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 adverse reactions, long-term immune response and safety follow-up. BBCR has successfully delivered cost-effective clinical plans […]
Increase investors’ evaluation in a competitive market. 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 Diligence can also inform and assist in deciding which products to budget for […]
The Strategic Clinical Innovation Organization SCIO SM (SCIO) method is explicitly designed to help pharmaceutical innovators address their concerns and maneuver around evolving challenges. SCIO SM allows for time and cost efficiencies and relief of risk management. The SCIO SM method aims to learn, predict and make better decisions for a successful drug opportunity. This […]
Developing drugs with substantial benefits in smaller, molecularly defined, pharmacologically relevant subpopulations of patients with the same clinically recognized disease is increasingly being viewed as a viable pathway for bringing drugs to market.
Developing innovative or repurposing drugs for orphan diseases can be rewarding, but navigating the challenges is not for the faint of heart. 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. […]
As one of the first consultancy teams to streamline clinical trials, BBCR’s boutique consulting team specializes in rare disease and orphan indications dedicated to supporting pharmaceutical innovators, and nurturing each product’s strengths. The BBCR Team provides knowledge in cell, biologics and gene therapies BBCR addresses sponsors’ questions in the ever-changing regulatory environment Clinical strategy for […]
Every clinical study has its unique challenges that initially may not have been factored for, presenting the need for study remediation and rescue. Experienced management can help sponsors to address prolonged trial timeline and high quality data. Rare Diseases and Precision Medicine Require Unique Approaches In Clinical Trial Design. There could be any number of […]
People tend to believe that a repurposed therapy can never be truly novel or transformative. Nothing could be further from the truth. About a third of orphan approvals by the FDA since the program began have been mostly for repurposed mass-market drugs. BBCR’s team of industry experts can help match treatments to rare genetic conditions […]
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 regulatory strategy. Our team will empower you with medical insight, effective regulatory expertise, strategy, and streamlined early clinical […]
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 companies with their clinical trial needs.