Archives: Speakers

Harsha K Rajasimha, Ph.D., is a serial entrepreneur, scientist, patient advocate, and philanthropist. Harsha is Founder and CEO of Jeeva Clinical Trials Inc.(https://jeevatrials.com) a AI-driven unified platform for sponsors to execute modern clinical trials with efficiency and universal accessibility. Harsha serves as the founder chairperson of the Indo US Organization for Rare Diseases (https://indousrare.org), where he is forging a new era of cross-border cooperation among various stakeholders of rare diseases in the US, India, and globally by convening the annual Indo US bridging RARE Summit (https://summit.indousrare.org) and the Abbey Meyers Khushi Bridging RARE Awards Gala.
Harsha’s 20 years of experience in precision medicine data research spans academia, federally funded research, healthcare and life science consulting, and multiple startups. Harsha made bold career moves after losing a newborn child to a rare congenital disease in 2012 and his younger brother with juvenile diabetes in 2017. He decided to apply his years of postdoctoral training at NIH and FDA to combat rare diseases. At Jeeva, Harsha leads the development of a unified software platform for efficient clinical trials for rare and common conditions that are universally accessible. He knew that technology is not the limiting factor and that patient-centered design guided by stakeholder needs and regulatory requirements would be critical ingredients of the continuously learning digital platform. By digitizing and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to diverse patients who need them anywhere by over 3x faster.
Harsha maintains academic affiliation at George Mason University since 2012 and has authored 17+ publications, book chapters, and patents. Harsha’s work has been recognized by Lead India Foundation 2020 Award for leadership and outstanding achievement in rare diseases, a travel award to join the NGO Committee on Rare Diseases at the United Nations headquarters, New York City in Feb 2019, NTT DATA Healthcare Life Sciences Silver award for outstanding achievement 2017, Sanofi Genzyme patient advocacy leadership award 2016, Bioscience company of the year 2014, NEI director’s innovation award 2012 for building their genomics data infrastructure. Harsha earned his M.S. in Computer Science (2004) and Ph.D. in Genetics, Bioinformatics and Computational Biology (2007) from Virginia Tech.

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 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.