Neil Patel
Oakland,MICHIGAN
Summary
Proven expertise in FDA regulatory affairs and compliance, honed at Michigan Medicine, with a strong foundation in clinical study reporting and stakeholder communication. Excelled in submission preparation and safety reporting, leveraging skills in Good Clinical Practices and data gathering to facilitate drug development and ensure adherence to FDA guidelines.
Overview
2
2
years of professional experience
Work History
Advanced Pharmacy Practice Experience
Michigan Medicine: Regulatory Affairs
08.2023 - 09.2023
• Acquired and applied knowledge of FDA regulations and procedures related to investigational new drug applications (INDs), including FDA CDER and CBER guidelines.
• Utilized various documents such as Investigators Brochures, Informed Consent forms, and clinical protocols (Phase 1, 2, and 3) to ensure compliance with FDA regulations and facilitate drug development.
• Assisted in preparing IND Exemption Requests, Pre-IND Meeting Requests and Meeting Materials, IND Amendments, and IND Annual Reports.
• Prepared documents for eCTD submission-readiness and communicated changes to others.
• Participated in building and validation eCTD submissions using LORENZ docuBridge and LORENZ eValidator, which are FDAutilized Reg Operations software tools.
• Submitted IND sequences to the FDA through the WebTrader Electronic Submission Gateway (ESG), in both eIND and eCTD format.
• Participated in discussions and received guidance from regulatory bodies such as the FDA and the International Council for the Harmonization (ICH) on topics including Exploratory INDs, Expanded Access, Chemistry, Manufacturing, and Control (CMC) needs for INDs, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice.
• Discussed and learned about Post-Market
Commitments/Requirements and the FDA PMC Database
• Discussed and learned about Pharmacovigilance tools like FAERS for regulatory intelligence and safety monitoring.
• Discussed and used FDALabel for regulatory intelligence research including comparison of approved drug labels and Summary Basis of Approval documents.
• Discussed and learned about Regulatory Information Management (RIM) tools, like Veeva Vault.
• Discussed and learned about the differences among the marketing pathways 505b1, 505b2, 505j.
• Discussed and learned about accelerated approval pathways like Fast Track Designation, Breakthrough Designation, Accelerated Approval, and Priority Review.
Pharmacy Intern
Michigan Medicine
05.2021 - 01.2023
- Expanded knowledge of various medication classes through continuous learning from experienced pharmacists and attending relevant training sessions.
• Worked effectively in a team to coordinate and compound
chemotherapy medications.
• Learned effective sterile compounding and garbing techniques.
• Developed communication skills by establishing a workflow in the work environment.
• Learned the use of closed system transfer devices with BD Phaseal and Halo products.
• Learned new pharmacy workflow systems by using DoseEdge and BD Pyxis.
• Trained new technicians in sterile compounding and demonstrated proper aseptic technique.
Education
Doctor of Pharmacy - Pharmacy
University of Michigan - Ann Arbor
Ann Arbor, MI04.2024
Bachelor of Science - Human Biology
Michigan State University
East Lansing, MI12.2019
Skills
- Clinical study reporting
- Safety reporting
- Compliance assurance
- Stakeholder Communication
- Data Gathering
- Good Clinical Practices
Projects and Presentations
Kraft S, Marineau E, Patel N. Characterizing Infusion Reactions to
Cancer Treatment in Relationship to COVID-19 Infection and/or
Vaccination
- Poster presentation at the American Society of Health-System
Pharmacists Midyear Clinical Meeting; Anaheim, CA; Dec, 2023.
eCTD and eIND (Alternative Format) Education and Discussion
• Project; Michigan Medicine; Regulatory Affairs – MICHR IND/IDE Investigator Assistance Program; Ann Arbor, MI
Sept. 2023
Psilocybin IND Amendment eCTD Submission
• Project; Michigan Medicine; Regulatory Affairs – MICHR IND/IDE Investigator Assistance Program; Ann Arbor, MI
Sept. 2023
CMC eIND Submission
• Project; Michigan Medicine; Regulatory Affairs – MICHR IND/IDE Investigator Assistance Program; Ann Arbor, MI
Sept. 2023
Role of IRB and FDA IND on Clinical Protocol Review
• Project; Michigan Medicine; Regulatory Affairs – MICHR IND/IDE Investigator Assistance Program; Ann Arbor, MI
Sept. 2023
Protocol Review
• Project and Presentation; Michigan Medicine; Regulatory Affairs – MICHR IND/IDE Investigator Assistance Program; Ann Arbor, MI
Sept. 2023
Chemistry, Manufacturing and Controls (CMC) and Good
Manufacturing Practice (GMP) Review
• Discussion; Michigan Medicine; Regulatory Affairs – MICHR IND/IDE Investigator Assistance Program; Ann Arbor, MI
Sept. 2023
Expanded Access
• Discussion; Michigan Medicine; Regulatory Affairs – MICHR IND/IDE Investigator Assistance Program; Ann Arbor, MI
June 2023
“Ublituximab vs Teriflunomide in Relapsing Multiple Sclerosis”
• Journal Club; Michigan Medicine Drug Information; Ann Arbor, MI
June 2023
P&T Committee Monograph and Presentation: Ublituximab
• Monograph Research and In-office Presentation; Michigan
Medicine: Med Use Policy, Ann Arbor MI
June 2023
Medication Use Evaluation: Sugammadex in Michigan Medicine Operating Rooms
• Research and In-office Presentation; Michigan Medicine: Med Use Policy, Ann Arbor MI
May 2023
“Hydrocortisone in Severe Community Acquired Pneumonia”
• Journal Club Brief; Michigan Medicine Health Systems; Ann Arbor, MI
May 2023
Drug Information Mannitol SBAR
• In-office Project; Michigan Medicine Health System, Ann Arbor MI
May 2023
Joint Commission Compounding Drug Record Organization
• In-office Project; Michigan Medicine Health System, Ann Arbor MI
Nov. 2022
Medication Use Evaluation: IV Acetaminophen
• Research and In-office Presentation; University of Michigan College of Pharmacy, Ann Arbor MI
Nov. 2022
Health Education: Prescription Label
• In-office Presentation; Michigan Medicine, Ann Arbor MI
Nov. 2022
Closed System Transfer Device and Pharmacy Workflow
• Research and In-office Presentation; Michigan Medicine, Ann Arbor MI
Timeline
Advanced Pharmacy Practice Experience
Michigan Medicine: Regulatory Affairs
08.2023 - 09.2023
Pharmacy Intern
Michigan Medicine
05.2021 - 01.2023
Doctor of Pharmacy - Pharmacy
University of Michigan - Ann Arbor
Bachelor of Science - Human Biology
Michigan State University
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