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
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...
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...
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...
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...
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...
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...
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.
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...
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.
Biomarkers and Surrogate Endpoints – Learn more about how BBCR can help get your product to market more efficiently with proper plan development and strategy. Interest is increasing rapidly in using surrogate endpoints as primary measures of the effectiveness of...
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.
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...
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.
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...
Trial failures can arise from factors such as failing to maintain suitable protocols, being unable to follow FDA guidance, complex procedures for participating patients, slow recruitment, lack of efficacy, safety issues, and/or insufficient funding to complete a trial. BBCR experts provide an understanding of the reasons a trial failed and offer insights to create and execute successful clinical trial management protocols and CRO management.
Trial Management that addresses risks The experienced trial management address risks such as: Scarce enrollment Multiple protocol amendments Poor patient retention Poor data quality Prolonged trial completion timeline Poor safety monitor [button...
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.
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...
Clients entrust BBCR to provide expert guidance in simplifying their clinical plans and developing customized strategies and cost-effective clinical trials that nurture product strengths.
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. Click the button below to learn more about how we have helped...
BBCR has been invited to speak at the upcoming 12th Clinical Trials Strategic Summit 2023 May 10th- 11th 2023 in Boston, MA
Speaking Topic: Increasing Investor’s Evaluation of SME Biotech in a Slumping Market BBCR will be speaking on the challenges investors face and how to successfully navigate today's Biotech market.
Welcome to BBCR’s next generation website! We invite you to come explore our new site, redesigned to provide a clear overview of how BBCR can help you with early clinical development, rare disease and orphan drug solutions.
We are pleased to share with you our newly enhanced website. Over the past several months, our team has carefully reviewed our processes, capabilities, and offerings in order to provide you with the clearest overview of how we help our clients. BBCR is dedicated to...
Translational Medicine and Epigenetics Program Consultation bridges the gap between pre-clinical and early clinical development. We invite you to learn more about how BBCR can help with your clinical development needs.
Translational medicine is a bridge between pre-clinical and early clinical development (from bench to bedside), creating the foundation for precision medicine in late clinical development. A translational medicine program includes the adopting biomarkers to mitigate...
Drug repurposing offers your product shorter journeys to the clinics. It is especially crucial to rare and neglected diseases, cancers, and neurodegenerative diseases. Learn how we can help at bbcrconsulting.com
The BBCR consultants, experienced in orphan, rare and ultra-rare diseases, have advised biotech and venture capitalists for new indications evaluation and prioritization. BBCR’s team of industry experts can help match treatments to rare genetic conditions and unsolved...
BBCR provides expert guidance for Orphan drug development. Our consultants have the experience to guide you through the Orphan clinical research process with a clinical plan and regulatory strategy for an accelerated approval.
Streamlining Clinical Development with Clinical and Regulatory Expertise Our team will empower you with medical insight, practical regulatory, translational medicine, and clinical research expertise, and streamlined clinical trials. [button...
BBCR maintains a philosophy of fostering continual improvement and productivity in the areas of Medical Affairs and Clinical Research
Our goal is to optimize every aspect of the research and development process We will: Improve protocol development, including current trends in clinical trial designs and endpoints Benchmark relevant historical trial enrolment with unmet needs and ongoing trial...
Build the first step for a successful study – An early strategy ensures efficiency in Clinical Development
Designed primarily to meet regulatory requirements for therapies targeting large patient populations, the existing development model lacks flexibility and efficiency to address today’s drug development demands. Challenges include managing product pipelines, targeting...
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. The development of Cell and Gene Therapies is challenging due to complex study designs, adequately monitoring of...
Due Diligence is critical before dedicating precious time and resources to a research project that appears to hold commercial promise.
Due Diligence is typically performed by investors but can, and should, be conducted by sponsors to increase their chance of financing success, partnering, mergers, acquisitions (M&As), and product licensing. For companies developing multiple products, Due...
BBCR’s SCIO method aims to learn, predict and make better decisions for a successful drug opportunity.
Learn the potentials of each preclinical asset, and predict the level of certainty for each strategic option. Today’s technological molecules require innovation in the development process. We cannot keep using yesterday’s assumptions for tomorrow’s drugs. Marketed...
A translational medicine program includes the adoption of biomarkers to mitigate Phase I and II clinical risks, identify patient subpopulations, facilitate decision-making, and accelerate the release of a drug on the market.
BBCR’s epigenetic expert, Dr. Claudio Carini, has been a pioneer in epigenetics leading the effort of major pharmaceutical companies. BBCR helps to bridge the gap between pre-clinical and early clinical development. Translational medicine is a bridge between...
BBCR’s 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 orphan indications.
Expert guidance is essential in an area where patients are few; a lack of previous studies may hamper progress as you mount an orphan petition and negotiate a clinical plan with the FDA. BBCR consultants have the experience to guide you through the Orphan clinical...