information about B&D Consulting, visit www.bakerdconsulting.com.
ABOUT BAKER & DANIELS
Baker & Daniels LLP provides advice and counsel to regional, national and international clients with legal and business needs. With more than 370 attorneys and legal professionals, the full-service law firm has offices in Indianapolis, Fort Wayne, South Bend, Chicago, Washington, D.C. and Beijing. For more information about Baker & Daniels, visit www.bakerdaniels.com.