How to achieve cost-effective clinical trials by putting a clinical/regulatory strategy/roadmap in place before entering into clinical trial phases.

1. BBCR CONSULTING
Cost-Effective Clinical Development
With BBCR Consulting
1ST Strategic Clinical Innovation Organization
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2. AGENDA
o SCIO Introduction
• SCIO Concept
• SCIO Impacts on Clinical Trials
o BBCR Consulting
• BBCR Values
• BBCR Method
• Experienced Team
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3. 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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4. 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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5. 5
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

6. 6
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 Feedbacks
TIMING
INFORMATION

7. GAP
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Pre-clinicalDiscovery
Phase I Phase II Phase III
Clinical Tactics (CRO)
Only Pre-clinical Data
• High Risk
• High Cost
• Low Efficiency

8. 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

9. 9
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

10. 10
SCIO Impacts
Cost-effective & Risks-Reduced Clinical Trials

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BBCR Values
Strategic Clinical Innovation Experts

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Best Team
Best Quality
Best Services

14. 14
NETWORK
INNOVATION
INTEGRITY

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INTEGRITY
INNOVATION
NETWORK
Regulatory Strategy
and Regulators’
Feedbacks
Customize Clinical
Strategy Prior to First-
In-Man
Streamline Trial Design
for Cost-Efficiency and
Risk Management
Clinical/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 Method
Strategic 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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19. 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

21. Lori Perreira Zahra Shahrokh Wade Fox
PhD
Board of Advisor
• Reimbursement
strategy
• Orphan
• Gene Therapy
Board of Advisor
• CMC
• Biologics
• Small Molecule
• Biotechnology
Product
Board of Advisor
• Market Analysis
• Medical Devices
• Medical
Technology

22. CONTACT US
Find us! Drop Your Questions Online!
Location
1 Broadway, Cambridge
MA, USA 02142
Phone
+1(617)401-2327
Email
INFO@BBCRConsulting.com
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For an immediate help, we created
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website to provide further assistance
with any question you may have.
www.BBCRConsulting.com
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