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
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 read some of our Case Studies below PROJECT An executive at a pharmaceutical company asked BBCR to review its biosimilar pre-clinical data and prepare the IND package. In addition to evaluate the innovator approved indications to identify the fastest...
Biomarkers are now a routine part of drug development. BBCR can help you understand their role and move your product to market faster.
Biomarkers are now a routine part of drug development Identification and adoption of biomarkers are especially valuable in rare disease and precision medicine product development. The FDA recognizes biomarker development as a high priority area for future research....
Do Not Make Mistakes!
Mistakes made with the first interactions with the FDA are on record for your product’s life. I’m sure you’ve heard about “opportunity cost” when it comes to business, and life in general. Meaning, every choice you make has an opportunity cost attached to it because...
Microbiome and ALS: An Unsuspected Link
Amyotrophic lateral sclerosis (ALS) is a group of rare neurological rare diseases that mainly involve the nerve cells (neurons) responsible for controlling voluntary muscle movement. Voluntary muscles produce movements like chewing,...
The FDA Innovation Office
The former FDA commissioner, Scott Gottlieb, MD, had envisioned that the Innovation Office at the FDA could leverage an improved understanding of biomarkers to build modalities and to be able to take some of the risks and costs out of drug development. In his words:...
Links between the Microbiome and Autoimmunity are nothing new
An autoimmune disorder occurs when the body’s immune system attacks and destroys healthy body tissue by mistake. There are more than 80 types of autoimmune disorders. The blood cells in the body's immune system help protect against harmful...
Alzheimer’s Disease and Periodontal Disease Linked by Anaerobic Bacteria
Alzheimer’s disease is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks. In most people with the disease symptoms first appear in their mid-60s. It is...
Mitochondrial Diseases and the Challenges of Clinical Trials
Mitochondrial diseases are a genetically heterogeneous group of disorders caused by mutations or deletions in mitochondrial DNA (mtDNA) displaying a wide range of severity and phenotypes. These diseases may be inherited from the mother (mitochondrial...
Inventor of the PCR, Kary Mullis, Dies
Inventor of the PCR, Kary Mullis, Dies Kary Mullis, whose invention of the polymerase chain reaction technique earned him the Nobel Prize in Chemistry in 1993, died of pneumonia on August 7 at 74 years old. Writing in The Scientist in 2003,...
Longer Stretch To The Finish Line for CNS Diseases
Disorders of the central nervous system (CNS) account for the most frequent health disruptions afflicting our society as a whole today: Alzheimer’s, migraine headaches, stroke, addictions, depression, autism, panic, epilepsy… And yet, drugs developed to...
Cost vs. Value: Can We Have Both?
More than ever new drug developers today have to have a very realistic attitude towards drug development. Biotech and pharmaceutical companies are aggressively slashing prices in order to win business in a hyper-competitive industry. In order to make a study worth...
Could Seamless Adaptive Designs Advance Rare Disease Clinical Trial Design?
Could Seamless Adaptive Designs Advance Rare Disease Clinical Trial Design? Clinical development of a new drug product is a lengthy and costly process. For rare diseases, this lengthy clinical development process is not acceptable and adaptive design methods in...
Re-estimating Sample Size While Maintaining Statistical Power
Sample size re-estimation within a confirmatory trial (Phase III) provides a mechanism for the appropriate use of the information obtained during a confirmatory study to inform and adjust the necessary sample size going forward. This process increases the confidence...
Gene Therapy for Type 1 Diabetes Targets Treatment of Autoimmunity
Diabetes mellitus affects millions of people in the United States and worldwide. It has become clear over the past decade that the chronic complications of diabetes result from lack of proper blood glucose concentration regulation, and particularly the...
Gene Therapy for Rare Disorders Europe 2019 – October 15th – 17th, London
BBCR is excited to be attending the 3rd Annual Gene Therapy for Rare Disorders Europe Conference October 15th - 17th in London. We would welcome the opportunity to connect during the conference. Please be in touch by email at...
What is Strategic Clinical Innovation Organization
The Strategic Clinical Innovation Organization (SCIO) concept 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...
Getting More Drugs Approved for Rare Diseases
There’s encouraging news for rare diseases experts and patients. Today, pharmaceutical companies are devoting more resources to developing treatments for less-common disorders and diseases that affect mostly minority populations. The trend, which is slowly...
The cost of Trial Failure- ImmusanT Celiac Drug Trial Failure ‘Devastating’
Dec 23, 2014- Cambridge-based ImmusanT Inc. has raised $12 million in financing for its celiac-fighting immunotherapy Nexvax2 and its two celiac diagnostic tools, funding that will progress the clinical trials and development of both...
Understanding Personalized Medicine
Personalized medicine or precision medicine is a medical model emphasizing the customization of healthcare, with all decisions and practices being tailored to individual patients in whatever ways possible. Precision medicine seeks to provide an objective basis for...
Innovation in Rare Diseases
In the last three decades, biopharmaceutical companies have made great progress in the fight against rare, or “orphan,” diseases (each of which affect fewer than 200,000 people in the United States) and scientists are working each day to make the coming...
BBCR is Hiring! Boston Biotech Clinical Research is looking for a Full Time Associate Clinical Scientist to join our team!
CAREERS Job Opening: Full Time Associate Clinical Scientist About Boston Biotech Clinical Research, LLC BBCR is a global clinical-regulatory consulting, rare disease expert, offering strategic, innovative and cost-effective solutions to small and medium drug...
Is There Room in the Pharma Industry for Small Niche Providers?
As many Pharma companies scramble to partner with large CRO’s, is there still room in the industry for the small niche provider? Over 70 comments from Pharma professionals with both client and vendor experience contributed. While many Pharma groups are seduced by the...
Overcoming Barriers to Patient Recruitment in Clinical Trials
Clinical research organizations face a multitude of challenges in recruiting and enrolling patients for clinical trials. Studies show that general barriers to a patient’s enrollment include a fear of being a “guinea pig,” concerns about the complexity of research...
Patient-Centricity: Empower and inform patients making them partners in the research process
In recent years, the American healthcare system as a whole has attracted a great deal of scrutiny, which has heralded a continuous series of efforts aimed at improving and optimizing the system. In the midst of such developments, a question has emerged for those with...
Patient-Centricity: Tailoring Treatments to Individual Patients
The concept of patient-centricity is inherently multifaceted; it encompasses both the recognition of participants as central to clinical trials and the possibility of tailoring clinical interventions to individuals. Recently, the latter notion has been the subject of...