PROFESSIONAL & CAREER MILESTONES
Key positions in Operations and Management of Business units
- Contributed to the establishment and management of clinical operations, central clinical and bioanalytical laboratory for three most successful independent CROs in india, Pharma majors and Hospitals
- Establishment and management of a central clinical laboratory and regional centre for speciality biomarkers in aeas of oncology, In born errors of metabolism, infectious diseases (TB,HIV,HCV, HBV, malaria, Dengue) diagnosis and treatment monitoring, therapeutic drug monitoring in transplant medicine, psychiatry and endocrine disorders.
- Establishment of clinical research department within a pharmaceutical major to support medico marketing, in-licensing and co-development to initiate clinical development programme in coordination within academic medical centers and independent tertiary care hospitals.
- Contributed to organic and inorganic growth of business units by means of in-licensing, out-licensing/technology transfers, Health care professional (HCP) and key opinion leader engagement/ management, restructuring innovation, production and systems to support global business expansion and presence. Identify, evaluate strategic acquisition and partnership in established and emerging markets across the globe.
- Restructured CRO operations to provide clinical development of speciality generic pharmaceuticals, clinical end point based generic development (for oncology, locally acting GI drugs and topical formulations), medical devices and FMCG products.
- Responsible for managing medico marketing, clinical research and restructuring formulation R&D for two pharma majors.
- Establishment of clinical pharmacy practice unit and pharmaceutical care centre within a academic medical centre and teaching hospital.
Professional & Technical Skills
- Have a clear depth of operations and management experience across the entire value chain of pharmaceuticals, Biotech, Nutraceuticals, Medical devices industry which include discovery, development, licensing/regulatory, production, medico marketing and sales.
- Expertise in establishment and management of clinical operations, clinical laboratory and pharmaceutical care within academic medical centers and independent tertiary care hospitals.
- A sound understanding of all aspects of discovery and development process combined with the leadership and motivation skills to successfully manage cross functional project teams engaged in discovery, preclinical and clinical development, formulation and analytical development, pilot and scale up production.
- Development and Implementation of Good Clinical and laboratory Practices and Good Clinical Data Management Practices and sponsor contracts to meet regulatory guidelines both National and Global food, drug and devices regulatory agents, guidelines and standards.
- Extremely goal oriented and results driven, with a keen eye for business development opportunities in the Pharmaceutical, Biotechnology, contract research and manufacturing services industry. Have a proven ability to build and develop successful partnering and licensing deals.
- Responsible for promoting contract research organisation capabilities and services to outsourcing decision makers and influencers at pharmaceutical and biotech companies with the objective of identifying business opportunities, securing requests for proposals and winning contracts.
- Responsible for addressing queries, developing study designs, guidances, protocols, standard operating procedures for complex clinical and bioanalytical developmental challenges in collaboration both at the service provider and the regulatory authority levels.
- Proficiency in Microsoft office. Working knowledge on software packages for word processing, image analysis, statistical analysis, graphics, html language etc. Used bio animations and computer simulated experimental pharmacology and physiology tools as both research and teaching aids. Proficiency in SAS Pheedit, LIMS, Win Nonline, SPSS, Graph Pad Prism, Winstat and Data management tools like Oracle Clinical with RDC.
- Significant experience in directing industry and academic groups, senior level collaborations among multiple stakeholders, and working in matrix environments.
- Established and skilfully directed cross-functional, multidimensional and focused groups within the organisation and external partners including key opinion leaders in research, clinical practice, regulatory affairs, business process and strategy.
- Been a highly motivated executive with experience in the pharmaceutical, generic, consumer health and device industries with a record of significant accomplishments in product innovation, product development, project management, technical service, technical transfer, off-shoring/outsourcing, and change management.
- Provided functional leadership through directing and managing analytical research and development, product development, process development, technology transfer, stability studies, pilot and pivotal production.
- Been a results driven leader with people, organization and communication skills. Recognized for leadership, efficiency, follow through and trouble shooting. Formed cooperative and productive relationships between all levels of organizational personnel.
- Led, managed and worked with R&D associates in project management, clinical research and development, medical affairs, drug safety and regulatory affairs.
- Evaluated medical, pharmaceutical, and regulatory market trends, consumer needs, opportunities and planned product innovation priorities accordingly.
- Built and led a culture of success and high employee engagement in a laboratory setting, including team selection, development and creating high performance teams.
- Successful in building a world class technical and management team. A proven ability to attract and develop outstanding talent.
- Managed external partnerships with a record of positive results and outcomes, defining, negotiating, managing expectations and managing contracts.
- Gained experience in working in a matrix environment, especially related to product development and global drugs and devices regulatory filings, submissions and product supply.
- Have established strong relationships at and prior interactions with the highest levels of global regulatory agency to enable filings, submissions, approval and licensing.
Operations & Management Competencies
- Overseen management and direction for all planning, control and logistics for the operations and execution of the business process including employment, promotion, performance evaluation, training, counselling and discipline of Operations staff.
- Participated in the overall management of the company as a member of the top management team and responsible for influencing change in the organization as core management team member including driving cultural change in the teams by fully participating and contributing in change management initiatives.
- Overseen planning and scheduling resource allocations and ensure staff performance and quality standards are met. Managed resourcing managers and review performance of the business process, operations and make recommendations for improvement in quality and efficiency.
- Responsible for on time identification, recruitment, training and retaining of personnel to meet customer proposals, feasibility teams and projects.
- As a member of the executive board worked closely with the Chairman, Directors, Key personnel and managers for the development and implementation of operational standards, policies, systems and procedures. Responsible for ensuring coordination and integration of Operations with other functional areas within and associate companies.
- Built execute strategy, managed and monitored business development along with marketing and sales team. Provided presales and post sales support in technical aspects. Provided input to, and review/approval of, study bid proposals and contracts.
- Planned, designed and implemented appropriate training programs for both administration and scientific personnel to enable effective and timely project execution and attain client satisfaction.
- Fostered a supportive and inclusive working environment through individual leadership, teamwork and an effective human resource management.
- Possess good intercultural sensitivity and previous experience of working internationally, ideally leading international teams.
Product Innovation and Development
- Developed several functional food formulation and nutraceuticals to address diseases specific deficiencies. Particular focus has been in the management of Diabetes and Metabolic syndrome (RECOLINA), Protein energy maltnutrition and cancer cachexia, Tuberculosis, liver and renal dysfunctions.
- Novel ophthalmic drug delivery system to optimize the delivery of a non-steroidal anti -inflammatory agent for the treatment of pre and post cataract surgery. First aqueous suspension of Indomethacin eye drops (INDOFLAM).
- Endothelin as a novel drug target for coronary artery disease and hypertension lead to the development of several endothelin receptor antagonists.
- Phosphodiesterase types IV and V inhibition as a novel non- steroidal drug target for pulmonary hypertension, asthma and COPD.
- Clinical development and launching of the world’s first disease specific probiotics for gastro intestinal disorders, Urogenital disorders and chronic liver disease (BIFILAC and ECOFLORA).
- Oral formulations (Buccal/Sublingual spray)with enhanced bioavailability properties for essential nutrients and potent drugs.
- Novel Nicotine replacement therapy in the form of Oral dissolving thin film (FUIZ TOBACCO).
- Novel anti-emetic formulation for aged and cancer patients in the form of Oral dissolving thin film of Ondansetron.
- Novel drug delivery system for potent pharmaceuticals requiring dose reduction.
- Development of Biosimilars, Oncology, locally acting and topical generic drugs.
- Designed and Conducted first clinical end point Bioequivalence study for USFDA submission.
- Contributed to several Para IV ANDA, NDA, 510K and 505 (2) b filings.
- Novel phytopharmaceutical for Women’s health, Autoimmune disorders, psoriasis, atopic skin disorders and musculoskeletal disorders.
- Novel Herbal mosquito repellent mixture to be formulated as lotion, vaporizer and coils free of smoke.
Drug targets and disease mechanisms
Develop novel drug targets for Diabetes and metabolic syndrome, cardiovascular and cerebrovascular disorders -myocardial ischemic/reperfusion injury, respiratory- asthma, pulmonary hypertension and COPD, renal disorders-renal calculi and cancer cachexia. Mechanism of Drug and disease induced nutritional deficiency.
Development of disease specific probiotics in gastrointestinal disorders, urogenital infections and hepatic diseases.
EMPLOYMENT HISTORY
Industry
Nov 2016 – Present, Consultant, Pharma/CRO/Healthcare care technology/Hospitals, Bangalore
- Providing consultation in the establishment, operations, project management, KOL management,business unit restructuring, accreditation, strategic business development and product development/licensing for pharma, biotech, functional food industry, hospitals, clinical laboratories and contract research organizations.
- As a Patient advocate, Consultant in Integrative medicine and Functional nutrition, Currently engaged in enabling clinical data and data science to translate into clinical practice to empower predictive, precision, personalised and preventive medicine.
- Particular interest in advocating, developing and implementing integrative health and functional medicine/nutrition protocols to address woman and child health, chronic metabolic diseases, autoimmune disorders, developmental disorders, age management and regenerative health.
- Developed protocols and programme to enable sustainable health and healing by incorporating appropriate medical systems,healthcare technologies, medical devices into clinical practice and patient care.
- Responsible and relevant engagement in initiatives towards Zero budget natural farming, conservation of biodiversity, sustainable clean source of food chain and renewable energ.y
2016 May - 2016 Oct Vice President and Regulatory Affairs, at Apex Labs Pvt Ltd, Chennai
A leading indian pharma and nutraceutical company with global operations. Engaged in restructuring the research and development division to meet global regulatory guidelines to conduct both proprietary and contract research. Formulated and executed business strategies for in-licensing, out-licensing, co-development, brand acquisition and merger of products and technologies.
2014 Feb - 2016 April Director, Fivecom Softech Solutions Pvt Ltd and Signmed Healthcare & Research Pvt Ltd, Bangalore, INDIA
Fivecom is a KPO company offering lifescience intelligence, business analytics and key opinion leader management services to pharma, biotech and healthcare industry.
Signmed is a personalized and preventive medicine center with polyclinic consultation, pharmaceutical care, diagnostic imaging and clinical laboratory facilities. As a founding director and management consultant, was responsible for conceptualizing, planning and establishment of the center.
2012 Dec - 2014 Jan Chief executive officer, Brainwave Biosolutions Ltd, Chennai
A company providing life science intelligence services to global pharma, biotech and medical devices industry in the areas of key opinion leader management, Data analytics and management, intellectual property and patent research.
2004 June - 2014 Feb Founder, Director, Alticure research Private Ltd, Chennai
Alticure is a company providing consultation in the establishment, operations and project management of hospitals, clinical laboratory medicine and biomedical research, pharma, biotech, food industry and contract research organizations.
2007 Dec - 2010 Jan Chief Executive Officer, Huclin Research Limited, and Executive Director, Regenix Drugs Ltd, Chennai
A Contract clinical research and bioanalytical services company for Pharmaceutical, Biotech, Nutraceuticals and medical devices industry. As a executive director at Regenix , provided consultation in areas of strategic partnership, In-licensing and marketing of medical devices and companion diagnostics.
2005 July - 2007 Nov Vice president and Director, Regional laboratory, Vimta Labs Ltd, Chennai and Hyderabad
A publicly traded contract research and central clinical testing laboratory for the Hospitals, Pharma, Biotech, Neutraceuticals, Food, FMCG and medical devices industry. As a Vice president and Director of clinical and laboratory services with Vimta Labs Limited, a publicly traded full service global contract research services company, managed several clinical development projects for speciality pharmaceuticals and generics. Been responsible for both preclinical and clinical development of novel drug delivery systems. NCEs, Phytopharmaceuticals, Nutraceuticals, NDDS, Therapeutic switches, Medical devices, Diagnostic aids and Biomarkers. Managed a large cross functional team of more than 500 which included life scientists, Clinicians, Paramedics, Physician assistants, bioanalytical, business development, marketing and sales personnel. As a director of regional laboratory, headed the clinical and laboratory operations of a most advanced central clinical and bioanalytical laboratory for clinical biochemistry, microbiology, anatomical pathology, molecular biology, and genetic analysis.
2003 Aug - April 2005 Head, Clinical Research, Jhaver Research Foundation (a division of Tablets India Limited), Chennai, INDIA.
Responsible for establishment of clinical research department to engage in new product development and providing medico marketing support. Identify, evaluate and collaborate with strategic partnership overseas in the Europe, UK, US and Japan for in licensing, co- development and marketing novel products into india.
2001 Feb - July 2003 General Manager, Operations- Lotus Labs Pvt Ltd., Bangalore., INDIA and
Head of Department, Assistant Professor, Clinical Pharmacy Practice, KIMS, Bangalore
As a General Manager, Operations at Lotus Labs Pvt Ltd., my role involved setting up the clinical operations and central laboratory facility. Fostering cultural and technical competency within in the personnel to prepare them for client and regulatory audits. Engage in technical collaboration with external partners and vendors with complimentary capabilities to support product development requirements of the client. Develop and review Clinical Trial Protocols, SOPs, In house staff training in GCP and GLP practices.
1994 Sep - 2000 Dec Research Scholar and Fellow- Medical Research Council, British Lung foundation & Wellcometrust , UK and Department of Physiology and Pharmacology, Strathclyde Institute For Pharmacy and Biomedical Sciences, Glasgow, UK. A MRC, British Lung Foundation and The Wellcome Trust Funded Project Investigating- “ Role of Endothelin in the Myocardium and Cardiovascular system and “Novel Mechanisms regulating cGMPsignalling in airway smooth muscle”-with special emphesis on membrane bound phosphodiesterase –5 (PDE-5) using various Molecular and Biochemical pharmacology tools.
1991 June - 1994 Sep R & D executive and Clinical Research Co-ordinator at Recon Ltd a division of Bangalore Pharmaceuticals and Research Laboratories (BPRL) Ltd., Bangalore, India.
Pre-clinical pharmacological screening of several natural and synthetic drug molecules. Following extensive pre-clinical pharmacological studies, was responsible for Organization and Supervision of Clinical trials of a blue green algae Spirulina fusiformis in diabetic and hyperlipidaemic patients. Formed part of the team of researchers who were responsible for introducing the product into the market as a dietary supplement (adjuvant) for diabetes. Preparation of dossiers for new drug formulations and documentation for ANDA application and export registration of generic pharmaceuticals. Developed oral, ophthalmic and topical formulations. Supervision of manufacturing and formulation development of pharmaceuticals. As a project co-ordinator to the academia and clinical evaluation centres, Research supervision of postgraduates in pharmacy and medicine. Consulting the product management team in the marketing department to prepare literature of new products, liaising with opinion leaders and expert clinicians to develop and design product concepts, medico marketing aids and monographs for product promotion.
Academia (1992-2013)
- Academic advisor and examiner for postgraduate and doctoral programme in lifesciences at Madras Medical Mission institute for paramedical sciences, Dr M G R University, SRM University, Sri Ramachandra Medical University Chennai, Meenakshi Medical College and Hospital, kancheepuram.
- Asst. Professor at the Department of Clinical Pharmacy Practice at KIMS Hospital and Research Centre, Bangalore, INDIA.
- Visiting Professor, at Al-Ameen college of pharmacy , Bangalore, INDIA.
- Tutor for BSc Pharmacy and MSc Pharmacology students at University of Strathclyde, UK. Supervision of postgraduate and Doctoral students in Biochemical Pharmacology, Cardiovascular Pharmacology and Pharmaceutical Sciences.
- Visiting Faculty pharmacology, clinical toxicology and applied biochemistry to Pharmacy graduate students at Govt. College of Pharmacy, University of Bangalore, India.
Association With Professional Bodies
- Council member of GLG (Gerson Lehrman Group)
- Member Association of Clinical Research Professionals(ACRP) and Founding member of Association of Contract Research Organisations (ACRO) India chapter
- Member Federation of International Pharmaceutical Professionals (FIP)
- Member AOAC International
- Member SOCRA
- Member Cardiology Society of India (MCSI)
- Member Indian Diabetic Association, Southern Chapter
- Member European Society of Clinical Pharmacy
- Member United Kingdom Society of Clinical Pharmacy
- Member of the International Society for Heart Research (ISHR)
- Scottish Signal Transduction Group (SSTG)
- Member of International Pharmaceutical federation (IPF)
- Member British Society for Cardiovascular Research (BSCR)
- Scottish Cardiovascular Forum (SCF)
- Member Indian Pharmaceutical Association (IPA)
- Member of American Society for Advancement of Science (ASAS)
- Faculty member Novo Nordisk Diabetic Update Conferences
- President, The Indian Students Society (1996-1998), University of Strathclyde, UK
- Secretary, the Pharmacological Society (1995-96), University of Strathclyde, UK
- Life member “ Shutter Bugs” Photographic Society, INDIA
Education & Training
- 1997-2001 Research Fellow in Cellular and Molecular Biology , Strathclyde Institute for Pharmacy & Biomedical Sciences, Glasgow, Scotland, UK
- 1998 – 2000 Masters in Business Administration, Strathclyde Business School, Glasgow, Scotland , UK.
- 1994 – 1997 Doctoral Research Scholar in Physiology & Pharmacology, University of Strathclyde, Glasgow, Scotland , UK.
- 1994 Institute of Biology accredited training for personnel working under the Animals (Scientific Procedures) Act 1986
- Scottish PIL Training Committee, West of Scotland (SCT-W94013), UK
- 1991-1993 Masters in Pharmacy ( Pharmacology ) University of Bangalore, Bangalore, India
- 1987-1991 Bachelors in Pharmacy (University of Bangalore, Bangalore, India) and a Registered Pharmacist (Reg No. 15536)
Awards And Honours
- British Lung Foundation (BLF), Research Fellow, 1997-2000
- Medical Research Council (MRC), UK, Research Fellow 1994-2000
- Overseas Research Student Award, CVCP, UK 1994-1997
- David Livingston Scholarship, UK, 1994-1997
- Faculty member, Novo Nordisk Diabetic update conference, 1993
- Junior Research Fellow, University Grants Commission, India, 1991-1993
- Research Grant- Bangalore Pharmaceuticals & Research Laboratories, India, 1991-1993
Experience and interest in establishing, restructuring and strategic alliances in the Hospital, pharma, biotech, healthcare technology and contract research space, funding structures and opportunities, driving organic and inorganic business expansion. Capable of building, fostering collaboration and multidisciplinary teams both within the industry and academia.
Experienced in working with partners and clients across the globe which includes but not limited to North America, South America , Europe, UK, Japan & China in the areas of generics, speciality pharmaceuticals, nutraceuticals, cosmetics, FMCG and medical devices involving contract research and manufacturing, in-licensing, co-development, co-marketing, out-licensing, brand acquisitions and mergers.
