Tanzeel Huma

Fibrosis and vision loss

• Writing and submitting applications and progress reports to funding bodies (CEPI, WHO, NIH) that support medical research. • Literature review for designing the non-clinical research design for the vaccines in development. • Creating, and planning the non-clinical research plan of the developing vaccine which include peptide analysis, dosage screening, immunogenicity, secondary structure determination by Circular Dichroism Spectroscopy, antimicrobial, and fluorescence microscopically analysis of peptide treated cells, basic microbiological and biochemical techniques. • Developing and designing the non-clinical studies for the new vaccine research, pharmacological research studies, safety pharmacology etc., to check the effect on various tissues and organs of mice, rat, rabbits, and monkeys. • Writing and reviewing the module 3.2.S (Drug substance) and 3.2.P (Drug product): Including the manufacturing process, effectiveness, process development, structure, secondary structure of the compound, Circular Dichroism Spectroscopy, antimicrobial etc and preparing the documents for the IND, CTA and NDA applications. • Preparation of investigation brochure (IB) for the vaccines (COVID-19, Hepatitis B). • ICH guideline review and points to consider for the manufacturing process of the new vaccine. • Providing the required documentation for the application, communication with the concerned authorities. • Writing the Module 2 (non-clinical) for the IND, CTA, and NDA applications for the FDA, pFDA, and other countries submission, following the global guidelines, i.e., CTD and/or ASEAN CTD format. • Literature review and search of the non-clinical data for hepatitis B vaccine, communication with R and D department about the development. • Follow-up with the regulatory authorities about the application status and, fulfilling the requirements of the application. • Regulatory pathway and registration conditions/regulations of major regulatory authorities in different regions.

• Designing and conducting experiments, making observations and measurements, researching information, analyzing data, preparing or supervising the preparation of laboratory reports and scientific papers, presenting findings at scientific meetings and conferences, and supervising the work of staff. • Preparation of brain slices for the patch clamps, histology, PCR. • Designing and conduction the experiments to evaluate the effect of different diagnostic compounds on the hippocampus, frontal cortex neuronal cells of mice and rats, making observations and measurements, researching information, analyzing data, preparing or supervising the preparation of laboratory reports and scientific papers • Literature review, model plan and designing for the in vitro neurodegenerative disease models using the neuronal cells i.e., N-methyl-D-aspartate (NMDA), Glutamate, lipopolysaccharide (LPS), t-BHP and Corticosterone models. • Cell based models of Alzheimer’s disease, Analyzing using Cell-based Assays, line apoptosis, neuronal growth, toxicity, proliferation, dendrite extension etc. • Designing and conducting experiments making observations and supervising the research staff for preparing the neuronal cells and cellular models for the neurodegenerative disease investigation. • International clients dealing, Kaerus, SK Pharmaceuticals, Almone: Discussing project, designing experiments, developing project plan, meeting deadline and timely delivery of the projects, i.e., HerG cells, Potassium channel cells, Cardiac cells used in the patch clamp analysis of different diagnostic drugs to investigate the potential toxicity of the proposed drug in development. • Collaborate with industry/academia to apply the results of research and develop new techniques, products or practices. • Communicate results to the scientific community via published papers. • Using specialist computer software to analyze data and to produce diagrammatic representation of results.

Expected to complete in 2013

Visiting research Assistant at Yale University School of Medicine, USA.