BBCR Voice

From the Perspective of Researchers, Clinicians, and Regulatory Experts

The most efficient path in the clinical research process is a moving target. Technology innovation and regulatory requirements require constant updates.  Through BBCR Voice, we aim to share not only our knowledge and expertise but also solutions to current challenges. BBCR embraces the challenges of developers and investors seeking a more straightforward path to market.

Recent Posts

“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.

“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.

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...

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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.

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.

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...

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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.

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.

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...

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

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

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...

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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.

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.

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...

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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.

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.

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...

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BBCR uses innovative approaches to de-risk your product development. For our clients interested in Proof of Concept and Proof of Mechanism – PoC and PoM – Our team has the expertise to ensure successful product development at any stage of development.

BBCR uses innovative approaches to de-risk your product development. For our clients interested in Proof of Concept and Proof of Mechanism – PoC and PoM – Our team has the expertise to ensure successful product development at any stage of development.

The BBCR team designs Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies with the drug clinical plan and regulatory strategy in mind. Proof of Mechanism (PoM) Usually in Healthy Volunteers, Phase 1 study Essential for the selection of appropriate dose...

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

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

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...

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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.

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.

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...

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Collaborating with Boston Biotech Clinical Research can streamline the clinical trial process. We customize a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements. We invite you to learn more at bbcrconsulting.com.

Collaborating with Boston Biotech Clinical Research can streamline the clinical trial process. We customize a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements. We invite you to learn more at bbcrconsulting.com.

Providing Expert Guidance for Orphan Drug Development 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...

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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.

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.

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

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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.

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.

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...

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BBCR is highly experienced in developing innovative approaches to de-risk your product development during the early clinical development stage, including designing Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies. Reach out to us at bbcrconsulting.com to learn more.

BBCR is highly experienced in developing innovative approaches to de-risk your product development during the early clinical development stage, including designing Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies. Reach out to us at bbcrconsulting.com to learn more.

BBCR specializes in the strategy and delivery of early-phase clinical development services to enable informed, timely decision making for our clients. Proof of Mechanism (PoM) Usually in Healthy Volunteers, Phase 1 study Essential for the selection of appropriate dose...

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Interest is increasing rapidly in using surrogate endpoints as primary measures of the effectiveness of investigational drugs in definitive drug trials. Learn more at bbcrconsulting.com.

Interest is increasing rapidly in using surrogate endpoints as primary measures of the effectiveness of investigational drugs in definitive drug trials. Learn more at bbcrconsulting.com.

The primary difference between a biomarker and a surrogate endpoint is that a biomarker is a “candidate” surrogate marker. In contrast, a surrogate marker is a test used and taken to measure the effects of a specific treatment. In orphan diseases and precision...

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BBCR has extensive experience in early development Phase 1 and 2 process and strategy, from pre-clinical to pre-IND. Our early drug development experience includes the development of clinical strategy and plan, including target product profiles and clinical protocols.

BBCR has extensive experience in early development Phase 1 and 2 process and strategy, from pre-clinical to pre-IND. Our early drug development experience includes the development of clinical strategy and plan, including target product profiles and clinical protocols.

Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process and strategy. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road...

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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.

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.

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...

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BBCR has many useful resources on our website that highlight our case studies and offer timely and informational news and content via our blog.

BBCR has many useful resources on our website that highlight our case studies and offer timely and informational news and content via our blog.

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...

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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.

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.

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...

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With Biomarkers now a routine part of drug development, BBCR works with companies in assisting with the identification and adoption of biomarkers, especially valuable in rare disease and precision medicine product development.

With Biomarkers now a routine part of drug development, BBCR works with companies in assisting with the identification and adoption of biomarkers, especially valuable in rare disease and precision medicine product development.

The FDA recognizes biomarker development as a high priority area for future research. BBCR can help your company with your product development plan and validation. [button...

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