BBCR helps orphan drug developers find direction in clinical trials involving biologics, biosimilars, small molecules, medical devices, and repurposing. BBCR consultants have the experience to guide you through the development process with a clinical plan and a regulatory strategy. Our team will empower you with medical insight, effective regulatory expertise, strategy, and streamlined early clinical […]
We are pleased to share with you our newly enhanced website. Over the past several months, our team has carefully reviewed our processes, capabilities, and offerings in order to provide you with the clearest overview of how we help our clients. BBCR is dedicated to supporting pharmaceutical innovators in the specialized rare diseases and orphan […]
As one of the first consultancy teams to streamline clinical trials, BBCR’s boutique consulting team specializes in rare disease and orphan indications dedicated to supporting pharmaceutical innovators, and nurturing each product’s strengths. The BBCR Team provides knowledge in cell, biologics and gene therapies BBCR addresses sponsors’ questions in the ever-changing regulatory environment Clinical strategy for […]
If you’re interested in learning more about drug repurposing to treat rare disease, BBCR can help with your regulatory consulting needs. We offer expertise in the following areas: FDA meeting and submission Pre-IND integrated development plan Clinical consultant Clinical study design and protocol CRO and project management Study remediation and rescue
A 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 […]
The World Orphan Drug Congress USA will be a live virtual conference. BBCR’s Team invites you to send an email at [email protected]/bbcr2. We hope to meet many of you that will attend the World Orphan Drug Congress. We are very much interested in learning about your programs to determine if BBCR’s expertise in Rare Diseases […]