Dr. Candida Fratazzi, CEO & FounderSeveral small and medium biotechs are lining up toward the front of the starting line of this marathon today. But most of them are still not rightly prepared for the long race ahead. Reports state that only one out of ten drugs that enter the clinical trial stage gets approved.
But what are the factors that lead to such a plight?
“The clinical trial process has not changed for decades. Although we are witnessing the adoption of multiple tools and technologies, they cannot solve the core problems of high expense or failure,” answers Dr. Candida. Also, patient enrollment, lower patient retention rate, mistakes around CRO selection and management, and protocol complexities restrict small and medium biotech companies from introducing their innovative product to market at the right time.
This is where Boston Biotech Clinical Research (BBCR) Consulting—a leader in clinical development innovation—steps in. The company collaborates with biotech, pharmaceutical, and device companies to develop a clinical and regulatory roadmapconsisting of simplified clinical programs, streamlined protocols, and cost-effective trials.
A Tale of Passion, Perseverance, and Dedication
BBCR Consulting was founded by Dr. Candida, who has more than two decades of experience in the biomedical research arena. She started her journey as an academician and was driven by her passion for developing clinical strategies for several drug candidates, present in INDs, and end-of-phase II briefing documents. She was actively involved in research around Cystic Fibrosis, Fabry disease, Gaucher’s disease, and Multiple Sclerosis and served in various leadership roles in biotech and pharmaceutical companies. As she climbed the ladder, Dr. Candida’s vision for doing something more clinically relevant kept growing. She gradually became more interested in understanding the different nuances of clinical trials.
At this point, Dr. Candida witnessed closely that most small and medium biotech companies face issues around a poor development strategy, protocols unfriendly to patients, costly and complex studies, biomarkers adopted at a later development stage, and doubtful data. That’s why many of them fail to make a successful transition from the preclinical stage to human trials—commonly known as ‘Valley-of-Death’ (VoD). To change the status quo, she focused on developing an innovative approach that includes a translational and early clinical research strategy that better validates and confirms trials at the later phases. And the journey of BBCR Consulting began!
Dr. Candida devised an innovative, translational method, the Strategic Clinical Innovation Organization (SCIO) concept.The SCIO process integrates nonclinical molecular proteomics into clinical research, thus supporting the regulatory strategy building the efficacy and safety evidence since the first in man to reduce risk in late clinical trials while preparing the product for market positioning.
The SCIO Path to Seamless Approvals
BBCR Consulting’s SCIO concept revolves around three major elements—the clinical research, the design and evaluation of the data in phases I and II of the trial, and the adherence to regulatory requirements and surrogate biomarkers. Traditionally, any treatment had the capacity only to satisfy approximately no more than the need of 50 percent of the patient population in the best-case scenario. In comparison, the SCIO process aims to stratify the patient population to expand the treatment responders to close to 80 percent of the patient population to a given therapy. BBCR’s method drives immense benefit for the patients and sponsors while preventing them from failing the trial.
In the early stages of a trial, the SCIO process has been proven to offer better data quality and study design while reducing the failure of the trial in the later stages. “Our goal is to become the leader in clinical development innovation. We support pharmaceutical innovators and nurture their product’s potential and strengths,” adds Dr. Candida. The company also promotes a perfect match between the product mechanism of action (MOA) and the target indication, bringing together the right population with meaningful endpoints (clinical and surrogate). To further assist small and medium biotech companies in adopting the right approach in the early clinical development stage, BBCR Consulting’s team carries out negotiations with the regulatory agencies, helps clients adopt the correct endpoint, and develops surrogate endpoints out of the biomarker.
A Passionate Workforce Scripting Exemplary Successes
What enables BBCR Consulting to offer such a comprehensive service is the proficiency of its people. The company’s experienced team provides integrated consulting, addressing all project needs seamlessly. Its senior advisors are renowned experts in the field and have served as senior management of top pharma companies, FDA, and other government review committees. Their expertise spans from regulatory, personalized medicine to clinical research. They have more than 20 years of experience developing orphan drugs for rare diseases, including genetic disorders, oncology, neurodegenerative, and autoimmune diseases.
Backed by working collectively and having solid expertise in the clinical development space, BBCR Consulting has established itself as one of the top-tier leaders in the field of clinical trial management. The company also has a long legacy of supporting several clients through drug development and clinical research. For example, Dr. Candida developed a clinical plan for a second-to-market treatment for a rare disease. This project had several challenges stemming from the lack of patients’ naivety to treatment and its value in the marketplace. Nevertheless, the FDA approved the clinical plan proposed at the first submission without any changes, and later the product was granted market approval worldwide.
In another instance, a start-up engaged with BBCR Consulting to develop the clinical plan of three compounds for the treatment of three ultra-rare diseases in 2018. During the pre-IND meetings, given the ultra-rare status of the three indications, the company proposed the adoption of a real-world-evidence (RWE) comparator arm. The FDA accepted the RWE data and the proposed clinical plans. Thanks to the successful and positive FDA feedback, the start-up was bought within nine months.
BBCR Consulting took part in another exciting project at the end of 2019 to address the challenge of very slow patient enrollment. Unfortunately, after a few months into the project, the COVID-19 pandemic hit the world. “Regardless, we reviewed and interviewed the sites selected by the CRO and decided to discontinue approximately 35 percent of them,” Dr. Candida mentions. In addition, with the site’s feedback, the team learned that the patient engagement tools adopted were costly and unable to acquire qualifiable patients. To this end, the company terminated the patient engagement tools. In addition, to engage the remaining clinical sites, the team established an active and continuous communication, support, and motivation program for the remaining clinical sites, which completed the trial enrollment in 14 months despite the pandemic.
SCIO is our proprietary translational and early development process which overcomes the silos and one at the time approach
Paving the Way for Next-gen Clinical Trial Management
With several such successes, BBCR Consulting is heading toward a promising future. The company is firmly rooted in its belief that there are no goals without a strategy, and any therapeutic product needs a strategy to generate quality data. In addition, the company is integrating cutting-edge technology tools into its SCIO approach.
-
A clinical trial is similar to running a marathon, requiring organizations to figure out the right strategy, medical needs, potential competition, and target product profile from the get-go
BBCR Consulting has already integrated bioinformatics tools to develop SCIO-generated strategies and is looking to adopt AI tools in the future. “Going forward, our personalized medicine senior advisor will include molecular biomarkers in the early development studies to stratify patient responders and non-responders to a given treatment, thereby accelerating the drug development and market approval,” concludes Dr. Candida.
