Vineeth Kumar

About Vineeth Kumar

Pharmacometrics, Population Pharmacokinetics modelling, PBPK, Hands on GastroPlus, NCA…

Experience

1. Manager - Pk Pd & Pharmacometrics

   Tata Consultancy Services

   Mar 2021 — Present

   Open-Source R Programming and Clinical Study ToolsNCA and compartmental PK modeling for Phase 3 clinical trial data using R.Bioequivalence and statistical analysis for pivotal Phase 3 studies using RLed PK data handling, visualization (TLFs), and created NONMEM input datasets from SDTM.Developed in-house R tools for NCA, BE assessment, and simulation of PK profiles.Designed and implemented population PK modeling strategies for clinical programs.2. Modeling & Simulation Strategy (GastroPlus)Conducted risk assessment and bio-complexity evaluations to identify critical bioavailability attributes (CBA).Recommended in-vitro techniques for predictive, bio-indicative testing.Built, validated, and evaluated mechanistic absorption PBPK models for 505(b)(2) and generic products.Provided regulatory support for SUPAC-related bio-waiver applications using PBBM modeling.3. Clinico-Regulatory SupportReviewed and interpreted clinical study PK data; authored PK sections of clinical study reports.Supported protocol synopses and clinical development planning.Drafted BCS-based bio-waiver justifications and PBPK model reports for regulatory submissions.

Education

• National Institute of Pharmaceutical Education and Research

  M. Pharm., Pharmaceutical Technology (Formulations)

  2011 — 2013

Skills

• Nmr
• Pharmaceutical Research
• 2 D- Nmr Techniques
• Dissolution
• Glp
• Drug Delivery
• Qbd and Doe
• Anda
• Pharmacokinetics
• Pharmacology
• Hplc
• Uv/Vis
• Doe (Design Expert Software)
• Pharmaceutics
• Drug Discovery
• Formulation
• Risk Assessment
• Clinical Research
• Regulatory Affairs
• Lifesciences
• Differential Scanning Calorimetry