Rare Disease

Rare Disease

“The beginning is the most important part of the work.” — Plato. BBCR is dedicated to developing and nurturing a product’s unique strengths from conception to market. Our expertise with cell, biologics and gene therapy as they relate to rare disease is the cornerstone of our consultancy practice.

June 19th, 2024 | Rare Disease

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

Dr. Candida Fratazzi is a pioneering figure in the area of rare diseases and orphan drug early-stage clinical research and regulatory strategies. With an impressive 20-year track record in this specialized field, Dr. Fratazzi’s contributions have been significant.

May 14th, 2024 | Rare Disease

Her journey began when she founded BBCR Consulting, an organization dedicated to strategic clinical innovation, aiming to streamline the often convoluted processes of clinical trials. Drawing from her extensive 25 years in biomedical research, Dr. Fratazzi introduced the SCIOTM concept, a revolutionary approach aimed at creating efficiencies in the intricate journey of bringing biotech products […]

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 craft customized strategies that achieve cost-effective trials. Reach out today to learn more.

April 17th, 2024 | Rare Disease

BBCR’s mission is to deliver cost-effective clinical plans and regulatory strategies for cell and gene therapy programs in the areas of rare disease. Cell and Gene therapy are the new frontiers in the fight against devastating diseases, including rare diseases and cancers. Clinical trial results have been promising, and the next generation of Cell and […]

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

March 13th, 2024 | Rare Disease

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 | Rare Disease

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 […]

BBCR’s mission is to deliver cost-effective clinical plans and regulatory strategies for cell and gene therapy programs in the areas of rare disease. We invite you to learn more at bbcrconsulting.com.

January 16th, 2024 | Rare Disease

Cell and Gene therapy are the new frontiers in the fight against devastating diseases, including rare diseases and cancers. Clinical trial results have been promising, and the next generation of Cell and Gene therapies holds tremendous promise for many patients and families. We can assist with strategies that move products to market faster, including: A […]

Why a Strategy Plan Before First in Human

November 15th, 2023 | Rare Disease

Innovation in clinical research is a long-term need due to several factors, including the high failure rate and skyrocketing costs. Healthcare has been changing rapidly for many years. The COVID-19 pandemic has accelerated by helping drive the shift to value-based healthcare. Instead, the productivity of pharmaceutical development has been declining due to high failure rates […]

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

October 12th, 2023 | Rare Disease

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 | Rare Disease

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 | Rare Disease

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 […]

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