Dr Anita Chugh, PhD
Vice President and Head, Discovery Biology
Dr Anita holds a PhD from All India Institute of Medical Sciences (AIIMS), and her Post-Doctoral Fellowship from McMaster’s University, Hamilton, Canada. She has over 20 years’ experience in drug discovery biology, spanning both empirical and contract service roles. She has extensive experience in the area of urology, metabolism and inflammation, and has a track record of identification and progression of candidates to clinics. As one of the founding employee of Advinus, Anita played a pivotal role in setting up its Biology department.
Dr Bheemashankar Kulkarni, PhD
AVP and Head, Discovery Chemistry
Dr Kulkarni completed his PhD from Bhabha Atomic Research Center, Bombay, India and was associated with prestigious academic institutions like Boston University, University of Hawaii, Institute of Molecular Cell Biology and University of Gent, Belgium for his Post-doctoral research. Dr Kulkarni has over 24 years of experience in drug discovery chemistry. Dr Kulkarni has experience in multiples 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 Krishnappa H, MVSc., PhD, ERT, DABT
Senior Director and Head, Safety Assessment
Dr Krishnappa is a Toxicologist with 25 years of experience in Safety Assessment in the area of Pharmaceutical, Agrochemical and Biotechnology. He has expertise in ensuring pre-clinical regulatory studies in compliance with the principles of GLP, covering OECD, EPA, FDA, EMEA, DCGI and other Regulatory guidelines. Dr Krishnappa is involved in planning, execution and interpretation of Toxicology and Safety Pharmacology studies in required species in supporting Investigational New Drug (IND) submission, New Drug Application (NDA), Agrochemical Development, Vaccines, Biopharmaceuticals, Bio-similar etc., as per GLP principles and various testing guidelines. He is an AAALAC International ad hoc specialist.
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 in 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 Natesan S, PhD
Vice President and Head, Corporate Quality Assurance
Dr Natesan completed his Ph. D from the Indian Institute of Science, Bangalore, India. He has over 30 years of Research & Development experience, including over 24 years of pre-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 quality assurance functions in GLP and GMP areas, as well as driving the TBEM in the company. His areas of expertise are GLP studies, primarily in analytical areas covering physical-chemical studies, pre-clinical safety assessment, E-fate, residues and product characterization, as well as 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 V Pardhasaradhi, PhD
Director and Head, 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. He 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 Shaji George, PhD
VP and Head, Process 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 an impressive list of publications in peer reviewed journals such as Journal of American Chemical society and Royal Society of Chemistry. He has a vast experience of conducting 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 Vijayasarathi, MVSc., PhD
Dr. Vijayasarathi has over 45 years of experience in the field of pathology. He is involved in study designing, conducting and histopathological evaluation of the toxicological potential in variety of animal models. He has nearly 80 scientific publications to his credit and has presented several research papers at National and international conferences. He is currently serving as the president of Society of Toxicological Pathologists in India and is also life member of many scientific organizations. 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.