PEOPLE INTERVIEWED

OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). OPDP oversees the regulation of prescription drug promotion and advertising. OMPI provides oversight and direction for new and ongoing policy initiatives in broad-based medical and clinical policy areas.

Dr. Corrigan-Curay brings to the position a unique legal, scientific policy, and clinical background with expertise in risk and scientific assessment, and clinical trial design and oversight. Before joining FDA, she served as supervisory medical officer with the Immediate Office of the Director, National Heart, Lung and Blood Institute (NHLBI), at the National Institute of Health’s (NIH) and served in director and acting director roles with the Office of Biotechnology Activities (OBA), Office of Science Policy at NIH, where she was executive secretary of the NIH Recombinant DNA Advisory Committee. She has held positions as an attending physician with the VA Medical Center, a policy analyst with the Congressional Office of Technology Assessment, and a practicing attorney in Washington, D.C.

Dr. Corrigan-Curay earned her law degree from Harvard Law School, her medical degree from University of Maryland School of Medicine, and a bachelor’s degree in history of science from Harvard/Radcliffe College in Cambridge, MA. She completed her training in internal medicine at Georgetown University Medical Center, where she also served as a clinical assistant professor of medicine. She continues to practice internal medicine part-time at the Veterans Affairs Medical Center in Washington, D.C.

He received his medical degree from Columbia University, and his Master's degree in clinical epidemiology from Johns Hopkins University. He trained in internal medicine at the Hospital of the University of Pennsylvania, and in neurology at Johns Hopkins Hospital.

Dr. Dal Pan is board certified in internal medicine and neurology. He was an instructor in the Neurology Department at Johns Hopkins. He next worked for Guilford Pharmaceuticals in Baltimore, and then for HHI Clinical Research and Statistical Services in Hunt Valley, MD. He joined FDA in July 2000 as a medical officer in the Division of Anesthetic, Critical Care, and Addiction Drug Products.

Mike has a bachelor's degree in chemical engineering and a master's degree in biotechnology, both from the University of Pennsylvania.

She spent 16 years working for Amgen in microbial and mammalian cell culture manufacturing support and helped gain commercial FDA and international regulatory approval of the EPO/NESP manufacturing facility in Longmont, CO.

He has helped many cleanroom users solve their cGMP issues. Mr. Pandolfi has been responsible for the EMEA Service Department, and a member of the Global Life Science organization in 2015.

He is a leading specialist in health analytics, big data, predictive modeling, and personalized medicine for oncology. He has received multiple innovation awards, including the highest lifetime award in data mining, is a frequent speaker, and a highly published author with 60 granted patents, 100+ publications (25+ in oncology) and one book.

Prior to joining KPMG, Bharat served in various leadership positions within a large multinational engineering and electronics conglomerate, including as leader of the Health Services Center for Innovations, head of the Personalized Medicine program, and as general manager of the Healthcare Analytics and Business Intelligence Group. Bharat also led the HCLS anticorruption analytics practice at a Big Four firm, where he focused on the use of advanced analytics to detect and prevent fraud, waste, and abuse across all health sectors.

Rene is the co-author of 25+ patents in area of automation and bioprocessing. His passion for technology makes him a visionary leader. Rene's main areas of expertise are Automation, IoT, AR-VR and digitalization. He is currently working on innovative solutions which have the potential to transform how the bioprocess is being executed.

Her personal mission is advancing pharmaceutical manufacturing processes to enhance plant operations and, more important, improving patients’ access to critical therapies. Dr. Romero-Torres received her PhD from Purdue University in analytical chemistry.

Throughout her 13 years, she has managed multiple product lines including clarification, aseptic, virus filtration, and Single Use & Systems. Merrilee has served as the Head of the BioContinuum™ Platform, a convergent portfolio of advanced processing and software, automation and analytics technologies, since January, 2017.

* The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the U.S. And Canada.