Expert Details
Drug Discovery & Development, Preclinical Safety Assessment: Toxicology, Pathology & Regulatory affairs
ID: 731324
Sweden
Expert as a lead in the project team, in pharma ExpertD/CROs, contributed to the development of some of the following best known molecules/drugs: Voltaren (CIBA-GEIGY,Novartis), AZT- Zidovudine (Welcome), Zantac-Ranitidine Hcl (SKF-GSK), Symbicort, Crestor, Iressa, Losec/Nexium, Pulmocort, Seroquel (AstraZeneca).
After completing his BVSc & AH: DVM (Gold medalist, First rank in the University) and MVSc at Bombay Veterinary college, obtained Ph.D in Toxicology and Experimental Pathology from University of Surrey(U.K). He is a Fellow of International Academy of Toxicological Pathology - USA., UK/EU Registered Toxicologist.
Expert has published papers and presented papers in international seminars. He is a member and actively contributed in international organizations in the field of toxicology & pathology. He is principal author of more than 800 safety evaluation study reports, of various new compounds marketed or to be marketed. These reports are submitted to various regulatory authorities of several countries, including, USFDA/ Health Canada, EMA, MHRA, UK, HSA, Singapore, Medsafe, New Zealand and DCGI, India.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2011 | Degree: Fellow IATP - Fellow of International Academy of Toxicologic Pathology,USA | Subject: Toxicology and Pathology | Institution: Accredited/certified Fellow of International Academy of Toxicologic Pathology,USA |
| Year: 2009 | Degree: EU/UK Registered Toxicologist | Subject: preclinical safety assessment, Toxicology | Institution: British Toxicology Society |
| Year: 1998 | Degree: Ph.D | Subject: Toxicology and Pathology | Institution: University of Surrey, Guildford, UK |
| Year: 1981 | Degree: M.V.Sc – Master of veterinary medicine – Toxicology and pathology, | Subject: Toxicology and pathology, | Institution: Bombay veterinary - Medical College |
| Year: 1979 | Degree: DVM/ B.V.Sc & AH – Bachelor of Veterinary Medicine and Surgery – Science. | Subject: Veterinary Medicine and Surgery – Science | Institution: Bombay veterinary - Medical College |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2013 to Present | Employer: Undisclosed | Title: Founder and Chief : Toxicology, Preclinical safety and Pathology consultancy | Department: |
Responsibilities:ExpertS. Expert at present as a consultant, provides expert drug discovery & development, toxicological, pathology (histopathology slide evaluation) and regulatory services, to pharmaceutical, biotechnology, chemical and agrochemical companies. He designs and manages IND enabling preclinical development programs including in-vitro models, pharmacology/efficacy studies, safety pharmacology, toxicokinetics (TK), genetic toxicology studies, metabolism studies, acute and repeat dose safety studies. Also NDA required programs, including chronic toxicology studies, reproductive toxicology studies, genetic toxicology/mutagenicity studies and carcinogenicity studies. He prepares required regulatory IND or NDA dossiers for submitting to US FDA, European, Japanese, Australian, New Zealand and Indian, agencies. |
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| Years | Employer | Title | Department |
| Years: 2008 to 2013 | Employer: Advinus Therapeutics Ltd., A TATA Enterprise, | Title: Vice- President and Head of Safety Assessment (Toxicology, Pathology, Safety Pharmacology and vivari | Department: |
Responsibilities:From 2008 to 2013, as Vice- President and Head of Safety Assessment (Toxicology, Pathology, Safety Pharmacology and vivarium), at Advinus Therapeutics Ltd., A TATA Enterprise, Expert was responsible for overall management/incharge (team of about 130 staff) & accountable for all scientific, technical, managerial and business development activities. He provided guidance to staff and clients on Drug Discovery and Development process, strategy and testing programs and regulatory interactions. Developed and directed innovative toxicologic methodologies to meet customer needs in early drug development and lead generating process. Interacted with Business Development in providing direction and strategic input in client interactions. Expert successfully led Advinus Therapeutics Ltd., first ever FDA inspection in India, without any Form 483 observations. |
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| Years | Employer | Title | Department |
| Years: 2003 to 2008 | Employer: AstraZeneca R&D, Sweden, Global Head Safety assessment | Title: Principal toxicologic pathologist– toxicology and pathology, histopathology slide evaluation, | Department: |
Responsibilities:From 2003 to 2008, He worked at AstraZeneca ExpertD, Sweden, Global Head Safety assessment as a Principal toxicologic pathologist– toxicology and pathology, histopathology slide evaluation, he worked from discovery to product development, in various therapeutic areas such as : Oncology, Metabolic/diabetes, Cardiovascular, CNS, Pain, Gastrointestinal, Respiratory and Inflammation. |
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| Years | Employer | Title | Department |
| Years: 1998 to 2003 | Employer: Torrent Pharmaceuticals Ltd. | Title: Chief/Head Toxicologist and pathologist/consultant | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 1996 to 1998 | Employer: Ranbaxy, Dr.Reddy’s, JRF, GVK-Biosciences | Title: Consultant – Preclinical Safety Assessment - Toxicology, Pathology. | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 1983 to 1995 | Employer: Research Centre (HRC), Cambs, England,U.K, | Title: Senior toxicological pathologist- | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 1980 to 1982 | Employer: CIBA-GEIGY/ Novartis, Basel, Switzerland, Drug Safety Evaluation | Title: Pathologist – Toxicology – Preclinical safety Assessment, | Department: |
Responsibilities:Available upon request. |
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Career Accomplishments
| Associations / Societies |
|---|
| MEMBERSHIP OF PROFESSIONAL BODIES: • Member- Associate of Royal College of pathologists – U.K • Member of British Toxicology Society • Member of British Society of Toxicological pathologists • Member of European Society of Toxicologic pathology • Member International Academy of Toxicology and pathology • Member of Indian Society of Toxicological pathologists |
| Licenses / Certifications |
|---|
| EU/UK Registered Toxicologist & Pathologist, accredited/certified Fellow of International Academy of Toxicologic Pathology,USA – Fellow IATP, Member Associate of Royal college of pathologists (UK), |
| Awards / Recognition |
|---|
| University Gold Medallist: First rank in the University, First class with distinction, Bombay veterinary - Medical & Surgery- College, in DVM/ B.V.Sc & A.H. |
| Publications and Patents Summary |
|---|
| Published papers and presented papers in international seminars. Principal author of more than 800 safety evaluation study reports, of various new compounds marketed or to be marketed. These reports are submitted to various regulatory authorities of several countries, including, USFDA/ Health Canada, EMA, MHRA, UK HSA, Singapore Medsafe, New Zealand and DCGI, India. |
Additional Experience
| Training / Seminars |
|---|
| These reports are submitted to various regulatory authorities of several countries, including, USFDA/ Health Canada, EMA, MHRA, UK HSA, Singapore Medsafe, New Zealand and DCGI, India. |
| Marketing Experience |
|---|
| Preclinical Safety Assessment – Toxicology & Pathology Consulting: The process from positive efficacy findings to filing for IND (Investigational New Drug) application is costly, time consuming and with lot of hurdles to cross. Our collaboration and association will get the candidate which is most likely to be successful, with minimal safety liabilities, in shortest time period, with least cost to IND. |
| Other Relevant Experience |
|---|
| Multiple. |
Fields of Expertise
animal research, animal study, applied toxicology, biotoxicology, carcinogenicity, chemical toxicology, clinical chemistry, dermatotoxicology, drug regulation, drug safety testing, drug toxicology, environmental safety, environmental toxicology, hematotoxicology, in vitro toxicology, in vivo toxicology, industrial chemical toxicology, inhalation toxicology, neurotoxicology, pathogenesis, reproductive toxicology, small animal toxicology, tissue irritation, toxicological hazard, toxicology, veterinary toxicology, adverse drug reaction, applied dermatotoxicology, histochemistry, aquatic toxicology, drug metabolism, animal science