Multi Vaccine Development Program. Not For Profit Research Society

Executive Team

The Executive team is led by a Program Director appointed by the MVDP Board.

Kavita Singh Program Director

Kavita SinghKavita, has been the Program Director of MVDP since July 2009 when MVDP was initiated as a project of ICGEB. Kavita has completed her MBBS from Govt. Medical College, Patiala and MD (Medical Microbiology) from PGI, Chandigarh. She completed one-year certificate course in Executive Program in Business Management from IIM, Kolkatta in 2007. Kavita has spent about 11 years in Indian Pharmaceutical (Ranbaxy Laboratories) and Biotechnology (Shantha Biotechnics) companies working towards development of novel & generic drugs, therapeutic proteins and vaccines. In her last position, she was also responsible for Business Development of the Contract Research Organization (Fortis Clinical Research Limited) in addition to clinical operations.

Her present responsibilities at MVDP are to oversee early translational research of the different vaccine candidates, to identify external vendors for process development, cGMP production and toxicology studies of vaccine candidates and clinical trials. She is also responsible for identifying new projects and formulate developmental plans in consultation with the board to reduce the impact of identified potential risks. She is also responsible for obtaining approval of management board following technical review of new vaccine candidates and identify funding sources and co-ordinate execution.

Paushali MukherjeeAssociate Director - Project Management and Bioanalytical Development

Paushali MukherjeePaushali, Associate Director, Project Management and Bioanalytical Development has been working with MVDP since March 2015. She holds a PhD in Anthropology from Delhi University who evolved into an experienced Immunologist. With more than 20 years of experience, she specialises in studying cellular and humoral immune responses to infectious diseases and vaccines (recombinant, subunit, peptides, VLPs) both in in-vitro and in-vivo models. She has lead teams through pre-clinical animal studies and clinical trials immunoassays for novel malaria vaccines. As In-charge of Immunoassay Laboratory (GCLP-like laboratory) at ICGEB, she standardized and validated various immunoassays including ELISAs for recombinant proteins, immunofluorescence, Bioplex, binding inhibition assays and in-vitro parasite growth inhibition assays for pre-clinical and Phase I clinical development of novel malaria vaccine candidates. She has hands on experience in cell cultures, cellular and humoral immunological techniques, multi-parameter flow cytometry (cell surface and intracellular cytokine staining), immunofluorescence, Neutralization assays, ELISPOT assays, ELISA, growth inhibition assays (GIA, ADCI), Bioplex/Luminex and production of monoclonal antibodies. She has more than 20 peer-reviewed publications to her credit.

At MVDP she is responsible for managing Project timelines including financial managements, coordination with CROs, CMOs and funding agencies. She is also involved in preparation and review of regulatory dossiers for submission to RCGM, CDL Kausali and DCGI. She is instrumental for bioanalytical development which includes designing, optimization, qualification and validation of in-vitro cellular and humoral assays that mimic in-vivo immune responses. She also carries out biostatistical analysis and interpretation of results.

Meenakshi BakshiConsultant - Quality Assurance

Meenakshi BakshiMeenakshi, Consultant-Quality Assurance , has been associated with MVDP since January 2016. She is a qualified Quality Management professional with Master's degree in Clinical Biochemistry and Post Graduate Diploma in Clinical Research. Her work experience spanning over 19 years includes design and implementation of Quality Management Systems (QMS) in domains of clinical laboratories and clinical research organizations (CROs: Phase studies, Bioavailability/Bioequivalence studies and cosmetics). She has acquired necessary skill sets and competence in design and implementation of QMS, audits (investigative sites, data bases, software and platforms, information technology, reference labs, systems, vendors), accreditations & inspections of reference laboratories and CROs (both pharmaceutical and cosmetics), advice on quality and efficiency/process improvements.

She has handled responsibilities across geographies namely India, China, Singapore and Belgium for Medpace Inc., Fortis Clinical Research, SRL's laboratory at Fortis- Mohali, DMC&H. As CEO and Scientific Director she has headed Cosmetics and Dermatology CRO CIDP, India. She has performed several audits in the fields relevant to GCP/GLP/GCLP/ISO15189 (for medical laboratories) and cosmetic studies. Her key trainings include Good Clinical Practices (GCP) by British Association of Research Quality Assurance (BARQA) in 2009, IA & QMS on ISO 15189: 2012 and Good Clinical Laboratory Practices (Whitehall Training, UK) in 2016.

In her role as Consultant QA, she is responsible to identify, design, implement and maintain QMS at MVDP in accordance with national & international regulations governing human research. This primarily involves SOPs management systems, document review of Phase I study during all phases in clinical, bio analytical and reference laboratory domains, managing training program pertaining to Good Clinical Practices (GCP) and Good Clinical Laboratory Practices (GCLP). She is an advisor on all quality matters at MVDP. She performs audits of third parties and vendors of contracted activities of MVDP.

Geetanjali Associate Director - Clinical Development

GeetanjaliGeetanjali ­joined MVDP as a Associate Director: Clinical Development in December 2016. She has completed her MBBS from Government Medical College, Amritsar and her MD (Pharmacology) from All India Institute of Medical Sciences, New Delhi. She has been associated with Pharmaceutical Drug Industry for the last 15 years.

She has worked closely with many R&D teams to strategize and formulate Regulatory roadmaps for development of New Drugs (both NCEs and Differentiated drug products), vetted clinical and non-clinical development plans, extensively reviewed clinical and non-clinical data for scientific and regulatory compliance and prepared/ supervised regulatory filings for Phase I/ II/ III clinical trials and NDA filing. She is credited with national and global NDA filing for Synriam, a new anti-malarial drug.  Her strengths include IND filing (India, US, EU) for NCEs and differentiated drug products, product development for global market with focus on Integrated Product Development with most optimum regulatory and clinical path, Project Gap Analysis and formulating strategies to minimize product failure, designing clinical trial protocols and other CT related documents, Clinical and Non-clinical data review.  At MVDP, she would help in strategic planning, formulating regulatory and clinical roadmaps for vaccines aiming at Integrated Product Development in compliance with national and International regulatory guidelines.

Rajender Jena Manager - Product Development

Rajender JenaRajender works as Deputy Manager Product Development at MVDP. He completed his M.Sc. in Biotechnology from the Berhampur University, Odisha in 2004.

Prior to joining MVDP in Oct-2011, Rajender served Intas Biopharmaceuticals for six years. Apart from other responsibilities he was looking after the complete process development of biotherapeutic proteins (biosimilars). He comes with rich process development experience covering preclinical, early and late stage development and process characterization. At Intas, he was a part of the team which developed many cyotokines and hormones, which are presently undergoing preclinical and clinical testing while one molecules has been launched in the Indian market.

His current responsibilities at MVDP covers various aspects of process development for the vaccine candidates from clone to antigen development with a specific emphasis on bridging the gap between the research and industry.

Ankita SinghSenior Clinical Research Associate

Ankita SinghAnkita, joined MVDP as a Clinical Research Associate in March 2016. She holds a Masters in Biotechnology from M.I.E.T, Meerut (2011) and one year Post-graduate certification in Clinical Research from Indraprastha Apollo Hospital, Delhi (2012). She also holds certificates in Medical Writing and Good Clinical Practice from Sanofi.

Prior to joining MVDP, Ankita has worked as clinical research associate for both drug and device clinical trials for 4 years. She has hands-on experience of managing multi-centric clinical trials. She also has actively communicated with Ethics committees and regulatory authorities for follow ups of oncology (Phase III) and cardiology (Phase IV) trials. Ankita has developed protocol for academic research project on stem cell at Indraprastha Apollo Hospital, Delhi. At MVDP, she supports the team to manage and monitor both in-house and site-related Phase I clinical trial activities. As a team member, she is responsible for submissions and follow-ups of applications to Ethics Committee. She oversees compliance to the clinical trial protocol at Investigator sites as per applicable regulations, Standard Operating Procedures and Good Clinical Practices.

Rajeev SehgalDeputy Manager - Accounts cum Administration

Rajeev SehgalRajeev serves as an Accountant cum Administrator at MVDP since May 2010. He is responsible for overseeing MVDP´s accounts and administrative functions, including the oversight of MVDP's grant funds. He manages the day to day accounting/billing and expense; coordinates with external Chartered Accountant and manages the taxation responsibility of the organization. In addition, he works closely with the Program Director of MVDP on administrative matters including policy making relating to the overall day-to-day management.

Prior to joining MVDP in 2010, he served for over 23 years in manufacturing and FMCG sector in various areas including financial accounting, audit and taxation.

He holds M.Com (Rajasthan University) and B.Com (Delhi University) degrees.