Lead Regulatory Affairs
Bioseed Research India – DCM Shriram Ltd
Total years of experience :16 years, 4 Months
Area of Specialization
15 plus years of experience together from Seven years of academic research and teaching experience in crop physiology, biotechnology, biochemistry, plant molecular biology and agronomy of crop plants. More than 10 years of corporate research and product development experience.
First-hand experience in gene isolation and functional characterization of stress responsive genes from stress adapted crops; Groundnut, Horsegram, Finger millet.
More than 10 years of corporate research and project management experience in crop biotechnology in tobacco, rice, cotton, tomato, hot pepper, brinjal etc. Have expertise in different crops, transformation techniques and transgenic characterization for trait expression. Biotechnology research programs, regulatory affairs, liaisoning, stewardship of the product evaluation. This includes one year in the Jatropha germplasm collection and evaluation for biotic and abiotic stress resistance. Accountable for establishing a regional Misson Biofuels office in Shimoga district, Karnataka.
More than five years of experience in Biosafety Regulations of food/feed and environmental Risk Assessment of GM products, outreach to all concerned stakeholders, Global scientific affairs of biotech traits and technology trends in crop improvement programs. Contract Research Organizations-CRO collaboration for risk assessment studies to fulfil regulatory compliance.
Presently playing active role in strategic advice and guidance in recombinant DNA technologies of biotic and abiotic traits to develop crops for disease resistance and yield enhancement. Coordinating lab and greenhouse research program monitoring. Writing research grant proposals in mandate crops like cotton, maize, brinjal, tomato and mustard. Preparation of regulatory dossiers, data analysis, interpretation and submission of dossiers to regulatory board for timely approvals.
Liaison with regulatory authorities and CROs for timely decisions of evaluation studies. GM products, food-feed safety and environmental risk assessment studies. Crop Protection formulations evaluation and risk assessment studies for registration and commercial use. Transboundary movements of GM and Non GM research materials.
Handling DSIR recognitions and renewal of R&D centers, preparation and submission of annual reports of IT returns to DSIR based on the ongoing and future research programs to claim fiscal incentives u/s 35(2AB).
Methodical knowledge of national and international regulatory framework. Scientific affairs of crop traits, Better understanding and review of regulatory guidelines of legislation. Stewardship of regulatory system/s from IBSC, RCGM, GEAC, NBA, NBPGR, PPQ&S for continuous research support and growth of the organization.
Achievements: During my current job roles, myself accountable for achievements of the company at various levels directly. To name some, Successful in obtaining corporate certificates for R&D, Applications preparation and submission and regulatory approvals from government of India, New leads established in crop protection formulation studies, established department of regulatory affairs, Established regulatory protocols for trait evaluation in crops.
My journey in the corporate sector so far made to learn important abilities to be flexible, strategic planning and execution of operations, aptitude to learn and work on new projects in short time, to keep updated on technologies in the related areas of work. Most important all these helped me to be good in communication and writing skills.
Rice transgenic lines expressing abiotic stress tolerance gene/s (ROS) were evaluated under contained greenhouse conditions to select elite event/s. The transgenic rice lines were analyzed for various characteristics through phenotyping and genotyping for trait characterization. The various characteristics through the physiological studies, biochemical assays, molecular characterization of trait expression was studied. During the course of analysis, developed standard operating procedures for SOD enzyme assays. Drought induced ROS genes expression profiling was studied as a result identified and cloned promising candidate gene/s expressing at 50% FC. Event characterization studies were carried out for the stable integration and expression of the trait. Based on the experimental results, the prominent rice transgenic lines were selected. Further seed multiplication trial conducted under contained greenhouse conditions to use for Elite Event Selection trial. Obtained RCGM permission for BRL-I trial.
During my second term in Avasthagen, the work carried out on Hot Pepper transformation by non-tissue culture based method to develop transgenics expressing for nutraceuticals properties.
Achievements:
•Developed SOPs for SOD enzyme assays.
•Drought induced expression profiling of ROS pathway genes well documented.
•Prominent rice transgenic lines were identified.
•The new research project was initiated to develop a POC in tobacco using ROS pathway genes in the proposed drought mitigating model to develop drought tolerant crops.
•Successfully transgenic rice breeding experiments conducted between japonica and indica rice under greenhouse conditions to transfer transgenic trait/s to indica lines.
•The research grant proposals submitted to funding agency to develop crops for drought tolerance.
•The success of the project was achieved by good teamwork and coordination
Worked as PostDoc research fellow in Potato Genome Sequence Consortium in Chile national research institute. Main responsibilities were to clone and characterize regulatory genes from anthocyanin biosynthetic pathway to enhance nutraceutical properties in potato. Production of colored potatoes by enhancing the expression of regulatory factors which impart pink, red brown colored potatoes.
Jatropha plantation operations in Karnataka. Jatropha is an alternative source for renewable energy wherein the seeds contain nearly 30-40% oil. The extracted oil can be converted into biofuel by transesterification process. The resulted product is called biodiesel, which has high combustion efficiency.
Achievements:
•Jatropha fields were surveyed extensively in southern parts of India and collected wide-range of germplasm.
•Jatropha Breeding program- Identified physiological and genetically potential lines having high female to male flower ratio with higher yields and oil content. Further, to develop new hybrids, cross breeding program was initiated in collaboration with TERI, New Delhi.
•Our team was accountable for standardization of Jatropha bare root nursery protocols, and worked out plant production and protection measures and developed Jatropha nursery manuals.
•Developed efficient research team to study the effect of bio/microbial fertilizers in Jatropha. To coordinate different research field operations of Jatropha plantations in different regions of Karnataka.
•Established a new regional Mission Biofuels branch office in Shimoga, Karnataka to oversee Jatropha plantations, nurseries and field research operations
Centre of Excellence for Drought research project to develop transgenic crops for abiotic stress tolerance. The project, sponsored by DBT. Govt. of India
PGPB- Postgraduate in Biosafety and Regulatory Affairs of International GM Regulatory System National and International Regulatory Framework General risk assessment of GM crops Environmental risk assessment Food and feed safety assessment other related biosafety studies
Brief description: Suitable stress protocols were developed for maximum expression of novel stress responsive genes in viz. Groundnut and Finger Millet. Nearly 1000 recombinant clones were obtained by subtractive hybridization from stress adaptive species in (groundnut / Finger Millet). To confirm stress response nature of transcriptome, expression analysis was carried out using dot blot expression studies. Sequenced clones were annotated at NCBI Blast search to see type of genes expressing under stress. Subsequently classified into different groups. More than 600 EST sequences were deposited in NCBI public domain. Few unique stress genes were further characterized for its specific expression using northern, RT-PCR, Real Time PCR analysis. Few of the stress specific gene viz. (EcDS- Elusine coracana drought stress), drought stress induced putative Sigma factor was further characterized by functional genomic approach using VIGS (Virus Induced Gene Silencing). Attempts were made for isolation of full length genes using different methods. Further using different physiological, biochemical and molecular experiments, it was validated for their stress responsive nature.
Brief description: We incorporated the gene coding for the enzyme isopentenyl transferase (IPT) that regulates cytokinin biosynthesis sourced from agrobacterium is incorporated in to tobacco plant. PCR positive transgenic plants producing high concentration of cytokinins were morphologically similar to wild types were selected. The physiological and morphological traits influenced by marginal increase in cytokinin levels were tested in primary transgenic plants T1, T2 and T3 generations. The transformed lines showed increased cytokinin content, delayed leaf senescence in all the generations. The transformed lines also showed increase in high nitrate reductase (NR) activity and assimilation rate at all the generations. These results indicate that a marginal increase in endogenous levels of cytokinin (iPA, DHZR and tZR were estimated by ELISA) is useful in delaying leaf senescence and by maintaining high photosynthetic rate in leaves resulting high biomass accumulation and also high capsule weight.
In Brief: Studied varied subjects in agriculture sciences related to Agronomy of field operations, Agronomy of crop soil science and management. Gained knowledge in different crops operations of cereales, vegetables, fruit and plantation crops. Subjected related to crop pest management, soil science, agricultural economics and marketing. Agricultural statistics and crop breeding aspects were also covered in detail.