(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.
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.
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.
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.
held a fellowship in Infectious Diseases at the Medical College of Virginia
, affiliated with Virginia Commonwealth University
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.
was given a National Foundation for Infectious Diseases
(NFID) Postdoctoral Fellowship Award for nosocomial research in 1988.