Dr. Ravichandra B.V. DVM, MVSc, DABT, ERT(UK)

Heading a Global Department supporting both RnD and non-RnD Depts for integrated generic and specialty drug products development for global market. Providing scientific and regulatory expertise in nonclinical & clinical drug development/safety evaluation and risk assessment. Planning, direct management, outsourcing, monitoring, controlling, reporting, and interpretation of toxicology, ADME/pharmacology/efficacy studies. Health based exposure limits (HBEL)- PDE, OEL toxicology monographs for pharmaceuticals drug substance, intermediates & interaction with manufacturing plats on implementation of these limits in cleaning validation (MACO), attending the regulatory inspections at plants. Toxicological risk assessment of leachable/extractable for CCS of drug products & manufacturing components using ISO, PQRI/ELSIE guidance. In silico QSAR - Derek-Sarah Nexus, Caseultra, Leadscope, Toxtree, OECD QSAR toolbox. Impurity qualification by risk assessment through different approaches of PDE, TTC, AI, Metabolite, risk-benifit. N-nitrosamines, NDSRIs - setting AI limits by readacross of surrogates, structural and chemical basis, advanced in vitro and in vivo mutagenicity and genotoxicity assays for NDSRIs. Novel alternative methodologies (NAM) to address complex toxicology issues by innovative toxico-regulatory approaches. Regular resolving of the queries raised by different regulatory bodies such as USFDA, BfArM, MHRA, other EU countries, ANVISA, CFDA, SFDA, TFDA, CDSCO and RoW markets. To overcome hurdles in design of tailored nonclinical programs (scientific & pragmatic/innovative regulatory strategies, cost effective/ optimized CRO interaction; insight in regulatory expectations & ensure regulatory compliance). Rich International experience of negotiating, developing & out sourcing nonclinical research to India, USA, Europe, Australia, China, Brazil, Russia, etc.

India lead and Part of Global Team involved in, Toxicological risk assessment Human Food Safety assessment Toxicology and safety assessment of drug residues, products, substance, impurities, leachable, extractables, etc. ADI, MRL assessments, withdrawal period establishment for edible tissue, eggs, milk. Leads the Centre of excellence (CoE) working group for HBEL - PDE &, OEL. Support to Manufacturing plants for safety and toxicology. Early discovery screening of drug candidates/lead selection/lead optimisation. Nonclinical drug development and study outsourcing and monitoring at external CROs. In silico QSAR assessments for toxicity endpoints. USFDA, EU, EFSA, Codex Alimentarius (JECFA/WHO), etc. submissions. Industry representative for V-ICH Human Food Safety working group and CVM-AHI

 Preclinical, clinical & Regulatory support to obtain Marketing Authorizations for USFDA, EU, MHRA (UK), Russia, Brazil, China, India & other emerging markets.  Study designing, monitoring, Co-ordination and controlling the progress of various preclinical studies (toxicity, PK, PD/efficacy studies etc) at external CROs for human drug substance, products, impurities and animal bioequivalence studies by regular follow-ups and feedback to ensure the conduct is in line with study protocols.  Bio-waiver strategies for generics based on available studies/ literatures support or with minimal conduct of nonclinical bridging studies  Genotoxicity/mutagenicity assessments for different categories in pharmaceuticals with existing and novel strategies with experimental data, QSAR, read-across/surrogate approaches and product/class specific assessments.  Product stewardship - Toxicological and safety expert evaluation for all drug products, drug substances, medical devices, packaging materials, impurities, intermediates etc. required during integrated product development and marketing.  Toxicological hazard identification and risk assessments/characterisation for different pharmaceuticals, medical devices, impurities and extraneous matters. • In silico QSAR (E.g. DEREK, SARAH, Toxtree, OECD, etc.) run, analysis, interpretation of toxicology data to support risk assessment • Regular resolving of the toxicological queries raised by different regulatory bodies such as USFDA, EMA, etc. in new product submission and marketed drugs. • Authoring/Review of Permissible daily exposure (PDE), occupational exposure limit (OEL)  Impurity/intermediate qualification by nonclinical study conduct or by risk assessment using PDE, AI/TD-50, TTC approach.  Leachables/extractables qualification in drug products by by risk assessment following ISO/PQRI  Excipient or inactive ingradient qualification  Environmental risk assessment (ERA) based on EU guidelines for generic drug products

Regulatory Toxicologist and Preclinical Scientist

· Regulatory Toxicology, Product safety evaluation and Preclinical Toxicity/ADME/Efficacy Studie. · Direct management, monitoring, planning, controlling, reporting, and interpretation of toxicity (acute/repeated subacute, subchronic, chronic/genotoxicity - mutagenicity, clastogenicity/ environmental tox/etc.), ADME/pharmacology efficacy studies and preparation of nonclinical part of regulatory dossiers, regulatory scientific advice procedures · Health hazard identification and risk assessment of pharmaceuticals/chemicals/intermediates/ impurities, etc. with different routes · Toxicological Review/preparation of monographs for ADI (acceptable daily intake), PDE (permitted daily exposure), OEL (occupational exposure limit) monographs for pharmaceuticals, impurities, leachable/extractable, etc. · QSAR analysis: Structure activity relationship (SARs) to support risk assessment of chemicals/impurities · Impurity qualification by risk assessment through ADI approach, TTC approach, etc. · Regular resolving of the toxicological queries raised by different regulatory bodies such as USFDA, EMA, etc. in new product submission and marketed drugs. · Due-diligence, strategic planning and facilitated scientific and regulatory decision on non-clinical development of drugs · Analyze the material safety data sheet of various chemicals; Extract information from various toxicology databases · Rich International experience of negotiating, developing and out sourcing preclinical research.

Toxicologist: Rodent & Non-Rodent (Dog, Rabbit) toxicity studies Regulatory Toxicology and Product safety evaluation IND and post-IND directed Tox studies Non-clinical Toxicity and Immunogenicity studies for Vacines and Biologics (Hormones, growth factors, etc.) Toxicokinetics, Clinical Pathology GLP, AALAAC, NABL accedited facility SCHEDULE-Y,OECD, ICH, WHO, EMEA, FDA, DBT, etc guidelines

Rodent toxicity studies (acute, subacute and chronic) Toxicokinetic studies Genotoxicity studies. Chromosomal aberration assay - In vitro (Human peripheral blood lymphocytes, CHO-K1 cell line) and in vivo Ames assay Micronucleus assay Single cell gel electrophoresis (Comet assay in CHO-K1 cell line, Human peripheral blood lymphocytes, rats & mice) Laboratory Animal Husbandry

Genotoxicity studies: Ames Assay Chromosomal aberration assay