Early Clinical Development
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 | Early Clinical Development
Categories
- Biomarkers & Surrogate Endpoints
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- Early Clinical Development
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- Orphan Diseases
- Pre-IND
- Precision Medicine
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- Real World Evidence
- Regulatory
- Regulatory Affairs
- Strategy and TPP
- Translation Medicine and Epigenetics
- Trial Management
- Trial Rescue
Recent Posts
- BBCR and its consultants are dedicated to advancing innovative and repurposed treatments for orphan diseases, an area where impact is high, but the path is complex.
- BBCR’s mission is to support domestic and international pharma, biotech, and device companies by nurturing their products’ strengths, while improving efficiency and safety. We specialize in strategy and provide early clinical research services to enable informed, timely decision-making for our clients.
- BBCR brings deep expertise in early-stage development, including Phase 1 and Phase 2 process and strategy, spanning pre-clinical work through pre-IND. Our early drug development capabilities encompass clinical strategy and planning, including the creation of target product profiles and the design of clinical protocols.
- BBCR partners with clients to identify, develop, and advance a product’s unique strengths from early concept through to market. Our consultancy is grounded in deep expertise across cell, biologic, and gene therapies, with a particular focus on rare disease.
- BBCR’s team of experts help clients match treatments to rare genetic conditions and unsolved diseases, then work collaboratively with a product developer on the best plan to market. To learn more, visit bbcrconsulting.com.