Rutul Patel

Experience

• 

  International Society for Pharmacoeconomics and Outcomes Research (ISPOR)

  Jun 2017 - Jun 2018

  SECRETARY STUDENT CHAPTER

  ISPOR KSV KBIPER STUDENT CHAPTER, GANDHINAGAR

• 

  G M E R S MEDICAL COLLEGE, GANDHINAGAR

  May 2018 - May 2019

  Clinical Pharmacist Intern

  * Performing ward round in collaboration with other health care professionals.* Patient’s history collection and patient counselling.* Medication Order Review* Drug therapy designing and dose adjustment.* ADR monitoring* Medication Adherence and Compliance check* Monitoring and detection of drug resistance. * Any other duties as delegated by mentor/guide/HOD.

• 

  Lambda Therapeutic Research

  Jun 2019 - Feb 2023

  * Provide scientific inputs in providing feasibilities of study designs on different Product for BA/BE & Clinical Trial studies* Coordinating with internal departments and other stake holders for handling sponsor queries and provide technical feasibility of study conduct* Provide pharmacokinetic inputs/write-up in designing of clinical study protocols for BA/BE & Clinical Trial studies.* Review Pharmacokinetics aspects of BA/BE, Clinical Phase I, II and III protocols and Clinical reports.* Provide literature support in clinical studies* Prepare the Comprehensive Summary - Bioequivalence report (CS-BE).* Support technical discussion with valid scientific justifications with the sponsor and resolve study related queries / regulatory queries.* Conducting pharmacokinetic meta-analysis/additional analysis of studies to provide technical advices and support to sponsor for complex formulations and their regulatory acceptability.* Review of preliminary results of the clinical studies and corroboration of study outcomes with the historical studies and the literature citations. Also ensuring the study outcomes are presented in compliance to the desired regulatory submissions across globe.* Preparation of results of PK analysis in line with protocol, SOPs and Guidelines.* Conducting in-silico modeling viz simulations, IVIVC, Pop PK analysis and other modellings to support sponsors with their clinical development of projects.* To ensure functionalities following OECD GLP principles and ensure its compliance.* Any other responsibilities as assigned by the Head of the Department/ Management. Show less * Provide scientific inputs in providing feasibilities of study designs on different Products for BA/BE studies and clinical trials* Provide pharmacokinetic inputs/write-up in designing of clinical study protocol* Review the clinical BA/BE, Clinical Phase I, II and III protocols and Clinical reports* Provide literature support in clinical studies* Prepare the Comprehensive Summary - Bioequivalence report (CS-BE)* Support technical discussion with valid scientific justifications with the sponsor and further resolve study related queries / regulatory queries.* Coordinating with internal departments for handling sponsor queries for preparing feasibility of study conduct* Conducting pharmacokinetic meta-analysis of studies and to provide technical advices and support to sponsor for complex formulations.* Review of preliminary results of the clinical studies and corroboration of study outcomes with the historical studies and the literature citations.* Preparation of results of PK analysis in line with protocol, SOP's and Guidelines.* Conducting in-silico modeling viz simulations, IVIVC, pop PK analysis and other modellings to support the projects.* To work as per OECD GLP principles and ensure its compliance.* Support preparation, training and implementation of SOPs for GLP compliance. Show less

  • Senior Technical Officer - Pharmacokinetics

    Apr 2021 - Feb 2023

  • Technical Officer - Pharmacokinetics

    Apr 2020 - Mar 2021

  • Technical Associate - Pharmacokinetics

    Jun 2019 - Apr 2020
• 

  Labcorp Drug Development

  Feb 2023 - Jun 2023

  Clinical Pharmacokineticist

  * Liaise with the relevant bioanalytical departments over the transfer and quality of PK and PD data.* Fulfill the role of a study Pharmacokineticist:• Responsible for PK(/PD) deliverables within assigned projects.• Review draft protocols for allocated studies to ensure they meet the Sponsors requirements in terms of PK(/PD) analysis and study objectives.• Responsible for development of PK(/PD) Analysis Plans, to include methodology, definition of derived variables, and data-handling rules.• Conduct or review/QC interim PK(/PD) analyses, interpret the data, and attend dose escalation teleconferences to support dose progression in allocated studies.• Conduct or review/QC non-compartmental PK and PD analyses as specified in the report and analysis plans.• Conduct modeling/simulation of PK, PD, and PK/PD data and provide interpretation of the results.• Responsible for PK(/PD) input to reports including Clinical Study Reports.• Independent peer review of PK and PD deliverables (e.g., protocols, Analysis Plans, PK reports, Clinical Study Reports).* Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP.* Contribute to review and amendment of departmental processes and supporting documentation. Provide PK input into other disciplines’ activities and participate in interdepartmental processes.* Represent Pharmacokinetics in internal and external audits.* Perform other duties as requested by management. Show less

• 

  Fortrea

  Jul 2023 - now

  Clinical Pharmacokineticist

  Formerly known as Labcorp Drug Development* Liaise with the relevant bioanalytical departments over the transfer and quality of PK and PD data.* Fulfill the role of a study Pharmacokineticist:• Responsible for PK(/PD) deliverables within assigned projects.• Review draft protocols for allocated studies to ensure they meet the Sponsors requirements in terms of PK(/PD) analysis and study objectives.• Responsible for development of PK(/PD) Analysis Plans, to include methodology, definition of derived variables, and data-handling rules.• Conduct or review/QC interim PK(/PD) analyses, interpret the data, and attend dose escalation teleconferences to support dose progression in allocated studies.• Conduct or review/QC non-compartmental PK and PD analyses as specified in the report and analysis plans.• Conduct modeling/simulation of PK, PD, and PK/PD data and provide interpretation of the results.• Responsible for PK(/PD) input to reports including Clinical Study Reports.• Independent peer review of PK and PD deliverables (e.g., protocols, Analysis Plans, PK reports, Clinical Study Reports).* Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP.* Contribute to review and amendment of departmental processes and supporting documentation. Provide PK input into other disciplines’ activities and participate in interdepartmental processes.* Represent Pharmacokinetics in internal and external audits.* Perform other duties as requested by management. Show less