This is a collection of all our flyers to date. It shows how Fusion is growing.

1. Fusion PharmacologyTHE 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)

2. Fusion PharmacologyWhy 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

3. For information and further contact:
Elizabeth Stevens e-mail Elizabeth.Stevers@fusionseasia.com or tel +971 989 9258
Yvonne Lungershausen e-mail Yvonne.Lungershausen@fusionseasia.com or tel +61 8 8125 1900
Company Focussed Webinar
The Fusion partnership of companies and organisations is working hard to present to the
global pharmaceutical industry as a single structure with a wide set of high-tech
capabilities.
APAC , including Australia, Indonesia, Singapore and Malaysia can offer a highly
competitive and high quality environment in which to conduct your clinical trials.
Our populations of patients and normal volunteers are ideal for rapid recruitment and
special studies. Our medical centres are highly equipped and the partner CROs can provide
the highest accredited standards
We would like to invite you to host a company-specific webinar for your company.
If you tell us the ideal date/time, the names and interests of the attendees and of any
specific questions you may have, we will set up a webinar where the only attendees will be
your company invitees plus scientists and workers from the Fusion team matched to the
sorts of things that you want to ask.
Examples:
• Tell us about your imaging capability?
• What is the regulatory system in Malaysia?
• How can we use your populations for Japanese submission?
• What facilities do you have for Phase I Oncology
• Can you do large molecule bioanalysis and immunogenicity studies?
• What about Data Management and Statistics support?
The webinar will be set up and will take the format of a general 12 -20 minute
presentation and then a moderated Q and A session between your experts and our
workers. At the end, you will fully understand what working with our group can offer
you.

4. Fusion Biosimilars.
Using our geography to meet a new need….
From India through Asia, biosimilar production is a growing commercial activity. Starting initially with the Insulins
and mostly with Indian manufacturers, there are a large number of companies now producing all types of novel
biosimilars and large molecules. Our aim is to provide a full service to these companies to take their biosimilars
from conceptualisation through to Marketing Application in all major markets.By approaching us through the Fusion
system, we are able to apply the experts you need to provide all the services applicable to APAC.
Regulatory support. Including taking your product through Regulatory submission in all major markets
including US FDA, EU, Japan and the New World markets. This task is performed by our Regulatory
Partners based in Europe. From programme design through pharmacovigilance and working closely with our
laboratory partners will design your immunogenicity package including method development and validation.
Our central laboratory will organise your global sample management.
Introduction to manufacturing and formulation sites meeting local requirements.
The APAC countries have different requirements from one another. We will guide you accordingly depending
on the best site for your drug development programme.
Development of Investigator brochure and Toxicology packages.
We will perform a gap analysis of your package and introduce you to, or organise pre-clinical studies in an
APAC location using our partners. We will provide full GLP compliant laboratory facilities.
Clinical programme design utilising the sites and populations of APAC.
We have within our group, Phase I/2a capability in both healthy volunteers and special ethnic populations
applicable to the region (including those for Japanese registration) We also have an oncology Phase I Unit in
a well-equipped hospital with full laboratory and imaging facilities. Veeda Clinical Research provides a very
large clinical unit in Ahmedabad with bio-analytical capabilities. We also have clinical facilities in Malaysia
including both monitored Phase I facilities and Phase I Oncology. We have a special strength in glucose
clamping technologies and the advancement of biosimilar insulins.
Full bio-analytical, special assay and Data management//Statistics across the region.
our bio-analytical tam is well known both for its small molecule and large molecule and immunogenicity. The
immunogenicity programme, will be dovetailed with the pharmacovigilance need.
We have special understanding of the issues of biosimilars and vaccines and we will negotiate with the
various regulatory authorities on your behalf.
If you have a drug development project which might benefit from the environment of the Asian region then
please approach, in the first instance contact the most convenient person listed below who will co-ordinate
a group of our experts tasked with making a preliminary analysis of your needs and will try and identify how
we can assist you.
Elizabeth Stevens Elizabeth.stevens@fusionseasia.com (SE Asia)
Yvonne Lungershausen; Yvonne Lungershausen@cprpharma.com (Australia and New Zealand)
Preeti Makhijani: Preeti.Makhijani@veedacr.com (India)

5. An introduction to a new service.
We have now been working in SE Asia for some time. We have observed the increasing number of companies,
especially from the Indian subcontinent who wish to use the excellent environment of APAC to develop their drugs in
a welcoming and high-quality environment; but so often problems are encountered and perceptions of regulatory
requirements are sometimes wrong
Having helped some clients through this hurdle we have come to recognise a real need for a formalised service
which we have not developed as ‘Fusion Fix-it’.
By approaching us through the Fusion system, we are able to apply the experts you need to provide all the services
applicable to APAC.
Regulatory support. Including taking your product through Regulatory submission in APAC.
We have special knowledge of Malaysia, Indonesia and Australia.
Introduction to manufacturing and formulation sites meeting local requirements.
The APAC countries have different requirements from one another. We will guide you accordingly depending
on the best site for your drug development programme.
Presentation of Investigator brochure and Toxicology packages.
We will perform a gap analysis of your package and introduce you to, or organise pre-clinical studies in an
APAC location using our partners. We will provide full GLP compliant laboratory facilities.
Clinical programme design utilising the sites and populations of APAC.
We have within our group, Phase I/2a capability in both healthy volunteers and special ethnic populations
applicable to the region (including those for Japanese registration) We also have an oncology Phase I Unit in
a well-equipped hospital with full laboratory and imaging facilities.
Full bioanalytical, special assay and Data management//Statistics across the region.
our bioanalytical tam is well known both for its small molecule and large molecule and immunogenicity
We have special understanding of the issues of biosimilars and vaccines.
Through our Dubai-based member, JVLT, we will try and assist companies to source Arabia-based
investors We have a novel investment platform using Limited Liability Partnerships which lends itself well
to the Islamic investor.
If you have a drug development project which might benefit from the environment of APAC then please approach, in
the first instance Elizabeth Stevens who will co-ordinate a group of our experts tasked with making a preliminary
analysis of your needs and will try and identify how we can assist you.
CONTACT: Elizabeth Stevens
elizabeth.stevens@gvjlt.com (investment)
or, Elizabeth.stevens@fusionseasia.com (science and drug development)
for a first interaction with our group.

6. Fusion Pharmacology
Fusion Quality Assurance.
It is essential for the integrity of the partnership of Fusion that the members have a common
core of Quality Assurance which ensures that each of the members is currently compliant with
its own SOPs and yet at the same time, the individual corporate quality infrastructure is
consistent throughout and that there are no conflicting practices.
To this end, Fusion is evolving a central Quality Assurance function concerned with ensuring this
integrity and at the same time providing on a contract basis the essential audit and review
processes. These will be central to all Fusion programmes but may also be a business activity in
its own right and so may be contracted independently when a client has a need.
Chakrapani Majumdar, Head of QA for Veeda Clinical Research heads up and
co-ordinates this function. Mr Majumdar has worked in a number of roles in
the pharmaceutical industry both within CROs and also with MNCs including
Novartis, Ranbaxy and Zydus Cadilla. Described by one MNC during an audit
as running ‘the best QA department that they had met in the industry’ it is a
pleasure to welcome Chakrapani to the Fusion Alliance.
The services to be offered by the Fusion Quality Assurance Group are
specifically defined to meet the needs of our target client-base and include:
• Clinical Quality Assurance Support.
• QMS design and management support
• CSV; Computer System Validation Support. GCP and GLP Audit Support.
• Specialised Audit Support for Clinical Data Management, EDC audits, Site audits
and Generic Study Audits.
• Training Programme Design Support and Document Management Support.
If you wish to discuss any of the above matters then please initially direct your enquiries to
to Chakrapani at Chakrapani.Majumdar@fusionseasia.com
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

7. Fusion PharmacologyTHE BEST OF BOTH WORLDS
Access the Asia Pacific Region with Confidence
FUSION’S NORTHERN PARTNER ARRIVES
The partners of Fusion Pharmacology, the rapidly
evolving APAC early Clinical Pharmacology Group
have been joined by a Northern Participant in the
collaborative membership of the group.
Re-awakening an old collaboration between the
Phase I Unit at Kitasato University and Veeda
Clinical Research in Plymouth UK, we are now able
to offer the advantages of joint studies between the
two units.
Prof Yuji Kumagai and his team have been leaders
in developing collaborations between all the major Northern Asian Countries such as
China, Taiwan and Korea through a collaborative network and we are pleased that this first
step enables the members of the Fusion group to
develop in the greater Asian market.
Our intention is to utilise the multi-ethnicity of APAC
and our contacts with Kitasato to offer to our client base a
a fast, effective and easy way to write bridging studies
into their early clinical development programmes.
The Asian Clinical Pharmacology network developed by
Prof Kumagai has links on a global basis.
For more information about how you might
take advantage of this new dimension to our
partnership please contact:
Elizabeth.Stevens@fusionseasia.com
Or
Yvonne.Lungershausen@cprpharma.com

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