Orphan Diseases
In orphan diseases and precision medicine, developing a biomarker plan during translation into early clinical development moves treatment to market faster, and still meets the FDA’s expectations.
June 15th, 2023 | Orphan DiseasesCategories
- Biomarkers & Surrogate Endpoints
- Company News
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- Due Diligence
- Early Clinical Development
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- Medical Affairs and Clinical Research
- Miscellaneous
- Orphan Diseases
- Pre-IND
- Precision Medicine
- Rare Disease
- Real World Evidence
- Regulatory
- Regulatory Affairs
- Strategy and TPP
- Translation Medicine and Epigenetics
- Trial Management
- Trial Rescue
Recent Posts
- Our experienced CRO Management and Drug development team identify study remediation strategies and provide a resource for any Study Rescue. We invite you to reach out to learn more – visit bbcrconsulting.com.
- A pioneering figure in the area of rare diseases and orphan drug early-stage clinical research and regulatory strategies, Dr. Candida Fratazzi has an impressive 25-year track record in this specialized field.
- BBCR is committed to cultivating and enhancing a product’s unique strengths at every stage, from initial conception to successful market launch. With deep expertise in cell therapy, biologics, and gene therapy—particularly in the realm of rare diseases—we provide strategic guidance and innovative solutions that form the foundation of our consultancy practice.
- BBCR embraces innovative strategic consulting for highly effective clinical development planning and regulatory strategy. Reach out today to learn more about how we can help advance your project.
- Partnering with BBCR Consulting streamlines the clinical trial process by delivering tailored clinical and regulatory roadmaps. Our approach focuses on simplified programs and optimized protocols, designed to align seamlessly with each client’s unique requirements.