Archives: Speakers

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 is Executive Director of Clinical Program Optimization at Keenova, where she leads numerous operational teams. With over 20 years of experience across academia, global CROs, and sponsor organizations, she brings deep expertise in multiple therapeutic areas and clinical research strategy. Carrie holds a Master’s in Clinical Research Administration and is known for driving site innovation, reducing burden, and fostering strong partnerships in clinical trial operations.

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.

Steering the helm for biotechs at Danforth Advisors, my strategic procurement proficiency shapes the landscape of clinical development. With a laser focus on sourcing strategy and risk mitigation, my contribution has been pivotal in advising organizations through critical transitions, including mergers and acquisitions. The expertise I honed while advising on operational growth strategies and variabilizing workforces underscores my current mission to optimize our clients’ partnerships and exit strategies.

My tenure as a Senior Director at Danforth Advisors cultivated a deep understanding of clinical sourcing, from preclinical and translational stages to real-world evidence and late-phase data analysis. This comprehensive background facilitates my current role, where I’m committed to advancing sourcing of trials & digital health through robust supplier and stakeholder engagement, thereby empowering the acceleration of our clients’ portfolio growth and fostering strategic partnerships.

Réne Stephens is a biopharmaceutical research and development industry consultant with over 25 years of business operations and outsourcing experience. He has worked within pharmaceutical, CRO, SMO, medical imaging, academic CRO, and EDC companies, and private consultation. Réne understands the critical path of development and has a wealth of experience in outsourcing/procurement strategies, practices and negotiations, vendor relationship management, oversight and governance, clinical operations, finance, contracting, process development and improvement, and technology solutions. He holds a BA in Corporate & Organizational Communications (WKU), and an MSHS in Clinical Research Administration (GWU). While at Astellas Pharma Global Development as Executive Director and global head of Contracts & Outsourcing, Réne also served as the Global Procurement Lead for TransCelerate Biopharma, Inc., acting on behalf of and supporting the 20 biopharmaceutical company consortium for vendor selection, negotiation, and governance. He is the former moderator for the quarterly Linking Leaders Outsourcing Roundtable meeting, where current issues are discussed among development outsourcing heads; and, he is a regular speaker at conferences and symposia on business operations topics as related to drug development, outsourcing, vendor and site contracting, and oversight/governance. Since 2017, he has been supporting biopharmaceutical companies in this function as the Managing Member and founder of Renatus Consulting, LLC.