CURRICULUM VITAE

VENKATA GANGADHAR.V
CONTACT: +91 -7378845675 EMAIL: venkatagangadharvanteddu@gmail.com

A dynamic & result-oriented professional with exceptional expertise of 7+ years in Non-Clinical

safety Studies – Regulatory and Investigate ♦ Drugs, Chemicals and Medical devices
Development and Risk Assessment ♦ Hazard Characterization and Classification.

PROFILE SUMMARY

 Technically astute, diligent & passionate with an experience of over 7 years in regulatory
toxicology, currently spearheading with Mankind Research Centre, IMT Manesar,
Gurgaon as Senior Research scientist- NDDR Department.
 Conceptualizing, developing, conducting, controlling & reporting safety studies of
pharmaceuticals, chemicals and medical devices to meet international (USFDA/ICH,
OECD, ISO, FIFRA (OCSPP), WHO, EMA, MHRA, PMDA/MHLW, GHS, CLP and
REACH) & national (DCGI) regulatory requirements in a role as Study
Director/Monitoring Scientist.
 Identification of potential pharmaceutical and biological leads through investigative
toxicology studies.
 Experience in scientific literature searching and data analysis of different type of toxicity
studies, compiling monographs, product summary tables, processing Toxicology
Assessment Reports.
 Working and handling experience in Quality Systems like OECD & FDA current Good
Laboratory Practice (cGLP), current Good Clinical Practice (cGCP), current Good
Manufacturing Practices (cGMP), ISO and AAALAC.
 Adept in literature searching using various databases (PCPC, EFSA, TOXPLANET,
EMBASE, TOXNET, PUBCHEM, PubMed/MEDLINE, NTP, SCOPUS, NLM, EPA,
ScienceDirect, and NATURE).
 Proficient in regulatory affairs to support the development of new cosmetic, nutritional
and medical products.
 Conducting risk assessment & biological qualification of
pharmaceuticals/impurities/residual solvents/ingredients/active chemicals in relation to
human exposure and safety considerations.
 Preparation of toxicological monographs for PDE (permitted daily exposure) & OEL
(occupational exposure limit) for pharmaceuticals and impurities as per ICH guidelines.
 Expert on animal (rodents and non-rodents) handlings, dosing techniques, blood
1
 collection, surgeries and formulation strategies.
 Hands on experience on preparation of the safety data sheets (SDS) and other safety
related protocols.
 Proficient in preparation of clinical demographics, clinical trial protocol, information
brochures (IB) and Summary of Product Characteristics (SPC/SmPC).
 Proficient in drug and Device approval pathways- BLA, IND, PMA, PMN (510K) NDA- 505
(b) (1), 505 (b) (2) 505 (j) and EMA regulatory authorization.
 Practical working experience in CE marking of medical devices as per European Union
MEDDEV guidelines.
 Setting and controlling the budget for various non-clinical programs as per company and
project needs.

STRENGTHS

 Adaptive, organized, detail-oriented, motivated with excellent verbal, scientific writing

and presentation skills.
 Adept in fast-paced, multi-tasked, and result driven environment; strong decisive &
troubleshooting skills.
 Ability to conceptualize processes for product development with sophisticated quality
control measures in compliance with specified standards; performing root-cause analysis
to prevent reoccurrences & defective issues.
 Functional exposure to optimal utilization of available resources; versatile leader &
mentor, able to build teams, inspire & empower individuals to strive toward ever-higher
levels of achievement.
 Proactive & industrious, with a significant exposure to both collaborative & independent
research; high-performing professional with a reputation of un wavering accuracy &
consistently delivering results towards designing, coordinating & analyzing various
compounds and their outcomes.
 Sound knowledge in finding out the Effect Levels (EL’s: NOAEL, LOAEL, NOEL,
MTD/LD) and its extrapolation to First in Human Dose (FIH) from the cage by cage
toxicity studies approach.
 Proficient in Organ/compound specific toxicology with well-versed scientific literature
familiarity.

Toxicology platform:-

 Acute and subacute oral toxicity studies as per OECD guidelines.

 Acute and subacute intravenous toxicity studies.
2
  Acute, subacute and subchronic dermal toxicity and Skin irritation studies as per
OECD guidelines.
 Assays: Ames, Microneucleus Assay, Chromosome Aberrations Assay, Mouse
Lymphoma Assay, Comet Assay.

Pharmacokinetic platform:-

 Serves as a DMPK representative for service based DMPK studies.

 Design and oversee in-vivo mouse, rat and dog pharmacokinetic and tissue distribution
studies including dose range finding studies to support toxicokinetic studies.
 Evaluate metabolic pathways and prediction of possible metabolites and proposing the
structures of metabolites that are observed in microsomes / hepatocytes.
 Directly responsible for designing, executing and presenting with in a program (PK/PD).
 Prepare Nonclinical Pharmacokinetics and Bio pharmaceutics sections of IND for
regulatory submissions.

ORGANIZATIONAL EXPERIENCE
Mankind Research Centre, IMT Manesar, Gurugram, IN
Senior research Scientist- NDDR since May’2018

 Non-clinical subject matter of expert (SME) providing input on programs and studies,
including external partnerships and due diligence reviews in licensing and business
development opportunities.
 Designing, implementation and management of animal toxicology and biocompatibility
studies in compliance with cGLP standards.
 Strategizing, planning and reporting of pharmacology (efficacy) studies of
pharmaceuticals and biopharmaceuticals.
 Building a network of supporting CRO’s capable of delivering timely, high quality, and
cost-effective toxicology data for research and clinical programs.
 Execution of project outsourcing through the Confidential Disclosure Agreements (CDA),
Master Service Agreement (MSA) and Project Contract Documents (PCD).
 Selection, audit & qualification of potential CRO’s as per scientific & cGXP’s requirements.
 Management and Monitoring of non-clinical studies at the CRO’s as per company SOP’s
And ensuring the global regulatory/compliance requirements.
 Authoring the Non- clinical sections for IND, PMA, CTA, BLA, and NDA regulatory
submissions.
 Submitting and supporting the CE marking of devices as per European Union

3
 requirements.
 Preparation of Clinical Trial Protocols and Trial Investigator Brochures as per standard
demographics, regulatory, and ethical principles.
 Developing Clinical & Vigilance Standard Operating Procedures (SOP’s) and quality
standards.

SAI Life Sciences Ltd, Pune, IN

Research Associate Oct’15 – May’ 18

 Acted as the Study Director for carrying out the regulatory toxicology and efficacy studies
of NCE’s, Biopharmaceuticals and Pharmaceuticals in compliance cGLP.
 Strategize, conduct, and reporting of investigative toxicology studies of small molecules
and biologics to support the selection and timely development of potential drug candidate
through close interactions with other discovery toxicologists, and affiliated cross-
functional departments.
 Served as the study personnel in the conduct of carcinogenicity studies of NCE’s.
 Designing the risk assessment strategies through the identification of toxicological
pathways.
 PDE and related risk assessment documents for pharmaceuticals and chemicals.
 Developing animal ethical protocols for IAEC/CPCSEA approval as per the ethical and
AAALAC principles as a part of study conduct.
 Ensured and assisted the BD teams towards best client/sponsor KPI’s through proper
study execution.
 Functioned as the Auditee during in-house and regulatory audits.
 Developed SOP’s relevant from and formats as per cGLP quality system.
 Adhered to periodic calibration & maintenance of assigned equipments.

ADVINUS Therapeutics (a TATA enterprise), Pune, IN

Research Scientist – Preclinical Division April-2015 to Oct- 2015

 Acted as a Study Director for carrying out the regulatory toxicology and efficacy studies of
NCE’s, Biopharmaceuticals and pharmaceuticals in compliance cGLP.
 Strategize, conduct, and reporting of investigative toxicology studies of small molecules
and biologics to support the selection and timely development of potential drug candidates
through close interactions with other discover toxicologists, and affiliated cross-functional
departments.
 Designing the risk assessment strategies through the identification of toxicological
pathways.

4
  PDE and related risk assessment documents for pharmaceuticals and chemicals.
 Developing animal ethical protocols for IAEC/CPCSEA approval as per the ethical and
AAALAC principles as a part of study conduct.

 Functioned as the Auditee during in-house and regulatory audits.

 Developed SOP’s, relevant form and formats as per cGLP quality system.

 Adhered to periodic calibration & maintenance of assigned equipments.

SPHAERA Pharma Ltd., IMT Manesar, Gurugram, IN

Research Biologist-Dept. of Pre-Clinical Sep-2013 to Apr-2015

 Designed and developed rodent models for oncology xenograft models, pain and
inflammation models.
 Conducted Brennan surgeries & jugular/femoral vein cannulations as a part of efficacy &
pharmacokinetic studies.
 Rendered support in planning pharmacokinetic & pharmacodynamics studies.

Venus Medicine Research Centre, Baddi, IN

Executive Assistant- R&D Jun-2012 to Sep-2013.
 Served as the Study director/Study personnel in conducting the toxicology,
biocompatibility, safety pharmacology and pharmacopoeial studies as per national and
international regulatory requirements.
 Acted as a study personnel during the conduct of pharmacology and in-vitro genotoxicity
studies.
 Preparation of study plans and reports as per regulatory compliances.
 Adhered to cGLP standards during the conduct of various studies and ensured adherence
to the quality systems.
 Developed animal ethical protocol for IAEC/CPCSEA approvals.
 Designed appropriate SOP’S and relevant forms & formats.
 Functioned as the Auditee during in-house and regulatory audits.

EDUCATIONAL DETAILS

 Pursuing Ph.D. (Part-Time).

 2011: Masters in Pharmacology (M.Pharm) from The T.N Dr. MGR medical University,
Chennai with 76 percentage.
 2009: Bachelor of Pharmacy (B.Pharm) from Pondicherry Central University, Puducherry
with 7.5 CGPA.

5
 ACCOLADES

 Successfully conducted the safety evaluation of Novel Chemical entities and Biosimilars
which are in currently late clinical/marketing stages.

COMPUTER/SOFTWARE EXPOSURE

 Knowledge on winnonlin, Graphpad prism software.

 Packages: MS Office (Adept in excel, word, PowerPoint), Photoshop.
 Well acquainted in scientific data retrieval from various internet portals like Science Direct,
Pub Med, Scopus, Springer link, Wiley, Nature.

PERSONAL DETAILS
Father's Name : Ramalingam.V
Mother’s Name : Venkata Vijaya Lakshmi.V
Date of Birth : 15-06-1987
Gender : Male
Marital status : Married
Languages : English, Telugu, Tamil, & Hindi
Address : No-6, Varatharasanar Street, Ariyankuppam,
Puducherry- 605007.