Founder and Principal Consultant
Aniruddha Amrite is a strategic leader in drug development with over 17 years of industry experience. Dr. Amrite has contributed to the development and approval of five commercially available drugs across diverse therapeutic areas, including oncology, rare diseases, and CNS. He has extensive expertise in clinical pharmacology, DMPK, and the application of modeling and simulation in drug development. His leadership roles include heading clinical pharmacology teams, developing strategies for small molecules, mAbs, ADCs and RNA-based therapies, and engaging with global regulatory agencies to drive successful IND/CTA filings and drug approvals.
David McDougall possesses extensive expertise in drug development, utilizing pharmacokinetic, pharmacodynamic, and exposure-response modeling to inform strategic
decision-making. He has successfully managed pharmacometric analyses for multiple NDA/BLA submissions and has extensive experience collaborating with regulatory agencies, including the FDA, EMA, and UK MHRA.
Highly proficient in pharmacometrics and statistical software, David is skilled in using tools such as NONMEM, PsN, R, RMarkdown, and Berkeley Madonna. He excels at producing submission-quality, reproducible pharmacometric reports using LaTeX.
With over 10 years of clinical experience across various therapeutic areas in major teaching hospitals in Australia and the UK, he has a strong ability to contextualize modeling and simulation solutions within clinical frameworks. He effectively communicates technical analyses to decision-makers in clear, accessible language.
Principal Consultant
Biplab Das is a skilled and accomplished DMPK/ Safety Toxicology/Clinical Pharmacology scientist with over 25 years of pharmaceutical industry experience. Dr. Das has been involved in various DMPK roles across drug discovery and development with both strategic and hands-on scientific contributions. He has experience in pre-clinical and clinical development of different modalities including small molecules, mAbs, ADCs , and siRNA therapeutics. He has wide experience in bioanalysis and has supported ADME analyses in a range of therapeutic areas .He has extensive experience in all DMPK related studies including PK profiling, pharmacological response exposure relationship, mass balance, metabolite profiling, QWBA, DDI assessment. He has been involved in 5 successful NDA applications and many successful IND applications
Winn is a formally trained clinical pharmacist with more than 10 years of experience in pharmacokinetics and pharmacodynamics modeling. He received his PhD from the University of Strathclyde in Glasgow, UK. He continued his post-doctoral training with the Pharmacometrics Research Group at Uppsala University focusing on novel in vitro methodologies utilizing various pharmacometrics approaches to predict optimal drug dosing combinations. In 2018, Winn joined a private consulting firm, Model Answers, specializing in using model-based analysis to support all phases of preclinical and clinical drug development. Winn recently served as Associate Director at Parexel where he worked with numerous biotech and pharmaceutical companies encompassing various clinical indications and therapeutic areas such as infectious disease, oncology, immunology, and rare diseases. His expertise includes clinical population pharmacokinetics (POPPK)/ pharmacodynamic modeling (PD), first-in-human (FIH) dose selection, and mechanistic modeling using a variety of pharmacokinetic applications including NONMEM, R, WinNonlin, and others.