Case Studies

Over the years, BioBridges has successfully supported hundreds of programs for emerging and established pharmaceutical, biotech, and medical device companies. Whether your program needs highly specific individual skills, CRO oversight, or functional teams, the BioBridges Career Portfolio® Management model will successfully help you accomplish the work at hand.

Clinical Development Guidance and Support

An emerging oncology company that relied heavily on outsourcing was moving into phase 3 of their first clinical program. They needed a plan and processes to develop and sustain proper oversight of key functional areas of their phase 3 program to prepare for a successful marketing submission and for future programs in their pipeline.

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Clinical Regulatory Writing Submission Team

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.

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Quality Assurance Review and Correction

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.

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Cross-Functional Submission Preparedness

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.

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Early Clinical Development Support

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.

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Program Management, Cross-Functional Project Teams, and Acquisition Support

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.

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Data Cleaning, Data Integration, and Data Management Support

A global pharmaceutical company had over 4 active INDs, with more than 20 clinical studies in phase 2 and phase 3 in oncology indications.  Full-service CROs were utilized for each program, but after turnover at both the client company and the CROs, a decision was made to reassign the studies to a central, US based staff. This new study allocation lead to a lack of continuity, internally and externally, and the new team was having trouble getting up to speed on the clinical status of the programs.  In parallel, a business decision was made to internalize data management operations.

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