The BBCR team will empower Sponsors with medical insight, ODA application experience, strategic clinical planning, and streamlined trial design.
Rare Disease
Orphan drug designation provides critical incentives for the ODA, including significant tax credits for qualified clinical testing. Learn more about Precision Medicines’ Impact on Orphan Drug Designation or contact BBCR today at (617) 401-2327.
August 14th, 2023 | Rare Disease
The Strategic Clinical Innovation Organization (SCIO) method is explicitly designed to help pharmaceutical innovators address their concerns and maneuver around evolving challenges. SCIO identifies time and cost efficiencies and relief from risk management on their journey to market approval. Reach out today to learn more.
August 8th, 2023 | Rare Disease
An early-phase strategy improves productivity and the path to market approval. SCIO SM Advantages Accelerate Patient Recruitment Reduce Patient Number Reduce Clinical Development Time Reduce Trial Monitoring Time Increase Patient Retention Facilitate Decision Making Increase Data Quality The FDA has been calling for a smarter, more innovative process for market approval, and SCIO SM is […]
BBCR has extensive experience in biologics for rare diseases and can assist with the development of a targeted strategy to meet your study needs. Reach out today to learn more.
July 17th, 2023 | Rare Disease
Cell and Gene therapy are the new frontiers in the fight against devastating diseases, including rare diseases and cancers. Strategies that move products to market faster: A cost-effective Clinical Plan that saves time and resources Medical Monitoring Ad-interim Chief Medical Monitor Indications Selection and Prioritization Trial Design and Protocol Study Remediation and Rescue Clinical research […]
BBCR has many useful resources on our website that highlight our case studies and offer timely and informational news and content via our blog.
July 12th, 2023 | Rare Disease
In addition, our Resources section includes published studies and conference updates that highlight the breadth and depth of our experience in the areas of orphan diseases. 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. Our operational mission is to […]
The BBCR mission is to deliver cost-effective clinical plans and regulatory strategies for cell and gene therapy programs. We invite you to learn more at bbcrconsulting.com.
July 10th, 2023 | 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 […]
BBCR is highly skilled to meet clients’ needs in the fast paced and ever-changing regulatory environment. As specialists in Orphan and Personalized Medicine, BBCR helps clients identify areas of need or economic interest and helps them find homes for treatments for rare diseases and precision medicine.
June 20th, 2023 | Rare Disease
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 […]
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 Disease
BBCR 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 […]