Case Studies

Filtered by Client: Pharma

Biotech Meets Big Pharma Situation: A biotech company licensed their product currently midstream in development to a big pharma company. The two groups had very different approaches and decision and action speeds in product development.   Solutions: Halloran worked as an intermediary ... Clinical Process Roadmap For A Global Operations Group Situation: A global medical device company with clinical operations staff in multiple locations that had grown through acquisitions wanted to harmonize their SOPs into a single repository of global SOPs. They wanted a mechanism to organize the procedures into a useful job ... Clinical Quality On Demand Situation: Rapidly growing biopharma entering Global Phase 3 development without an appropriate clinical quality system and little internal expertise in clinical QA. Solutions: Gap Analysis conducted by Halloran found that the Quality System was overly ... From Bankruptcy to a Deal Situation: A cash-constrained pharmaceutical company, which spent $360MM on two products, sold its later stage Phase 2 asset to a virtual NewCo for development. The asset needed to continue being developed without interruption. Solutions: A Halloran project manager was ... Global Program Steered Back On Track Situation: During a Vendor Management training program conducted by Halloran, additional issues were brought to the forefront by the participants. The company was in crisis at a critical time with a major global trial starting and alarming turnover within the clinical ... Growing Company Needs Operational Infrastructure SItuation: Company with targeted therapies in all stages of clinical development in oncology. Operational strategy was to scale capabilities to manage development programs in-house in preparation for an initial public offering. There were scientists and physicians on board but ... Keeping Up With Mergers Situation: A rapidly growing global pharma company had new development leadership coming in anticipation of numerous acquisitions and wanted to identify and close areas of weakness. Solutions: A gap analysis identified a Clinical Trial Management System that had never ... Midstream Leadership with Virtual Development Mandate Situation: New leadership joined a commercial stage company after shareholders rejected a strategic acquisition to augment their limited pipeline. The development organization had been formed under the assumption that it would be a fully integrated pharmaceutical company and now ... Navigating Conversion From Paper to e-Diary Situation: Specialized division within large, global pharmaceutical company with innovative preventative medicine pipeline, with strategic initiative to move from capturing subject diary data on paper, to capturing this information directly into electronic form via ... On-Demand Clinical Operations Expertise Situation: Biopharmaceutical company developing a revolutionary class of drugs using novel technologies was transitioning their lead compound from research to development and needed clinical leadership to drive program development, planning, and ... On-Demand Regulatory Expertise Situation: A sudden departure of Senior Regulatory staff at a drug development company created a skill gap just as they were seeking non-profit grant funding.  The funding source required demonstration of adequate and experienced support for IND planning and ... Part Of The Team Situation: Lean biopharma led by expert industry executives with a promising discovery pipeline was in need of a critical path to rapidly select a development candidate in a neurological indication. Solutions: Halloran provided interim project management to help both with ... Phase 3 Readiness Situation:  A mid-sized pharmaceutical company preparing to begin a global, pivotal clinical program for their key product needed an assessment of organizational compliance and readiness. The program was highly complex with >10 vendors and over 100 sites in 12 countries. ... Preemptive Training to Mitigate Compliance Risks Situation: A global pharmaceutical company acquired a small biotech company with a novel product for seriously ill liquid tumor patients. Upon post-acquisition due diligence, the compliance issues identified in the mid-stream proof of concept trials were alarming, and the ... Quality System Optimization For An Industry Leader Situation: Halloran completed a quality systems gap analysis for a large, global medical device/pharmaceutical company which identified a number of areas for compliance remediation. Halloran implemented an extensive remediation plan that included process re-design, SOP ... Quality Systems Gap Analysis and Remediation for a Medical Device Leader Situation: A market leading medical device company with a robust pipeline of Class II and III surgical devices recognized challenges in quality and delivery in their clinical organization and requested an organization-wide gap analysis. Solutions: Halloran conducted ... SPA (Special Protocol Agreement) Negotiation Situation: A company was seeking Special Protocol Agreement with FDA for a single pivotal study with an advance oncology indication.  Following three rounds of review, company asked Halloran to review protocol and previous FDA comments on endpoints, follow up, and other ... Starting Off On the Right Foot Situation: Venture capital seeded start-up biotech with novel therapeutic modality sought to identify possible first targets based on scientific and clinical development criteria. Solutions: Halloran attended launch meetings with the entrepreneurs and investors to flesh out ... Submission Readiness Evaluation Situation: Established biotech company was filing its first NDA with new clinical and biostatics leadership after a five-year pivotal study. Company was concerned with compliance "drift" over the course of the study and sought external review and critique of clinical systems, ... Systems Implementation Situation:  The clinical division of a large medical device company with 10+ global locations and 50+ active clinical trials chartered an enterprise-wide systems initiative to automate and optimize processes for data collection/management, safety event processing, site ...