JP

Dr. Jignesh Patel

Shree S. K. Patel College of Pharma Edu and Research, Ganpat University, Parul University, Certara University, Indian Institute of Public Health Gandhinagar, CBCC Global Research

ORCID iD 0000-0002-6056-8189

About

• Dr.Jignesh Patel is pharmaceutical scientist with having more than 20 years of experience in pharmaceutical research contributing to >100 therapeutic products in market treating >1 lakh patients every year.
• He has done his bachelor & master in pharmacy from L.M.College of Pharmacy (LMCP), and PhD in Pharmacology under the guidance of Dr.R.K.Goyal, Professor at LMCP and Ex-vice-chancellor of M.S.University, Vadodara. He has done various clinical pharmacology courses from NIH, USA.
• He had published >40 articles in various scientific journals indexed in Pubmed, Scopus etc.
• He has received many national and international awards of US$2200, Rs.131000, US$500 from UK, USA, Australia etc. for his research work and scientific publications.
• He had worked with India’s top pharmaceutical industry, Sun Pharma’s R & D Centre, Vadodara for 10 years as “In-charge of Phase 1 clinical trial unit with human pharmacodynamics lab”. Dr.Jignesh is pioneer of setting up India’s first phase 1 clinical trial unit of Sun Pharma in 2008. He is also the pioneer of setting up India’s dedicated first Phase 1 clinical trial unit & human pharmacodynamics labs of CBCC Global Research, India & USA in 2018.
• He has directly led clinical development of more than 10 New Medicines INDs for USFDA, more than 14 NDDS, 37 medical devices, 3 Biosimilars, 2 vaccines & more than 140 generic products for USFDA, EMA, MHRA and other regulatory market. During his early career, he has worked at various hospitals and has handled clinical trials of global pharma industries including Sanofi, GSK, Pfizer, BMS, Boehringer Ingelheim, J & J, Medtronic, AstraZeneca, Novartis etc. for global clinical trial in Europe and UK hospital sites.
• He has faced and cleared regulatory audits for clinical trials from USFDA, EMA, MHRA, CDSCO, ANVISA, Malaysia Regulatory Authority.
• Currently he is working as Professor, PhD Guide and Head: Clinical Research Department at Parul University.
• His areas of expertise include translational research, clinical development strategy designing and first-in-human clinical trials, SAD-MAD studies, thorough QT-QTc studies, human pharmacodynamics and various clinical pharmacology studies, design, conduct, analysis and interpretation of clinical trials of drugs, modified release formulations, NDDS, biologics, biosimilars, medical devices and vaccines to make "Go" or "No Go" decisions.

Employment

  • Shree S. K. Patel College of Pharma Edu and Research, Ganpat University Professor, PhD Guide & Industry Consultant
    2026 - Present
  • Parul University Professor, PhD Guide, Head & Industry Consultant
    2022 - 2025
  • CBCC Global Research Senior Director
    2018 - 2022
  • Sun Pharmaceutical Industries Ltd In-charge
    2008 - 2018
  • VIBGYOR Scientific Research Pvt. Ltd. (Now, have merged in CBCC Global Research) Manager
    2006 - 2008
  • Ganpat University Assistant Professor
    2002 - 2006
  • Sterling Hospitals Clinical Scientist
    2002 - 2004
  • Intas Pharmaceuticals (India) Intern Production Officer
    2000 - 2000

Education

  • Certara University Noncompartmental Data Analysis (NCA) in Pharmacokinetics
    2022 - 2022
  • Indian Institute of Public Health Gandhinagar Certificate in Research Methodology
    2013 - 2014
  • National Institute of Health Course in Clinical Pharmacology and Clinical Research
    2007 - 2020
  • National Cancer Institute Course on Human Participants Protection
    2007 - 2007
  • North Gujarat University PhD: Pharmacology
    2002 - 2006
  • L.M.College of Pharmacy M.Pharm.:Pharmacology
    2000 - 2002
  • L.M.College of Pharmacy B.Pharm.
    1996 - 2000

Projects & Funding

Projects & funding information is unavailable.

Publications (42)