About​

ClinPharm Dev Solutions is a boutique consulting firm specializing in Clinical Pharmacology and Pharmacometrics. We partner with biotech and pharma companies to design efficient, model-informed development strategies that accelerate IND, NDA, and BLA milestones.

Your Premier Drug Development Partner

Aniruddha Amrite, PhD, MBA
Founder and Principal Consultant
ClinPharm Dev Solutions LLC

Dr. Amrite brings over 18 years of experience in Clinical Pharmacology and Pharmacometrics across preclinical, clinical development, and full life-cycle management. He has led the design and delivery of Clinical Pharmacology and DMPK strategies for programs in oncology, rare diseases, CNS, and anti-infectives—contributing to multiple successful NDA and BLA submissions.

Prior to founding ClinPharm Dev Solutions, Dr. Amrite held senior leadership roles including Vice President & Head of Clinical Pharmacology at Pyxis Oncology and Senior Director at Dicerna Pharmaceuticals. He built and led teams responsible for IND-enabling studies, model-informed drug development (PopPK, PBPK, ER), and regulatory interactions with the FDA, EMA, and PMDA.

He holds a Ph.D. in Pharmaceutical Sciences from the University of Nebraska Medical Center and an MBA in Strategic Leadership & Business Analytics from the University of Illinois Urbana-Champaign. conjugates.

He has expertise in all phases of drug development and has lead successful clinical development programs leading to a registration and approval of 5 commercially available drugs in different therapeutic indications including oncology, rare-diseases, and CV-metabolism.

Dr. Amrite is passionate about integrating quantitative modeling, regulatory science, and business strategy to enable smarter, faster drug development decisions.

Why Clients Choose ClinPharm Dev Solutions

  • Deep experience across modalities — small molecules, mAbs, ADCs, bispecifics, RNA therapeutics.
  • Hands-on Modeling & Simulation (PopPK, PBPK, QSP, exposure–response) integrated with regulatory strategy.
  • Flexible engagement model: project-based, interim leadership, or end-to-end development support.
  • Proven record of successful IND/NDA submissions and regulatory interactions across the U.S., EU, and Japan.

Our Team

Meet our experienced drug Development Professionals.​