ClinActis - Case Study: Global Colorectal Oncology

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

Case Study: Global Colorectal Oncology

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


Oncology Experience Indication

Study

Design Study Phase

No. of sites

No. of patients

Location Responsibilities Client (Blinded)

Study status

Study Start Date

T-cell Lymphoma Open-label III 35 80 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Ongoing Mar-14

GIST Double-blind III 40 180 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Ongoing Dec-14

Prostate Cancer Double-blind III 45 130 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Ongoing Jan-14

Pancreatic Cancer Double-blind III 33 90 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Ongoing Nov-13

Colorectal Cancer Double-blind III 38 124 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Ongoing Jul-13

Colorectal Cancer Open-label III 21 100 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Ongoing May-15

Esophago-gastric adenocarcinoma Double-blind III 16 140 HK,KR, MY, PH,

TH PM, Reg, Monitoring EU Pharma Ongoing Apr-15

Melanoma Double-blind III 40 100 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Closed Jul-14

Melanoma Open-label III 30 75 SG, HK, KR, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Closed Jul-14

Hepato cellular carcinoma Open-label III 28 110 SG, HK, KR, TW,

PH, MY, TH PM, Reg, Monitoring EU Pharma Closed Mar-14

Breast Cancer Double-blind II 2 8 SG Monitoring EU NGO Closed May-13

Pleural Mesothelioma Double-blind II 3 12 KR Reg, Monitoring US Biotech Closed Jun-15

Epithelial Cancers Open-label l 1 12 SG Monitoring US Biotech Closed Jun-15


Case Study – Global Colorectal Cancer

§  Study: Global Randomized, Double-blind, controlled Phase III §  Global enrollment duration: 2 years §  Study involving: 34 countries, 165 sites in Americas, EU and Asia Pacific §  Study recruitment target : 550 patients §  Responsibilities: ClinActis is responsible for Asia Pacific


Proactive Approach

When working as part of global trials, ClinActis recruits a month or two ahead of the US and Europe. With work commencing simultaneously in all countries, this table represents the countries that submitted for approvals for the study. Other countries involved were still awaiting approvals.

Country HA first EC FPI

Malaysia 17-Mar-14 30-Oct-13 15-Aug-14

Taiwan 17-Dec-13 24-Dec-13 25-Aug-14

Hong Kong 08-Apr-14 03-Dec-13 24-Sep-14

Philippines 20-Jan-14 15-Feb-14 29-Oct-14

France 20-Nov-13 11-Dec-13 13-Nov-14

Hungary 18-Sep-14 7-Aug-14 No recruitment

Slovakia 2-Sep-14 8-Jul-14 No recruitment

Spain 10-Oct-14 10-Jun-14 28-Nov-15

Czech Republic 20-Aug-14 16-Jun-14 09-Nov-15

United Kingdom 15-Sep-14 1-Sept-14 19-Dec-15

USA Pending


Proactive Approach (Continued)

§  Malaysia, Taiwan and Hong Kong achieved first recruitment 8 weeks after the sites were activated, with the Philippines in just 6 weeks

§  In comparison, in the other countries in Europe it took 1 year to recruit their first patient

§  US approvals were still ongoing §  Submissions can be faster in Europe,

due to the translational aspect which is obviously required in Asia

§  To overcome this and ensuring proper planning, by submitting the English documents

first to the IRB whilst having translations conducted in parallel. When the translations are ready, these can be submitted to the IRB during the IRB Q and A


Recruitment Strategies

§  Precise definition of patient population/ specific tumor characteristics during initial phase is the key to ensuring enrolment success

§  Bi-weekly phone call to support the site recruitment

§  Support sites in pre-screening activities include discussion the actual patient case with Sponsor to confirm patient’s eligibility

§  Provide the inclusion and exclusion checklist to ease the screening process §  Prepare physician referral and patient education materials §  Increasing awareness of the study through face to face meeting with targeted physician §  Newsletter and monthly recruitment status to maintain investigator’s interest in continued

participation


Recruitment Strategies (Continued)

§  Medical monitors work closely with site to explain and communicate precise definition of patient population, especially rationale of difference in frequency of CT scans (standard of care vs. investigational requirements) should be carefully explained

§  In some countries, the sponsor is required to pay for comparator or co-administered drugs to support the clinical trial activity

§  Creating a dialog with the investigator for opinions of the compound that could help sponsor to anticipate issues or questions from the site

§  Training investigators on the Informed consent process


Case Study – Key Results and Lessons Learned

§  Most submission to IRB/ CA completed ahead of schedule §  First global enrolment was from Asia §  The first patient was screened in Malaysia on 5 AUG 2014 and the first

randomization occurred on 15 AUG 2014. §  Good team work, communication and coordination within the stakeholders

are important in patient recruitment.


Contact Us for More Information

Imen Jelassi, PharmD, MSc EU Director, Strategic Relations M: +33 6 28 11 13 71 E: [email protected]

Bill Van Nostrand Head of Business Development, North America M: +1 908-229-5220 E: [email protected]

Health & Medicine

ClinActis - Case Study: Global Colorectal Oncology