Collaborative Expertise Secures Successful FDA Meeting for Phase 2b Oncology Trial

Securing Type C meeting with FDA for Oncology Trial: Case Study Overview

APCER Life Sciences played a pivotal role in assisting a US-based biopharmaceutical company to successfully navigate a complex FDA Type C meeting for its Phase 2b oncology trial.

This meeting was crucial for the company’s drug development strategy, as it sought guidance from the FDA on key trial aspects such as endpoints, sample size, and the feasibility of obtaining orphan drug designation. APCER provided integrated medical writing and regulatory affairs support, ensuring the company was well-prepared to address the FDA’s requirements and challenges.

Medical Writing and Regulatory Support for FDA Type C Meeting: Case Study Highlights

• One of APCER’s key contributions was the development of a targeted briefing document. This involved formulating clear and precise questions for the FDA that focused on critical areas like appropriate trial endpoints, sample size, and assessing the feasibility of securing orphan drug designation.
• APCER’s medical writing team helped craft questions that were both comprehensive and focused, paving the way for productive discussions with the FDA.
• In addition to the preparation of a briefing document for securing Type C FDA meeting, APCER’s expert medical writing team took charge of authoring comprehensive documentation, including the Investigator’s Brochure and study Protocol.
• By meticulously preparing these documents, APCER provided a solid foundation for the company to present its case to the FDA, making sure that all relevant clinical and pre-clinical data were accurately represented.

How APCER Helped Navigate the Regulatory Landscape

Navigating the regulatory landscape for oncology drugs is inherently challenging due to the complexity of the therapeutic area and the evolving nature of the regulations.

• APCER’s regulatory affairs team addressed these regulatory challenges by guiding the company through the intricate pathways associated with IND (Investigational New Drug) development.
• Their expertise ensured that the company could effectively respond to regulatory demands, minimizing the risk of delays and improving the likelihood of achieving their objectives.
• Through the collaborative efforts of APCER’s medical writing and regulatory teams, the company was able to present a well-prepared case during the Type C FDA meeting.
• Overall, APCER’s support not only ensured managing FDA Type C meeting timelines but also laid the groundwork for the company’s future success in its oncology drug development.

APCER’S Integrated Medical Writing and Regulatory Affairs Capabilities

From meticulously crafted documents to navigating regulatory hurdles, APCER’s integrated medical writing and regulatory affairs teams can become an extension of a client’s team. Our powerhouse synergy can effectively dismantle the complexities of drug development, empowering sponsors to bring life-saving treatments to patients faster.

APCER’s integrated medical writing and regulatory affairs services team can offer:

• High-quality deliverables that consistently exceed client expectations and comply with regulatory authorities’ requirements.
• Publishing and submission of electronic dossiers in different countries such the US, the European Union, the United Kingdom, and Canada.
• Customized and fully compliant solutions to meet the ever-changing regulatory landscape.