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ClinActis CNS Expertise

ClinActis Pte Ltd
ClinActis Pte Ltd
ClinActis Pte LtdClinActis Pte Ltd

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 Experience • 45 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 and Japan • Extensive knowledge of regulatory frameworks, best KOLs and sites across the region • Vast therapeutic experience including Cardiovascular, CNS, Endocrinology, Infectious diseases, Oncology, and Respiratory

ClinActis CNS Expertise

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ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902
Telephone: +65 6436 5500 - info@clinactis.com
CNS Expertise
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.
ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902
Telephone: +65 6436 5500 - info@clinactis.com
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.
ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902
Telephone: +65 6436 5500 - info@clinactis.com
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.
ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902
Telephone: +65 6436 5500 - info@clinactis.com
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.
ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902
Telephone: +65 6436 5500 - info@clinactis.com
Operational Expertise – Regional Footprint
ClinActis Experience
§  45 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
ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902
Telephone: +65 6436 5500 - info@clinactis.com
Central Nervous System (CNS) Experience
Indication Study
Design
Study
Phase
No. of
sites
No. of
patients
Location Responsibilities Client
(Blinded)
Study
status
Study
Start Date
Alzheimer’s
disease
Double-
blind
III 20 200 SG, HK,
TW, PH,
MY, TH
PM, Reg,
Monitoring
EU Pharma Ongoing Dec-12
Dementia Double-
blind
III 4 40 SG, AUS Feasibility, Site
Selection
SGP
Pharma
Closed Oct-12
Brain Injury Double-
blind
IIIb/ IV 12 200 SG, HK,
PH
PM, Reg,
Monitoring
EU Pharma Closed Apr-13
Progressive
Supranuclear
Palsy
Double-
blind
IIb/III 15 30 HK, TW,
PH, MY,
TH
Feasibility, Site
Selection
EU Pharma Closed Mar-14
Schizophrenia Double-
blind
II 12 100 KR, MY Feasibility,
Request for
Proposal
JPN
Pharma
Closed Mar-15
Amyotrophic
Lateral
Sclerosis
Double-
blind
II/III 1 20 TW Site Selection,
Start-up
EU Pharma Closed Feb-16

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ClinActis CNS Expertise

  • 1. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com CNS Expertise
  • 2. 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. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com 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.
  • 3. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com 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.
  • 4. 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. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com 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.
  • 5. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Operational Expertise – Regional Footprint ClinActis Experience §  45 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
  • 6. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Central Nervous System (CNS) Experience Indication Study Design Study Phase No. of sites No. of patients Location Responsibilities Client (Blinded) Study status Study Start Date Alzheimer’s disease Double- blind III 20 200 SG, HK, TW, PH, MY, TH PM, Reg, Monitoring EU Pharma Ongoing Dec-12 Dementia Double- blind III 4 40 SG, AUS Feasibility, Site Selection SGP Pharma Closed Oct-12 Brain Injury Double- blind IIIb/ IV 12 200 SG, HK, PH PM, Reg, Monitoring EU Pharma Closed Apr-13 Progressive Supranuclear Palsy Double- blind IIb/III 15 30 HK, TW, PH, MY, TH Feasibility, Site Selection EU Pharma Closed Mar-14 Schizophrenia Double- blind II 12 100 KR, MY Feasibility, Request for Proposal JPN Pharma Closed Mar-15 Amyotrophic Lateral Sclerosis Double- blind II/III 1 20 TW Site Selection, Start-up EU Pharma Closed Feb-16
  • 7. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com ClinActis Approach to CNS Trials     §  Pharmaceutical companies developing new CNS products face special obstacles. §  ClinActis has experience in a number of CNS studies involving, but not limited to, Alzheimer’s disease, brain Injury, schizophrenia, Progressive Supranuclear Palsy and Amyotrophic Lateral Sclerosis. §  Demonstrated ability to manage complex central nervous system (CNS) trials in Phase II-IV in Asia. §  Extensive experience with medical feasibility studies, providing critical data about regions, countries, sites, investigators, standards/quality of care, and monitoring work. §  With our experience and expertise, we have the ability to provide proactive solutions to potential clinical trial issues related to : − Design and development of CNS trials − Biomarkers and other validated approaches: CNS Toolkit, diagnostic adjudication − Patient recruitment strategy − Translation of study material and assessment tools − CNS training internally and site staff − Sourcing local vendors e.g. central lab, IWRS, drug depot etc.
  • 8. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com ClinActis Experience With Asian Clinical Sites Indication Total no. of sites No. of sites in SG No. of sites in HK No. of sites in TW No. of sites in PH No. of sites in MY No. of sites in TH No. of sites in KR Alzheimer’s disease 28   3 3 4 5 6 3 4 Dementia 4 2 0 0 0 0 0 2 Brain Injury 12 4 2 0 6 0 0 0 Progressive Supranuclear Palsy 15 0 3 5 5 10 7 0 Schizophrenia 12 0 0 0 0 6 0 6 Amyotrophic Lateral Sclerosis 1 0 0 1 0 0 0 0 Total 72 9 8 10 16 22 10 12
  • 9. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Advantages of Conducting AD Clinical Trials in Asia     §  Large and increasing size of dementia population offering a large patient pool: e.g. a total of 3,628 Asian subjects have been pre-screened in our study. §  Provide optimal care for patients (low income, residents in urban area, limited treatment options, seeking alternative treatment) §  Relatively few/little competition trials for patients to choose §  A large numbers of patients with dementia living with caregivers §  Able to recruit motivated clinical investigators (some are KOLs) to join international/global clinical trials §  Conductive hospital infrastructure, healthcare team and ethic/ regulatory environment for clinical research activity
  • 10. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Key Challenges of Conducting AD Trials in Asia     §  Protocol criteria deviation (e.g. low BMI of <18, low creatinine clearance <50 ml/min) in Asia population vs. Caucasian population for global trials. §  Less experience of site team in conducting such trials §  Caregiver pressures (concerns about the safety of the products, patient as trial subject, their presence in every protocol visit etc.) §  Language/Cultural Barriers §  Frequent or Long term follow up of protocol visits cause inconveniences to patients or caregiver
  • 11. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com Overcoming The Challenges Through ClinActis     §  Appropriate protocol design to meet the disease status for Asia population (e.g. lower BMI etc.) §  Provide re-training to the investigator or site team §  Motivating investigators by providing additional educational meetings or publications opportunity §  Set up referral system with district clinic or healthcare body §  Producing appropriate educational materials to raise awareness for physicians and patients/caregivers §  Advertised through newspaper, radio or poster §  Arrange appropriate transportation for AD patients (majority is elderly patients) §  Compensation for caregivers’ time §  Frequent telephone follow up or site visits (occasional) by the study monitor to the site in order to provide the support to the site §  Newsletter to provide latest recruitment status as well as the information (e.g. safety) about the investigational products.
  • 12. ClinActis Pte Ltd - 112 Robinson Road - #06-04 - Singapore 068902 Telephone: +65 6436 5500 - info@clinactis.com 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