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
Our experienced CRO Management and Drug development team identify study remediation strategies and provide a resource for any Study Rescue
Every clinical study has its unique challenges that initially may not have been factored for. Experienced management can help sponsors to address prolonged trial timeline and high quality data. Rare Diseases and Precision Medicine Require Unique Approaches In Clinical...
BBCR embraces innovative strategy consulting for effective clinical development plan and regulatory strategy.
Our industry is looking for an innovative process. 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...
PKAN drug fails Phase III trial: How to avoid a similar disaster.
Retrophin's experimental PKAN drug fosmetpantotenate fails phase III trial Pantothenate kinase-associated neurodegeneration (PKAN) is a rare disease characterized by a progressive neurodegenerative disorder and buildup of iron in the brain which is estimated to affect...
Inflammation is a recognized cause of Neurodegeneration.
Neuroinflammation is inflammation of the nervous tissue. It may be initiated in response to a variety of cues, including infection, traumatic brain injury, toxic metabolites, or autoimmunity. In the CNS, including the brain and spinal cord, microglia are the resident...
High cost and cycle time delays of protocol amendments
In practice, for a given clinical trial, it is not uncommon to have 3–5 protocol amendments after the initiation of the clinical trial. One of the major impacts of many protocol amendments is that the target patient population may have been shifted during the process,...
Potential of Gene Therapies in Rare Disorders
BBCR Consulting, for the first time this year, decided to attend on October 15th - 17th in London- UK, the European edition of the Gene Therapies in Rare Disorders conference. In our opinion, the event, as promised, proven to be: ”…uniquely focused conference that...
Generic EpiPen to reduce costs
Teva received approval to market generic versions of Mylan’s epinephrine auto-injector for emergency treatment of allergic reactions for both adults and children in August 2018 after several years of delays in getting the generics approved. Teva Pharmaceutical EpiPen...
Biologic treatments show promise in providing clinical solutions to a variety of diseases. Boston Biotech Clinical Research has experience in biologics for rare diseases and can help develop a targeted strategy for your needs.
Biologic treatments show promise in providing clinical solutions to a variety of diseases Due to biological’s unique characteristics, study designers may find that results in pre-clinical trials do not predict acute, chronic and late onset immunogenicity and safety....
Repurposing acts to 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, then work with a product developer on the best plan to market.
People tend to believe that a repurposed therapy can never be truly novel or transformative. Nothing could be further from the truth. One attractive option of Drug Repurposing is to use a scientific approach to identify new uses for existing drugs. About a third of...
The Strategic Clinical Innovation Organization (SCIO) concept developed by BBCR was designed specifically to help pharmaceutical innovators address the concerns and maneuver around evolving challenges. SCIO allows for time and cost efficiencies, and risk mitigation.
Find opportunity for efficiencies early in the clinical development process A Clear Path to Approval The Strategic Clinical Innovation Organization (SCIO) concept developed by BBCR was designed specifically to help pharmaceutical innovators address the concerns and...
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...