The client was preparing to start a major submission for a marketing authorization in a rare disease and was faced with critical timelines and a complex development program. They needed their Clinical Submission Team Lead to be decisive yet adaptive during what was expected to be a challenging submission process.
As an established pharmaceutical company focused on neurological diseases was preparing for a submission and realized that they had not fully completed the necessary quality GMP and GCP activities during the course of the program.
An emerging oncology and rare disease company with little internal infrastructure was experiencing rapid growth after demonstrating potential efficacy in phase 1 of their first oncology indication and was moving towards a fast-track submission. As the company worked to expand their internal infrastructure, they needed functional expertise across disciplines to ensure development success.
An emerging cellular therapeutics company was entering phase 1 clinical testing for their lead hematology candidate based on their antibody-coupled T-cell receptor (ACTR) technology. In order to move their vision for a singular therapeutic platform approach to treat many different cancers through the development process, they needed a plan, processes and hands-on support.
A large, established pharmaceutical company was planning to submit a new drug application for a biological product to treat a rare disease. Concurrently, the company was working through a variety of corporate initiatives that—while positive—were impacting productivity, including corporate restructure, headquarters relocation, and several acquisition integrations.
A virtual company submitted their first IND and needed an effective and nimble project team to oversee their clinical program, develop clinical documents for regulatory submissions, and support overall business development.
A premier academic institution and research center with critical partnerships with large pharma, biotech, and device organizations recognized a gap: they required industry experience to effectively collaborate with their sponsor partners. Additionally, our client faced the emerging challenges of managing the ever-changing considerations resulting from COVID-19, which were amplified due to their lack of experience with a remote work force.
