• Established Investigational New Drug (IND) application for induced pluripotent stem cell (iPSC)-based cell therapy. This includes, but is not limited to • Analyzed and interpreted the preclinical study data and drafted reports with GLP compliance for IND enabling preclinical studies • Prepared IND package in eCTD format including CMC and preclinical studies.• Conducted experiments to test product stability and characterization assays sensitivity• Supervised qualification experiments for switching from RUO to GMP compliant reagents in the manufacturing process• Managing and training personnel including senior scientists, QA team, biologists and lab technicians about the concepts of cell therapy and strategies for translation of R&D projects from bench to bedside• Presenting the progress and findings from the preclinical studies at multiple international conferences independently as invited talks and / or posters presentations

• Designed and managed in-vitro (protocol validation and product characterization) and in-vivo (studies in rats and pigs for toxicity, biodistribution and tumorigenicity) preclinical studies for the cell-therapy project to transplant iPSC derived Retinal Pigment Epithelium (RPE) for restoring vision in Age-related Macular Degeneration (AMD) patients. Compiled, audited and finalized reports from these studies.• Prepared and approved SOPs, batch records and reports for the preclinical studies.• Managed and supervised team of senior scientists, ophthalmic surgeons, veterinary surgeons, lab technicians and research fellows involved in the preclinical studies.• Performed in-house document control for the preclinical studies.• Identified and completed deviations, performed change controls, and corrective and preventive actions (CAPA).• Oversaw calibration and maintenance of equipment used in the preclinical studies• Training the FDA-compliant cGLP & cGMP guidelines to the study personnel.• Trained and consulted investigators within NEI, DTM and other federal or academic research environments about regulatory affairs, technology transfer, and in developing IND applications for cell and gene therapies.

• Optimized GLP grade Retinal Pigment Epithelium (RPE) differentiation and maturation protocol for clinical grade generation of functional RPE.• Using High-Throughput Screening, identified compounds rescuing RPE from the proteotoxic stress - mimic the phenotype of Age Related Macular Degeneration (AMD); identified the pathways involved in the rescue and tested these compounds in vitro - can be potential therapeutics for AMD.

Review and edit scientific documents - grant applications, manuscripts, abstracts, book chapters, and clinical protocols.

•Facilitate acceleration of clinical translation of stem cell-based technologies•Designing clinical models using embryonic– and induced pluripotent– stem cells for functional analysis & screening of neurological disorders•Conduct cell biology experiments using various genetically modified stem cell lines.•Collaborate research work with peripheral nerve injury research group at John Hopkins University, Baltimore.

Identified and disseminated tools for quantitative mapping and assessment of the diverse biomedical research portfolios, to aid NIH staff in portfolio analysis during the grants review process.Tools included: HistCite, Sci2, IN-SPIRE

Science editing, Writing Consultancy, Presentation Development and Support

RESEARCH WORK RELATED TO - • Manufacture of innovative 3-D nerve guides with chemotactic growth factor gradients for accelerated nerve regeneration. • Manufacture of dermal implants using electrospinning of collagen and gelatin. • Effect of TGFβ-1 in dermal scarring and contracture formation and how to minimize them. • Use of collagen for the development of tissue engineering electrospun scaffolds for dermal, muscle, bone and vascular implants