Fusion Pharmacology THE BEST OF BOTH WORLDS

Access the Asia Pacific Region with Confidence

Fusion Pharmacology is a consortium of partners which provides global pharmaceutical and biotechnology

companies with high quality , efficient and cost effective Early Phase Clinical Trial Services in the Asia-Pacific

region.

� Ethno-bridging studies

� FIH Studies for large and small molecules including oncology studies.

� Ethnicity arms incorporated into FIH studies

� Cost effective Bio-equivalence Studies

� Tropical Disease studies

� Access to Special Oncology populations

� Counter-seasonal studies

A credible partner

Fusion Pharmacology is the marketing name of a group of SE Asia based partners offering to the global pharmaceutical

industry the best that this region can offer. Fusion Pharmacology partners have a long history of successfully submitting

data to the FDA and EMA, and provides confidence to pharmaceutical and Biotech companies looking to bring their drug

development programs to the Asia Pacific region. A fusion of a State-of-the-art phase 1 unit at Ampang hospital in Kuala

Lumpur combined with a Phase I Oncology Group in the prestigious Prince Court Hospital, also in Kuala Lumpur and CRO

services based in Singapore and Australia, Fusion Pharmacology offers a cost effective access to Korean, Chinese, Indian,

Japanese, Caucasian and Malay populations.

Quality Assured

Fusion Pharmacology operates in full compliance with:

• ICH GCP Guidelines

• OECD Principles of Good Laboratory Practice (GLP)

• Audited by the US FDA and other national agencies.

• FDA Good Laboratory Practice for Nonclinical Laboratory Studies (21CFR58)

• FDA Electronic Records; Electronic Signatures (21CFR11)

Fusion Pharmacology Why include the Asia-Pacific?

Ethnicity Studies

� Incorporate Asian data into your Phase 1 program to fast track access to Asian markets

� Cover extrinsic and intrinsic ethnicity factors using partner sites for Phase 1 or Bridging studies

� Add value to your asset for out-licensing by incorporating ethnicity into your programs

Fusion Pharmacology has a network of partners across the Asia Pacific which facilitates access to various ethnicities. By

incorporating ethnicity factors into first in human programs sponsors can optimise the value of assetsThe ability to include ethno-

bridging cohorts into standard Single Ascending Dose study will now provide clients with the data required to progress to incorporate

late phase study sites in the region, potentially saving years in drug development. Alternatively the client can out-license via different

jurisdictions increasing the value of their products

Cost Effective Bioequivalence Studies

� Utilise cost effective sites in South-east Asia

� Local Bioanalytical capability in Singapore

� Project Management and Quality Assurance oversight

A new site for Phase I Oncology studies

� Prestigious private hospital with excellent Oncology team.

� Access to large urban population base

� Experienced CRO Involvement and support.

� Provides full accredited clinical laboratory for safety blood and urine samples and special analyses including FACS.

� Biomarker and large molecule bioanalytical capability as well as experienced LC/MS/MS team.

A Phase I Unit with Phase 2a capability for non-oncology drug development studies

� Situated in major District General Hospital

� Full ITU support for FIM and high-risk drug studies.

� Experienced leadership team with good project management support.

� Biomarker and large molecule bioanalytical capability as well as experienced LC/MS/MS team.

Region Specific Specialties

� Assistance with Malaria and Dengue Fever studies

� Access to partner institutions across the Asia-Pacific region

� Greater access to oncology patient populations

� High recruitment of Australian skin cancer populations

� Southern hemisphere location enables year-round counter-seasonal flu and allergy studies

� We can provide full support for your trials including a data management and statistics team lead by international experts

For information and further contact:

Elizabeth Stevens e-mail Elizabeth Stevens @galenguernsey.gg or tel +971 989 9258

Yvonne Lungershausen e-mail Yvonne.Lungershausen@cprservices.com.au or tel +61 8 8125 1900