Hemang Patel

About Hemang Patel

At Johnson & Johnson Innovative Medicine, leadership in global medical affairs and evidence generation is not just a role—it\'s a commitment to excellence. Our team expertly steers phase 4 clinical studies in multiple myeloma, embracing regulatory compliance and strategic cross-functional collaborations that ensure the timely submission of critical safety reports.With a strong foundation in medical science and pharmaceuticals, I have cultivated a proficiency in quality assurance procedures. These skills were honed through rigorous medical monitoring and data reconciliation for gastrointestinal cancer studies, always with a focus on participant safety and regulatory adherence. Our collective efforts have resulted in successful outcomes, including a pivotal interim safety database lock.

Experience

1. Study Responsible Scientist (Associate Director)

   Johnson & Johnson Innovative Medicine

   Nov 2022 — Present · Detroit, MI, US

   Demonstrated outstanding leadership skills while overseeing a global medical affairs-operations and evidence generation teams, responsible for the implementation and operations of three phase 4 global clinical studies on multiple myeloma in compliance with BLA and PMR requirements for CARVYKTI and DARZALEX. Utilized proficient collaborative skills to facilitate cross-functional team collaborations, enabling timely submission of annual reports and providing safety details for regulatory documents such as PBRER, DSUR, PADER, and PMR Provided clinical expertise and valuable study insights to health authority information requests, resulting in productive and efficient interactions with regulatory authorities Led medical monitoring initiatives and conducted protocol deviation assessments for a CRO outsourced study to ensure patient safety and maintain data quality and integrity in alignment with ICH GCP guidelines Participated in various study outreach activities, including investigator meetings, steering committee meetings, site outreach, and study consultations, fostering study representation and engagement throughout the study lifecycle Designed steering committee and adjudication committee charters and engaged with KOLs to receive their assessments on various study aspects and AE data capturing resulting in an assessment to improve study operations and data monitoring Collaborated with MSLs and CRO-site monitors to engage study sites, improving study recruitment and ensuring high-quality data collection while learning from both successful enrollments and enrollment challenges sites to refine medical outreach strategies Reviewed study data and engaged with stakeholders such as SRP, MRP, and GMAL to enhance study visibility and plan publication activities

Education

• Utah State University

  PhD, Biological Engineering

  2006 — 2011

• Utah State University

  MS, Biological Engineering

  2003 — 2005

• Mahatma Gandhi Missions College of Engineering

  BE, Biomedical Engineering

  1998 — 2002

Skills

• Tissue Engineering
• Glp
• Biomaterials
• Sem
• Gel Electrophoresis
• Image Analysis
• Experimental Design
• Dna and Rna Extraction
• Dsdna and Total Protein Quantification
• Fluorescence Spectroscopy
• Cell Viability Assays
• Flexcell Tension Plus System
• Pcr Primer Design
• Supervising Staff
• Gene Expression Analysis
• Luminometer
• Scaffod Design and Characterization
• Elisa
• Aseptic Technique
• Elispot
• Cell Biology
• Zymography
• Fluorescence Microscopy
• Laboratory Managment
• Taqman
• Nanoparticle Synthesis and Characterization
• Antibody Conjugation
• Handling Human Biopsy Samples
• Cell Culture
• Afm
• Data Analysis
• Primary Cell Isolation and Culturing
• Plasmid Amplificaiton Using E. Coli
• Sas
• Western Blotting
• Research Manuscript Writing
• 3d Cell Cultures and Co-Cultures
• Lab Safety
• R
• Nanotoxicity Assesment