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Paving Industry Sponsored Research in Klinik Kesihatan

Dr Akhmal Yusof CEO Clinical Research Malaysia

Outline

• A brief history in time : • The Numbers

• The Therapeutic Area

• The Sites

• How ISR could help KK?

• Closing notes

KK involvement in ISR by State • KK starts to conduct ISR as early 2011

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2

4

6

8

10

12

14

SelangorWP KL & PutrajayaPahang N Sembilan Kedah Perak Kelantan Penang Sabah Johor Sarawak

No KK involved in ISR by state (2014-2016)

1 2

4

2 1 1

2 1

1 2

3

1

1

7 10

9

12

1

1

2

1

1 2

1

1 1

2 2 2 2 2

3

5

6

10 11 11

13

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2

4

6

8

10

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14

No

. of

app

rove

d t

rial

s

States in Malaysia

No. of KK conducting ISR by State

2014 2015 2016 2017 Total

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50

9

1 4

12

6

1 0

10

20

30

40

50

60

Yr 2014 Yr 2015 Yr 2016 Yr 2017

No

. of

app

rove

d t

rial

s

Year

No. of Approved ISR in KK (2014 – 2017 (Mar))

# Participating KK Sites # Approved Trials

Notes: 1. The same trial could be conducted at multiple sites. 2. 1 trial approved to be conducted at KK site (as of Mar 2017) i.e. KK Putrajaya involved in CQVM149B2303 trial (Respiratory)

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3

2 2 2 2

1 1 1

0

1

2

3

4

5

6

7

8

9

Endocrinology Epidemiology O & G Cardiology /Vascular disease

Respiratory Vaccine Gastroenterology Neurology Paediatrics

Therapeutic Area of Trials involving KK from 2014 -2016

No. of Approved Trials

CRM INDUSTRY SPONSORED RESEARCH AWARD 2016 TO INVESTIGATORS

What is the benefit conducting ISR? Imagine…..

The intangible value of ISR

TECHNOLOGY TRANSFER

DESIGN STUDY PROTOCOL

STUDY METHODOLOGY

DATA MANAGEMENT

EXPANDING RESOURCES

INCREASE TREATMENT

OPTIONS

PROVIDE RESOURCES TO

STUDY SITES

PROVIDE NEW KNOWLEDGE

GLOBAL RECOGNITION

CONSISTENT TIMELINE

RELIABILITY QUALITY

How are we performing?

1. Where does Malaysia stands in ASEAN region conducting ISR?

A. Number 1

B. Number 2

C. Number 3

D. Number 4

Country Number of ISRs*

(2013 – 31/12/2016)

Thailand 741

Singapore 600

Malaysia 311

Philippines 207

Vietnam 154

Indonesia 111

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Source: ClinicalTrials.gov, 20th January2017 * Studies received from 01/01/2013 to 12/31/2016

Where does Malaysia stand in SEA (2013 – 2016)

How could CRM help KK to conduct ISR?

Scope of CRM Services

CRM Investigator's Dialogue 2016

Investigator Engagement

Focus training to Investigators

CRM Roadshow Protocol Deviation Workshop

Hospital Pulau Pinang Roadshow

Hospital Ampang Roadshow

GCP Refresher

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‘I am AWARE’ campaign aims to raise patient and public awareness in clinical trials by providing the necessary means for patients and public to get information on clinical trials or to participate in any ongoing trials.

Malaysia Research Environment : The Opportunities

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• Common diseases : Cardiovascular, Cancer, Diabetes

• Public Healthcare spending keep growing • An increase of 57% in the number of clinical trials

in less than 4 years. • Consistent timeline for Regulatory and IRB approval

• Population 31.7 million 0–14 years: 24.5% 15–64 years: 69.4% 65 years and over: 6%

Source: Department of Statistics, Malaysia, 2016

• Multiracial (English widely spoken and understood)

Malaysia Research Environment

5th January 2017, International Living in its Annual Global Retirement Index 2017 honoured Malaysia for the third consecutive year of being named the country with the “Best Healthcare in the World”

The ranking is based on: • the price of medical procedures • facilities available • excellent hospitals • highly trained doctors • affordable care

(source: www.internationalliving.com)

Malaysia is one of the Best Healthcare In The World

Cost Per Patient per Visit

Frost and Sullivan Asia clinical trials whitepaper- February 2017

Clinical Trial Density

Frost and Sullivan Asia clinical trials whitepaper- February 2017

5Key Strategies

Bulletins

Publications

Poster Presentation

DIA Glasgow 29th March 2017 National Heart Association Meeting (NHAM), PP65, 8th April 2017

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25

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45

2014 2015 2016

Growth of CROs 2014-2016

79%

15%

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84

114

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40

60

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100

120

2014 2015 2016

Growth of Sponsors 2014-2016

154%

36%

Source: Malaysia’s Clinical Research Ecosystem, Applied Clinical Trials, Jan 26, 2017

5 Year Plan

• Making a Difference : NEW VALUE PROPOSITION

• Training & Development

• Recalibrate & Manage Performance

• Clearer Career Development

Building a Global Trusted Research Organisation

5 year Blue print

Clinical Research

Excellence and Advancement

Centre Malaysia (CREAM)

Sustainable Value

Proposition (SVP) Project

Project Accelerate

To manage own dedicated centre specializing on early phase development and oncology

To complete the Clinical/Scientific ecosystem and drive research that matters for Healthcare solutions

To create research training academy that is respectable in the SEA region

CRM 5 year strategies (2017 to 2020)

CRM provides global health solutions for the people through clinical research

Our deep understanding of the local clinical research landscape with the international standards of operations coupled with fundamental backing of the MoH provide us an incomparable advantage to deliver research and create high skilled job opportunities.

We believe…

…Thank you.