Case Study: Pneumonia

ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - [email protected]

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

Jared Byer, MBA US Director, Strategic Relations M: +1 913-980-0028 E: [email protected] Imen Jelassi, PharmD, MSc EU Director, Strategic Relations M: +33 6 28 11 13 71 E: [email protected]

Case Study: Pneumonia

Health & Medicine