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
Drug Repurposing is an enticing market with surging growth forecasts. The orphan class of biological products deserves special attention for drug repurposing as it provides a vital niche to the patient and society and are currently minimally investigated.
If you're interested in learning more about drug repurposing to treat rare disease, BBCR can help with your regulatory consulting needs. We offer expertise in the following areas: FDA meeting and submission Pre-IND integrated development plan Clinical consultant...
Boston Biotech Clinical Research (BBCR) works with biotech, pharmaceutical, and device companies to develop a clinical and regulatory roadmap consisting of simplified clinical programs, streamlined protocols, and cost-effective trials.
Our Boston-based, integrated, boutique consulting team specializes in rare disease and orphan indications, and is dedicated to supporting pharmaceutical innovators and nurturing each product’s strengths. The BBCR mission is to simplify clinical research, encourage...
BBCR’s experience and understanding of how the FDA views orphan applications and structuring a development program to deliver the data and rationale to satisfy the FDA can substantially reduce the review period and increase approval.
A strategic approach creates opportunity for time efficiencies The Orphan Drug Act is an important piece of legislation that uses financial incentives to encourage the development of drugs that treat rare diseases and precision medicine impacting disease...
We are excited about the recognition by the DIGITECH insight magazine that included the BBCR’s proprietary SCIO process within the top 10 innovations in drug development for 2022.
Read more about BBCR's Streamlined Clinical Development Strategies in DigiTech Insight
BBCR uses innovative approaches to de-risk your product development. For our clients interested in Proof of Mechanism and Proof of Concept – PoM and PoC – BBCR 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...
Trial for Duchenne muscular dystrophy cell therapy.
Duchenne Muscular Dystrophy is the most common fatal genetic disorder to affect children around the world. The first patient, a six year old boy, received, in November 2021, an infusion of DT-DEC01, a novel cell therapy containing Dystrophin Expressing Chimeric Cells...
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.
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...
The Omicron SARS-CoV-2 Variant and Vaccines
From the beginning, pharmaceutical companies engaged in the development of COVID-19 vaccine were aware that to defeat the pandemic they had to address proactively virus variants. Moderna in a Nov. 2021 press...
COVID-19 vaccine booster for children aged 12–15.
The FDA reviewed data from Israel from children 12–15 years old who received a booster five months after the primary Pfizer-BioNTech COVID-19 vaccine and is amending the Emergency Use Authorization (EUA) to allow the booster five months after the primary two-dose...
Omicron, the second variant of concern after the Delta SARS-CoV-2 variant.
Several SARS-CoV-2 variants have been identified since the beginning of the COVID-19 pandemic: Alpha (B.1.1.7 and Q lineages) Beta (B.1.351 and descendent lineages) Gamma (P.1 and descendent lineages) Epsilon (B.1.427 and B.1.429) Eta (B.1.525) Iota (B.1.526) Kappa...
BBCR consultants have the experience to guide you through the development process with a clinical plan and a regulatory strategy. We invite to reach out to learn more.
Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. We understand that navigating the rare disease development process requires expert guidance....
The BBCR team is highly experienced in crafting innovative approaches to de-risk your product development during the early clinical development stage.
Depending on your project goals, our consultants’ work with you to design cost-effective early clinical studies that holds potential for reducing Phase III failures. Our team of consultants can assist in the areas of: POM & POC Translational Research Clinical Plan...
BBCR’s team expertise in rare diseases and precision medicine, combined with SCIO approach, helps streamline trials for swift regulatory approvals. For our clients, this ensures that the proper focus is given to cost containment and value-based developments that allow sponsors to move more treatments to market faster.
BBCR provides expert market guidance and embraces innovative strategy consulting for effective clinical development plan and regulatory strategy. Developing drugs for rare diseases and precision medicine indications can be rewarding, but navigating the challenges is...
BBCR has developed an approach to meet the challenges of researchers and innovators seeking a clearer path to market. Learn more about the advantages of our Strategic Clinical Innovation Organization (SCIO) concept.
We aim to transform the transition stage between pre-clinical and clinical endpoints with smart strategy that, at a minimum, redirects the costs to benefit patients. The FDA has been calling for a smarter, more innovative approach, and we believe SCIO is the...
Drug Repurposing can lower the need for early stage clinical trials. BBCR’s team of industry experts can help match treatments to rare genetic conditions and unsolved diseases.
According to recently released data, 12 out of the 28 drugs approved in the first quarter of 2020 by the FDA were repurposed drugs. The drug repurposing approval process is an effective tool that accelerates the development of drugs for new indications or drug...
BBCR is pleased to present the following White Paper – Surrogate Endpoints for an Accelerated Orphan Drug Approval
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...
Medical device companies need to think about clinical data strategy from conception to market, from preparing due-diligence ready datasets for funders to post-marketing safety surveillance for regulatory authorities. BBCR can help.
Medical devices have their own special complications as it relates to clinical trials. We work closely with each client to bring device innovation to market faster and more affordably. Working with the BBCR team will help that streamlines clinical trials and help you...
Our industry needs innovative strategies, and reduced-risk clinical trials. BBCR clinical development services and drug development consulting integrates real world evidence (RWE) into clinical development plans and regulatory strategies.
Focus must go to cost containment and value-based developments that allow sponsors to move more treatments to market faster. BBCR’s team expertise in rare diseases and precision medicine combined with SCIO approach helps streamline trials for swift regulatory...
BBCR works with clients beyond consulting, to create cost-effective clinical trials and strategies that nurture product strengths
Streamlined Clinical Development Strategies Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements. Specializing in rare...
Transformation in drug development is ongoing
Over the past forty years, the drug development process has changed significantly. In the last twenty years, the industry has invested in gathering scientific data to inform clinical questions. Since 2000, the clinical research's primary objective has been to marry...
BBCR offers expertise in the areas of Product Development Planning and Validation or Qualification when biomarkers are a part of your product development plan.
How BBCR Can Help BBCR’s biomarker expert is renowned in the field. He is a senior advisor on the biomarker committee at the NIH and former global biomarker expert at Novartis, Roche, and Pfizer.Insightful strategy is the most effective way to ensure quality when...
Boston Biotech Clinical Research specializes in rare disease, working with biotech, pharmaceutical, device companies and investors to help streamline the clinical trial process.
Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements. BBCR Consulting offers world-class regulatory, clinical research,...
Understanding how a Strategic Clinical Innovation Organization can help streamline the clinical trial process.
The Strategic Clinical Innovation Organization (SCIO) method provides biotech, pharmaceutical and device manufacturing companies with a cost-effective, customized approach to clinical development planning. This approach, pioneered by BBCR, aims to reduce the risks...
BBCR offers streamlined clinical development and clinical and regulatory expertise to a variety of clients both domestically and internationally.
The BBCR team of experts has worked in pre-clinical and clinical product development and regulatory affairs. We believe that understanding the perspective, challenges, and needs of our clients allows us to serve as a trusted adviser throughout the clinical development...
Document preparation and submissions is critical to the success of bringing your product to market. Rely on the BBCR team to know what to submit and when for the most efficient process.
Documentation of clinical processes and preparing the essential paperwork for timely submission can open doors to expediting the approval process. Boston Biotech Clinical Research can provide: Strategy and guidance for FDA meeting requests, briefing packages,...