Dr. Natesan S, PhD, RQAP-GLP, MRQA
Vice President, Business Excellence and Corporate QA
Dr. Natesan completed his PhD from the Indian Institute of Science, Bangalore, India. He has over 30 years of Research & Development experience, including over 25 years of non-clinical regulatory studies in compliance with the principles of GLP, covering OECD GLP, FDA GLP and EPA GLP. He is a certified Quality Assurance Professional (SQA, USA) as well as a certified auditor for Tata Business Excellence Model (TBEM), which is based on the Malcolm Baldrige National Quality System. He is currently responsible for driving TBEM practices in the company. His Corporate QA role is primarily for cGMP areas and for mentoring GLP QA team. His areas of expertise include analytical areas, physical-chemical studies, non-clinical safety assessment, E-fate, residues, product characterization, and cGMP quality systems for production and supply of materials for early stage clinical trials. Dr. Natesan has published over 65 articles in national and international journals/books, including a book. He is also the Founder President of the Indian Chapter of the Society of Quality Assurance, and works closely with the SQA organization in USA. He has extensive experience in successfully facilitating several GLP audits/inspections by the Monitoring Authorities of OECD countries, Indian National GLP Compliance Monitoring Authority, USFDA and several sponsors worldwide.
Dr. Krishnappa H, MVSc., PhD, ERT, DABT
Vice President and Head, Department of Safety Assessment
Dr. Krishnappa is a Toxicologist with 25 years of experience in Safety Assessment of Pharmaceuticals, Agrochemicals and Biotechnology products. He has expertise in ensuring GLP compliance of preclinical regulatory studies covering OECD, EPA, FDA, EMEA, DCGI and other Regulatory guidelines. Dr Krishnappa is involved in the planning, execution and interpretation of Toxicology and Safety Pharmacology studies in support of regulatory submissions for Investigational New Drugs (IND), New Drug Applications (NDA), and registration of Agrochemicals, Vaccines, Biopharmaceuticals, Biosimilars etc.. Dr. Krishnapppa is an AAALAC International ad hoc specialist.
Dr. V Pardhasaradhi, PhD
Vice President and Head, Department of Analytical R&D
Dr. V. Pardhasaradhi obtained his Ph.D. in Chemistry from Mangalore University, India. He has over 24 years of R&D experience which includes conducting regulatory studies in compliance with the principles of GLP, covering OECD GLP, FDA GLP and EPA GLP. His R&D experience is in the field of Analytical chemistry, Bioanalysis, Residue analysis and Product chemistry. He has experience in setting up new laboratories and introducing new test parameters as per regulatory guidance documents. Dr. Pardhasaradhi has worked on various types of analytical method developments ranging from active ingredient and impurity analysis in pure materials to trace level analysis in complex matrices. He has more than 16 research publications and is currently guiding 3 students for their PhD program.
Dr. K S Rao, MVSc, PhD, DABT
Senior Director, Strategic Business Development
Dr. K.S. Rao is a Board Certified Toxicologist with more than 40 years of global experience in safety evaluation. His work experience includes Drug Development (small and large molecules) from Discovery Toxicology to IND and NDA filing, toxicological assessment of Agrochemicals, Industrial Chemicals (REACH), Food Additives, Nutraceuticals, Vaccines, Medical Devices and Cosmetic Ingredients, among others. Dr. Rao is Emeritus Member of the Society of Toxicology – SOT in US. Dr. Rao is the first Indian Toxicologist to be appointed for this status for being a member of the SOT for 40 years. He was instrumental in getting the Diplomate of American Board of Toxicology (DABT) examination to be held in India since 2009. Dr. Rao has published and presented several papers in international journals and seminars. Dr. Rao has interacted with regulatory authorities of several countries including FDA & EPA (U.S.A), EMA, Japanese Health and Indian Regulatory Authorities.
Dr. Vijayasarathi, MVSc, PhD
Expert Pathologist and Chief Mentor Pathology
Dr. Vijayasarathi has over 45 years of experience in the field of pathology. He is involved in study design, conduct and histopathological evaluation to understand the toxicological potential of pharmaceuticals, agrochemicals and biologicals in a variety of animal models. Dr. Vijayasarathi currently serves as the President of Society of Toxicological Pathologists in India and is also life member of many scientific organizations. He has nearly 80 scientific publications to his credit and has presented several research papers at national and international conferences. He is the author of nearly 400 safety evaluation study reports, including more than 25 carcinogenicity studies. These reports are submitted to various regulatory authorities of several countries, including FDA & EPA (U.S.A), European and Japanese Health as well as Indian Regulatory Authorities.
Dr. Shaji George, PhD
Vice President and Head, Department of Chemistry
Dr. Shaji George holds a PhD in Organic Chemistry from Indian Institute of Technology, Kanpur, India and did his postdoctoral research work at Umea University Sweden and the Complex Carbohydrate Research Centre, Georgia University, US. He has over 20 years of experience in the area of organic/process chemistry and has published in journals such as Journal of American Chemical Society and Royal Society of Chemistry. He has experience in managing and leading various FTE and custom synthesis activities for major pharmaceutical and agrochemical companies, and is also responsible for the process research, development and scale-up of investigational new drug molecules.
Dr. Bheemashankar Kulkarni, PhD
Associate Vice President, Department of Chemistry
Dr. Kulkarni completed his PhD from Bhabha Atomic Research Center, Bombay, India and did postdoctoral research at Boston University, University of Hawaii, Institute of Molecular Cell Biology and University of Gent, Belgium. Dr. Kulkarni has over 24 years of experience in drug discovery chemistry. Dr. Kulkarni has experience in multiple therapeutic areas and he was instrumental in nominating several preclinical and clinical candidates. He has authored more than 34 journal articles, holds over 20 patents and has won many awards including the Best Scientist Award from the Association of Scientists of Indian Origin in America, San Diego, California, USA, 2000.
Dr. S Shivaram, PhD
Director and Head, Genetic & Ecotoxicology, Department of Safety Assessment
Dr. Shivaram has over 26 years of experience in Genetic Toxicology and Ecotoxicology. He has designed, conducted and evaluated the safety of hundreds of candidate Drug Substances, Biopharmaceuticals, Agrochemicals, and Industrial Chemicals in terms of their Genotoxic and Ecotoxic potential. He has authored more than 160 Safety Evaluation Genetic Toxicology and Ecotoxicology study reports of various new compounds that are marketed or to be marketed. These reports are submitted to various regulatory authorities of several countries, including the FDA & EPA (U.S.A), European, Japanese and Indian Regulatory Authorities.
Dr. K Venugopala Rao, MVSc, PhD, DABT
Director and Head, Safety Pharmacology, Outsourcing and New Initiatives, Department of Safety Assessment
Dr. K. Venugopala Rao is a post graduate in Veterinary Pharmacology and Toxicology (MVSc) and a PhD in Toxicology with more than 25 years of experience in Toxicology. He is also a US Board Certified Toxicologist (Diplomate of American Board of Toxicology). His responsibilities include the planning, execution, review and interpretation of non-rodent toxicology studies and the battery of Safety Pharmacology studies under GLP for Investigational New Drug (IND) enabling study packages. He leads the outsourcing of non-rodent toxicology studies and has led more than 70 such studies. He also leads the development of new initiatives in the in vitro toxicology area.
Dr. Syed Manzoor Sulaiman, MVSc, PhD, ERT, DABT
Director and Head, Acute, Teratology and Medical devices, Department of Safety Assessment
Dr. S.M. Sulaiman is a US Board Certified Toxicologist with more than 23 years of experience in Safety Evaluation. He is an expert in the toxicological assessment of Pharmaceuticals (small and large molecules), Vaccines, Recombinant DNA products, Agrochemicals, Industrial chemicals, Dyes, Food and Feed additives, Biocides, Enzymes, Nutraceuticals and Medical Devices. Dr. Sulaiman has published and presented papers in international journals and conferences. He has authored more than 300 safety evaluation reports of various new compounds that are marketed or to be marketed.
Mr. D P Santhosh Kumar
Assistant Director, Department of Safety Assessment
Mr. D.P. Santhosh Kumar is a post graduate in Zoology (M.Sc.) and is working with Advinus since 1993. He is certified as a European Registered Toxicologist and is an Associate Member of Academy of Sciences for Animal Welfare (Animal Welfare Board, Government of India). He has been instrumental in completing more than 300 safety evaluation reports of various compounds marketed or to be marketed. These safety study reports include Single dose studies, Repeat dose studies, Chronic studies, Reproduction studies and Carcinogenicity studies. These reports were submitted to various regulatory agencies of several countries.
Mr. Manjunatha S
Assistant Director, Department of Analytical R&D
Mr. Manjunatha has a Master’s degree in Agricultural Sciences and over 24 years of experience in conducting regulatory analytical studies in compliance with GLP. His specialized expertise is in environmental fate studies, residue studies including field trials and soil sciences. He has conducted a number of regulatory GLP studies as study director for successful submissions in various countries. He has experience in conducting studies involving radiolabelled compounds. Apart from being a Radiological Safety Officer, his current responsibilities include leading a team for conducting regulatory studies on environmental fate and pesticide residues.
Dr. Hari N Pati, PhD
Director, Department of Chemistry
Dr. Hari N. Pati received his MSc degree from Sagar Central University, and his MPhil and PhD degrees from Delhi University. He was an NIH post-doctoral fellow at Furman University, USA, following which he conducted postdoctoral research at the University of Saskatchewan, Canada as a CIHR fellow. Dr Pati has more than 20 years of experience in synthetic, medicinal and process chemistry. His areas of interest and responsibility include the synthesis and scale-up of active pharmaceutical ingredients (APIs) and new chemical entities (NCEs).
Dr. Niranjan M Paingankar, PhD
Director, Department of Chemistry
Dr. Niranjan completed his PhD from The Institute of Science, Mumbai (1995) in Synthetic Organic chemistry. He has 22 years of experience in the field of Process Research and Development/Scale up, Process Safety and Technology Transfer, and filing of non-infringing process patent for generic API. His major contributions include reduction in manufacturing cost of intermediates and APIs by process modification, streamlining of cycle time, man power utilization and maintenance of equipment efficiency. He has five patents and two publications to credit.
Dr. K Kamala, MVSc, IBTP
Head, Pathology, Department of Safety Assessment
Dr Kamala obtained her Master’s degree in Veterinary Pathology from UAS, Bangalore and is a Diplomate of the Indian Board of Toxicologic Pathology. She has been working in the field of Toxicologic Pathology for over 17 years.
Dr. Kamala currently heads the teams of pathologists, clinical pathology and histotechnique in Advinus. She has completed the pathology work for over 200 repeated dose toxicity studies and reproduction studies for various pharmaceutical and agrochemical compounds, and 9 chronic studies including 6 carcinogenicity studies in rats. She has also handled 19 carcinogenicity reports (rats and mice) for various agrochemical compounds. Dr. Kamala also conducts peer reviews for sub chronic toxicity and chronic studies.
Dr. S Ganiger
Assistant Director, Reproduction Toxicology, Department of Safety Assessment
Dr. Ganiger is a graduate in Veterinary Science (BVSc) and a Board Certified Toxicologist (Diplomate of American Board of Toxicology). He has been working with Advinus since 1993 from which time he has worked as study director and technical co-coordinator in Safety Assessment. He is the author of about 100 Safety Evaluation study reports of various new compounds marketed or to be marketed. The study reports included single dose, repeated dose, carcinogenicity and reproductive toxicity studies. He is also the designated Quarantine Officer at the Safety Assessment Department.
Mr. B P Karamudi
Assistant Director, Department of Analytical R&D
Mr. Karamudi has a Master’s degree in Agricultural Sciences and has over 24 years of experience in conducting regulatory analytical studies in compliance with GLP. His specialized expertise is in formulation development for agrochemicals, physical chemical property testing and soil sciences. He has conducted number of regulatory GLP studies as study director for successful submissions in various countries. He is instrumental in developing various types of commercial agrochemical formulations with high success rate in the market. His current responsibilities include leading a team for conducting regulatory studies on physical chemical property testing and storage stability studies.
Dr. G R Madhavan, PhD
Director, Department of Chemistry
Dr. Madhavan has an MSc (Chemistry) from University of Hyderabad and a PhD (organic chemistry) from Osmania University. He has more than 21 years of experience in medicinal chemistry and synthetic chemistry, with 25 patents and 10 publications. He has provided leadership to research groups that have advanced several drug candidates into preclinical development, three candidates into clinical studies (Balaglitazone and Ragaglitazar and CNX-011-67), and two other candidates from preclinical to clinical stage.
Mr. Abhishek Sharma
Assistant Director and Head, Process Analytical and Quality Control, Department of Chemistry
Mr. Abhishek Sharma has an M.Sc. Tech degree in Pharmaceutical Chemistry. He has over 16 years of industry R&D experience in Analytical Chemistry in regulated GLP and GMP settings. In this time, he has led numerous studies as study director and supported several studies for IND/IMPD submissions to various regulatory agencies worldwide.
Mr. Sharma is responsible for the analytical activities in the areas of medicinal chemistry, process development research and GMP manufacturing to support drug development.
Mr. Bhavesh Patel
Associate Director, Department of Drug Metabolism and Pharmacokinetics
Mr. Bhavesh Patel has a Master’s degree in Biochemistry from the Biochemistry Department of the MS University of Baroda. He has over 16 years of industry experience in the Bioanalytical area. Mr. Patel has been involved with the installation of the initial liquid chromatography-tandem mass spectrometry instruments in the country in an industrial setting. He leads bioanalytical method development and GLP compliant validation and preclinical and clinical sample analysis of small molecules and biologicals, Formulation analysis for GLP toxicology studies, as well as the in vitro & in vivo sections of Drug Metabolism and Pharmacokinetics.
Mr. Satish Murthy V, MSc, RQAP-GLP
Associate Director and Head, GLP Quality Assurance
Mr. Satish Murthy holds a postgraduate degree in Zoology from Bangalore University. He is a certified Registered Quality Assurance Professional in GLP from the Society of Quality Assurance, USA. Mr. Murthy has over 20 years of experience in GLP Quality Assurance functions. During this time, he has faced a number of inspections from the Monitoring Authorities of Germany, Netherlands, India and US FDA, in addition to numerous audits by sponsors.
Mr. Shankar S
Head, Pharma Formulation Analysis and 14C studies, Department of Drug Metabolism and Pharmacokinetics
Mr. Shankar has a Master of Pharmacy degree in Pharmaceutical Analysis from Dr. MGR Medical University, Chennai, India, and about 14 years of industry experience. His area of focus is analytical and bioanalytical method development and validation for regulatory studies, and the conduct of mass balance an tissue distribution studies using radiolabelled drug. Till date, he has completed more than 200 studies. Mr. Shankar was also instrumental in setting up the 14C-ADME studies for pharma compounds at Advinus, and he has thus far completed over 30 studies in this area. He has received training in safe use of radioactive materials from the national agency AERB (BARC) and has received their certification.
Dr. Ritika Uppal Mukherjee, PhD
Principal Scientist, Drug Metabolism and Pharmacokinetics
Dr. Ritika Uppal Mukherjee received her PhD in Bio-inorganic Chemistry from the Department of Chemistry, Yale University, USA, following which she conducted postdoctoral research at the Athinoula A. Martinos Center, an affiliation of Massachusetts General Hospital and Harvard Medical School. At Advinus, she manages the in vitro DMPK section specializing in physicochemical characterization, metabolism and biotransformation, permeability and drug transporters and drug-drug interaction studies. She has led several studies as a study director, and has played major role in structure elucidation and understanding metabolic pathways of new drug candidates. Dr. Mukherjee has published in several high-impact international journals and presented talks and posters at several international conferences.