Dr. Deepika Lakhani is an internationally recognized regulatory professional with over 15 years of experience with the Food and Drug Administration (FDA) and industry. Her interest in regulatory affairs started during her Doctorate studies at Virginia Commonwealth University where she collaborated with the FDA on an academic research project that fostered her interest in understanding regulations impacting the pharmaceutical and medical device industry. Right out of graduate school she started working as a reviewer at the Center for Drugs Evaluation and Research at the FDA where she spent >5 years in different capacities followed by >5 years at Center for Devices and Radiological Health. During her tenure at the FDA, she has reviewed, led cross-discipline teams, and contributed to policies impacting drugs, biologics, medical devices, tobacco products and combination products and served as FDA’s liaison to ISO committees. More recently in the healthcare industry she has lead efforts for global regulatory approvals of drugs, medical devices, combination products and emerging technologies and demonstrated expertise in tactically leading global regulatory teams using her sharp acumen for regulatory strategy and expertise in policy to maximize regulatory success. Through her experience working at the FDA and then in the industry at AstraZeneca and while consulting for Johnson and Johnson, she has gained in-depth understanding of global regulatory pathways from a vast portfolio of drugs, medical devices, and combination products. Most importantly she has a mindset that bringing products to market, especially those that are innovative, can benefit from a creative regulatory process and strives to provide “regulatory enablement” using both standard and out-of-the-box thinking.

Deepika received her bachelor’s degree in pharmacy in Delhi, India and her PhD in Pharmaceutics from Virginia Commonwealth University. She has multiple peer-reviewed publications, received many awards for excellence and leadership while at the FDA and in the industry.