Catalyst Oncology offers the opportunity to assemble industry-leading experts in a dedicated full- or half-day session to assess the progress of your asset’s development. Based on the analysis of the data provided and discussion with your team, they will provide insights and suggestions around optimizing the developmental activities and pathway for your program. This early stage focused review will provide clarity on the best preclinical strategy to implement leading to an optimized clinical trial design in the right patient population at the best sites.
Starting the journey
The initial introduction will usually be with senior members of the consulting team to understand the needs of your project and to ensure we have the right people and experience to help you. We also run through how the workshop process would operate and which skills areas and subject matter experts would be involved. This entails sharing CVs of the individuals, potential timelines, deliverables, and costs for the workshop.
We provide a range of expertise including Physician related study design, population, and safety considerations, regulatory strategy, formulation, manufacturing, toxicology, translational science (including biomarker strategies), statistical aspects and clinical operational delivery. The expertise provided would be fully tailored to you and the needs of your program.
Next steps
The next step is progressing to a formal proposal and consulting agreement, outlining details, and signed by both parties with confidentiality agreement to enable transparent and comprehensive discussions.
Post this step, open discussions will be enabled by provision of relevant aggregated data sets (in vitro, in vivo, regulatory strategy/filings, slide decks, developmental plans, previous trial data if not first in human, etc.). The Catalyst Consulting team will send you a secure SharePoint link to a site ahead of the meeting serving as a secure data room allowing them to review the data sets/information and provide key questions in advance to help prepare for a productive meeting.
At the workshop
You will be appointed a clinical project lead (CPL) to coordinate events. The CPL will facilitate all interactions pre-, during and post-meeting providing an advance agenda. On the day, each subject matter expert (SME) will review the client’s feedback given (i.e., regulatory, CMC, clinical strategy) on their advance questions posed, and open discussions and provide feedback and observations. The SMEs key aims are to make recommendations and provide guidance around the developmental pathway of the asset, including any mitigation strategies around reducing risk, this usually leads to cross-functional discussions for a rounded overview.
Finally, the project manager (PM) will capture the key points of the discussion and any recommendations. These will be summarized in a report, along with suggested next steps and any deliverables agreed.
