Mamta Puri-Lechner has more than seven years of experience in regulatory strategy and regulatory affairs. Mamta has developed regulatory strategies to align with global and regional requirements for small molecules, cell and gene therapies, and live biotherapeutics with an emphasis on the areas of oncology, immuno-oncology, and hepatology. Her area of expertise includes Phase 2 and Phase 3 studies and being the primary regulatory liaison across multiple countries. Her focus has been in the hematology/oncology space. At Halloran, Mamta provides regulatory support for product development programs ranging from early-stage to late-stage development.
Before joining Halloran, Mamta was the Associate Director of Regulatory Affairs at Arog Pharmaceuticals, Inc., a Dallas-based oncology biotech. During her time there, she was responsible for designing and implementing regulatory strategies, acting as the global regulatory liaison with multiple regulatory agencies, and gaining regulatory approval for many Phase 3 studies. Before that, as a Regulatory Affairs Manager at Arog, she represented the company at two Type B formal meetings with the FDA and led the approval mechanism of the Voluntary Harmonization Procedure (VHP) across multiple European countries.
Northwestern University, Evanston, Illinois, Postdoctoral Scholar, Biochemistry, Molecular Biology and Cell Biology
Carnegie Mellon University, Pittsburgh, Pennsylvania, Doctor of Philosophy, Developmental and Molecular Biology
Maharaja Sayajirao University, Baroda, India, Master of Science, Biotechnology
St. Xavier’s College, Mumbai, India, Bachelor of Science, Life Sciences and Biochemistry