SITUATION
A European biotechnology company developing an innovative bi-specific antibody for Gastrointestinal tumors partnered with Pivotal to initiate its Phase I trial in Europe. The sponsor sought to rapidly move from a preliminary synopsis to a finalized protocol that could support regulatory submission and study start-up in record time. Given the early-stage nature of the asset, the sponsor required specialized medical/oncology advisory services and protocol development expertise to ensure the study design was both scientifically sound and regulatory compliant.
CHALLENGES
- From concept to protocol: The sponsor initially provided only a synopsis, requiring extensive consultation and medical input to transform the concept into a robust clinical protocol.
- Tight timelines: To meet corporate and investor expectations, the submission had to be launched within a very short timeframe, leaving little time to prepare all the documents and manage regulatory aspects.
- Complexity of study design: As a novel bi-specific antibody with limited prior human data, the study required careful consideration of safety, dose escalation strategy, and patient eligibility criteria.
SOLUTIONS
Pivotal´s Oncology Medical Team with extensive experience in Early-Phase studies and Medical Writing undertook the challenge to accelerate protocol development and secure a smooth regulatory start-up.
Key actions included:
- Expert medical/oncology advisory: Senior oncologists provided in-depth input on study design, dose escalation schema, safety monitoring, and patient selection to ensure the protocol was scientifically robust, ethically sound and carefully tailored to operational realities of the participating PIs and sites.
From synopsis to protocol: Pivotal transformed within few weeks
- From synopsis to protocol: Pivotal transformed within few weeks the Sponsor’s synopsis into a comprehensive Phase I protocol, ensuring alignment with ICH/GCP standards and country regulatory expectations.
- Medical writing: Our oncologists leveraged their experience writing medical documents to efficiently develop a final protocol, addressing Sponsors’ needs and implementing changes in real time, ensuring accuracy, clarity, and consistency across all sections.
- Speed without compromise: Processes were streamlined to allow protocol finalization in a compressed timeframe, enabling regulatory submission earlier than initially anticipated.
STRATEGY
- Close collaboration with the Sponsor: Frequent workshops and feedback loops with the Sponsor’s team ensured that scientific and strategic priorities were rapidly integrated into the protocol draft.
- Parallel workflows: Medical advisory, protocol drafting, and regulatory readiness activities were conducted in parallel rather than sequentially, significantly shortening the overall timeline.
- Agile communication model: A single Pivotal point of contact coordinated input from advisors, writers, and project managers, ensuring efficient decision-making and rapid delivery of results.
RESULTS
- Protocol development accelerated: Pivotal delivered a final, ready to submit protocol in 7 weeks during winter Holidays.
- Regulatory start-up launched rapidly: The early completion of the protocol allowed the Sponsor to begin regulatory submissions significantly ahead of schedule.
- Sponsor´s confidence in Pivotal reinforced: By combining medical insight with operational excellence, Pivotal positioned the trial for a successful start in the target country, laying the foundation for the development of the bi-specific antibody program of our client.
MEDIA CONTACT
Ms. Natalia Farr
