http//:www.crc.gov.myhttp//:www.crc.gov.myhttp//:www.crc.gov.myhttp//:www.crc.gov.my

Clinical Research in Clinical Research in

MalaysiaMalaysia

Network of Network of CRCsCRCs

Ministry of Health MalaysiaMinistry of Health Malaysia

Contents

New drug development

The Clinical Research Industry: research as an industrial activity?

Malaysia as the emerging clinical trial hub in Asia

Regulation of clinical research in Malaysia

Conducting GCP compliant trials in Malaysia; and the role of MOH’s Network of CRCs

Becoming a clinical investigator; what’s in it for you & how CRC can help?

New drug development

During new drug development, a critical phase is the clinical

development phase when the new molecular entity (NME)

undergoes testing in human to demonstrate safety & efficacy.

Phases of Clinical Trial

Estimates drug activity for targeted indication

Estimate of serious toxicities

Estimate dosage for subsequent

studies

Basis for confirmatory study design

Phase 2

Therapeutic exploratory

Assess tolerance: Maximum tolerable dose

PK and PD

Estimate activity

Normal volunteers

Phase 1

Human pharmacology

Phases of Clinical Trial

Safety: Refine risk/benefit ratio

Special populations

Uncommon ADR

Refine dose

New indication

Phase 4

Therapeutic use

Demonstrate efficacy

Establish safety profile

Basis for benefit/risk assessment &

registration

Dose-response relationship

Phase 3

Therapeutic confirmatory

And it is hugely costly….

Ref: DiMasi a JA, W. Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs Journal of Health

Economics 22 (2003) 151–185

The Clinical Research Industry

The pharmaceutical, biotechnology, and medical-device industries must constantly discover and develop innovative therapeutic products (drugs or devices), and invest hugely in research & new product development

Contract Clinical Research Industry has emerged over the last 20 years to serve the Pharma/Biotech industries by providing more efficient (faster time to market) and cost effective (cheaper) clinical development services. This is called Clinical Trial Outsourcing

And increasingly Pharma/Biotech industries or their CROs are also offshoring clinical trials to emerging markets, including Asia

“Within two to three years, up to 65% of FDA regulated clinical trials for top pharmaceutical companies will be conducted

abroad.” Tufts Outlook 2007 Report, 3 January 2007

Market value of Contract research industry

Worldwide, contract research is estimated to be worth about USD 15

billion in 2006; much of that on

clinical trial services (55% of total)

Some of that revenue is coming to Asia…

S00936938 – Scrip. Issue: 3204 Page No: p15

Amgen plans clinical development organization in India

Amgen is setting up a clinical development organisation in India in a move to step up its presence in key emerging markets.

“Asian CRO markets (Phase I–IV) earned revenues of $1.2 billion in 2006” Frost & Sullivan report Oct 2007

Contract research opportunities in SE Asia

includes Malaysia, Thailand and Singapore only

Does Malaysia have had much success?

Note These statistics are based on the number of applications received by National Pharmaceutical Control Bureau for the clinical trial import license for unregistered products.Drug-related clinical trials for registered products which do not require clinical trial import license is not controlled by the Drug Control Authority.

0

10

20

30

40

50

60

70

80

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008

1

2

3

4

NMRR industry sponsored studies 2008

11.614Diabetes Mellitus2

9.912Oncology3

14.918Psychiatry1

5.87Nephrology7

6.68Infectious Disease6

7.49Haematology5

9.912Cardiology4

%NTherapeutic Area#

UP TILL 15/DEC/2008

NMRR industry sponsored studies 2008

4.15Gastroenterology9

4.15Neurology10

5.06Medicine8

2.53Urology14

2.53Rheumatology13

3.34Endocrine/Metabolic12

4.15Respiratory11

%NTherapeutic Area#

NMRR industry sponsored studies 2008

2.53Hypertension15

100%121Total

0.81Traumatology20

0.81Paediatrics19

0.81ENT18

1.72Reproductive Medicine17

1.72Hepatology16

%NTherapeutic Area#

Malaysia’s Competitive strengthWe can do better, and we must

Contents

The Clinical Research Industry: research as an industrial activity?

Malaysia as the emerging clinical trial hub in Asia

Regulation of clinical research in Malaysia

Conducting GCP compliant trials in Malaysia; and the MOH’s Network of CRCs

Malaysia’s competitive strength

1. Committed Malaysian government support to develop

the contract research industry

2. Conducive Clinical Research environment:

Qualified and well trained medical professionals who are English literate, and working in modern medical facilities

Supported by local CRCs & dedicated clinical resaerchcoordinators (SRNs)

Large patient population, especially diabetes, cancer, heart diseases and hepatitis, from diverse multi-ethnic cultureLow cost advantage

Efficient logistics for trial supplies & biospecimen

Availability of competent CROs

3. Compliant Regulatory environment

Enforcement of compliance with GCP/ GLPIPR protection regime

Fast timelines for ethics review & regulatory approval (IND/CTX)

Contents

The Clinical Research Industry: research as an industrial activity?

Malaysia as the emerging clinical trial hub in Asia

Regulation of clinical research in Malaysia

Conducting GCP compliant trials in Malaysia; and the MOH’s Network of CRCs

National Committee for Clinical Research (NCCR)

As testimony to the government of Malaysia’s commitment to support clinical research, the NCCR is chaired by the MOH

Director-General himself

Objectives : Policy formulation & guideline development, Infrastructure & human capital planning, Training and Advisory on regulation

Activities:Dialogue with Industries and Investigators

Survey on research infrastructure Guidelines drafting & implementation: GCP, Bioequivalence (BE),Good Lab Practice (GLP)

Training on GCP/GLP

Inspection of clinical trial sites to check compliance

Review processes for application of clinical trials

Regulatory guidelines: Application to Conduct Drug-Related CT, for Application For CTIL

Local Guidelines and Legal Requirements

Guidelines:

Malaysian Guidelines for GCP (Updated 2004)

Guidelines for Application to Conduct Drug-Related Clinical Trials in Malaysia (2nd edition)

Guidelines for Application of CTIL and CTX in MalaysiaLaws

Control of Drugs and Cosmetics Regulation 1984

The Poison Regulation (Psychotropic Substances) 1989Sale of Drugs Act 1952

But no specific legal provisions addressing the conduct of Clinical Trial, only administrative provisions through Malaysia GCP Guidelines

“1.26 Drug Control Authority (DCA) An authority established for the purpose of regulating the Control of Drugs and Cosmetics Regulations, 1984

5.20.3 The DCA will enforce the rules and punitive action will be decided by the DCA “

Malaysia has adopted ICH GCP as our own national guideline

Clinical trials in Malaysia/Asia are predominantly FDA/EMEA submissions; ICH GCP and related regulations are the

relevant quality standards we must comply with

Beyond GCP: Is your trial GXP compliant?

GMP(ANNEX 13 for IMP) and GDPSupplies

GPP, ICMJEPublication

ICH E3, ICMJEReport

ICH E9 and PSI, GSPStatistics

GCLP (BARQA), GLPLab

Part 11, ISPE, GVPIT

E6, E9, GDMPData mgt

ICH E2A/B/C, CIOMS, MedDRA, GPVPSafety

GCPMonitoring

GCP (protocol), also E1,E7,E10,E11 Trial design

GCP (E6), HelsinkiEthics

GXPTrial functions

Contents

The Clinical Research Industry: research as an industrial activity?

Malaysia as the emerging clinical trial hub in Asia

Regulation of clinical research in Malaysia

Conducting GCP compliant trials in Malaysia; and the role of MOH’sNetwork of CRCs

Institute for Medical Research (IMR)

Institute of Public Health (IPH)

Institute of Health Management (IHM)

Clinical Research Clinical Research Centre (CRC)Centre (CRC)

Institute for Health System Research (IHSR)

Institute of Health Promotion (IHP)

National Institute For Natural Products and Vaccinology (9Bio)

NATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH

Mission of CRC

Public health research missionTo improve patients’ health outcomes through ethical and quality clinical research

Contract research missionCRC shall contribute to the development of Malaysia as the clinical research hub for the contract research outsourcing industry

Clinical Research Centre Ministry of Health

Operational since 2000.

Function as the clinical research arm of the

Ministry of Health

1. Act as a one stop centre to meet all your clinical trial outsourcing needs

2. Provide a network MOH hospitals (those with experienced & GCP certified investigators) as investigative sites for clinical trials

National Institute of Health MOH MalaysiaNational Institute of Health MOH Malaysia

Director, Network of CRCsDirector, Network of CRCs

CRC

Johor

(yr

2006)

CRC

Johor

(yr

2006)

CRC

Pahang

(yr

2004)

CRC

Pahang

(yr

2004)

CRC

Sarawak

(yr

2003)

CRC

Sarawak

(yr

2003)

CRC

Penang

(yr

2003)

CRC

Penang

(yr

2003)

CRC

Sabah

(yr

2006)

CRC

Sabah

(yr

2006)

CRC

Perak

(yr

2001)

CRC

Perak

(yr

2001)

CRC

HKL

(yr

2000)

CRC

HKL

(yr

2000)

CRC Network

Advisory Committee

CRC Network

Advisory Committee

CRC

Negeri

Sembilan

(yr

2006)

CRC

Negeri

Sembilan

(yr

2006)

CRC

Melaka

(yr

2006)

CRC

Melaka

(yr

2006)

CRC

Terengganu

(yr 2006)

CRC

Terengganu

(yr 2006)

CRC

Kedah

(yr

2006)

CRC

Kedah

(yr

2006)

CRC

Kelantan

(yr

2006)

CRC

Kelantan

(yr

2006)

CRC

Klang

(yr

2007)

CRC

Klang

(yr

2007)

CRC

Selayang

(yr 2006)

CRC

Selayang

(yr 2006)

CRC

Perlis

(yr

2007)

CRC

Perlis

(yr

2007)

CRC

Ampang

(yr

2007)

CRC

Ampang

(yr

2007)

CRC

Serdang

(yr

2008)

CRC

Serdang

(yr

2008)

Providing access to 550 clinical investigators and 17 million patients from diverse therapeutic areas in the public healthcare

system in Malaysia

Network of CRCs in MOH Hospitals Network of CRCs, MOH

CRC Network as central point of contact

A One-stop centre to meet all your needsSingle point of contact to access all MOH hospitals for trial Fast & reliable feasibility assessmentFacilitate institutional approval processFacilitate ethics and regulatory (IND/CTIL) approvalsStandard research agreement; sign only one contract with CRC Uniform and transparent pricingAccountable financial admin procedure to pay investigators & nurses and patientsDeploy trained dedicated clinical coordinators (SRNs) to support trial at site Provide multiple trial insurance coverage where requiredComprehensive range of clinical trial services

Thank You

www.crc.gov.mywww.crc.gov.mywww.crc.gov.mywww.crc.gov.my