Case Study: Pneumonia

ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902
Telephone: +65 6436 5500 - info@clinactis.com
Case Study:
Pneumonia

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.

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.

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

Pneumonia Overview
Need For Adult Studies
In Asia, Pneumonia is estimated to cause almost one million adult deaths per year with many
of these deaths occurring in the elderly. A large number occur in those with good life
expectancy, including 160 000 among those aged 15–59 years. However, adult CAP has been
poorly studied in Asia until recently. Knowledge of local aetiology is critical to making rational
decisions about empirical antibiotic treatment, as differences in aetiology may result in poor
response to therapy chosen to cover pathogens common in western studies.
What is Pneumonia?
Pneumonia is a form of acute respiratory
infection that affects the lungs. The lungs are
made up of small sacs called alveoli, which fill
with air when a healthy person breathes. When
an individual has pneumonia, the alveoli are
filled with pus and fluid, which makes breathing
painful and limits oxygen intake.

Pneumonia Overview (Continued)
Economic Costs
The cost of antibiotic treatment for all
children with pneumonia in 66 of the
countdown to 2015 countries for
maternal, newborn and child survival is
estimated at around US$ 109 million per
year. The price includes the antibiotics
and diagnostics for pneumonia
management. Source: WHO –
https://goo.gl/8fuXDc
Causes
•  Pneumonia is caused by a number of
infectious agents, including viruses,
bacteria and fungi. The most common
are:
•  Streptococcus pneumoniae – the most
common cause of bacterial pneumonia in
children;
•  Haemophilus influenzae type b (Hib) –
the second most common cause of
bacterial pneumonia;
•  respiratory syncytial virus is the most
common viral cause of pneumonia;
•  in infants infected with HIV,
Pneumocystis jiroveci is one of the most
common causes of pneumonia,
responsible for at least one quarter of all
pneumonia deaths in HIV-infected
infants.

Pneumonia in Asia
Epidemiology
•  In Asia, Streptococcus pneumoniae (S.
pneumonia) is one of the main
pathogens that cause pneumonia.
•  Singapore: Mean annual hospitalization
rate with pneumococcal infection: overall:
10.9% per 100 000;
•  Hong Kong: IPD annual incidence: 7.7%
per 100 000;
•  Malaysia: Overall incidence pneumoniae
infections: 75.4% per 100 000;
•  Taiwan: Annual incidence of admissions
with CAP: 36.5% per 10 000 in 2004;
IPD incidence: overall: 216 per 100 000;
•  Thailand: IPD incidence in adults aged
≥75 years: 26% per 100 000;
Morbidity/Mortality
•  Korea: Pneumonia is the 5th most
common cause of death for population in
their 70s, and the 4th biggest cause of
death among those in their 80s.
•  Philippines: Pneumonia is ranked 3rd
among the causes of morbidity and fourth
among the causes of death.
•  Singapore: Pneumonia is the No. 2 killer
across all ages after cancer.
•  Hong Kong: Pneumonia was the second
leading cause of death in 2014.
•  Malaysia: In 2009, pneumonia was the 4th
leading cause of death.

Experience with Antibacterial and CABO Trials
Study
Type
Phase
(# of
Trials)
Location Countries #
Enrollment
CRO
Services
Provided
Years
Study
Performed
Patients Months
Goal Actual Goal Actual
CABP 3 Asia 04
(Taiwan,
Korea,
Malaysia,
Singapore)
250 215 12 18 PM, co-monitors 2006-
2008
HAP 3 Asia 02
(Malaysia,
Singapore)
100 50 12 24 Monitor 2002-2004

Lessons Learned From Previous Experience for CABO Trials
Most of the patients were treated with empiric treatment during the admission in ICU or A&E.
In order to minimize the risk to overlook the potential patient during the admission by giving
empiric antibiotic treatment, we created awareness among the hospital by providing protocol
info during department update. We must involve medical officer and nurses from different
departments like A&E, family clinic as part of study team. Provide referral fees for different
hospital departments, especially ICU department.
After office hour, there is no Study Coordinator to support and lack of awareness of medical
officer on-duty about the trial. Consequently, they will have no recruitment after the office
hours. Put a poster in a visible part of the hospital and dedicate an on-call Study Coordinator
to work after office hours and provide the contact number to the night duty staff are the
measures to improve the situation.
In busy hospitals with heavy workload for routine patient care, it may undermine clinical
research work and consequently delay in obtaining the laboratory and other tests results for
inclusion. Consequently, most patients receive empiric antibiotic treatment before obtaining
the results. For this reason, we need to set a special lab sampling arrangement that must be
agreed by the hospital lab director to process our blood sample as priority e.g. dedicated staff
to do the blood sampling for our study, rent lab tools for the hospital etc.

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

Case Study: Pneumonia

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Case Study: Pneumonia