MANU M. R. M.Sc

Pashan, Pune, Maharastra, India, Phone no: +91-992*******,

E-mail: adif7j@r.postjobfree.com

Objective:

To integrate my professional skills to drive emerging concepts of toxicology for a challenging and enriching journey leading to value additions to the organization.

Academic Qualification:

Post-Graduation Degree M.Sc. (Bio-Technology, 2007)

Institution : Indian Academy Centre for Research & Post Graduation Board : Bangalore University

Post-Graduation Degree, M.B.A. (Project Management, 2013)

Board : Sikkim Manipal University

Work Experience:

Working as Research Scientist in the Department of Drug Safety Assessment at Lupin Limited, Pune, India (From Dec 2016 to Nov 2020).

Worked as Senior Research Officer in the Department of Toxicology at Glenmark Pharmaceuticals Limited, Navi Mumbai, India (From July 2011 to Dec 2016).

Worked as Associate Research Scientist in the Department of Safety Assessment (Toxicology) at Advinus Therapeutics Limited, Bangalore, India (From September 2007 to July 2011).

Role and Responsibilities:

Study Director- Preclinical GLP toxicity studies.

Responsible for completion of assigned projects and timely delivery of reports with utmost quality.

Critical analysis and evaluation of toxicology studies for deriving appropriate decision in safety assessment.

In-charge of small animal experimental zone and clinical pathology laboratory.

Leading a team of 5 toxicologists with involvement in recruiting, training and assigning roles and responsibilities to team members team members

Technical Standing:

General Toxicology (As Study Director):

Study plan preparation, data compilation, report preparation according to FDA, ICH, Schedule- Y and OECD guidelines.

Coordinating and conducting acute, sub-acute and chronic exploratory and general toxicology studies in rats, mice and hamsters

Coordinating and conducting metabolic and tissue distribution studies in rats using radio labeled test item to find out absorption, distribution and excretion pattern.

Coordinating and conducting 3T3 Neutral Red Uptake (NRU) Phototoxicity Assay in Balbc 3T3 Cells and Immunotoxicity assay in PBMC.

Preparation and review of SOPs and formats required for the studies/experiments to be conducted.

Data mining and scientific data retrieval for toxicity literature and studies by using Toxplanet, Toxnet, OECD, IUCLID Data set, US FDA; Drugs@FDA, Medline, PubMed, Pubchem, ECHA etc.

Coordinating and providing summary of all the non-clinical safety data to CDM for phase- I trial approvals as per the regulatory requirements with appropriate references.

Writing drug monographs, assessment of Permissible Daily Exposure (PDE) and Occupation Exposure Limit (OEL).

Writing and reviewing Investigator's Brochure (IB) (non-clinical toxicology part)

Proficiently handling PROVANTIS modules for real time online data capturing.

Statistical Analysis:

Capturing and compilation of the data from the respective analysis. The statistical analysis of the experimental data will be carried out using the validated package in Excel and analyzing of data using validated software called SYSTAT version12.0, GRAPHPAD PRIM for the statistical analysis.

Analyzing the data and plotting the data to check dose response curves in preclinical and clinical safety studies.

Statistical interpretation for the summarized data.

Techniques Known:

Dosing routes: Oral, Intra-peritoneal, Subcutaneous, Intra-venous and Intra-muscular in rodents (rat mouse, hamsters etc.).

Blood collection: Orbital plexus and Tail vein puncture and (rat and mouse), Jugular vein (rat) Ear vein (rabbit), saphenous vein (guinea pig) and Cephalic vein (beagle dogs).

CSF collection: Rats, Guinea pigs and hamsters.

Necropsy: Collection and fixation of tissues from rats, mice, rabbits, hamsters and dogs in regulatory toxicity studies, perfusion fixation for Neurotoxicity Studies.

Histotechnique: Trimming, processing, paraffin embedding and sectioning of tissues using automatic instruments and manual methods.

Staining technique: Hematoxylin & Eosin staining, application of special stains like Immunohistochemistry (IHC), PAS, Masson trichrome, Gomori’s & Oil red O staining techniques to demonstrate different cellular components.

Clinical Pathology:

•Analyzing the blood samples for Hematology (ADVIA 2120, Beckman Coulter),

•Clinical chemistry (Hitachi 902 and/or RXL MAX DIMENSION, Randox Daytona)

•Coagulation parameters (START 4)

•Manual slide preparation and reading DLC and Reticulocyte count

•Analyses of rodent and non-rodent urine samples using Clinitek urine analyzer.

•Conducting ELISA for quantitative determination of hormones like Prolactin, FSH, LH, Testosterone, Troponin-I, C-reactive protein etc., in serum and plasma (using BIORAD micro plate washer and reader).

Reproductive toxicity studies:

•Knowledge of regulatory type reproductive toxicity studies

•Collection of sperm sample from vas deference to analyze the motility of live sperms

•Preparation of sperm smears for sperm morphology analysis

•Preparation of stains for non-gravid uterus to confirm the pregnancy (ammonium

•Sulphate staining).

•Testicular and cauda epididymal sperm count and homogenization resistant testicular spermatid counts in rat.

Accomplishments:

Standardization of dose range finding (DRF) embryo-fetal developmental toxicity study in rabbits.

Standardized and validated testosterone and other male fertility endpoint tests in rats.

Standardized and validated Kidney injury markers in rats using MILLIPLEX® Multiplex Assays Using Luminex®

Validation of an Adrenal Cortical Function Assay with Adrenocorticotrophic Hormone Challenge in Sprague Dawley Rats.

Standardized and validated in Immunotoxicity and Phototoxicity studies.

Strength and ability:

An overview on drug regulatory affairs like, quality, safety and efficacy of dossier determination from preclinical and clinical data.

Knowledge on the preparation and compilation of preclinical common technical data for submission to regulatory authorities.

Knowledge on Preparing 510(K) and nonclinical summary reports of medical devices as per FDA requirements.

Reproductive toxicity studies

Knowledge on ScheduleY and IHC guidelines.

Basic knowledge REACH and Ecotoxicology testing

Fast learner on any usage and handling of software

Good at instrument handling and troubleshooting skills.

Training &Workshop:

Attended Workshop on PK-PD Modelling approach using Phoneix Winnonlin (July 2017)

Attended Sensitization Workshop on GLP, conducted by NGCMA (May, 2017)

Attended Sixth conference of Society of Toxicologic Pathology –India (Oct, 2016)

Attended Workshop on comprehensive toxicology (Jul, 2015)

Attended Preclinical GLP Study Director veterinary collage, Bangalore (Oct, 2012).

Participated Quality Control and Trouble Shooting techniques training program organized by Randox India.

Yearly internal training on Good Laboratory Practice (GLP) by Dr. Natesan, Advinus, Bangalore.

“Designing Right QC” strategies to assure the Quality of Patient results organized By

BIORAD at St.John medical college, Bangalore.

Undergone training on SYSTAT version 12.0,year -2007

Undergone training on Graph pad prism version 4.0,year-2008

Awards Received:

Year

Title

Awarded By

2010

Insta award

Adivnus Therapeutics Limited

2013

Spot award

Uexcel-Glenmark Pharmaceuticals limited

2013

Business Excellence award

Uexcel-Glenmark Pharmaceuticals limited

2014

Spot award

Uexcel-Glenmark

Pharmaceuticals limited

2016

Business Excellence award

Uexcel-Glenmark

Pharmaceuticals limited

2019

Value Ranger award

Lupin Limited

References:

Dr. Venkatesha Udupa

Vice president, Glenmark Pharmaceuticals Limited, Mumbai

Email: adif7j@r.postjobfree.com

Mobile Number: +91-981*******

Dr. Srinivasa Honnegowda

Head - Global Preclinical and Product Safety, Innovation & Development, Abbott Healthcare Pvt Ltd

Email: adif7j@r.postjobfree.com

Mobile Number: +91-983*******

Declaration:

I hereby declare that the information furnished above is true to the best of my knowledge and belief

Thanking you.

Place: Pune

Yours faithfully,

Manu M R

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