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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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