


Healthcare is one of the world's most complex and rapidly evolving ecosystems. Diverse stakeholders, varying clinical practices, reimbursement systems, and policy environments shape healthcare decisions across countries. At the same time, advances in therapeutics, digital health, real-world evidence, and artificial intelligence are transforming how healthcare innovations are developed, evaluated, and adopted.
At ETI, we help life sciences, healthcare, and health technology organizations bridge the gap between scientific innovation and real-world patient impact. ETI partners with clients to design, generate, and communicate evidence that is scientifically rigorous, regulatory-ready —enabling informed decisions across development, regulatory, medical affairs and commercialization pathways.

Our approach integrates scientific rigor, strategic relevance, and practical implementation from the outset by combining expertise in biostatistics, evidence generation, regulatory science, real-world data.

Priya Kulkarni, Ph.D., is a healthcare leader, statistician, and evidence strategist with more than 20 years of experience spanning biopharmaceutical development and digital health. She has held scientific and leadership roles at Genentech, Roche Information Solutions, Merck, and Pfizer, partnering with cross-functional teams across clinical development, regulatory affairs, medical affairs, commercial strategy, and health technology innovation. Her experience spans the full product lifecycle—from discovery and development through regulatory approval, launch, and post-market evidence generation—across multiple therapeutic areas and global markets.
Throughout her career, Priya has led evidence strategies for some of the industry's most complex and high-impact programs, including breakthrough oncology therapies, drug-device combinations and AI-enabled digital health technologies. Recognized for her ability to bridge science, strategy, and decision-making, Priya helps organizations transform data into evidence, evidence into insights, and insights into meaningful patient impact.
She holds a Ph.D. and M.A. in Statistics from the University of California, Santa Barbara, and an M.Sc. in Applied Statistics and Informatics from the Indian Institute of Technology (IIT), Bombay.
"We have data. We're not sure what evidence we actually need ."
Fit-for-purpose evidence planning from first study to final submission. A clear, prioritised evidence roadmap aligned to your regulatory, payer, and clinical goals.
"We're evaluating an asset and need an independent scientific read — quickly."
Independent scientific review and evidence assessments for investment, M&A, or portfolio decisions.
"Our team runs studies but doesn't yet think strategically about evidence."
Training and mentorship that builds lasting internal capability to generate, interpret, and apply evidence at scale.
"The FDA and CE mark pathways for our SaMD are unclear..."
Clinical and regulatory evidence strategy for SaMD, IVDs, AI algorithms. FDA, CE mark, and international pathways.
"Our product got approved. Payers still won't cover it."
Economic evidence strategy that moves payers, customers and health systems from awareness to coverage and adoption.
"We know real-world evidence matters. We don't know where to start ..."
End-to-end RWE Support: RWE strategy, data source selection, study design and analysis, CRO oversight for claims, EHR, and registry data.
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