Regulatory Affairs R D
Resume:
ARYA PRIYANKA
To excel in the activity involved by effective application of my skills and expertise and contribute my best to the growth of the organization with knowledge acquired overtime.
Pharmaceutical R&D (pre-clinical), Regulatory Toxicology, Toxicology Risk Assessment, Regulatory affairs, Medical Writing, Scientific data analysis.
S.No.
Description
Board/University
Year
CGPA/Percentage
1
M.S (Pharm.)
Regulatory toxicology
NIPER, Mohali
2014
8.88
2
B. Pharmacy
Osmania University, Telangana
2012
67.27% (first class)
3
Intermediate (10+2)
Board Of Intermediate Education, A.P
2007
90.0% (first class)
4
C.B.S.E. (10th)
Central Board of secondary Education
2005
75.2% (first class)
S.No.
Description
1
DABT Certified Toxicologist, Nov 09, 2023 to Dec 31, 2028.
2
Pharmacy Council of India, Registered Pharmacist.
3
Pursuing Part time PhD from KL University (Koneru Lakshmaiah), Vaddeswaram, Mangalagiri, Andhra Pradesh, India. (On going, currently in second year)
Topic: Integration of Regulatory Guidelines and toxicity data from Animal Toxicology Studies to derive Health Based Exposure Limits for Pharmaceutical Impurities based on Risk Assessment Principles of Toxicology.
WORK EXPERIENCE:
No of years worked
Company Name
Position Held
01 Apr 2023 –Present
Hetero Drugs, Hyderabad
Deputy Manager (Toxicologist)
22 July 2019 –30 Mar 2023
Hetero Drugs, Hyderabad
Assistant Manager (Toxicologist)
06 Oct 2018 – 21 July 2019
Hetero Drugs, Hyderabad (Client)
Freelancer Toxicologist
20 Feb 2017 - 05 Oct 2018
Imed Global Solutions Pvt. Ltd. Hyderabad Now Changed to Clinchoice Private Limited, Hyderabad Telangana
(Full time Employee for Johnson and Johnson)
Executive Toxicologist
01 April 2016 – 17 Feb 2017
Syngene International Ltd. Biocon Park
(Full time Employee for Baxter)
Associate Scientist
25 Aug 2014 - 31 March 2016
Syngene International Ltd. Biocon Park
(Full time Employee for Baxter)
Senior Research
Associate
Deputy Manager (Toxicologist) CDMA (Clinical Development and Medical Affairs)
Hetero Labs Limited, Hyderabad, India
(01 Apr 2023 – Present)
Total working Hours: (1 year 3 months)
Preparation/Calculation/Review of toxicological expert statements for cleaning validation of PDE and worker's safety OEL/OEB and LD50.
Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development of toxicology study data through close interactions with regulatory filing teams, and affiliated nonclinical and clinical development functions as necessary.
Design/Preparation/Review/Finalization of Preclinical study plan, study Reports etc. and oversee the conduct, interpretation, and reporting of regulatory toxicity studies.
Review of Study Plan, Study Report Review of Genotoxicity study like In-vitro Mammalian Chromosome Aberration Study.
Assistant Manager (Toxicologist) CDMA (Clinical Development and Medical Affairs)
Hetero Labs Limited, Hyderabad, India
(22 July 2019 – 30 Mar 2023)
Total working Hours: (3 years, 8 months)
Preparation/Calculation/Review of toxicological expert statements for cleaning validation of PDE and worker's safety OEL/OEB and LD50 Report (which includes through Literature search for both pre-clinical and clinical studies, interpretations of toxicology data, WOE of studies, Justification for selection of NOAEL, Derivation of NOAEL/LOAEL if not reported in literature, Pharmacokinetic data, Risk Assessment, Selection of Uncertainty factors, Calculation of PDE and OEL).
Safety and Risk assessment of Drugs/Metabolite/Impurities/Chemicals etc.
Providing PDE Reports for Drugs/APIs as per EMA Guideline.
Providing PDE Reports for Residual Solvents as per ICH Q3C (R8) Guideline.
Providing PDE values/Reports for genotoxic impurities as per ICH M7 Guideline.
Elemental Impurity Assessment as per ICH Q3D (R2).
Safety/Suitability of Excipients as per ICH Guidelines.
Qualification of Impurities in Parenteral Products/Injectables etc.
Providing Allowable Limits for Enzyme Contents in APIs, Upper Limits for Vitamins and Hormones, RfDs for Chemicals etc.
Apply the Literature Review and utilize tools such as Read-Across, Threshold of Toxicological Concern (TTC) and in silico data to assign the Occupational Hazard Category (OHC), Safety and Risk assessment and Determine the PDE/ADE for Intermediates in the Synthesis of APIs Drugs/Metabolite/Impurities/Chemicals etc.
Working on in-silico toxicity prediction tools by using DEREK Nexus/LHASA and Toxicity evaluation of impurities as per QSAR related Guidelines.
Risk Assessment of Chemicals for special populations like Children as per Paediatric Regulatory Guidelines.
Critically Evaluate Literature and Toxicology Reports/Summaries to generate various Risk Evaluation Documents to be implemented by EHS and Quality for APIs handled across the Hetero enterprise. These include: Occupational Health Categorization (OHC); Occupational Exposure Limits (OELs); Acceptable Daily Exposure (ADE)/Permissible Daily Exposure (PDE) and Safety Data Sheets (SDS).
Support Containment Strategies and Equipment Selection/Manufacturing Facility Selection by providing Toxicological input into the overall Risk Assessment process.
Interact across a Matrix Environment with multidisciplinary teams (Chemical Development, Drug Safety, Discovery, R & D, F R & D, A R & D, Quality, etc.) on Occupational Toxicology including advising MFG Plants on the Hazards and Handling Chemicals of F, R&D compounds.
Addressing the Queries of FDA, EMEA, Canada, QA audit on PDE/OEL/OEB/LD50 Reports on Cleaning Validation for Share Manufacturing Facilities.
Assisting F R & D, R & D, and Hetero MFG Plants/team/QA people for MACO Calculation and various strategies and queries at Manufacturing Facilities as per GMP Guidelines
Address and Resolve Toxicological issues arising in Drug/Formulation Development programs, and adequately assess the relevance of any toxicological findings to human safety.
Collaborate on design of investigative toxicity studies in support of F R & D compounds as needed.
Support the Evaluation, Toxicology interpretation and reporting of Regulatory Toxicity studies performed by external contract laboratories (CROs).
Remain updated with guidelines related to toxicology, cleaning and validation of pharma manufacturing plants, health based exposure limits etc.
Analyse and Communicate the Hazardous properties of Active Pharmaceutical Ingredients, Intermediates and other Chemicals to support the establishment of Safe Working conditions at Hetero Production Sites.
Support local colleagues/team mates/subordinates on questions that they may have related to hazardous substances.
Knowledge of OECD/FDA/EPA/OPPTS/NDCT 2019 guidelines for Preclinical Toxicity Studies.
Knowledge of various toxicology/ pharmacology/ clinical/ regulatory databases like TOXNET, ECOTOX, PubMed, e-Chemportal, clinicaltrails.gov, EFSA etc.
Knowledge of Dose Calculation/Conversion/HED Calculations from Animal study NOAELs etc.
Assisting MFG Plant scientists for Dose Calculation/Conversion/ NOAEL Conversion etc.
Assisting F R & D team by Sharing Literature on for Physico-Chemical properties of Drugs, like Solubility, Secondary dilution data, Isoform data and toxicokinetic data, Treatment Duration etc.
Assisting F R & D, R & D, and Hetero MFG Plants/Team by sharing Literature on Clinical Dose, Minimum Daily Dose, Maximum Daily Dose, BCS Classification for drugs etc.
Providing LD50/Minimum Lethal Dose, MTD, Acute toxicity data/Single dose toxicity data for drugs to Manufacturing plants.
Technical discussions with other Toxicologists of External CROs for PDE Reports (Indivirutus, Sugen, Vimta Labs).
Communicate Toxicity Study Results to Cross Functional Program Teams and provide Safety Risk Assessment/Mitigation Strategy.
Preparation and Review of Nonclinical Overview and Summary as a part of eCTD for Literature based
submission (Module 2.4 and 2.6).
Role: Toxicology Studies Monitoring Scientist
Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development of toxicology study data through close interactions with regulatory filing teams, and affiliated nonclinical and clinical development functions as necessary.
Monitoring Pre-clinical studies, conducted at external CROs.
Design/Preparation/Review/Finalization of Preclinical study plan, study Reports etc. and oversee the conduct, interpretation, and reporting of regulatory toxicity studies.
Review of Study Plan, Study Report Review of Genotoxicity study like In-vitro Mammalian Chromosome Aberration Study.
Support the evaluation, interpretation and reporting of regulatory toxicity studies performed by external contract laboratories (CROs).
Knowledge of OECD/FDA/EPA/NDCT 2019, India guidelines for preclinical toxicity studies.
Work closely with Study Director/Scientists within and outside toxicology function in executing various aspects of non-clinical safety studies.
Actively participates and Discussion with in CROs/Client communications, telecoms and e-mail communications. for smooth conduct of Non-Clinical Toxicology studies.
Discussion with Pre-clinical CROs to get quotation, toxicology services etc for Inhalation toxicology studies, Subcutaneous studies etc.
Making Decisions on test item quantity needed/Calculations etc. for conduct of pre-clinical toxicology studies and sharing that information to Hetero manufacturing plants.
Plan, Design, and Effectively Manage/Conduct and Oversee Designated Toxicology Programs necessary to support the selection and timely development of Potential Drug Candidates through close interactions with F, R & D Toxicologists, and affiliated Nonclinical and Clinical Development functions as necessary.
Coordinate Toxicological/Nonclinical Safety Evaluations of Drug/formulation Development Candidates locally and internationally with external contract laboratories, consultants, and development partners.
Role: Team Leader
Support colleagues/team mates/subordinates on questions that they may have related to toxicology related tasks and hazardous substances.
Ability to ensure that tasks within areas of responsibility are completed accurately in a timely manner.
Able to potentially lead a team of juniors to develop their skill to be self-sufficient and have high quality reports.
Working on share point of Hetero CDMA team, and to receive toxicology related tasks, analytical reports, COAs, product specifications of different pharma products from various Hetero production/manufacturing sites batch wise, then risk characterisation of those products and PDE calculations and deriving the safety of product and closing the requests in share point.
Preparation/Standardisation/Revision of the SOP for PDE/OEL/OEB/LD50 Reports.
Interviews for Medical Writing/Toxicologists/Pharmacologists/Pharm-D, Fresher's.
Conducting timely Training Presentation/Lectures to teammates on Toxicology/PDE/OEL/OEB/LD50/Literature Search/Toxicology principles/Risk Assessment.
Able to potentially lead a team of Juniors to develop their skill to be self-sufficient and have high Quality Reports.
Freelancer Toxicologist (06 Oct 2018 – 21 July 2019) (Client: Hetero Drugs) (9-months)
Preparation of PDE and OEL Report (which includes Literature search for both pre-clinical and clinical studies, WOE of studies, Justification for selection of NOAEL, Absorption data, Risk Assessment, Selection of Uncertainty factors, Calculation of PDE and OEL).
Executive Toxicologist
Imed Global Solutions Pvt. Ltd. Hyderabad (Full time Employee for Johnson and Johnson)
(20 Feb 2017-05 Oct 2018)
Total working Hours: (1 year 8 months)
Safety assessment of fragrances and flavours, RIFM (Research Institute of Fragrance Materials) Project.
(Repeat and DART systemic end point assessment; MOE assessment).
Preparation of PDE and OEL Report (which includes Literature search for both pre-clinical and clinical studies, WOE of studies, Justification for selection of NOAEL, Absorption data, Risk Assessment, Selection of Uncertainty factors, Calculation of PDE and OEL). Biocon Project.
Literature search and scientific data retrieval from various online databases for preparation of safety assessment report of the cosmetic ingredients and OTC products by using data bases like PCPC, Cosing, RIFM, Drugs@FDA.
Safety evaluation of various topical health care, cosmetic and consumer healthcare products.
Toxicology Risk assessment for raw materials and formulations for cosmetic applications including Margin of Safety calculations and approval of products.
Preparation of Raw Material Toxicology Profiles (RMTP) for raw materials.
Preparation of safety assessment reports for Raw material and their ingredients to aid in their
qualification for use in various consumer products.
Assessment of cosmetic products formulae at different stages of product development cycle and their margin of safety calculations.
Safety assessment of fragrances and flavors used in consumer products.
Risk assessment, Risk characterisation, Risk mitigation of Chemicals, Raw materials, Excipients.
Elemental impurity assessment, ICH Q3D.
Risk Assessment and MOS of OTC products like tablets, ointment, nasal sprays, mouthrinse, eye drops etc.
Clinical safety assessment of skin care cosmetic products.
Literature search and safety data (preclinical and clinical) collection for identified issues seeking toxicology and/or clinical safety (skin tolerance) support.
Literature review for hazard assessment of ingredients intended to be used in consumer and preparation of their toxicology profiles.
Assessment and approval of Fragrances and Flavors used in consumer products.
Assessment of skin tolerance of cosmetic ingredients and products from preclinical and clinical perspectives.
Review and Interpretation of clinical skin safety studies (patch test, phototoxicity, irritation and sensitization studies)
Safety assessments for impurities, degradants and products as per regulatory requirements.
Maintain documents via the product safety and compliance Jhonson and Jhonson SharePoint site.
Preparation of NCO_CCDS, for APIs.
Preparation of Nonclinical overview and summary as a part of eCTD for Literature based
submission (Module 2.4 and 2.6).
Associate Scientist
Syngene International Ltd. Biocon Park (Full time Employee for Baxter)
(01 April 2016 – 17 Feb 2017)
Total working Hours: (11 months)
Risk Assessment of EU Residual Solvents (IV, Renal and Nutrient Franchise products) in Medical Devices.
Working on various share points of client globally with analytical teams, QA teams to receive analytical reports, COAs, product specifications of different pharma products from various production/manufacturing sites batch wise, then risk characterisation of those products and PDE calculations and deriving the safety of product.
As a GLP study personnel conduct of repeat dose IV infusion study of Medical Devices in Rats. (eg: Peritoneal dialysis bag, tubings etc.)
As a Study personnel conduct of skin irritation and skin sensitisation, acute oral and dermal, repeat dose oral, dermal, subcutaneous, IV studies in Rodents, Guinea pig and Rabbits.
Preparation and Review of GLP Study plans and Study Reports and interpretation of the studies and deriving NOAEL, LD50 and Classifying test item according to GHS, CLP etc.
Training of new joinees on toxicology risk assessment projects.
Standardisation of the Regulatory Toxicology projects.
Senior Research Associate
Syngene International Ltd. Biocon Park (25 Aug, 2014-31 March 2016)
Total working Hours: (1 year, 7 months)
Regulatory Toxicologist
Worked on MSDS (Material Safety Data Sheet), Toxicology Section 11,
GHS/CLP Classification of Chemicals.
Toxicology Risk Assessment Project.
Chemical Assessment Project
Weight of Evidence (WoE) of Toxicology Studies.
Preparation of Preclinical Toxicity Summary Reports.
Derivation of PDE, OEL, and Margin of safety etc. for Extractables and Leachable, EU Residual Solvents, Elemental Impurities, Drugs in Shared Manufacturing Facilities etc.
Data mining and scientific data retrieval for toxicity literature and studies by using various online databases like:
Toxplanet/Expub; Toxnet
HSDB; DART; OECD SIDS; IUCLID Data set; US HPV Challenge Programme; NIOSH; OSHA; TSCA; SCOEL; IDLH; HAZ MAP; RTECS; NTP; CCRIS; JECFA; GENE TOX; CPDB; IARC; US FDA; Drugs@FDA; Medline plus.
ChemIDplus (for Chemical structure, Similar Structures, CAS No, SMILES etc.)
NLM; Pubmed; Pubchem; Chem spider.
ATSDR (Agency for Toxic Substances and Disease Registry) for MRL.
US EPA IRIS (Integrated Risk Information System) for Oral RfD and Inhalation RfC.
WHO for ADI.
ECHA (European Chemical Agency), REACH (Registration Evaluation Authorisation Restriction of Chemicals).
Scifinder.
Chemical book for CAS No., SMILES, Molfile etc.
Working on in-silico toxicity prediction tools by using Toxtree software, Druglikeness tool etc. (
Familiar with toxicology terminology, acronyms, and the concepts of routes of exposure, lethal doses, and exposure limits etc.
Familiar with toxicology endpoints like LD50, LC50, LDLo, TCLo, LC50, TD50, NOAEL, NOEL, LOAEL, LOEL, etc.
Familiar with FDA, OECD, ICH (Q3 A, B, C, D), GLP Guidelines, GHS Classification, CLP, Application of IND, NDA, Clinical trial studies and Biostatistics.
Actively participates in Client communications, telecoms and e-mail communications.
Role: Preclinical GLP Study Personnel
Worked as a Study Personnel in the conduct of in-vivo GLP/Non-GLP pre-clinical lab OECD regulated studies Acute Oral, Dermal, Eye and Skin Irritation studies, Chronic Dermal repeat dose toxicity studies, GPMT skin sensitisation studies in Rodents, Rabbits and Guinea pigs.
Preparation and Review of study plan, study reports, SOPs, Formats etc.
Function as Study Personnel/Deputy study Director for non-GLP and GLP toxicity studies and carry out all aspects of a GLP study from planning, conduct, reporting and archival.
Work closely with scientists within and outside toxicology function in executing various aspects of non-clinical safety studies.
Faced GLP Audit.
M.S. Pharma: Research Project: Cisplatin induced nephrotoxicity intervention of PARP inhibitors 3-Aminobenzamide.
Mini Project: Repeated dose 28 days oral toxicity of Butyl paraben and Propyl paraben in Female SD Rat GLP experience: Protocol writing, SOP designing and formatting maintaining regulatory documents related to animal housing, breeding, testing for inspections during mini project.
Participated in Toxgurukul Webinar Series -24th Lecture. Topic: Evaluating Safety of Botanical Dietary Supplements. Speaker: Dr. Cynthia, PhD, National Toxicology Program, USA, May, 2023.
Participated in Toxgurukul Webinar Series -26th Lecture. Topic: Safety Assessment of Vaccines. Speaker: Mukul Pore, MVSc, DABT, ERT. Founder Director, INTOX Labs, Aug 2023.
Participated in Toxgurukul Webinar Series -28th Lecture. Topic: Adversity, Reversibility, Translatability and Therapeutic Index in Non-Clinical Safety Assessment. Speaker; Dr. Shekar Chelur, MVSc, DABT, Senior Director, Toxicology, Surigene Oncology, Dec 2023.
Participated Free Webinar: Hosted By: SOT Carcinogenesis Speciality Section. Topic: Carcinogenomics-Assessing the Tumorogenic Potential of Chemicals through Genomic Biomarkers to Reduce the Reliance on the Rodent Cancer Bioassay, Date, Feb 23, 2024.
Participated in International Clinical Trials Day, 2023, Walk-a-thon, Jalavihar Water Park, Neckalace Road, Hyderabad.
Participated in the (IRISK 2016) Integrated Risk Information System Workshop on Extractables and Leachables by Dr.Shane Gadd.
Participated in the (IMIT-2017) “Interactive Meet on Insights in Toxicology” by Dr.K.S.Rao.
Spot Award for the Outstanding performance for preparation of Chemical Risk Assessment Documents.
Participated as a delegate in “5th International Symposium on Drug Metabolism and Pharmacokinetics” held at NIPER, Mohali.
Member of organizing committee in National Seminar, Pharma week and Sports meet held in RBVRR Woman’s College of Pharmacy, Telangana
Active participation in industrial tour to NATCO that took place in my college as part of our department’s activity.
Participated in Maths and Science Olympiads conducted at the school level.
Development of animal models.
Animal handling and Dosing (Oral, Subcutaneous, Intravenous, Intramuscular) in rodents, guinea pigs, rabbits etc.
Histopathology, Immunohistochemistry, Comet Assay, Micronucleus Assay and Biochemical Estimations.
Presented a poster on Nanotechnology and its applications on Pharmaceutical Dosage forms, 2011, AP.
Presented a poster on Role of Green Chemistry in Drug synthesis, National Conference on Recent Trends in Pharmaceutical Sciences A.P, 2011.
Presented a poster on Ocular Drug Delivery System in National seminar held at Sri Indu Institute of Pharmaceutical Sciences, Pharma Ignite 2012 A.P
Principles of Toxicology, Basic concepts of Toxicology and its significance in Pharmaceutical and Chemical Industry, Hetero Labs Limited, 2024.
OECD-407 Test Guideline, Repeat dose 28-day oral toxicity study in Rodents, Hetero Corporate Office, Sanath Nagar, 2023.
First in Human Dose, Based on NOAEL and MABEL Concept, Hetero Drugs Limited, 2023.
HBEL-PDE and OEL Derivation and Application in Cleaning Validation and OEB Banding Strategy, Hetero Research Foundation, 2022.
Effect of Drug induced Nephrotoxicity and Regulatory Consideration, 2012.
The value of Acute Toxicity Testing of Pharmaceuticals for estimation of Human Response 2011.
Presented seminar on Nanotechnology and its Pharmaceutical applications and won 1st prize at RBVRR Women’s College of Pharmacy.
MS Office (Word, Excel, Power Point), Reference management software (Endnote), Sigma Stat, Sigma Plot, Scientific data retrieval from various search engines.
Toxicology data bases like Toxnet, Expub, Scifinder, US EPA IRIS, ATSDR, WHO, ECHA etc.
Toxicity software like DEREK/SARAH/LHASA, Toxtree, Druglikenesss tool, Xybion Pristima-Electronic data capture system etc.
Date of Birth - Jan 18th, 1990
Mother’s Name - A. Veena
Languages Known - Proficient in English, Hindi and Telugu
Marital Status - Single
Skills and nature - Team Player, Time management, Perseverance, Agility and Inquisitive nature
Attribute - An unwavering passion towards the work is the key to success
I hereby solemnly declare that all the information provided here is as per the best of my knowledge.
Place: Hyderabad, India.
Arya Priyanka
Deputy Manager – Toxicology
M.S.Regulatory Toxicology, DABT
Mobile: 767*******; 888-***-**** (watsapp) Extn: 3686
Email: ********.****@******.***
Gmail: ****.**********@*****.***
32/2, IDA Balanagar Hyderabad, Telangana – 500 018
Hetero Corporate Office, Sanath Nagar
Inspiring human belief
in a healthier world.
www.hetero.com
Date: 18 Jul 2024
Permanent Address:
Arya Priyanka
D/O A.Gopal/A.Veena
H.No.9-1-224/7
Langur House, Prashanth Nagar,
Hyderabad 500008
Gmail Id: ****.**********@*****.***
Linkedin Profile: linkedin.com/in/arya-priyanka-33112b64
OBJECTIVE:
AREAS OF INTEREST:
ACADEMIC CREDENTIALS:
Professional Achievements:
DISTINCTIVE HIGHLIGHTS
EXPERIMENTAL EXPERTISE:
POSTERS PRESENTED:
SEMINARS DELIVERD:
COMPUTER PROFICIENCY:
PERSONAL DETAILS:
Dr. Mohan Krishnappa, DVM, MVSc, PhD, DABT
Vice President
Department of Safety Assessment and Toxicology
Biocon Park, SEZ, Bommasandra Jigani Link Rd, Phase-IV,
Bommasandra Industrial Area, Bengaluru, Karnataka 560099
Email: *****.**********@***********.***
Dr Mohan’s Profile
linkedin.com/in/dr-mohan-krishnappa-dvm-mvsc-phd-dabt-19a18735
Email: ************@*****.***
Dr. K. S. Rao MVSc, PhD, DABT
Subject Matter Expert (SME) - Safety Assessment at Eurofins Advinus Limited
Bangalore Karnataka
Land:+91-80-409*-****
E-mail: ******@*****.***
Dr. K. S.’s Profile: linkedin.com/in/dr-k- s- -rao-b0530b111
Twitter: toxrao
REFERENCE:
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