Market Analysis of Clinical Research in Asia Pacific

ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902
Telephone: +65 6436 5500 - info@clinactis.com
Market Analysis of
Clinical Research in
Asia-Pacific

ClinActis is exclusively focused on Asia Pacific, with solid expertise in applying international quality
standards to regional specificities. ClinActis is flexible in our approach to work scope and budgeting and
contracting process.
Delivering Quality to Our Clients
ClinActis is committed to implementing international standards in clinical trials. Our ability to deliver high
quality results to our clients is based on recruiting and maintaining the best talent within our
organization. ClinActis’ senior management is fully accountable for the quality of deliverables to our
clients.
Your Proactive Clinical Research Partner in Asia Pacific

ClinActis Pte Ltd is a full service CRO
providing clinical trial services to the
pharmaceutical, medical device, medical
nutrition and biotech companies in Asia
Pacific. Established in 2009, ClinActis Pte Ltd
is headquartered in Singapore.
ClinActis Value Proposition
ClinActis is a multicultural company. As such,
the team is able to communicate effectively
with international clients.

Mission and Vision

With headquarters based in Asia, all corporate
decisions are made within the region, in order to
better anticipate our client needs and adapt to local
specificities.
Vision
Our vision is to become the reference CRO
specialized in conducting clinical research in Asia
Pacific, offering state of the art quality services, with
cost effective solutions.
We strive to employ people with genuine expertise
in the region and with a passion for excellence, to
work with our clients in the most pro-active way, and
to build a relationship based on trust, transparency
and strong ethics.
Mission
Our mission is to provide our clients with unique
and dynamic expertise in applying global drug
development standards to the specificities of
each country in the Asia Pacific region.

Operational Expertise – Regional Footprint
ClinActis Experience
§  33 years experience in clinical
research in pharmaceutical and
biotechnology companies as well as
CROs
§  27 years experience in Asia Pacific,
including Australia/New Zealand,
China, Malaysia, Hong Kong, India,
Indonesia, the Philippines,
Singapore, South Korea, Taiwan,
Thailand, Japan and Vietnam
§  Extensive knowledge of regulatory
frameworks, best KOLs and sites
across the region
§  Vast therapeutic experience including
Oncology, Infectious diseases, CNS,
Cardiovascular, Endocrinology, and
Respiratory

Christophe Tournerie, MD – Owner and CEO
Dr. Tournerie has more than 20 years experience in clinical research in Europe
and Asia Pacific including Japan, working with biotechnology companies,
pharmaceutical companies and clinical research organizations.
After completion of his medical studies in Paris and various hospital
assignments in France, Dr. Tournerie spent a period of 3 years at the National
Medical Research Institute in France in the field of drug development in anti-HIV
products.
About Our Founder
His introduction to the pharmaceutical industry was as Medical Director in an American biotechnology
company developing anti-HIV products. Then, he moved to a large global CRO, heading the Project
management Department for South Europe, and then as Head of Operations in the Japan affiliate.
Later, Dr. Tournerie headed the Asian clinical research activity for a multi-national Pharmaceutical
Company, based in Singapore.
More recently, Dr. Tournerie was Vice President Asia Pacific for a large global CRO, based in
Singapore. During this assignment, Dr. Tournerie developed the business strategy for the region,
successfully established and directed operations in 12 countries and built a highly professional team.

Center of Discussion
From Singapore to Korea, a host of lesser known markets are emerging
from the shadow of larger, more dominant countries in Asia. With a sizeable
increase in trials and national governments investing heavily in clinical R&D,
major growth is predicted. China and India have been at the center of
discussions over the last 10 years, often being seen as the next big players
in the pharmaceutical industry. However, the excitement over the potential
of these countries has been dampened more recently, with companies
facing claims of questionable ethics and fraudulent activities, and regulatory
bodies presenting complex hurdles and lengthy timelines.
Emerging Talent – Asia-Pacific Market Analysis
During this time, less attention has been given to some of the other rapidly emerging markets in the Asia-
Pacific region, such as Singapore, South Korea, Taiwan, Malaysia, Thailand, the Philippines, Indonesia
and Vietnam. Across all these countries, there is a growing middle class with a higher disposable income;
an ageing population with longer life expectancy; urbanization; a greater incidence of major diseases; and
an increase in health consciousness. As such, the pharma market potential here is considerable, with
growth in each country expected to be substantial over the next five years, particularly in Thailand, the
Philippines and South Korea.

Center of Discussion (continued)
IMS Market Prognosis 2012 predicted the pharma market in Asia (excluding
Japan) to reach $350 billion by 2016 – $80 billion of this from China, but the
majority from these other less talked about markets. This accounts for 30%
of the $1.2 trillion that makes up the global pharma market(1). Each country’s
government has recognized the opportunity this industry can bring to
national development, and are therefore focused on supporting and
investing in the sector.
First and Second Tier
These emerging countries in Asia-Pacific can be divided into two tiers. The
first is made up of Hong Kong, Singapore, South Korea and Taiwan, which
have the most experience in clinical trials and are more developed in terms
of infrastructure, regulatory set-up, medical care and technology. Sites in
these countries work as part of a centralized healthcare system, with high-
quality facilities and investigators.
The second tier includes Indonesia, Malaysia, the Philippines, Thailand and
Vietnam. The clinical research environment for this group is less mature
compared to the first-tier countries, but is steadily progressing – offering
good quality research at a significantly lower cost than the US and Europe.

First and Second Tier (continued)
Many investigators in these countries received
their training overseas – largely in the US and
Europe – and, with the sizeable increase in
international clinical trials being conducted at
local sites, personnel there are gaining
experience fast. In addition, there are large
pockets of people in the populations who
cannot afford medical care; a trial gives them
access to treatments and care they would
otherwise be unable to pay for. There are
obvious advantages to working in Asia-Pacific;
it presents cost efficiencies (country
dependent, but about 30% less than Western
nations); large treatment-naïve patient pools;
high incidence in both developing and
developed world diseases; and shorter start-up
timelines. However, despite these – and the
volume of trials there – many in the industry
still have concerns about expanding clinical
development activities into the region (table 1).

Perceived Risks
Questionable Data: With the shift to performing clinical research in
emerging markets, Asia is gaining more experience working on global trials.
This is providing site personnel with the opportunity to participate in training
and have regular communication with study staff from countries that are
much more advanced in clinical R&D. Furthermore, international presence
in the region is growing, so the skill sets and knowledge of ICH Good
Clinical Practice (GCP) are being transferred across territories. This
exposure, along with the increase of audits and inspections taking place,
has underlined the international requirements that site personnel need to
adhere to. Since the vast majority of studies implemented in Asia are international, many sites in both tiers
have worked on trials where the results have been used for EMA and FDA submissions(2).
Quality is constantly improving right across the region, with the quality of data coming from trials in tier
one countries comparable to that of Western standards. Singapore has led the way, followed by South
Korea, which implemented Korean Good Clinical Practice legislation in 1995 and then revised this to be in
line with ICH-GCP in 2001. The quality of trials in Taiwan has also been ranked among the best by
worldwide institutions(3). By 2012, the FDA had conducted 67 inspections in the majority of countries in the
region – none of which issued an official action-indicated notification – with 29 of these presenting no
objectionable conditions or practices at all. This signifies that data coming from sites in Asia-Pacific are
meeting the acceptable global standards(4).

Perceived Risks (continued)
Under-Developed Infrastructure: The infrastructure varies greatly between
countries and even within each nation itself. Singapore boasts one of the
world’s best healthcare infrastructures(5). Meanwhile, in some second-tier
countries, certain provinces can be more advanced than others and, when
sophisticated equipment is called for, they borrow from the better
equipped hospitals; overall advances in technology and equipment are
visible, even if the building appears less developed. The choice of site
depends on the clinical study’s complexity, the logistics, standard of care
and type of treatment, among other criteria.
For a Phase 1 study where multiple pharmacokinetic sampling is required, or a complex oncology trial
which relies on sophisticated diagnostics equipment, a first-tier country should generally be considered.
Second-tier countries present advantages where a large patient pool and less advanced equipment is
needed, for certain therapeutic areas such as infectious and tropical diseases, or when the protocol
requires treatment-naïve patients. Although Southeast Asian nations are at different stages of
development, significant advances are being made and the large increase in GCP-certified sites have
been established to support clinical research activities. Singapore, Malaysia and South Korea’s
governments, for example, have been taking an active role in investing and building local research
networks.

Complex Regulations: Governments in each of these countries
have recognized that clinical trials bring additional revenue, better
medical access and a higher standard of care. By working hard
with the regulatory and ethical bodies to improve processes, they
realize that this, in turn, will attract more studies. In addition,
regulatory bodies in the region are making the move away from
just maintaining their own benchmarks, and recognize they need
to adopt international standards.
Across most countries, regulatory processes are becoming much more transparent and
streamlined. However, there are some where the approval process is still lengthy. In the
Philippines, for instance, it currently takes about six months to gain approval; but since the
recruitment potential is so huge, in the long term, opening up a trial there will result in
shorter overall study timelines and a decrease in total spend. Establishing good
relationships with regulatory authorities and engaging local personnel experienced in
liaising with them are key to cutting down approval timelines. If a sponsor experiences
longer timelines than projected, it is likely the responsible person does not truly know how
to navigate the country’s system.

Investigator Motivation: Asia has a large pool of well-educated, highly
motivated and enthusiastic investigators who have conducted their
studies at reputed institutions in the US or Europe. In most of the
countries, it is the institution that is paid the per-patient fee, although in
the Philippines this is a part institution/part principal investigator payment.
Still, the main motivation is to work as part of international clinical trials,
growing their expertise and hopefully having their name in a publication,
as this will help develop their career. Investigators are more conservative
than in the West, so generally when they provide feasibility results there
will be no great surprise with the recruitment rates.
Recruitment and Retention: According to a 2012 report from Tufts Center
for the Study of Drug Development, clinical site activation rates in Asia-
Pacific are at one of the highest, with 91% of sites successfully
progressing through the study start-up stages and recruiting the first
patients in at speed. Not only are site activation rates high, but
investigative sites achieved target enrolment levels at 107% – making it
the top region in that respect(6).

Recruitment and Retention (continued): Despite these figures, with clinical
research activities in this part of the world growing and the increase of
complex protocols, it is necessary to emphasize the importance of patient
recruitment. This is being recognized at site level – in Singapore, for
example, some sites now have in-house recruitment teams to support this
activity. Within all Asian cultures, physicians are highly regarded and
patients put their complete trust in their doctors, which works in favor of
recruitment and maintaining low drop-out rates.
In Asia, more of an emphasis is placed on the informed consent process, ensuring site staff are
sufficiently trained in this area, and are educating trial subjects early on. On top of this, extra efforts
must be made to make sure participants feel involved for the trial duration. A 2013 report from the
Center for Information and Study on Clinical Research Participation showed that in Asia-Pacific the
prospect of receiving clinical results and regular updates about research during the study were the top
factors for influencing their decision to take part. A further analysis indicated that a significantly higher
percentage of trial participants in Asia-Pacific were receiving updates on either a daily basis or at least a
few times a week, compared to the US and Europe(7).

Recruitment and Retention (continued): Retention strategies are key
to success in the region:
q  Assigning a dedicated study coordinator to each trial subject in
order to create familiarity
q  Including personal touches, such as birthday cards in pediatric
studies
q  Building in efficiencies – for example, combining a study visit
with other regular visits the patient needs to make
q  Patient meetings, to create a sense of community and reinforce
important messages
q  Weekly phone calls
The same report showed a considerably higher proportion of Asia-Pacific trial participants
rating free procedures, free study drugs and their relationship with the staff as major
motivators to stay in – 121%, 140% and 100% more than their European counterparts,
respectively.

Culture and Geography: Many people underestimate the large number of
diverse cultures, religions and languages making up Asia-Pacific, and
companies should incorporate multiple country-specific strategies when
preparing to work in the region. Although Asian cultures are becoming
westernized, there are still many elements of cultural sensitivity to be
exercised. Numerous patient and physician motivations and rules of
interactions must be understood around patient engagement. For site
interaction, again there are different ways to communicate and negotiate
to ensure motivation. In addition, Asian countries can be prone to natural
disasters, such as typhoons and earthquakes. Given the increasing
governmental support for disaster planning, the risks from these events
can be mitigated. Most sites are compliant in storing source documents in
flood and fireproof areas, but this is an essential checkpoint for site
selection.

Adoption of Western Trends: Risk-Based Monitoring - In first-tier
countries where source documentation is available and there is a
very high level of data quality, Risk-Based Monitoring (RBM) is
already being implemented. For the more developing countries in
tier two, RBM would be difficult to adopt at this stage, mainly
because source documentation is not always readily available. In
Indonesia and the Philippines, it is possible that some patients
may not even know their own date of birth. As sites take on
experience in trials, at the same time receiving more training,
RBM will be implemented – but it will still be a few years
before this is the case.

Patient-Centricity: In the Asian marketplace, patients pay over 50% of
healthcare expenditure out of their own pocket(8). Therefore, in order for
companies to grow and be successful in this market, patient-centricity is
key and needs to begin at the R&D stage, not just later on in a drug’s
lifecycle. Patient-centric strategies are already widely adopted for clinical
trials across Asia but, as in the West, they are still evolving and have not
yet reached full potential. Technology is at the heart of this, and so it is in
first-tier countries that these activities can currently be maximized.
Positive Outlook: Beyond China and India, the rest of Asia is also a very
attractive draw for clinical trials. Like anywhere, setting up a study in Asia-
Pacific comes with its challenges, but governments are investing hugely,
monetary and infrastructure-wise, as well as forging strategic relationships, to
create a positive and efficient trial landscape. With such a variety of nations in
the region, each with such different characteristics, finding a country or
countries which complement a protocol is easily achieved. High population
densities in metropolitan areas, coupled with large hospital infrastructure, allow
individual study sites to recruit greater numbers of patients more cost
effectively, while keeping timelines on target – and engaging the highly
experienced local practitioners who know the intricacies of national systems
and sites is key.

References

1.  Asia Pacific Insight 3, IMS Health, 2013
2.  Gupta SK, Drug Discovery and Clinical Research, 2011
3.  Chan WK and Chen DS, Taiwan as a clinical trial center of excellence in
the Asia Pacific, Asia Pacific Biotech, 2007
4.  Sahoo U, Clinical Research in Asia: Opportunities and Challenges, 2012
5.  The World Healthcare Report 2013, WHO, 2013
6.  Getz K, Enrollment Performance: Weighing the "Facts", Applied Clinical
Trials, 2012
7.  Global study on public and patient perceptions of clinical research, Center
for Information and Study on Clinical Research Participation, 2013
8.  Asia Pacific Insight 4, IMS Health, 2014

Contact Us for More Information

Imen Jelassi, PharmD, MSc
EU Director, Strategic Relations
M: +33 6 28 11 13 71
E: ijelassi@clinactis.com
Bill Van Nostrand
Head of Business Development,
North America
M: +1 908-229-5220
E: bvannostrand@clinactis.com

Market Analysis of Clinical Research in Asia Pacific

Recomendados

Recomendados

Mais conteúdo relacionado

Mais procurados

Mais procurados (19)

Destaque

Destaque (14)

Semelhante a Market Analysis of Clinical Research in Asia Pacific

Semelhante a Market Analysis of Clinical Research in Asia Pacific (20)

Último

Último (20)

Market Analysis of Clinical Research in Asia Pacific