Our mission is to support domestic and international pharma, biotech, and device companies by nurturing their products’ strengths while improving efficiency and safety. We specialize in strategy and provide early clinical research services to enable informed, timely decision-making for our clients. Learn more about the services we provide within the areas of Early Clinical Research […]
Tagged: Accelerated Orphan Drug Approval
BBCR is committed to meeting the challenges of sponsors and investors seeking a clear path to market.
September 27th, 2023 | Accelerated Orphan Drug ApprovalWhy choose BBCR for your product development needs?
July 12th, 2022 | Accelerated Orphan Drug ApprovalBBCR can help streamline product development and help to successfully navigate your clinical and regulatory journey. BBCR focuses on: Acceleration Cost-effectiveness Risk reduction Data collection and analysis support
BBCR’s experience and understanding of how the FDA views orphan applications and structuring a development program to deliver the data and rationale to satisfy the FDA can substantially reduce the review period and increase approval.
February 16th, 2022 | Accelerated Orphan Drug ApprovalA strategic approach creates opportunity for time efficiencies The Orphan Drug Act is an important piece of legislation that uses financial incentives to encourage the development of drugs that treat rare diseases and precision medicine impacting disease sub-populations. BBCR’s team of experts can help your company create a roadmap specially customized to ensure successful product […]
BBCR is pleased to present the following White Paper – Surrogate Endpoints for an Accelerated Orphan Drug Approval
November 29th, 2021 | Accelerated Orphan Drug ApprovalRare Diseases are conditions that affect less than 200,000 people in the U.S. However, over 7,000 Rare Diseases affect more than 400,000,000 people worldwide, including ~25 million in the U.S. and ~30 million in Europe (1). In recent years, the number of orphan drugs approved has increased significantly. However, developing and marketing orphan drugs remains […]