Challenge: A world leader in tissue-based cancer diagnostics based in Denmark was notified by the FDA that they were not in compliance with the ASR regulation. The company submitted a project plan to become compliant, but after the FDA did not respond for more than a year, the company sought assistance resolving the issue and dealing with the FDA.
Beaufort Solution: Beaufort helped the company resolve ASR compliance issues with the pre-IDE submission and crafted an appropriate pre-IDE submission and project plan. Prior to mediating the pre-IDE meeting with the FDA, Beaufort helped the company develop a presentation and assisted with a dress rehearsal.
Challenge: A leader in assay and sample technology development for tests used in the pharmaceutical and molecular diagnostics industries needed a regulatory strategy for its analyte-specific reagent (ASR) diagnostic kits.
Beaufort Solution: After identifying pathways to a Class II device classification, Beaufort prepared a strategic regulatory plan for the test kit, enabling the company to satisfy regulatory requirements in a cost-effective manner. Beaufort drafted a pre-IDE filing, including a clinical trial plan, and provided coaching to the client as they prepared for their pre-IDE meeting with the FDA. After successful meetings with FDA officials, the company relies on Beaufort for continued support as necessary, including assisting with pre-clinical and clinical trial activities.
Challenge: A company that offers comprehensive contract manufacturing services required regulatory support.
Beaufort Solution: The company needed a clear regulatory strategy for bringing their project to market in the shortest possible timeframe. In addition, the client needed clinical trial management and data entry to support a 510(k) submission to FDA. Beaufort provided ongoing regulatory consultation and conducted the clinical trials, including site identification/qualification, clinical study and regulatory document preparation, IRB submissions, site monitoring, and data entry in support of the company’s first 510(k) submission to FDA.
Challenge: A growing in vitro diagnostics company needed regulatory and clinical trial assistance for a 510(k) submission and a CLIA waiver.
Beaufort Solution: The company’s previous interactions with FDA highlighted a need for assistance in finalizing their clinical trial protocol, subsequent clinical trial management, and preparing for a pre-IDE meeting with FDA. Beaufort developed a comprehensive clinical trial protocol that provided the statistical power to support the intended uses. Beaufort prepared the company for interactions with FDA and meetings with the agency. Following these meetings, FDA supported the clinical plan which enabled the trials to move ahead and Beaufort located, qualified, and coordinated clinical trial sites for a highly time-sensitive trial.
Challenge: A small, innovative U.S. company requested regulatory support for submission of a 510(k) for a new medical device.
Beaufort Solution: The lack of internal expertise and infrastructure threatened this client’s ability to successfully achieve their business objectives. Beaufort was initially brought in for regulatory support, but as the project progressed, the client realized they needed assistance with clinical trial management as well. Beaufort created a collaborative environment to carry out the many responsibilities with the various partners in order to achieve the necessary results, including 510(k) clearance of this client’s medical device.
Challenge: A European company focused on the development of oncology vaccines needed assistance in planning for a U.S. IND, as well as a global Phase II clinical program.
Beaufort Solution: 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.
Challenge: A division of a global molecular diagnostics company needed a regulatory strategy for a completely new technology.
Beaufort Solution: Division management had a clear plan for the scope of their product but lacked the regulatory expertise necessary to devise the most time and cost-effective approach for launching a new product. The company engaged Beaufort to develop a comprehensive regulatory strategy focusing on all aspects of the new technology, including biomarker targets and methodology. Beaufort provided a complete regulatory strategy that classified the device for the company including identification of potential predicate devices and assessed the possible pathways for the product, as well as timelines, associated tasks, and costs for each type of submission. The company is using this strategy to plan its current product development. In follow-up to the initial Regulatory Strategy for 510(k) submission, the company tasked Beaufort with providing a Regulatory Opinion. Specifically, the company provided 14 questions regarding their top priority and most controversial products due to the biomarker detection and Beaufort provided comprehensive answers to all of the questions.
Challenge: A subsidiary of a global molecular diagnostics company needed assistance developing an effective regulatory strategy for a drug-of-abuse assay.
Beaufort Solution: In-house clinical trial plans and previous 510(k) submissions had been rejected by the FDA. The company engaged Beaufort to redefine the intended use of the assay and provide guidance regarding effective interactions with FDA. Beaufort redefined the intended use to specify the results of the product and to enable FDA to focus on the potential positive uses of the product. After previous applications, literature, and data were reviewed, Beaufort redesigned a clinical trial protocol that would support the new intended use of the assay, providing appropriate focus on the actual functionality of the product. This done, the client was positioned to move forward in their plans for the product.
Challenge: A leader in molecular-based diagnostic tests and testing platforms sought assistance in developing its regulatory strategy for repositioning several analyte-specific reagents (ASRs).
Beaufort Solution: The company wanted a comprehensive regulatory perspective encompassing the various potential pathways for converting ASRs into diagnostic kits, as well as assistance in creating the pre-IDE information packages for each product. Working with the company’s internal resources, Beaufort completed this assignment, and, in addition, reviewed relevant literature and created a pre-IDE information package which included a high level clinical trial protocol for FDA review.
Challenge: An established, privately-held European company wanted to introduce its products in the North American market.
Beaufort Solution: 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.
Challenge: A start-up biotechnology company needed a regulatory strategy designed to reposition a previously withdrawn compound.
Beaufort Solution: 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.
Challenge: A venture-funded European biotechnology company needed a regulatory strategy for a combination device-biological CNS product.
Beaufort Solution: 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.