Meeting Planning and Scientific Writing Support for the U.S. Food and Drug Administration, Center of Oncology Excellence Project Renewal
U.S. Food and Drug Administration (FDA), Health and Human Services (FDA/HHS)
The FDA Oncology Center of Excellence (OCE) was created to expedite development of oncology and hematology medical products and support an integrated approach in clinical evaluation of drugs, biologics, and devices for the treatment of cancer. In 2019, OCE launched Project Renewal, an initiative that aims to update safety and efficacy information for oncology product labeling by establishing a set of repeatable processes to evaluate scientific evidence from available published literature. The Project Renewal Process (PRP) included stakeholder engagement, a labeling evidence evaluation process (LEEP), and documentation and closeout. The PRP initiative identified and prioritized 40 products for review and was supported and carried out by a team of external scientists and clinical oncologists, oncology fellows, labeling and other subject matter experts, and expert organizations (e.g., American Association for Cancer Research). FDA contracted with NOVA to support LEEP, providing logistical support, science writing, and scientific expertise.
For each identified oncology product, a series of LEEP meetings was held to evaluate published data and provide considerations to modernize product labeling with high-quality scientific safety information and potential expanded indications for use. Project Renewal considered approximately four products each contract year. Every product had up to five LEEP meetings, with both remote and in-person participants. Initial kickoff and closeout meetings had larger audiences and required additional preparation and logistics.
Meeting Planning and Logistics
NOVA provided premeeting, onsite, and postmeeting planning and technical support for in-person and virtual LEEP meetings. For in-person meetings, NOVA coordinated premeeting logistics, including meeting room reservations, audiovisual and room setup, and security arrangements at FDA’s White Oak campus, as well as development and formatting of premeeting materials (agendas, invitations, background materials, bios, table tents, and nametags). NOVA assisted with participant registration using Cvent and arranged and tracked comprehensive travel logistics for participants, including lodging reservations, long-distance travel, and local transportation assistance. NOVA provided participants with detailed, personalized logistics information in advance of their travel. Onsite support included checking room and audiovisual setups; coordinating participant arrivals, security escorts, and participant check-in; and providing audio and technical assistance, as requested. Postmeeting support for in-person meetings included preparing a meeting attendee list for meeting minutes and coordinating travel reimbursements (e.g., preparing travel reimbursement forms, tracking status of completed forms, sending reminders, and reviewing completed forms and receipts for compliance with federal travel regulations). For virtual meetings, NOVA assisted with setting up Webex, as requested; distributing invitations, confirmations, and materials; and providing other technical assistance, as requested.
NOVA provided science writing support (and transcription, as requested) for the LEEP portion of the PRP. For each meeting in the product review cycle, NOVA prepared meeting minutes that included an attendee list, summary of presentations, detailed notes on discussions, next steps, and action items. Preparation of minutes required the ability to understand and synthesize complex scientific, clinical, and regulatory information related to safety and efficacy of oncology drugs. Draft minutes were delivered within three business days of the meeting, and NOVA collaborated with FDA, as needed, to revise and finalize the minutes. NOVA also provided quick-turnaround summaries of key points of discussion for reporting during meetings and a list of key action items the day after the meeting. NOVA also provided subject matter expertise, as requested, in preparation, review, and editing of draft Product Reports.
- NOVA successfully provided high-quality, timely meeting logistics and science writing support for all LEEP meetings.