Academics

Performed a progressive observational study for a period of 6 months, for the comparison of traditional Proton Pump Inhibitors such as Pantoprazole, Rabeprazole, Esomeprazole etc., with the novel Acotiamide which is an Oral Prokinetic agent. Selected a sample size of 100 subjects with Functional Dyspepsia within the age group of 18-55 years and was concluded as PPIs were effective in the Functional Dyspepsia subtype Epigastric pain syndrome whereas Acotiamide proved to be more effective in the subtype Postprandial Distress Syndrome.

In my academic project, I meticulously crafted a clinical trial protocol following the NIH-FDA Phase 2 and 3 IND/IDE protocol template, mirroring an existing study listed on ClinicalTrials.gov. With a focus on critical thinking and strict adherence to regulatory guidelines, I delved into key elements such as background/rationale, objectives, design, eligibility criteria, methods, quality control, and endpoints. My work stood out through thorough literature review, showcasing a comprehensive understanding of existing research and its relevance to the proposed study. I adeptly defined clear research objectives and articulated primary and secondary endpoints to measure intervention success. The study design and methodology were rigorously constructed, considering ethical implications and regulatory requirements, while precise eligibility criteria addressed recruitment challenges. Robust quality control measures were outlined, emphasizing data integrity and adherence to Good Clinical Practice (GCP) guidelines.

This project delves into the ethical intricacies inherent in research involving adults with diminished capacity to consent. Through a meticulous analysis, I elucidated the complexities surrounding consent in such scenarios and proposes viable measures to navigate these challenges. The handling of ethical considerations, coupled with a comprehensive understanding of legal frameworks, trained me with ethical awareness and interdisciplinary proficiency. This paper showcases prowess in research, critical thinking, and problem-solving. 

Demonstrated expertise in preparing regulatory documents such as Annual Reports, New Protocol submissions, and Form 1571 for IND amendments, ensuring compliance with FDA regulations. Proficient in navigating submission complexities, including hyperlinking, bookmarking, and formatting in ICH and eCTD formats for IND applications. Conducted thorough comparisons between ICH and eCTD formats, and regulatory requirements for Drugs (NDA), Biologics (BLA), and Devices (510K), showcasing a deep understanding of unique submission guidelines. Skilled in creating professional documents, cover letters, table of contents, and formatted reports for regulatory submissions.

This project enhanced my knowledge in comprehensive comparative analysis of food regulation systems in the EU and US, highlighting the critical roles of regulatory agencies and key regulations in ensuring food safety and consumer protection. It outlines the distinct responsibilities of agencies such as the FDA and FSIS in the US, and the collaborative approach involving EFSA, the European Commission, and member states in the EU. Key regulations in both regions, such as the General Food Law Regulation in the EU and FSMA in the US, are elucidated for their contributions to setting standards and enhancing food safety practices. Understanding these frameworks is emphasized for product classification, labeling requirements, and overall food claims. This project underscores the importance of regulatory compliance for maintaining the integrity of the food supply chain and emphasizes the skills acquired in regulatory analysis, comparative assessment, and communication of complex regulatory information.

In this project I spearheaded the development of an Investigator's Brochure (IB) for the investigational drug, PH-2024, leveraging insights from a similar product and adhering meticulously to regulatory guidelines, notably the ICH E6(R2) guideline. Curated unbiased data in a standardized format covering essential sections such as pharmacology, preclinical data, and clinical trial design, resulting in a comprehensive and regulatory-compliant document crucial for informed decision-making by stakeholders. Developed a robust Clinical Monitoring Plan (CMP) for a diabetes treatment study, ensuring protocol adherence, GCP regulations, and ethical standards throughout the trial process. These projects showcase my proficiency in navigating complex regulatory frameworks, synthesizing scientific data, and conducting ethically sound clinical trials.