PhD in Pharmacy (Pharmacology) with experience as Pharmacologist and Toxicologist in Drug Discovery & Development in a distinguished career spanning over 30 years.

The wealth of expertise includes Development of Cell based phenotypic assays and Various Animal Models for Pharmacological evaluation of Natural, Ayurvedic, Nutraceuticals & Synthetic Compounds for various human disorders such as Obesity, Diabetes, Cardiovascular, Oncology, Gastrointestinal, Neurological and Endocrine Disorders.

Expertise in development of Pre-clinical strategies, for drug discovery pipeline, including Drug metabolism & Pharmacokinetic studies (DMPK), Exploratory & Regulatory Toxicity Studies and Safety Pharmacological studies to Identify and develop early clinical candidates for various human disorders. Preparation of Target Product Profile, IND Dockets, IMPD, Investigators Brochure (Non-Clinical for IND candidates and due diligence of non clinical aspects of NCE’s which is part of out-license process).

Proven Expertise.

Two Decades of Expertise in Design & develop Pre-clinical Models for drug discovery programs in the area of Diabetes, Immunology, Obesity, Bone Disorders, Oncology, Cardiovascular Diseases etc. Seven years of experience in Drug Metabolism and Pharmacokinetic studies of NCE & Natural Products. Five years of Experience in Toxicology and conducted Acute, Sub acute and Chronic Toxicity studies as per OECD guidelines. Three years of experience as Manager, QUA-GLP approved Toxicology Lab and audited more than 25 GLP studies pertaining to Physicochemical Testing, Invitro Mutagenicity & Rodent Acute & Repeated Toxicity studies (Conducted as per OECD guidelines). Successfully managed two preclinical IND studies for NCE’s.  More than 60 scientific papers published in National & International Scientific Journals and more than 20 research articles are presented in National & International Scientific conferences. Thirteen National & International patents in Credit. Expertise in Designing Animal Facility & Allied Labs as per AAALAC (Accreditation of Laboratory Animal Care, International). Established nude/SCID mice facility for oncology research.

Recognized as Guide for PhD by JNTU, Hyderabad. (Three students have been awarded and three students are pursuing PhD).

QUALIFICATION:                     M. Pharma, PhD, (Pharmacology)

EXPERIENCE:                           ~25 Years in the area of Drug Discovery (Preclinical Pharmacology, DMPK & Toxicology)

Professional Experience:

| Period From | Period To | Employer's Name and Address | Position held and Nature of Work | | --- | --- | --- | --- | | Sept-2022 | Till Date | Cora Health Care Pvt Ltd | Scientific Consultant: Developing Nutraceuticals and Herbal products for Gut and Brain Health | | Sept 2020 | May-2021 | Trovia Discovery Pvt Ltd, Bangalore, INDIA | Head of Biology: To establish expertise and capabilities such as In vitro Biology, DMPK and In vivo Pharmacology in Preclinical Drug Development to support early drug discovery programs. | | Sept-2019 | August-2020 | Mynvax Pvt Ltd, Bangalore, India | Scientific Consultant: Design and execute preclinical studies to establish proof of concept of Vaccines in different species of laboratory animals. Vendor identification for GLP tox studies and monitoring IND enabling studies for human vaccines | | April-2018 | Till Date | The Consilience Research Advisors LLP,, Bangalore, India | Technical Consultant: To enable due diligence process of non-clinical aspects of NCE’s/IND’s which is part of out-license process.  Preparation of Target Product Profile, IMPD, IND Dockets and Investigators Brochure for Phase I clinical trials. | | September-2017 | August-2018 | Jai Research Foundation-Vapi, Gujarat- India | Principal Consultant: Established DMPK platform  with expertise to support Biopharma clients for their drug discovery and early development programs | | July-2017 | March-2018 | AMPHA LIMITED Oxfordshire, UK | Technical Consultant: Monitoring Non-Clinical studies for NCE. Preparation of Target Product Profile, IMPD, IND Dockets and Investigators Brochure for Phase I clinical trials. Assisting to preparePhase I clinical trial protocol for IND’s | | Aug-2016 | Jun-2017 | The Consilience Research Advisors LLP,, Bangalore, India | Head, Preclinical Development: Preparation of Target Product Profile for IND candidates. Responsible for due diligence of non clinical aspects of NCE’s which is part of out-license process.  Vendor Identification and evaluation for API synthesis and formulation development of NCE’s | | March- 2011 | July- 2016 | The Connexios Life sciences Pvt  Ltd, Bangalore, India | Group Lead, Preclinical Development: Drug discovery and development gap analysis, Preparation of strategic plans for IND enabling program. Managed a team of scientists in DMPK, safety pharmacology and regulatory toxicology. | | April-2009 | March- 2011 | The Connexios Life sciences Pvt  Ltd, Bangalore, India | Group Lead, Preclinical Biology: To develop Pre-clinical strategies, for drug discovery pipeline, including Exploratory Studies to Identify and develop early clinical candidates for Metabolic Syndrome | | 2007 May | Mar-2009 | The Connexios Life sciences Pvt  Ltd, Bangalore, India. | Lead Scientist (Assay development):, To establish robust cell based assays and Animal models that are divergent and provides necessary information to characterize the NCEs, which emerges as well characterized `preclinical candidate for Metabolic disorders such as Diabetes, Obesity, Hyperlipidemia and Atherosclerosis. | | 2005 | 2007-Apr | The Himalaya Drug Company Bangalore | Manager Head of QAU of GLP Test facility Overall, in-charge of the Quality Assurance Unit (QAU) of GLP Test facility. | | 2001 | 2005 | The Himalaya Drug Company Bangalore | Manager Overall, in-charge of all activities of the department of preclinical pharmacology and Toxicology, and planning studies in the department including study scheduling, protocol preparation, execution, reporting and documentation. | | 1999 | 2001 | The Himalaya Drug Company Bangalore | Assistant Manager Involved in development and standardization of various in vitro and In vivo experimental models in the area of preclinical pharmacology and  toxicology for screening of Phyto-chemicals for  various human disorders. | | 1994 | 1999 | The Himalaya Drug Company Bangalore | Sr. Scientific Officer Safety evaluation of chemicals and herbal drugs: Acute, sub-acute and chronic toxicity studies as per the guidelines prescribed by OECD. Development of Animal models, evaluation of drugs for various pharmacological activities and evaluation of pharmacokinetic & pharmacodynamic properties and mechanisms of drug action |

Additional responsibility/Achievements

1999-2001: Designed and Established Animal house facility and allied laboratories for the new department of Preclinical pharmacology and Toxicology

2002-2003: Established the Athymic/SCID mice facility at Himalaya Drug Company, R&D to conduct anti-cancer drug screening in various human cancer models in athymic/SCID mice.

2003-2004: Established the 99mTc generation unit and radioisotope laboratory.

2007-2008: Established DMPK capabilities at Connexios Life Sciences

2008-2009: Designed and Established Animal facility (As per AALAAC Standards) and allied laboratories at Connexios Life Sciences

Papers published in national and international journals