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Lila Ramaiah

Lila Ramaiah

Sr. Clinical Pathologist & Biomarker Strategist at Pfizer

Jersey City, New Jersey

I am a board-certified veterinary toxicologic clinical pathologist with more than 13 years of industry experience in drug safety assessment, demonstrated expertise in biomarker interpretation, as well as experience in management and strategic leadership. My goal is to continually develop myself professionally, while making significant contributions in drug development for my employer, for industry as a whole, and for patient health.

I currently serve as a Senior Clinical Pathologist and Biomarker Strategist in the Biomarker Safety & Translational Sciences group of Drug Safety R&D at Pfizer. In this capacity, I develop biomarker strategies and critically interpret biomarker data to support vaccine and other portfolio success. Notably, I was the clinical pathologist responsible for supporting the safety assessment of the mRNA COVID-19 vaccine BNT162b2. My expertise extends beyond clinical pathology. At Pfizer, I have led strategic initiatives or participated in senior advisory committees related to clinical biomarker qualification, biotherapeutics, immunogenicity, translational safety, and workplace equity/diversity.

My passion and vision is to improve patient health by advancing safety biomarker science through the development of innovative biomarker-based drug development tools. To this end, I have become a key scientific contributor to DSRD's digital and artificial intelligence initiatives to deliver insights by mining nonclinical study data. Externally, I am currently industry chair of the IMI TransBioline Drug Induced Kidney work package, chair of IQ Consortium’s DILI Biomarkers and co-chair of IQ’s DruSafe Biomarkers Working Groups, session co-chair and member of STP’s 2022 Scientific Program Planning Committee (SPPC), and an active member of STP’s Scientific and Regulatory Policy Committee. Furthermore, I co-chair and speak at successful PSTC-sponsored SOT symposia on important biomarker topics. I also serve as instructor for “Clinical Pathology: Principles for Pharmaceutical and Regulatory Scientists” which is part of the ACT week-long course “Toxicology for Pharmaceutical and Regulatory Scientists” (2018 to 2021).


Experience:

  • Associate Director, Veterinary Clinical Pathology - Safety Assessment (Huntingdon Life Sciences)
  • Senior Director - Veterinary Clinical Pathology (Envigo ++++)
  • Sr. Clinical Pathologist & Biomarker Strategist (Pfizer)
  • Director, Veterinary Clinical Pathology - Safety Assessment (Huntingdon Life Sciences)
  • Principal Veterinary Clinical Pathologist (Bristol-Myers Squibb)

Skills:

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