TCD MENA Overview on Clinical Research in Egypt & MENA Region

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  • TCD MENA 2017 1

    Title

    TCD MENA 2017 1

    Overview on Clinical

    Research in Egypt &

    MENA Region

    Hanaa Abdel-Maguid

    TCD MENA 2017 1

  • TCD MENA 2017 2TCD MENA 2017 2

    Overview

    Challenges

    Opportunities

    Integrated Approach

    Solutions Power of Collaboration

    Contents

  • TCD MENA 2017 3TCD MENA 2017 3

    Overview

  • TCD MENA 2017 4TCD MENA 2017 4

    Map of All Studies on ClinicalTrial.gov

  • TCD MENA 2017 5TCD MENA 2017 5

    Worldwide Pharma R&D Spending in 2016-2020

  • TCD MENA 2017 6TCD MENA 2017 6

    Number of Registered Studies Over Time

  • TCD MENA 2017 7TCD MENA 2017 7

    Number of Registered Studies with Posted Results Over Time

  • TCD MENA 2017 8TCD MENA 2017 8

    Challenges

  • TCD MENA 2017 9TCD MENA 2017 9

    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

  • TCD MENA 2017 10TCD MENA 2017 10

    Inefficient Business Models

    Lack of Pricing Flexibility

    Rare Qualified Resources

    Developing Investigators, Labs & Sites

    Recruitment Rate

    Regulatory Barriers: e.g. NSA

    CROs

  • TCD MENA 2017 11TCD MENA 2017 11

    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

  • TCD MENA 2017 12TCD MENA 2017 12

    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

  • TCD MENA 2017 13TCD MENA 2017 13

    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

  • TCD MENA 2017 14TCD MENA 2017 14

    Opportunities

  • TCD MENA 2017 15TCD MENA 2017 15

    Access to motivated well qualified experienced investigators

    High interest in conducting clinical trials

    Large treatment-nave 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

  • TCD MENA 2017 16TCD MENA 2017 16

    Integrated Approach

  • TCD MENA 2017 17TCD MENA 2017 17

    Innovation Players

    CRCs

    Universities

    MOH Hospitals

    RHD

    Regulatory

    Local

    Regional

    Global

    Pharma Companies

    NGOs

    PDPs

    Biotech

    Academia

    Sponsor CRO

    Study Sites

    MOH

  • TCD MENA 2017 18TCD MENA 2017 18

    Partnerships

    Training & Development

    New Skills

    New Practices

    New Technologies

    Big Data for better ROI

    Patient Centric Strategies.

    Integrated R&D Approach

  • TCD MENA 2017 19TCD MENA 2017 19

    Solutions-Power of Collaboration

  • TCD MENA 2017 20TCD MENA 2017 20

    Collaborate with R&D Stakeholders

    Innovation as Competitive Advantage

    Maximize Efficiencies

    Accelerate Product Development

    Improve Patient Focus

    Sponsors

  • TCD MENA 2017 21TCD MENA 2017 21

    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

  • TCD MENA 2017 22TCD MENA 2017 22

    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

  • TCD MENA 2017 23TCD MENA 2017 23

    Collaboration: Network of Study Sites

    Partnerships: Sponsors, CROs & Regulatory Bodies

    E-Solutions: e-Archiving, EDC, CTMS

    Training & Development: All Stakeholders

    CRCs

  • TCD MENA 2017 24TCD MENA 2017 24

    Training & Development : including clinical

    research in formal Curricula & post-graduate programs of

    Medical Schools

    Investigator Initiated Research: partnering with

    Sponsors & PDPs

    Universities

  • TCD MENA 2017 25TCD MENA 2017 25

    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

    TCD MENA 2017 26

    THANK YOU

    WWW.TCD-GLOBAL.COM

    TCD MENA 2017 26