Orphan Diseases

BBCR provides Orphan Drug solutions that empower sponsors with medical insight, ODA application experience, strategic clinical planning, and streamlined trial design.

March 13th, 2024 | Orphan Diseases

Our selected services include expertise with Biomarkers & Surrogate Endpoints, Regulatory Affairs FDA & EMA, Medical Affairs & Clinical Research, Due Diligence, and Trial Management & Trial Rescue. BBCR’s Strategic Clinical Innovation OrganizationSM (SCIO) method is explicitly designed to help pharmaceutical innovators address their concerns and maneuver around evolving challenges. SCIOSM identifies time and cost […]

By collaborating with Boston Biotech Clinical Research, you’ll be working with a team of experts who are dedicated to streamlining the clinical trial process.

February 13th, 2024 | Orphan Diseases

We provide expert guidance for Orphan Drug Development by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements. 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 […]

Why and how to invest in Early Strategy before First in Human

October 12th, 2023 | Orphan Diseases

Innovation in clinical research is a long-term need due to several factors, including the high failure rate and skyrocketing costs. Several factors contribute to the skyrocketing cost of clinical trials. Integration of advanced technologies into drug development. While these technologies offer valuable insights, they incur additional training, data analysis, and interpretation costs. Complexity of study […]

BBCR is committed to meeting the challenges of sponsors and investors seeking a clear path to market.

September 27th, 2023 | Orphan Diseases

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 […]

There remains continued interest in the use of surrogate endpoints as primary measures of the effectiveness of investigational drugs in definitive drug trials. BBCR’s published White Paper – Surrogate Endpoints for an Accelerated Orphan Drug Approval – remains a valuable resource in the area of orphan drug development.

September 20th, 2023 | Orphan Diseases

Rare 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 […]

Early Clinical Strategy: Portfolio Expansion Indication Selection

August 23rd, 2023 | Orphan Diseases

Expanding a product portfolio through the selection of additional indications can offer strategic growth opportunities. However, the process of selecting indications for portfolio expansion requires careful consideration of various factors. Here are few of them for your consideration: Synergy with Existing Capabilities: Building on established strengths can streamline development and increase the chances of success. […]

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 | Orphan Diseases

The BBCR team will empower Sponsors with medical insight, ODA application experience, strategic clinical planning, and streamlined trial design.  

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 | Orphan Diseases

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 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 | Orphan Diseases

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 | Orphan Diseases

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