Dr. Somesh Kakade
M. V. Sc. (Veterinary Pathology)
H-102, Arabiana CHS, Casa Rio, Palava City, Dombivali East, Mumbai,MAHARASHTRA
Summary
- Objectives : To achieve excellence in the field of “Toxicology” and make significant contribution in its emerging scenarios through proper utilization of conceptual ideas, skills and experience and also to take part in the integral growth of the organization with hard work and commitment.
- Executive Summary : Toxicologist with over 11 years of experience with reputed research oriented pharmaceutical companies like Glenmark Pharmaceuticals Limited and Suven Life Sciences Limited in the area of Toxicology, Toxicologic Pathology, Genotoxicology & in-vivo Pharmacology focused in Non-clinical Research and Development, Drug Development and Drug Safety Evaluation and Risk Assessment of Pharmaceuticals, with expertise in the complete lifestyle of a pre-clinical study conduct as per regulatory requirements for Novel Chemical Entity (NCE's) and Active Pharmaceutical Ingredients (API), preparation of safety assessment and efficacy reports, conduct of biocompatibility studies as per International Organization for Standardization (ISO), calculation of Permitted Daily Exposure (PDE), Occupational Exposure Limits (OEL) and Margin of Safety for Chemicals and Drugs.
- Currently serving in the role of Senior Research Officer – Discovery Toxicology, Glenmark Pharmaceuticals Limited, Mumbai.
- Makes contributions to scientific literature, conferences and/or understanding of company processes
- Sense of urgency and desire to get things done effectively and efficiently
- Able to demonstrate success in technical proficiency, scientific creativity, collaboration with others and independent thought
- Able to clearly communicate scientific information both written and oral with minimal assistance
Overview
10
10
years of post-secondary education
12
12
years of professional experience
Work History
Senior Research Officer, Discovery Toxicology
Glenmark Pharmaceuticals Limited
Navi Mumbai, MAHARASHTRA
11.2015 - Current
- Functioned as study director for the in-house exploratory toxicity studies with complete responsibilities from preparation of study plan, amendments, deviations, generation and interpretation of data to preparation of the study report.
- Ensured managing all activities with precise planning, design and conduct of the study, interpretation of the results etc.
- Adopted high quality standards and met the timelines for each study and prepared study reports within 2 weeks upon submission of Pathology phase summary.
- Worked in all activities related to in-life phase of the study (Selection of animals of appropriate age, gender and weight, animal handling, randomization, preparation of various reagents, formulation preparation, body weight recording, dosing of animals by various routes, observation of clinical signs, collection of various body fluids, bone marrow/blood smear preparation and staining, fasting of animals, necropsy, TK, etc.).
- Performed statistical analysis of data and prepared a flow chart on various statistical approaches on handling repeat dose tox data.
- Support for conduct and execution of repeat dose toxicity studies for generic drugs.
- To identify procedural aspects while conducting a tox study that will improve the overall conduct or interpretation of the study/result.
- To perform the necessary literature search and provide scientific inputs on study findings and novel targets.
- Performed clinical chemistry, hematology, coagulation and urine analysis for all studies.
- Maintained the required inventory of kits for all clinical pathology instruments and plan procurement of kits in a cost-effective way considering the requirement and expiry of kits.
- Maintained the clinical pathology instruments in the working condition by regularly performing preventive maintenance.
- Performed analysis of proper QC and RIQAS samples in a timely manner to ensure quality of results.
- Attending troubleshooting of all clinical pathology instruments.
- Reading and interpretation of all clinical pathology parameters and interact with study pathologist.
- Monitoring of repeat dose toxicity studies outsourced to GLP contract research organizations for NCE or Generic compounds as and when required.
- Ensured review of study plan, conduct of study and finalization of study reports as per plan to meet project specific timeline.
- To provide toxicology strategy, literature search and scientific input in relation to pre-clinical safety for new target ideation.
- Provide toxicology related support to new target as per screening cascade during discovery phase.
- Assist in validation of biomarkers or addition of new safety end points for the toxicology studies.
- To perform necropsy, organ collection/weighing and assist in Histotechniques as and when required.
- Reviewing and performing data verification/QC of Investigator's Brochure (IB) for the purpose of filling Investigational New Drug Application (IND).
- Permitted daily exposure (PDE) and Occupational exposure limit (OEL) assessment for Glenmark products.
- Preparation of SOPs and forms required for routine functions as required.
- To interact/communicate with the members within (in vivo team/animal house/genotox) and outside department (DMPK/Pharmacology) as required for the studies.
- Interact with vendors whenever required.
- To share of all exploratory study results within study team, relevant cross functional Team, HOD etc in timely and transparent manner.
- Submit necessary experimental protocols for IAEC approval and comply with animal welfare.
- Complete histopathology including gross pathology support for all in vivo experiments carried out for efficacy and safety related studies: Inflammation (COPD, Pulmonary fibrosis) and Immunology (Rheumatoid Arthritis & Psoriasis).
- Planning, designing and conducting acute and chronic efficacy studies for the discovery compounds.
- Responsible for establishing, validation and implementing of experiments that support the selection and development of therapeutic agents for the treatment of cancer, Inflammation (COPD, Pulmonary fibrosis) and Immunology (Rheumatoid Arthritis & Psoriasis).
- Contribute significant scientific inputs to projects as and when required.
- Validation of the various pharmacological models. Example: Cancer (CT26 xenograft model in mice), Psoriasis (IMQ or IL-23 induced Psoriasis Model in Balb/C mice), COPD (LPS induced neutrophilia, cigarette smoke induced COPD models), Pulmonary fibrosis (Bleomycin induced pulmonary fibrosis in C57 mice) and Rheumatoid arthritis (Type II Collagen induced Arthritis in DBA1 J mice).
- Presented new therapeutic target on immune-oncology including strategies and market analysis.
- Experience of writing publications, abstracts, slide sets, poster, manuscripts and SOP.
- X-ray evaluations for arthritis models.
- Procurement of study related equipment, chemicals & materials.
- Responsible for educating and training various techniques of histopathology & in vivo pharmacology to technicians & new joiners.
Scientist
Suven Life Sciences Limited, Hyderabad
Hyderabad, Telangana
07.2009 - 10.2015
- To work as a study director to prepare protocols, conduct various toxicological studies (acute, subacute, sub-chronic) in laboratory animals and preparation of study report of NCE's as per GLP compliance and IND filings with due consideration to OECD, EPA and ICH guidelines.
- To work as study pathologist in the conduct of toxicity studies and preparation of pathology report.
- To work as study director for genotoxicity studies and report preparation.
- To perform microscopic examination of tissues (histopathology) in various toxicity studies.
- To perform necropsy, gross pathological examination for various toxicological studies.
- To perform the clinical pathological investigation.
- To perform pathologic evaluation to decide target organ/tissues, interpretation of the report with clinical laboratory investigations (hematology, clinical chemistry and urinalysis) for rodents and non-rodents repeated dose toxicity studies in animal models like rats and dogs.
- Validation and generation of historical control data.
- Hands-on practice of histotechnique (Trimming, processing, embedding, sectioning & staining).
- Maintenance of pathology function to support in vivo in-house and sponsor toxicology studies.
- To provides significant technical/scientific inputs into the design of the studies, working as a part of the research team.
- To provide new capabilities, procedures, methods and models (animal based) to support all function of in vivo and in vitro Toxicology as and when required.
- To perform documentation as per good documentation practices and with due consideration to Good Laboratory Practices (GLP).
- Preparation and implementation of Standard Operating Procedures (SOP).
- To train the newly recruited staff in various toxicological procedures.
- Health monitoring of Laboratory Animals.
- Replying to QA (Quality Assurance) for the inspection reports.
- Archiving of data.
Veterinary Physician & Surgeon
Pet Pets & Pets Clinic
Mumbai, MAHARASHTRA
01.2009 - 06.2009
- Practiced veterinary medicine, reviewed pet health history, examined animals, conducted tests and prescribed treatments for diagnosed conditions.
Guest Lecturer
Bombay Veterinary College
Mumbai, MAHARASHTRA
07.2008 - 12.2008
- Prepared and delivered course content to facilitate and moderate classroom discussions and student-centered learning to Veterinary Graduate students in Veterinary Pathology.
Education
M.V.Sc. - Veterinary Pathology (85.94%. First Class)
Bombay Veterinary College
Mumbai 08.2006 - 12.2008
B.V.Sc. & A.H. - Veterinary Sciences (81.20%, Distinction)
Bombay Veterinary College
Mumbai 03.2001 - 07.2006
H.S.C. - Science (78.67%, Distinction)
New Arts, Commerce & Science College
Shevgaon 04.1999 - 02.2001
S.S.C. - All Subject (80.66%, Distinction)
Mahatma Gandhi Vidyalya
Yeli 04.1998 - 03.1999
Skills
Planning, design and execution of in-vivo toxicity and biocompatibility studies
PAPERS PUBLISHED
- Determining the effect of storage conditions on prothrombin time, activated partial thromboplastin time and fibrinogen concentration in rat plasma samples. Vinod Kumar Goyal, Somesh Kakade , Santosh Kumar Pandey, Anil Kalidas Gothi and Ramakrishna Nirogi. Paper published in LABORATORY ANIMALS, 2015, Vol. 49(4) 311–318.
- Evaluation of clinical chemistry analytes from a single mouse using diluted plasma: effective way to reduce the number of animals in toxicity studies. Vinod Kumar Goyal, Santosh Kumar Pandey, Somesh Kakade and Ramakrishna Nirogi. Paper published in LABORATORY ANIMALS, Dec 2015.
- Chronic Genotoxic Effects of Mercuric Chloride in Wistar Rats. Kakade S.V ., Sabale S.S., Shinde P.R., Kadam D.P. and Nehete R.S. Paper published in The Journal of Bombay Veterinary College, 2010 Vol: 18 (1)
- Chronic Toxicopathological Effects of Inorganic arsenic on Growth of Wistar Rats. Sabale S.S., Shinde P.R., Kakade S.V ., Kadam D.P. and Nehete R.S. Paper published in The Journal of Bombay Veterinary College, 2010 Vol: 18 (1)
SHORT COMMUNICATIONS
- Aortic form of Spirocerca lupi in German Shepherd Dog. Sabale S.S., Shinde P.R., Agarkar Y.D., Yerolkar A.J., Rathod S.B., Pawar Y.P., Mote C.S. Kakade S.V ., Princy Thomas, Kadam D.P., and Nehete R.S. Short communication in the journal of Bombay Veterinary College, 2008 Vol:16 (1)
ABSTRACTS
- SUVN-I1312004, a novel m1 muscarinic acetylcholine receptor-positive allosteric modulator: Potential for the treatment of Alzheimer's disease. Renny Abraham, Shankar Reddy Gagginapalli, Santosh Kumar Pandey, Somesh Kakade , Ramakrishna Nirogi. Abstract presentation in Alzheimer's & Dementia: Journal of the Alzheimer's Association, July 2015, Volume 11, Issue 7, Supplement, Pages P615–P616.
- Pathology of Experimental Newcastle Disease in Broilers and Effect of Herbal Medication (Immuved). Jadhav M.M., Dhumal R.V., Shelar P.D., Kakade S.V , Agarkar Y.D., Pagrut N.S., Pawar S.J., Suryawanshi D.S., Mote C.S. and Nehete R.S. Abstract presented in XXIV annual conference of IAVP, 1-3 Oct, 2007 held in Tirupati -600 007 .
- A case of Leopard with multiple pathological changes. Agarkar Y.D., Suryawanshi D.S., Sable S.S., Kakade S.V ., Shinde P.R., Nehete R.S., and M.S. Karawale abstract presentation in XXIII annual conference of IAVP, 27-29, December 2006 held in Chennai- 600 007.
- Occurrence of neoplasms in canines. P. P. Yogita, S. S. Sable, S. V. Kakade , P. R. Shinde, S. B. Rathod, K. Kalai, N. S. Pargut, Y. D. Agarkar, P. Thomas, P. V. Meshram, R. S. Nehete, A. J. Yerolkar and D. P. Kadam Abstract presented in Silver jubilee annual conference of IAVP, 10-12 Nov, held at IVRI.
CONFERENCE PAPERS
- Quantity of Plasma Not a Constraint to Measure Clinical Chemistry Analytes. S. Jana, V. Goyal, S. Pandey, A. Gothi, S. Kakade and R. Nirogi paper presentation in SOT 2014 Annual Meeting, At Phoenix, Arizona, USA.
- A Simple Method of Cerebrospinal Fluid Collection from Conscious Beagle Dogs and Its Application as a Surrogate for the Assessment of CNS Exposures. V. Goyal, S. Pagrut, S. Pandey, S. Jana, A. Gothi, S. Kakade, G. Bhyrapuneni and R. Nirogi paper presentation in SOT 2014 Annual Meeting, At Phoenix, Arizona, USA.
CONFERENCE / SEMINAR ATTENDED
- Sixth conference and continued education program on “ Toxicologic Pathology of Nervous and Musculoskeletal Systems ” organized by Society of Toxicologic Pathology-India at Pune, 21 - 23 October 2016.
- Fifth International Conference on “ Laboratory Animal Medicine and Management ” organized by LASA India & CPCSEA at Hyderabad, 7-9 February 2013.
- One Day Brainstorming Seminar on ‘ Animal Health, Well Being & Quality-The role of IAEC 'organized by LASA India with CPCSEA at Hyderabad, Feb 2012.
- XXIII Annual Convection of Indian Association of Veterinary Pathologists (IAVP) 27-29 December 2006 held in Madras Veterinary College, Chennai-600 007.
- A satellite seminar on “ Pathology of Emerging Zoonoses and Transboundary Diseases of Animals ” by CL Devis DVM Foundation, USA , 27-29 December 2006 held in Madras Veterinary College, Chenni-600 007.
- 1st Annual Course in Toxicologic pathology – Road to Toxicopathology jointly organized by Charles Louis Davis, D. V. M Foundation and Society for Toxicologic Pathology in India held at Pune during March ,13-15, 2008.
AFFIRMATION
I self-assuredly declare that, all the details given above of curriculum are fair and true as per best of my knowledge.
Timeline
Senior Research Officer, Discovery Toxicology
Glenmark Pharmaceuticals Limited
11.2015 - Current
Scientist
Suven Life Sciences Limited, Hyderabad
07.2009 - 10.2015
Veterinary Physician & Surgeon
Pet Pets & Pets Clinic
01.2009 - 06.2009
Guest Lecturer
Bombay Veterinary College
07.2008 - 12.2008
M.V.Sc. - Veterinary Pathology (85.94%. First Class)
Bombay Veterinary College
08.2006 - 12.2008
B.V.Sc. & A.H. - Veterinary Sciences (81.20%, Distinction)
Bombay Veterinary College
03.2001 - 07.2006
H.S.C. - Science (78.67%, Distinction)
New Arts, Commerce & Science College
04.1999 - 02.2001
S.S.C. - All Subject (80.66%, Distinction)
Mahatma Gandhi Vidyalya
04.1998 - 03.1999
Similar Profiles
Kinjal GoswamiKinjal Goswami
HRBP - Assistant Manager at Glenmark Pharmaceuticals LimitedHRBP - Assistant Manager at Glenmark Pharmaceuticals Limited
Buddhadev BasuBuddhadev Basu
Senior District Sales Manager at Glenmark Phamaceuticals LimitedSenior District Sales Manager at Glenmark Phamaceuticals Limited
JACKSON JOYJACKSON JOY
Assistant Manager - Projects at Acino Pharmaceuticals FZ LLC (erstwhile Pharmax Pharmaceuticals FZ LLC)Assistant Manager - Projects at Acino Pharmaceuticals FZ LLC (erstwhile Pharmax Pharmaceuticals FZ LLC)