Vishal Pathade Email & Phone Number

Hyderabad, Telangana, India

Hyderabad, Telangana, India

Bangalore

As part of Organisations strategic decision, I have been internally transferred from Naari Pharma (as Project Manager in Clinical operations) to Strides Arcolab in Medical Affairs department in Clinical QA/QMS team.

Noida Area, India

Handling Project deliverables from Clinical studies initiation perspectives. Played role of Project Management, Agreements (internal and external) and technical support when required.

Bangalore

Pre-formulation, in vivo Pharmacokinetics (PK) and Toxicokinetic (TK) report review

Pune, Maharashtra, India

Data interpretations and thorough review of all in Pharmacokinetic (PK) studies, report preparation of clinical candidate nominated (CCNs) for supporting IND filings. Writing scientific reports, review protocols and provide suggestions if required. Prediction of human PK parameters by using allometry and in vitro- in vivo extrapolations (IVIVE).PK modeling and simulations for PD study, human dose projections.Dermal PK and tissue distribution study.Review of study protocols and reports for studies such as acute and sub acute toxicity studies. Review of protocols and initial drafts for outsourced studies.Guide and support research project trainee, colleagues on recent activities.

Pune

Planning and execution of all nonclinical PK studies upon discovery working group request, investigational studies, studies to develop model. Including jugular and portal vein surgeries, Chronic bile duct surgery (BDC), intestinal perfusion, tissue distribution studies.Initiate and arrange discussion team for upcoming scientific topics.Organize journal club seminars for recent and relevant scientific articles and discuss among team of 20.Train newly joined colleagues, guide and support to research trainee, interns and fresher in team.

Pune Area, India

Promoted for active learning and key team member. Received and thoroughly accomplished all responsibilities handed over such as PK- in life phase, planning and execution of PK studies, portal vein cannulations in rodents for hepatocytes isolation. PK data modeling using Winnonlin, interpretation of PK data, in vitro-in vivo correlation for SAR, report preparation.Started maintaining IAEC protocols, Form B (approvals) and D (maintenance). Training to juniors and newly joined colleagues in terms of laboratory research activities.Support and guide team members to prepare and interpret scientific data on regular basis.

Pune Area, India

Started learning in vivo DMPK-preclinical group, grasped working knowledge and skills on rodents studies. Getting familiarized with research activity and work culture.

Academic In-charge for Regulatory body & Inspection Committees for conduct and functioning of Diploma & Degree level Pharmaceutical institutions such as, a) DTE (Directorate of Technical Education)- Compliance Report & Mandatory Disclosure b) MSBTE (Maharashtra State Board of Technical Education)- Academic Monitoring c) LAB Inspection e) AICTE (All India Council for Technical Education)- Compliance report & Mandatory Disclosure f) PCI (Pharmacy Council Of India)- SIF Report e) LIC (Local Inquiry Committee) report

Nagpur, Maharashtra, India

Master research project on herbal formulations from raw material and ingredients testing, formulation development, formulation testing and it's preclinical study.

Diploma In Regulatory Affairs, Regulatory Affairs, Distinction (75%)

M. Pharm, First Class With Distinction

B. Pharm, First Class

Hsc