Intellex Acquires Expert by Big Village

We're thrilled to announce that Intellex has acquired Expert by Big Village, effective March 22, 2024. This strategic move enhances our capabilities and strengthens our commitment to delivering exceptional solutions to our customers.

Stay tuned for more updates on how this acquisition will benefit our clients and experts.

For inquiries or more information, please contact us at info@intellex.com.

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Expert Details

Drug Discovery & Development, Preclinical Safety Assessment: Toxicology, Pathology & Regulatory affairs

ID: 731324 Sweden

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ExpertS. Expert has over 33 years of experience in safety evaluation- Toxicology & Pathology – histopathology slides evaluation, Regulatory, drug discovery & development research, having worked in Switzerland, UK, Sweden and India. He has experience both in the pharmaceutical Industry and the contract research organizations.

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.
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.
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.
Years Employer Title Department
Years: 1998 to 2003 Employer: Torrent Pharmaceuticals Ltd. Title: Chief/Head Toxicologist and pathologist/consultant Department:
Responsibilities:
Available upon request.
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.
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.
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.

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

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