Kimberly C. Koop, PharmD

Global Regulatory Lead, Oncology, Prostate Cancer

Led global regulatory strategy and execution for three clinical­stage programs (cardiometabolic and rare renal diseases), supporting development from early through late clinical phases. Directed major regulatory submissions and lifecycle activities (INDs, CTAs, IMPDs, NDA components) and managed global health authority interactions (FDA, EMA, MHRA, Health Canada, APAC). Provided strategic regulatory leadership to cross­functional teams (Clinical, CMC, Safety, Program), enabling timely trial approvals, site activation, and development progression. Developed and executed regulatory strategies that secured Orphan Drug and Fast Track designations, supporting accelerated development pathways. Led preparation of high­impact regulatory deliverables, including FDA briefing packages (Type B/EOP2, Type D), CHMP Scientific Advice, Pediatric Investigation Plans, DSURs, Investigator’s Brochures, and protocols. Provided ongoing regulatory intelligence and risk assessment to optimize global development strategy and ensure compliance with evolving requirements. Oversaw eCTD submission strategy and quality control, leveraging Veeva RIM to improve operational efficiency. Contributed to nonclinical strategy and labeling support for the plozasiran NDA (Module 4).

• Provided compounding services, medication therapy management, and patient care counseling at The Modern Chemist. • Supported business needs of an independent compounding pharmacy in the New York City Metropolitan Area.

• Co-led global regulatory affairs for a Phase 3 Neuroscience (pain) program at Regeneron, ensuring regulatory deliverables were met. • Managed meetings and communicated with subject matter experts to support the program's success. • Developed leadership skills in a fast-paced environment and gained expertise in global regulatory affairs.

Supported global regulatory strategy for the Phase 3 fasinumab program, managing IND/BLA lifecycle activities across U.S., EU, and international regions. Led cross­functional dossier planning and execution to meet strategic submission timelines. Secured FDA Fast Track designation for chronic low back pain within four months. Supported global health authority engagement, including preparation for PMDA interactions. Conducted regulatory gap assessments and ensured submission readiness in alignment with FDA, EMA, and ICH requirements. Supported combination product development, including Human Factors strategy.

• Supported solid tumor oncology and hematology programs at Amgen, assisting with agency type B and C meetings and preparing slide decks for an advisory committee meeting. • Opened INDs for early development programs, showcasing expertise in regulatory affairs and strategy. • Responsible for requests for information and module 1 documentation for a sBLA indication, ensuring regulatory compliance and attention to detail.

Supported global regulatory strategy for oncology programs, including IND development for LUMAKRAS® (sotorasib). Contributed to regulatory strategy for BLINCYTO®, supporting activities associated with accelerated approval. Authored Orphan Drug and Fast Track applications, securing expedited designations to support development timelines. Prepared FDA briefing materials and supported health authority interactions, advisory committees, and submission planning. Conducted regulatory landscape analyses and supported global submission strategy across clinical, CMC, and nonclinical functions.

• Developed global regulatory strategy at Amgen from 2017-2019 • Participated in industry forums at Rutgers University • Contributed to the Postdoctoral Rutgers pharmaceutical industry fellowship (RPIF) program

• Compounded and prepared IV medications for pediatric/adult inpatient and pediatric oncology pharmacy satellites • Maintained automated dispensing cabinet inventory and delivered medications to the units • Provided bedside discharge medication counseling for patients

• Managed drug inventory and ensured accurate medication for patients at Northwell Health. • Responded to drug information requests and collaborated with pharmacy team in a fast-paced environment.

Student National Pharmaceutical Association (SNPhA) National Delegate and Public Relations Liaison, Rho Chi Pharmacy Honor Society Historian, Phi Lambda Sigma (PLS) Vice President and Senator, Director of Generation RX within APhA (American Pharmacists Association Academy of Student Pharmacists), Student Representative of the LIU Pharmacy Assessment Committee, National Community Pharmacy Association (NCPA) Vice President, Lambda Kappa Sigma (LKS) Treasurer, Academy of Managed Care Pharmacy (AMCP) Active Member, American College of Clinical Pharmacy (ACCP) Active Member, Industry Pharmacist Organization (IPhO) Active Member, American Society of Health- System Pharmacists (ASHP) Active Member

Preparing pharmacists to become highly marketable professionals in the pharmaceutical and biopharmaceutical industries The RPIF Program is an industry-based training program that partners with the leading pharmaceutical and biopharmaceutical companies. It is designed for individuals with a Doctorate of Pharmacy to further their experience in the pharmaceutical industry through work experience and clinical research. https://pharmafellows.rutgers.edu/wp-content/uploads/2018/10/brochure-amgen.pdf

Summa Cum Laude