Rare Disease
In orphan diseases and precision medicine, developing a biomarker plan during translation into early clinical development moves treatment to market faster, and still meets the FDA’s expectations.
June 15th, 2023 | Rare DiseaseBBCR is honored to have contributed to the work, Bacterial Consortium Therapy for Prevention of Recurrent C difficile Infection, published April 15, 2023 in the JAMA Medical Journal.
June 7th, 2023 | Rare Disease
The microbiome is the collection of genomes, genes, and gene products of the microbiota living in a given environment, such as a soil patch or the gut of a human being. While bacteria are the most prominent players, we also host single-celled organisms known as archaea, fungi, viruses, and other microbes – including viruses that […]
BBCR is dedicated to supporting pharmaceutical innovators in the specialized rare diseases and orphan drug indications by developing and nurturing the product’s unique strengths. We invite you to learn more about our services at bbcrconsulting.com.
May 25th, 2023 | Rare Disease
Specializing in rare diseases, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps clients reach their goals by customizing a clinical and regulatory roadmap of simplified programs and streamlined protocols. Discover the many ways we help our clients by visiting bbcrconsulting.com or […]
BBCR specializes in strategy and provides early clinical research services to enable informed, timely decision-making for our clients. It is our mission to support domestic and international pharma, biotech, and device companies by nurturing their products’ strengths while improving efficiency and safety.
May 9th, 2023 | Rare Disease
Developing innovative or repurposed drugs for orphan diseases can be rewarding, but navigating the challenges is not for the faint of heart. Our regulatory and clinical research consultants are experts in biologics, cell and gene therapies, and small molecule developments. Identifying areas of need or economic interest can help sponsors find homes for treatments for […]
Drug repurposing offers your product shorter journeys to the clinics. It is especially crucial to rare and neglected diseases, cancers, and neurodegenerative diseases. Learn how we can help at bbcrconsulting.com
March 23rd, 2023 | Rare Disease
The BBCR consultants, experienced in orphan, rare and ultra-rare diseases, have advised biotech and venture capitalists for new indications evaluation and prioritization. BBCR’s team of industry experts can help match treatments to rare genetic conditions and unsolved diseases, then work with a product developer on the best plan to market. Candidate assessment for 505(b)(2) approval […]
RWE can accelerate approval timelines and reduce drug development costs as long as sponsor companies carefully uphold established evidence and engage in early dialogue with the FDA.
January 19th, 2023 | Rare Disease
Real-world evidence (RWE) is increasingly important in clinical trial design and drug approval. RWE is clinical evidence related to patient health status and treatment safety and efficacy that are generated in clinical practice. BBCR’s team understands the role RWE plays for Natural History in Rare Diseases. We invite you to be in touch to learn […]
BBCR provides expert strategies for Orphan Disease. The BBCR mission is to customize development plans, simplify clinical research, design cost-effective trials, streamline protocols, and create a regulatory roadmap.
December 19th, 2022 | Rare Disease
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 […]
A recent posting by Value Market Research highlighted BBCR Consulting among others relating to the global oncology Biomarker market and its projected broad growth.
December 14th, 2022 | Rare Disease
BBCR=Simplifying Clinical Research Interest is increasing rapidly in using surrogate markers as primary measures of the effectiveness of investigational drugs in definitive drug trials. The primary difference between a biomarker and a surrogate marker is that a biomarker is a “candidate” surrogate marker. In contrast, a surrogate marker is a test used and taken to […]
With BBCR’s Strategic Clinical Innovation Organization (SCIO) method, we are able to provide a clear path to market approval.
December 12th, 2022 | Rare Disease
The Strategic Clinical Innovation Organization SCIO SM (SCIO) method is explicitly designed to help pharmaceutical innovators address their concerns and maneuver around evolving challenges. SCIO SM allows for time and cost efficiencies and relief of risk management. The SCIO SM method aims to learn, predict and make better decisions for a successful drug opportunity. This […]
The BBCR mission is to develop customized strategies, simplify clinical plans and cost-effective trials, streamlined protocols, and create regulatory roadmaps. We invite you to learn more at bbcrconsulting.com.
December 6th, 2022 | Rare Disease
BBCR’s boutique consulting team specializes in rare diseases and orphan indications and dedicated to supporting pharmaceutical innovators, and nurturing each product’s strengths. The BBCR team provides consultancy in cell, biologics, and gene therapies BBCR addresses sponsors’ questions in the ever-changing regulatory environment Clinical strategy for orphan diseases and precision medicine RWE can be used to […]