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Title
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Overview on Clinical
Research in Egypt &
MENA Region
Hanaa Abdel-Maguid
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Overview
Challenges
Opportunities
Integrated Approach
Solutions – Power of Collaboration
Contents
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Overview
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Map of All Studies on ClinicalTrial.gov
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Worldwide Pharma R&D Spending in 2016-2020
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Number of Registered Studies Over Time
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Number of Registered Studies with Posted Results Over Time
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Challenges
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Economic Situation: need to maximize efficiencies
Cost of Outsourcing: Business Model (National,
Regional & Global)
Quality of Deliverables: need to avoid rework
Duration of Projects: Recruitment efficiency
Regulatory Barriers.
CROs retrenchment in Egypt.
Sponsors
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Inefficient Business Models
Lack of Pricing Flexibility
Rare Qualified Resources
Developing Investigators, Labs & Sites
Recruitment Rate
Regulatory Barriers: e.g. NSA
CROs
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Need to establish harmonized study sites
Need for Partnerships: Sponsors, CROs, Universities,
Research Institutions & Regulatory bodies.
Awareness of e-technologies
Deficient resources of qualified personnel.
Public perception of clinical research
CRCs
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Clinical Research Design & Methodology: not included
in the formal curriculum of most MENA medical schools or in
post-graduate training programs
Investigator Initiated Research: lack of funding
Lack of connection between Researchers &
Industry.
Negative perception of medical community.
Universities
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Guidelines: Different Clinical Trial Regulations across MENA
Lack of independent drug research authority (e.g.
FDA, EMA, SFDA): EDA?
Accredited Central Laboratories: Local, Regional
MOH Hospitals: Deficient resources (Equipment & personnel).
Concerns on patient access to treatment after trial
completion
Vulnerable patient groups.
MOH
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Opportunities
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Access to motivated well qualified experienced investigators
High interest in conducting clinical trials
Large treatment-naïve patient population
High prevalence of diverse disease areas
Strong doctor-patient connection.
Availability of drug production facilities.
Commercial potential for investigational products
Cost-Reduction
Evolving Ethical & Regulatory environment
Opportunities
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Integrated Approach
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Innovation Players
• CRCs
• Universities
• MOH Hospitals
• RHD
• Regulatory
• Local
• Regional
• Global
• Pharma Companies
• NGOs
• PDPs
• Biotech
• Academia
Sponsor CRO
Study Sites
MOH
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Partnerships
Training & Development
New Skills
New Practices
New Technologies
Big Data for better ROI
Patient Centric Strategies.
Integrated R&D Approach
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Solutions-Power of Collaboration
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Collaborate with R&D Stakeholders
Innovation as Competitive Advantage
Maximize Efficiencies
Accelerate Product Development
Improve Patient Focus
Sponsors
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Broader end-to-end Services
Business Model: Outcome Based
Risk-Based Monitoring: Statistical Algorithms
Pragmatic Innovative Solutions
New Technologies: EDC, turnkey CTMS platforms to
empower sites
Big Data: Business Intelligence tools using machine learning to
do not only descriptive, but also predictive & prescriptive
analytics
CROs
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Helping Sponsors to:
Bridge the Gap between Clinical & Commercial
functions: Pragmatic Clinical Trials
Treat patients as partners: Digital Platforms
Brand Clinical Trials: Patient Centric R&D Models
CROs
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Collaboration: Network of Study Sites
Partnerships: Sponsors, CROs & Regulatory Bodies
E-Solutions: e-Archiving, EDC, CTMS
Training & Development: All Stakeholders
CRCs
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Training & Development : including clinical
research in formal Curricula & post-graduate programs of
Medical Schools
Investigator Initiated Research: partnering with
Sponsors & PDPs
Universities
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Guidelines: Harmonized Clinical Trial Laws & Regulations
Partnerships: MENA Regulatory bodies
Training & Development: All Stakeholders
Clinical Trial Registries: Local, Regional& International
Central Laboratories: Local, Regional& International
MOH Hospitals: Development into equipped trained study sites
MOH
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Title
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THANK YOU
WWW.TCD-GLOBAL.COM
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