Archives: Speakers

Experienced BioPharma professional with a strong background in Genomics, Technical Support, Training, and Clinical Biomarker Operations.

Revati Tatake, PhD, is the Global Head of Pharma Research, Analysis and Competitive Intelligence at GlobalData Healthcare.  Revati has over 25 years of multidisciplinary experience in academic research and the healthcare industry, both on the client and agency sides of the business. Previously she worked as a VP of Databases and Analytics at GlobalData, where she made significant contributions to Pharma Intelligence Center. Before joining GlobalData, Revati worked at Citeline/Informa, where she was involved in competitive intelligence and analytics of clinical trials and drugs in the areas of Autoimmune/Inflammation, Central Nervous System, and Ophthalmology.  Earlier, Revati worked at Boehringer Ingelheim Pharmaceuticals for over 12 years as Senior Scientist to Senior Principal Scientist, where she led drug discovery projects involving traditional high-throughput screening, as well as innovative approaches for gene and cell therapies. She also worked at Boehringer Ingelheim as a Director of Competitive Intelligence for projects in cardiometabolic space and research beyond borders. She is a co-inventor on many issued US patents related cell and gene therapies and has several publications in peer reviewed scientific journals. Revati holds a PhD in Tumor Immunology from the Tata Cancer Research Institute in Mumbai, India. She did her postdoctoral fellowship at the University of Connecticut Health Center and Boehringer Ingelheim.

An effective team-building leader who takes new medical devices from concept through design, pilot & production manufacturing, clinical trial, FDA regulatory approval, production and service. As an associate professor of medicine, surgery and ophthalmology at the Boston University School of Medicine, led interdisciplinary teams in creating, designing, developing, implementing and testing innovative biomedical instrumentation. Wrote proposals which secured over $1 million in federal research grants. Commercialized one of four patented inventions, designed and ran clinical trial and secured FDA 510(k) clearance. Used over 30 years of laser experience to develop diagnostic and therapeutic instrumentation.

Current goals are to take Floelle Inc.’s patented small medical device through its Early Feasibility Study, pivotal clinical trial and FDA de novo 510(k) process (and the equivalent in Europe) into the market to restore the quality of life to one billion incontinent women worldwide, and to bring high value to physicians, third party payers, investors and governments, and well as removing trillions of absorbent products from landfills.

Specialties: Development of new product concepts, taking concepts all the way to servicing the finished product in the field, regulatory affairs, all aspects of medical device manufacturing, purchasing, program management, engineering management, operations management, ophthalmology, dermatology, gynecology, urology, laser surgery, 3-D imaging, image processing, pharmacodynamics, among many others.

Veronica Ludensky is the Director of Procurement, Clinical. She is responsible for establishing and growing the procurement function for clinical services to leverage the Flagship ecosystem to advance companies’ clinical development goals.

Veronica has almost two decades of experience in clinical sourcing functions for multiple compounds from Phase 1 through 4, in small biotech, large pharma and CROs. During her career, Veronica was responsible for supporting project teams across multiple therapeutic areas in selecting, negotiating costs, contracting and business oversight of CROs, laboratories and all other vendor types in support of clinical programs at AstraZeneca, Alexion Pharmaceuticals, Millenium Pharmaceuticals and Takeda.

Carrie Lewis has over 20 years of varied Clinical Research experience.  Carrie is currently an Executive Director, Clinical Program Optimization at Endo USA, Inc. where she oversees Clinical as well Business Operations, eTMF/inspectional readiness, and Training/Oversight.  Prior to Endo, Carrie garnered extensive knowledge in many roles while in academia, at large sponsors, generic sponsor, as well as a global CRO.  She has a Master’s Degree in Clinical Research Administration and has experience in multiple therapeutic areas.

Clinical Operations and research professional with 5 years of clinical research experience, including greater than one year of experience in the biotechnology sector and multiple years leading trials and teams at academic medical research centers. I leverage my deep understanding of the patient journey and site-level operations to bring a site- and patient-centeric perspective to sponsor-side clinical trial execution, driving high-quality studies delivered on time, on budget, and with meaningful impact.