Venkata Gangadhar Vanteddu
Ariyankuppam
Summary
- Technically astute, diligent & passionate with an experience of over 13 years in non-clinical and regulatory affairs currently spearheading with TATA ELXSI, Pune, as Subject Matter Expert.
- All elements of a non-clinical pharmacology end-to end cross functional, integrated asset plan to include scope, budget, timeline, resources, and risks that translate the strategy into operational objectives in close partnership with the multiple departments and provide technology and domain expertise for biological scientific teams that enable in silico, in vitro and in vivo experimentation.
- Non-clinical subject matter of expert providing input on programs and studies, including external partnerships and due diligence reviews in licensing and development opportunities.
- Collaborate with the functional areas like global patient safety, PK/PD, ADME, Statistics in the development of methods for assessing special clinical safety pharmacology studies.
- Expertise in collecting the scientific data by using the development of AI/ML capabilities for the entire research. Monitoring performance vs. plan and leading appropriate control processes.
- Planning and operational input into discovery biomarker and platform validation opportunities.
- All post submission regulatory interactions in regards to the safety information, responses and post-approval commitments made, in addition to long-term support for the compound.
- Collaborating with their cross-functional partners and teams to lead the planning and delivery of an asset strategy and executable plan.
- Develop and Write Trial Protocols; locate and assess the feasibility of sites.
- Conceptualizing, developing, conducting, controlling & reporting safety studies of pharmaceuticals, chemicals and medical devices to meet international (USFDA/ICH, OECD, ISO, FIFRA (OCSPP), ISO10993, WHO, EMA, MHRA, PMDA/MHLW, GHS, CLP and REACH) & national (DCGI) regulatory requirements in a role as Study Director/Monitoring Scientist.
- Review & compilation of Dossier (CTD/eCTD) as per regulatory guidelines.
- Identification of potential pharmaceutical and biological leads through investigative studies.
- 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 (TOXNET, PUBCHEM, PubMed/MEDLINE, NTP, SCOPUS, NLM, EPA, ScienceDirect, and NATURE).
- 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.
- Hands on experience on data analysis, preparation of the safety data sheets (SDS) and other safety related protocols.
- Proficient in drug and Device approval pathways-BLA, IND, PMA, PMN (510K), NDA- 505 (b) (1), 505 (b) (2) 505 (j), ISO10993 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.
- Responsible for end-to-end management of regulatory submissions including Planning, module 1, 2 & 3 authoring/review/publishing & dispatch.
- Deliver a dossier that meets the technical requirement (such as but not limited to eCTD, NeES, SEND and Paper) and regional/local regulatory requirements for which the submission is targeted (the Asia Pacific, Australia/New Zealand, Africa - Middle East, Europe, East Europe, Latin America and the United States). Regulatory submissions for devices, small molecules and NCE’s for End-to-End in the development R&D.
- Maintains critical regulatory information relating to assigned submissions within required systems and to required standards. and timelines. technical guidelines to produce business requirements and ensure that those requirements are implemented where appropriate at local level.
Overview
13
13
years of professional experience
2024
2024
years of post-secondary education
4
4
Languages
Work History
Subject Matter Expert and Team Lead (Non-Clinical)
TATA Elxsi
06.2021 - Current
Lead Scientist- R&D (Pre-clinical and Regulatory Operations), Business Development
Ribosome Research Centre Pvt Ltd.
06.2019 - 05.2021
Senior research Scientist- NDDR (Pre- clinical, Clinical Operations and Regulatory Toxicity)
Mankind Research Centre
05.2018 - 06.2019
Research Associate- Pre-Clinical Division
SAI Life Sciences Ltd
10.2015 - 05.2018
Research Scientist – Preclinical Division
ADVINUS Therapeutics (a TATA enterprise)
04.2015 - 10.2015
Research Biologist- Dept. of Pre-Clinical
SPHAERA Pharma Ltd.
09.2013 - 04.2015
Executive Assistant- R&D (Pre-clinical and Medical Affairs)
Venus Medicine Research Centre
06.2012 - 09.2013
Education
MBA - Operational Management
Bharathidasan University
Ph.D. - Pharmacology
Chandigarh University
Masters - Pharmacology
The T.N Dr. MGR medical University
Bachelor of Pharmacy - undefined
Pondicherry Central University
M.Sc. - Data Science
KARE
Tamilnadu 07.2024 - Current
Skills
- Non-Clinical, ADME, PK/PD, Toxicology and Safety Studies
- In-Vitro, In-Vivo and In-Silico methods for the Drug Development
- Regulatory and Investigative
- Risk Assessment
- Development of AI/ML capabilities
- Scientific Data Operations
- Team Handling
- Project Management Skills
Accomplishments
- Successfully conducted the safety evaluation of Novel Chemical entities and Biosimilars currently in late clinical/marketing stages
- 2 oncology molecules are in phase-2 trials
- 4 Australian and 1 German Patents filed
Personal Information
- Date of Birth: 06/15/87
- Gender: Male
- Marital Status: Married
Computer Software Exposure
- Clinical SAS
- NONMEM
- MONOLIX
- Winnonlin
- R
- OMICS
- MedDRA
- Graph pad prism software
- DICOM
- Power BI
- Automation
- MS Office (Excel, Word, PowerPoint)
- Photoshop
- Scientific data retrieval from various internet portals (Science Direct, Pub Med, Scopus, Ovid, Embase, Springer link, Wiley, Nature)
Timeline
M.Sc. - Data Science
KARE
07.2024 - Current
Subject Matter Expert and Team Lead (Non-Clinical)
TATA Elxsi
06.2021 - Current
Lead Scientist- R&D (Pre-clinical and Regulatory Operations), Business Development
Ribosome Research Centre Pvt Ltd.
06.2019 - 05.2021
Senior research Scientist- NDDR (Pre- clinical, Clinical Operations and Regulatory Toxicity)
Mankind Research Centre
05.2018 - 06.2019
Research Associate- Pre-Clinical Division
SAI Life Sciences Ltd
10.2015 - 05.2018
Research Scientist – Preclinical Division
ADVINUS Therapeutics (a TATA enterprise)
04.2015 - 10.2015
Research Biologist- Dept. of Pre-Clinical
SPHAERA Pharma Ltd.
09.2013 - 04.2015
Executive Assistant- R&D (Pre-clinical and Medical Affairs)
Venus Medicine Research Centre
06.2012 - 09.2013
Ph.D. - Pharmacology
Chandigarh University
Masters - Pharmacology
The T.N Dr. MGR medical University
Bachelor of Pharmacy - undefined
Pondicherry Central University
MBA - Operational Management
Bharathidasan University
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