Home / Author / Rajesh Krishna, PhD

Rajesh Krishna, PhD

Distinguished Scientist, Drug Development Science

Rajesh is a scientific key opinion leader with 25+ years in drug development, specializing in model-informed strategies for biologics, vaccines, and small molecules. Currently a Distinguished Scientist at Certara, he leads strategic consulting and the rare diseases center of excellence.  Previously, he founded Merck’s quantitative clinical pharmacology department and held key roles at Aventis and Bristol-Myers Squibb. Rajesh holds a PhD in Pharmaceutical Sciences (University of British Columbia) and an MBA in Strategy and Innovation (Warwick).  Consistently recognized among the top 2% of influential scientists, his work includes 100+ publications, 89 posters, and 4 books.  He is an elected fellow of AAPS.

Authored by Rajesh Krishna, PhD

Rajesh Krishna, PhD

Applying decision analysis to drug development for COVID-19 & future pandemics

Why Clinical Pharmacology & Pharmacometrics Should Collaborate

Resmetirom: A pioneering NASH clinical program

How does a clinical development plan help drug programs?

Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates

What are biosimilars & how are they developed?

Understanding the Role of Your Discovery Asset’s Target Product Profile

Methods to Increase Signal Finding in Rare Disease Drug Development

Stop if you don’t have an unambiguous drug effect for your new molecular entity!

Drug Development Considerations for Live Biotherapeutic Products

Artificial Intelligence: What is it & how can it accelerate rare disease drug development?

Why you should select your drug formulation before starting clinical studies

Key development considerations for cell therapies

Why are Human Radiolabeled Mass-balance Studies Important in Clinical Pharmacology & Drug Development?

Why FDA’s New Guidance on Circulating Tumor DNA is Critical for Oncology Early Clinical Drug Development

Reflections on the Recent ICH E11A Pediatric Extrapolation Guideline

The Utility of Model-Informed Drug Development for Rare Diseases

How to Fix Your Biggest Bioequivalence Mistakes

Experts Unravel the Top 5 Myths Related to Bioequivalence

Don’t Forget About Safety! How to Assess Drug Candidate Safety in Early Clinical Development

A Bird’s Eye View on Rare Diseases: Key Drug Development Considerations for Thyroid Eye Disease

Developing Targeted Covalent Inhibitor Drugs: 3 Key Considerations

A Day in the Life of a Clinical Pharmacology Consultant

Building a Robust Clinical Pharmacology & Model-Informed Drug Development Strategy for New Alzheimer’s Disease Drugs

Key Considerations to Ensure Maximal Probability of Antibody Drug Conjugate Development Success