Experience

PharmaPro Consulting

• United States
• Biotechnology Research
• 1 - 100 Employee

• Founder & CEO

  • Sep 2014 - Present

  Pharmaceutical Professional:Regulatory Affairs | Pharmacometrics | DMPK | Clinical Pharmacology Responsibilities: • Working with clients like Genentech, Roche, Daiichi Sankyo, GlaxoSmithKline, Mabion S.A. (Poland), ContraFect Corporation, SK Life Sciences, Rafael Pharmaceuticals etc. • Author the clinical pharmacology sections for submission to FDA, PMDA, SFDA, EMA, KFDA etc. which include - eCTDs modules 2.7.1 and 2.7.2 - Question-based Review (QbR) - Clinical study protocol - Clinical study reports (CSR) - Investigational New Drug (IND) Application - New Drug Application (NDA) - Pediatric Investigation Plan (PIP), - Pediatric Study Plan (PSP) - Orphan Drug Designation application (ODD) - Breakthrough Therapy Designations application • Help address questions relating to Clinical pharmacology, PK, PK/PD and POPPK from various regulatory agencies across the world. • Developed strategy and execute clinical pharmacology plans, PIP Binding elements and PSP plans • Serve as clinical pharmacology project leader & provide scientific leadership on Biologics, ADC’s and combination therapies, in oncology, immuno-oncology, diseases with unmet medical needs etc. • Based on project needs conduct hands on PK, PK/PD analysis, conducted QC-QR of IB’s, CSR’s, health authority submission documents. • Participate in due-diligence and in-licensing activities. Show less



Project Dontabhaktuni

• United States
• Higher Education
• 1 - 100 Employee

• Founder & Scientific Director,

  • Jul 2019 - Present

  This is nonprofit organization created to support upcoming scientists from around the world in field of drug development and other healthcare related fields. The objective of this project is to guide them and empower them in achieving their carrier goals, By providing them free workshops/trainings and giving them access to mentoring programs. Our goal is to match the mentors to the mentee based on what mentee’s are seeking to learn and what mentor can offer based on mutual areas of interest, educational background/training and time of availability. Show less


University of the Pacific - Thomas J. Long School of Pharmacy
• United States
• Higher Education
• 1 - 100 Employee
• Adjunct Professor

  • Aug 2021 - Present

International Society of Pharmacometrics
• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• ISoP Communications Committee (Volunteer)

  • Jan 2021 - Present


American Society for Clinical Pharmacology & Therapeutics

• United States
• Non-profit Organizations
• 1 - 100 Employee

• ASCPT Biologics Community Chair (Volunteer)

  • Apr 2021 - Present

• ASCPT Early Career Steering Committee Member (Volunteer)

  • Apr 2021 - Present


Eli Lilly and Company
• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Director, Global PKPD and Pharmacometrics

  • Mar 2012 - Aug 2014


ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company

• Biotechnology Research
• 200 - 300 Employee

• Associate Director Clinical Pharmacokinetics

  • Jan 2010 - Feb 2012

• Senior Scientist Pharmacokinetics

  • 2008 - Jan 2010


Astrazeneca
• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Scientist Pharmacokinetics

  • 2007 - 2008

Long Island University
• United States
• Higher Education
• 700 & Above Employee
• Research Fellow

  • Apr 2003 - Jun 2006

SFBCI Pharmanet
• Senior Scientist, Clinical Pharmacokinetics

  • 2006 - 2006

Forest Laboratories Inc
• Research Fellow

  • 2003 - 2003

Novartis
• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Research Fellow

  • 2002 - 2002