Curriculum Vitae Toxicology
Curriculum Vitae Toxicology
VENKATA GANGADHAR.V
CONTACT: +91 -7378845675 EMAIL: [email protected]
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
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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
Toxicology platform:-
Pharmacokinetic platform:-
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
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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.
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.
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.
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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.
Developed SOP’s, relevant form and formats as per cGLP quality system.
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.
EDUCATIONAL DETAILS
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ACCOLADES
Successfully conducted the safety evaluation of Novel Chemical entities and Biosimilars
which are in currently late clinical/marketing stages.
COMPUTER/SOFTWARE EXPOSURE
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.