• 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.