All Biopharmaceutical Case Studies
Beaufort has provided regulatory strategy and compliance, clinical research and quality assurance services to both established and emerging biopharmaceutical and biologics companies. The following case studies describe specific solutions that we have tailor-made for our biopharmaceutical and biologics clients.
A start-up biotechnology company needed a regulatory strategy designed to reposition a previously withdrawn compound. Founded by an academic physician, a chemist, and a business person, the company had a clear vision regarding its business objectives but lacked the expertise necessary to navigate the FDA regulatory maze. As a result, its initial in-house orphan disease application was rejected by FDA. Realizing its need for experienced guidance, the company engaged Beaufort to develop a comprehensive regulatory strategy taking the compound’s history into consideration. Beaufort prepared a new orphan drug application, which was cleared in one review cycle. Beaufort also provided ready-to-use information for investor and academic presentations. Since engaging Beaufort, the company has increased fundraising, cleared an additional orphan drug application, and is proceeding with a sound regulatory strategy.
A venture-funded European biotechnology company needed a regulatory strategy for a combination device-biological CNS product. The company’s product had demonstrated significant promise based on animal and theoretical models. However, it needed guidance in getting to the first stage of the IND/IDE process. The company engaged Beaufort to support this development. Beaufort worked with management to assess existing and potential competitive products and to determine which of the potential indications should prove most valuable. Our work included a regulatory strategy for optimally approaching the IND/IDE stage of product development with the result that the client now has a detailed plan with a streamlined set of possible indications.
An established, privately-held European company wanted to introduce its products in the North American market. Before engaging Beaufort, the company had been advised that it would be unable to register a major product in the United States. Beaufort worked with senior management to consider regulatory alternatives including a switch to cGMP-compliant manufacturing. As a part of the process, Beaufort provided a thorough review of all documents related to the company’s products, inspected its plant and other operations, and trained employees regarding regulatory process and criteria for submissions. As a result, the client passed a Health Canada regulatory inspection, won approval for its product in Canada, and is on the road to full cGMP compliance with an IND pending with FDA.
A European company focused on the development of oncology vaccines needed assistance in planning for a US IND, as well as a global Phase II clinical program. Beaufort designed an IND strategy that addressed the challenges facing an oncology vaccine, while taking into consideration the problems faced by other companies with similar compounds. Beaufort provided CMC support for the client’s manufacturing efforts. In addition, Beaufort consulted on and prepared the Pre-IND package for the FDA. The client received such a clear positive response to the package that a meeting with the agency was deemed unnecessary. This process facilitated the near-term development of their compound and led the way for the international Phase II program.
A European company focused on the development of oncology vaccines needed assistance in planning for a US IND, as well as a global Phase II clinical program. Beaufort designed an IND strategy that addressed the challenges facing an oncology vaccine, while taking into consideration the problems faced by other companies with similar compounds. Beaufort provided CMC support for the client’s manufacturing efforts. In addition, Beaufort consulted on and prepared the Pre-IND package for the FDA. The client received such a clear positive response to the package that a meeting with the agency was deemed unnecessary. This process facilitated the near-term development of their compound and led the way for the international Phase II program.
The US division of a global pharmaceutical firm needed support with clinical site field monitoring. Beaufort agreed to supplement the company’s full-time CRAs and contract monitors from a robust pool of qualified field monitors. Maintaining frequent contact with the client to stay abreast of ever-changing needs, Beaufort presents pre-screened and highly qualified candidates to the client’s management. This arrangement gives the client the ability to move forward with their field monitoring, knowing that their CRA pool can be supplemented with Beaufort field monitors across a wide spectrum of therapeutic areas and geographic locations. Beaufort’s flexibility, knowledge of monitoring practices, and our ability to deliver qualified CRAs in specific regions of the country has enhanced the client’s monitoring program and reduced travel costs.
The US subsidiary of a large, international pharmaceutical company needed assistance in preparing for several regulatory inspections. A majority of the company’s clinical and regulatory staff had never participated in a regulatory inspection and anxiety levels were running high. Beaufort began the project by interviewing all pertinent personnel to establish their experience level and determine the company’s preparedness for the inspections. Our work included extensive document reviews, mock audits, extensive training sessions, both seminar and one-on-one. Beaufort also developed white papers to share with regulatory authorities during the inspections. We developed a series of mock inspections and follow-up activities, and the client passed all regulatory inspections with minimal audit findings, including a major FDA pharmocovigilance inspection.
The US subsidiary of large, international pharmaceutical company identified a broad range of actions to increase its readiness for an upcoming FDA inspection. These actions included a review and revision of their Quality Document System, a review of their Computer System Validation (CSV) Plan, and performing Vendor Audit Assessments. Beaufort performed an in-depth review of the company’s current document system, including meetings with all key stakeholders. This review led us to suggest several alternative document structures. The final project deliverables included an SOP Assessment Report, complete Document Index, revised SOPs, Flow Diagrams, Glossary of Terms and Definitions, and an SOP Writing Style Guide.
