Upendra Bhatnagar Email & Phone Number

Hyderabad, Tg, In

Hyderabad Area, India

Responsible to provide core scientific and operational excellence to integrate multiple scientific disciplines in the delivery of pre-clinical GLP and non GLP biological services to the pharm/ biopharm, biotech, medical device and related industries.

Ahmedabad, Gujarat, India

Successfully managed overall GLP compliant operation of toxicology facility (Rodent, Canine & Primate) with audits by US-FDA, GLP monitoring agency & other regulatory agencies along with the regulatory submission of non-clinical data (‘Expert’ reports, IBs, INDs, Annual Update, BIAM summaries etc) and presentation of preclinical toxicity studies/results to Review Committee on Genetic Manipulation (RCGM), New Drugs Advisory Committee (NDAC), the expert committee (SEC) under the Drug Controller General of India (DCGI) to acquire permission for clinical trial/marketing authorization.

Bangalore

Completed due-diligence, strategic planning and facilitated scientific and regulatory decision on non-clinical development of a monoclonal antibody (Anti-infective program)/small molecules (Oncology and CNS program).Designed tailored nonclinical programs (study protocol preparation & review), interpretation of toxicological issues, preparation of regulatory submissions for FDA’s 505(b)(2) submission (development of metabolite and alternate indication/route/formulation of approved drug).Assisted clients for selection/qualification of CROs and managing toxicology studies, setting up toxicology units, Quality Assurance program along with providing training on GLP and Toxicology.

Bangalore

Designed/reviewed non-clinical drug development strategies, carried out gap analyses and conducted due diligence reviews for several molecules, ranging from discovery to clinical development assets, to support Sponsor's investment decision to on-board the assets.Completed designing, strategic outsourcing, monitoring and management of non-clinical programs covering toxicology, safety pharmacology and DMPK studies including bioanalytical and analytical method development and validation for 10 NCEs in different therapeutic areas.Prepared non-clinical section for regulatory submissions (‘Expert’ reports, CTXs, INDs, Annual Update, Safety Report etc) and took complete responsibility for the quality strategy and supervised all internal and external GLP activities. Established network of vendors of appropriate quality/technical capability and evaluated more than 60 CROs, Central Laboratories, and Bio-analytical Laboratories and worked with legal, regulatory, finance teams to finalize several contracts and projects

Pune, India

Established GLP compliant quality system, rodent & canine facilities and effectively managed overall operation of vivarium, pharmacokinetics, toxicology and quality assurance.Screened NCEs for their toxicity, generated qualitative structure toxicity relationship(QSTR) for lead optimization and candidate selection of anti-inflammation & anti-diabetes program. Managed toxicological program to support POC of three candidates (anti-inflammation and anti-tuberculosis) and supported one program (Pain management) for phase-3 clinical trial.Effectively coordinated nonclinical studies and managed toxicology programs/projects to support the timely development of drug candidates (anti-diabetics). Supported CMC manufacturing program by ensuring material qualification (impurities qualification).Assisted to evaluate in-licensing proposals and strategies complete nonclinical development plan for the selected molecules (anti-infective and anti-inflammation).

Managed various pharmacodynamic, pharmacokinetic studies along with exploratory and regulatory toxicity studies for PEGylated peptides and small molecule candidates across a number of therapeutic areas, including oncology, diabetics and immunology.Assessed quality system, capabilities and business models of non-clinical CROs located in Asian and European countries, established contracts and scheduled various non-clinical studies to established POC and safety of two candidates for regulatory submissions (INDs).Provided significant technical/ scientific input into the design of the projects, studies, worked as a part of a global product development team.Designed quality system and infrastructure (facilities, equipment) necessary to support the life science operation. Prospectively planed capital requirements and presented justifications for consideration on annual basis, or as needed.

Chennai

Established GLP certified Research Animal Facility and successfully, managed overall operation of animal facility and toxicology department. Provided strong leadership for employee development including cross training, working in a matrixed organization as high performance teams. Designed and implemented toxicology strategies and programs to support novel drug discovery/delivery projects (anti-infective, anti-inflammation and anti-diabetes).Screened various new molecules for their safety/toxicity, generated QSTR for lead optimization & predestine strategies in development of novel NCEs to perceive as candidate. Prepared non-clinical section for regulatory submissions (‘Expert’ reports, INDs etc).Conducted efficacy studies (anti infective, Inflammatory Bowel Disease/ Psoriasis), including protocol writing, experimental planning, coordination of studies within the team, data analysis and reporting to project teams, as well as providing strategy for future studies. Designed and Conducted Testing Program for Qualification of Impurities present in Active Pharmaceutical Ingredient (API) Using QSAR (Computer Assisted Toxicity Predicting Software “Topkat”) and ICH directed toxicity studies to receive approval for 17 test items from FDA / EDQM.

Vapi (Gujarat)

Timely, satisfactory and cost efficient completion of multiple sponsor projects with overall accountability in establishing a well-equipped Subchronic, Chronic and Neurotoxicity section in compliance to Good Laboratory Practice. Conducted over 100 in vivo safety evaluation studies (single and repeated dose general toxicity, reproduction toxicity, neurotoxicity and carcinogenicity studies) as Study Director and Introduced Functional Observational Battery, Chronic Toxicity, Carcinogenecity, Neurotoxicity and Biomonitoring Studies and standardized various analysis of Clinical Chemistry.As a section head, successfully performed project feasibility assessment and initiation, Resource procurement and planning, Project implementation, Milestone planning and tracking, production of key project progress reports and metrics.Participated in multiple proposal development teams, bid defense meetings, new Client meetings, and represented JRF at professional meetings. Was responsible for management of and communication between JRF Project team, sponsor, contract & financial management.Participated in the successful preparation of the submissions to Ministry of Health, Welfare and Sport Inspectorate for Health Protection Commodities and Veterinary Public Health, Netherlands and Quality Assurance Services, Australia to gain GLP and ISO 9002 accreditation and to gain NABL and DSIR approval.

Conducted systemic toxicity, reproduction toxicity and chronic toxicity studies on n-hexane extracted soybeanmeal

Ph.D, Toxicology

M.B.A., Total Quality Management

M.Sc., Parasitology & Immunobiology