Dr. Mullangi Ramesh -
Director - Pre-IND & Phase I
Dr. Mullangi has
completed his Ph.D. in Pharmacy and M.Pharm from Kakatiya
University.
Prior to joining us he
has worked with Dr. Reddy’s Laboratories Ltd, Hyderabad as
Director.
He was responsible for
Conceptualizing, Planning, Report generating and directing
the team towards meeting the discovery and development
project needs from Bioanalysis, Drug Metabolism and
Pharmacokinetic perspective of various therapeutic areas
viz., anti-diabetic, anti-cancer, anti-infective,
anti-obesity, COPD etc. He was responsible for preparation
of DMPK package portion for IB filing, IND filing, GLP tox
reports, writing and reviewing various outsourced
protocols (DMPK section), Regulatory submissions,
Non-confidential and confidential documents for the
prospective candidate drugs. He was leading multiple teams
towards project objectives, maintaining project
time-lines, participating/ presenting project progress
meetings, reviewing the CROs reports etc.
His core research areas
and expertise includes in Metabolism (in vitro and in
vivo) – Metabolic stability in various pre-clinical and
human liver microsomes, pre-clinical and human hepatocytes,
S-9 fractions, CYP phenotyping, CYP liability, UGT
phenotyping Metabolite identification and speculation of
metabolic pathway (pre-clinical and clinical) Method
validation and bioanalysis of various biological samples
(plasma, blood, serum, urine, feces and various tissues)
using LC-MS/ MS and HPLC using chiral and achiral columns
of pre-clinical and clinical studies Toxicokinetics, Mass
balance studies with radio-labelled compounds/ drugs,
Tissue distribution (with unlabelled and radio-labelled
compounds), Allometry scaling, PK-PD, Caco-2 permeability.
Lead NCE (new chemical entity) identification based on
pharmacokinetic and metabolism profile in pre-clinical
area and Pharmacokinetics optimization of NCEs for
enhanced oral bioavailability (prodrug and other
strategies). He has published 90 research articles and
review articles in various areas of drug metabolism and
pharmacokinetics (DMPK) and in method validations.
He has 98 papers and
presentations and 3 patents to his credit.
