We invite you to read some of our Case Studies below
Reduced Comparator High Cost for Biosimilars
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 and less risky trial to NDA approval.
PROPOSAL The BBCR team suggested to engage the FDA in a pre-IND meeting to gain feedback on the preclinical data. In addition BBCR prioritized the therapeutic indications, in both oncology and autoimmune diseases, per the criteria including recruitment of target patients, trial duration, number of patients and cost of trial.
RESULTS After evaluating different the indications in which the innovator had been approved, the BBCR team suggested a phase 3 trial for adjuvant treatment and adoption of surrogate endpoint which as such world reduce number of patients to recruit, length of study, and study cost.
Fast Value Growth for Start-up in Ultra-rare Diseases
PROJECT A start-up biotech asked Dr. C. Fratazzi to act as a CMO and to BBCR to provide support with pre-IND clinical strategy for the three compounds in the pipeline each of which for the treatment of an ultra rare disease.
PROPOSAL Dr. Fratazzi and the BBCR team suggested to engage the FDA in pre-IND meetings to discuss pre-clinical data needed prior to FIM study and adoption of Real World Evidence (RWE) as a comparator arm for Phase III pivotal studies.
RESULTS The FDA approved the use of RWE to define the individual ultra rare disease Natural History to be adopted as comparator arm in the Phase 3 pivotal study. The start-up was sold, within 9 months from work start, for $ 26.6M plus.
Learn More at BBCRConsulting.com
Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to 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.