cost-effective clinical development with strategic clinical innovation organization
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BBCR CONSULTING
Cost-Effective Clinical DevelopmentWith BBCR Consulting
1ST Strategic Clinical Innovation Organization
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AGENDA
o SCIO Introduction• SCIO Concept• SCIO Impacts on Clinical Trials
o BBCR Consulting• BBCR Values• BBCR Method• Experienced Team
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BBCR Consulting is the 1ST Strategic Clinical Innovation Organization
“Strategy and Roadmap for cost-efficiency and risk-management in clinical trials from pre-clinical to
market.”
SCIO Concept
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Increasing Complexity
of Trial Protocols
Patient Enrollment
Patient Retention
Decline in R&D
Productivity
Reasons Why Clinical Trials Are So Expensive
Slow Time-to-Market
Low Development Success Rate
Capitalized Costs have
doubled
Inefficiency
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Phase I Phase II Phase III Approval MarketPre-clinicalDiscovery
Traditional Drug Development Process
Pharmaceutical industry has been developing drug this way for decades; people believe it to be the RIGHT way.
Clinical Tactics
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Phase I Phase II Phase III Approval MarketPre-clinicalDiscovery Pre-IND
• Regulatory Strategy
• Clinical Strategy• Clinical/
Regulatory Roadmap
Innovative Drug Development Process
Pre-Clinical Data Regulatory Medical
Information
Marketing Analysis
KoLs FeedbacksTIMING
INFORMATION
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GAP Pre-
clinicalDiscovery
Phase I Phase II Phase III
Clinical Tactics (CRO)
Only Pre-clinical Data
• High Risk• High Cost• Low
Efficiency
Only Pre-clinical Data
Clinical Strategy (SCIO)Pre-
clinicalDiscovery
Phase I Phase II Phase III
Clinical Tactics (CRO)
• Pre-clinical Data• Medical Information• Regulatory
Information• Marketing Analysis• KoL’s Feedback
• Data Interpretation• Medical Evaluation• Regulatory
Pathfinding• Marketing
Understanding• Strategy Formation
Cost-Effective Clinical Trials
• Regulatory Strategy
• Clinical Strategy• Clinical/
Regulatory Roadmap
• Simplify Clinical Research
• Customize Clinical Strategy
• Manage Risk
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BBCR The First SCIO
BBCR CONSULTING is the First SCIO that
• Has a comprehensive understanding of the importance of strategy in clinical trials
• Has a seasoned Board of Advisors and a robust industrial network to provide supports
• With highest care and professionalism, we Customizes clinical and regulatory strategy for each life science product to ensure its best opportunity to succeed
• Devises and standardizes SCIO procedures to ensure the best quality services provided, and thus cost-effective clinical trials being realized
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SCIO ImpactsCost-effective & Risks-Reduced Clinical Trials
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BBCR ValuesStrategic Clinical Innovation Experts
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Best Team
Best Quality
Best Services
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NETWORK
INNOVATION
INTEGRITY
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INTEGRITY
INNOVATION
NETWORKRegulatory
Strategy and Regulators’ Feedbacks
Customize Clinical Strategy Prior to
First-In-ManStreamline Trial Design for Cost-Efficiency and
Risk ManagementClinical/Regulatory
Roadmap for Better Resources
Allocation
Regulatory Uncertainties
Universal Step-by-step Clinical
Development for Different Products
Clinical Development
Complexity and Associated Risks
Difficulty in Planning
Resources
Challenges Solutions
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BBCR MethodStrategic Clinical Innovation Experts
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Engagement
Vision Alignment ● Objectives ● Methodology ● Actions ● Timing
● Discovery● Solution Search● Strategy● Confirmation● Client Approval
● Clinical Roadmap● Regulatory Roadmap● Clinical Strategy● Regulatory Strategy
Cost-Effective Clinical Trials
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BBCR Experienced Team“SCIO concept requires a strong and experienced team!”
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Candida Fratazzi Federico Goodsaid Claudio Carini
President/CEO• Immunology• Inflammation• Orphan • Clinical
Strategy• Trial Design
M.D. PhD M.D. / PhD / FRCPath
Board of Advisor• FDA• Regulatory• Biologics• Orphan
Board of Advisor• Immunology• Autoimmune • Biomarkers• Precision
Medicine• Epigenetics
Lori Perreira Zahra Shahrokh Wade FoxPhD
Board of Advisor• Reimburseme
nt strategy• Orphan• Gene Therapy
Board of Advisor• CMC• Biologics• Small
Molecule• Biotechnology
Product
Board of Advisor• Market
Analysis• Medical
Devices• Medical
Technology
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CONTACT USFind us! Drop Your Questions Online!
Location 1 Broadway, Cambridge MA, USA 02142Phone +1(617)401-2327Email [email protected]
You Ask! We Answer!For an immediate help, we created “You Ask We Answer” Section on our website to provide further assistance with any question you may have.www.BBCRConsulting.com