Shaping the Future Industry Sponsored Research in Malaysia · Shaping the Future Industry Sponsored Research in Malaysia College Physician 12 Nov 2017 ... development and oncology

1

Shaping the Future Industry Sponsored Research in Malaysia

College Physician 12 Nov 2017

Dr Akhmal Yusof CEO Clinical Research Malaysia

Outline

• Introduction

• Meeting socio-economic demand of the country

• CRM Strategies: Where are we heading ?

• Closing notes

Oncology ISR provide at least RM17 million worth of medication since 2013 to MoH

A non-profit company wholly owned by Ministry of Health to create a supportive environment and complete ecosystem to grow Industry Sponsored Research (ISR)

4

Board Of Directors

YB Datuk Seri Dr. S. Subramaniam Minister of Health, Malaysia

Y. Bhg. Dato’ Seri Dr. Chen Chaw Min Secretary General in the Ministry of Health, Malaysia

Y. Bhg. Datuk Dr. Noor Hisham Director General of Health, Malaysia

Y. Bhg. Datuk Dr. Shahnaz Murad Deputy Director General of Health (Research & Technical Support) in the Ministry of Health, Malaysia

YB Senator Datuk Prof Dr. Sim Kui Hian Senior Consultant Cardiologist

Y. Brs. Dr. Goh Pik Pin Director of the National Clinical Research Centre, Malaysia

Mr Ewe Kheng Huat Executive Director of the Pharmaceutical Association of Malaysia

Prof Dr Adeeba Binti Kamarulzaman Dean of the Medical Faculty at Universiti Malaya

Adhere to We will gain TRUST

TRUST need to be maintain

Building a Trusted Organisation

1. Respect diversities – whistleblowing policy

2. Integrity – ABAC/FCPA 3. Professional Business

Conduct – No Gifts policy 4. Protecting company

assets-IP protection 5. Behaving in community

Good Legal Review System

• Standard Operating Procedure in place • reviewed and approved within 14 days

• reviewed by PUU Min of Health

• Transparent with presentation to PUU office quarterly

• Governed by Malaysia law

• Arbitration in Kuala Lumpur

• Indemnity to cover Institution and Study Team

Good Financial Control System

• Standard Operating Procedure • reviewed and approved by KSU office

• reviewed by Integriti

• Transparent with statement of account

• Audited by external auditor

Scope of Services

CRM believes in delivering…

Quality

Reliability

Speed

Quick Startup time : Improve internal timeline Feasibility, Budget Negotiation, Fast recruitment within 100 days

Deliver the commitment : ‘I am Aware’ campaign, Clinical Trial Day, Clinical Trial List in CRM website Quality Data Delivery

: Protocol Deviation Workshop & GCP Refresher

How are we performing?

Country Number of ISRs*

(2013 – 31/12/2016)

Thailand 741

Singapore 600

Malaysia 311

Philippines 207

Vietnam 154

Indonesia 111

12

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

Where does Malaysia stand in SEA (2013 – 2016)

Classification of Trials approved by ECs in 2016

(Jan – Dec 2016, n=162)

72

52

29

9

0

20

40

60

80

Jan- Dec16

No

. of

Ap

pro

ved

Tri

als

Yr 2016

Interventional (Drug) BABE Studies

Observational/Non-Interventional Medical Device

1 1 1 1 1 2 2 2 2 2 2 3 3 3 3 3 4 5 5 5

7 7

10 17 18

52

0 10 20 30 40 50 60

Advanced Therapy Medicinal Product (ATMP)EpidemiologyImmunology

O&GPublic Health / Epidemiology

AnaesthesiologyNutrition

OrthopedicPsychiatry

UrologyVaccine

GastroenterologyHepatologyNephrology

OpthalmologyRheumatology

DermatologyHematology

NeurologyPaediatrics

Infectious DiseasePulmonary / Respiratory Disease

EndocrinologyOncology

Cardiology / Vascular DiseasesBE

NO. OF TRIALS

THER

AP

EUTI

C A

REA

No. of Trials approved by ECs in Malaysia in 2016 according to Therapeutic Area (Jan-Dec 2016, n=162)

7 9

48

22 24

52

0102030405060

Phases of the Trials approved in 2016 (n=162)

No. of Trials Approved in 2016

15

Countries Timeline

Submission Regulatory Ethics

Singapore Approx. 30 days Approx. 30 days Parallel

MALAYSIA Approx. 30 business days Approx. 50 business days Parallel

South Korea Approx. 30 days Approx. 50 days Parallel

Hong Kong 30–60 business days 30–60 days Parallel

Japan Approval is by default if no objections within 30 days

4–8 weeks Sequential

Taiwan Approx. 30 business days Approx. 30–60 business days Both

Philippines 8-12 weeks 8-12 weeks Both

Speed : Quick start up time

Source: George Clinical India

Meeting socio-economic demands of the country

1055 new & ongoing ISRs

GNI of RM 233++ mil

1491 skill jobs

1000 ISRs

(new & ongoing)

1000 New Hi-Skill Jobs RM 578

million

(GNI)

17

2017 (Sep)

CRM’s 2020 KPI Targets

874 new & ongoing ISRs

GNI of RM 197++ mil

1118 skill jobs

2016

CRM strategies : Where are we heading?

1000 ISR by 2020

First PI growth since 2010 ( 185 in 2016 vs 69 In 2015)

New collaboration with DNDi, Univesities (Glasgow, Lancaster, Birmingham, Newcastle, Warwick, Cambridge & Melbourne)

1.4 Million hit for website, Media presence in print media, 6 International missions

Fastest growing site managers with 30% increase headcounts providing resources in public & private sectors

Early Phase trials via P1RP

Optimizing Oncology ISR via 3P-O and CRM-IKN support

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)

Guidelines for Phase 1 CT

People Development

Capability Development

Preparation of Sites

Risk Management

Launch November 2017

NPRA officer sponsored by CRM to

study at Christie Manchester Oct 2017

Scientific Review Panel lists finalized

and awaiting appointment by YBMK

Ampang CTU and Sarawak GH Phase I

Unit ready

Crisis Manual Completed

Pillar 1 Pillar 2 Pillar 3 Pillar 4 Pillar 5

NPRA = National Pharmaceutical Regulatory Agency

Phase 1 Realisation Project (P1RP) Updates

Phase 1 Guideline available in CRM

website

DNDi Translational Head visit to CRM and

Sarawak Biodiversity Corporation in April

2017

IMR & Aurigene work for Novel Anti-Cancer

Compounds & Associated Biomarkers recruitment

started in October 2017

ACCELERATE Pre Clinical

projects with Clinical/Scientific

organization

Collaboration with local

Universities/MoH for Bench to

Bedside Projects

P1RP Centralized Lab for

the region

ACCELERATE Pre Clinical

projects with Clinical/Scientific

organization

Collaboration with local

Universities/MoH for Bench to

Bedside Projects

P1RP Centralized Lab for

the region

NHAM CRM Research Track showcased basic science, translational research as well as late stage clinical research from various institutions in Malaysia including all universities in the areas of Cardiology

ACCELERATE Pre Clinical

projects with Clinical/Scientific

organization

Collaboration with local

Universities/MoH for Bench to Bedside

Projects

P1RP Centralized Lab for

the region

ACCELERATE Pre Clinical

projects with Clinical/Scientific

organization

Collaboration with local

Universities/MoH for Bench to Bedside

Projects

P1RP Centralized Lab for

the region

Visit to Hematogenix- Planning to Open lab to cater

for Asian Clinical Trials sites in Malaysia

33

84

114

142

2014 2015 2016 2017

Growth of Sponsors 2014-2017 (Aug)

CAGR 44%

58

59

80

98

10

2

2013 2014 2015 2016 2017

FULL

FEA

SIB

ILIT

Y C

OU

NT

YEAR

FULL FEASIBILITY STUDY GROWTH 2014-2017

Higher Full feasibility in Aug 2017 compared to full year 2016. Average conversion rate of 12% currently vs 10% in 2016

CAGR 12%

Creating Awareness About Clinical Research

I AM AWARE ROADSHOW LOCATIONS

Upcoming:

16 th MAY 2017 | INSTITUT KANSER NEGARA (IKN), PUTRAJAYA

Officiated by the Minister of Health, Datuk Seri Dr. S.

Subramaniam at National Cancer Institute,

PUTRAJAYA -(16 May 2017).

To celebrate the Clinical Trials Day launch, 33 satellite

hospitals across Malaysia, conducted the ‘I Am

Aware’ roadshow to further drive awareness among

public.

The launching of Clinical Trials Day

What could ISR contribute?

The intangible value of ISR

TECHNOLOGY TRANSFER

DESIGN STUDY PROTOCOL

STUDY METHODOLOGY

DATA MANAGEMENT

EXPANDING RESOURCES

INCREASE TREATMENT

OPTIONS FOR THE PEOPLE

PROVIDE RESOURCES TO

STUDY SITES

PROVIDE NEW KNOWLEDGE

GLOBAL RECOGNITION

CONSISTENT TIMELINE

RELIABILITY & QUALITY

PUBLICATION

2016 : 1 ISR

2017 : 7 ISRs

Local companies

MN companies

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 Visit us @ w w w . c l i n i c a l r e s e a r c h . m y

39