Transcript Brief of Clinical Trial

CRO and Job Opportunities
동아대 문화인류학과
전공특화 프로그램
Dec 10, 2010
Aviva Park(Hye Sook Park)
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The Dreamers
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자료\Superstark_MV_Web.wmv
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Agenda
Brief of Clinical Trial
Business Prospect
Company Introduction
Job and JD
Major Distribution of Parexel Korea Employee
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Brief of Clinical Trial
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임상시험이란?
임상시험용의약품의 안전성과 유효성을 증명할 목적으로,
해당약물의 약동, 약력, 약리, 임상적 효과를 확인하고,
이상반응을 조사하기 위하여 사람을 대상으로
실시하는 시험 또는 연구
Chemistry
Screening
1~2years
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Preclinical
studies
3~4years
Phase I
Phase II
5~6years
Phase III
Registration
(허가)
Sales,
Phase IV
1~2years
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임상시험관리기준 KGCP
[식품의약품안전청고시 제2009-122호, 2009.08.24]
임상시험의 계획  시행  실시  모니터링  점검 
자료의 기록 및 분석  임상시험결과보고서 작성 등에 관한 기준을 정함
정확하고
신뢰성 있는
결과의 획득
피험자
비밀 보장
피험자
권익 보호
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ICH-GCP
ICH Guideline for Good Clinical Practice

ICH 란?
 International Conference on Harmonization of Technical Requirement for
Registration of Pharmaceuticals for Human Use
 3 regions: European Union, United States, Japan
 표준화된 약물 등록의 요건을 합의하기 위해 구성

ICH-GCP
 KGCP (임상시험관리기준)과 거의 동일한 내용
 Should be followed when generating clinical trial data that are intended to be
submitted to regulatory authority
 May be applied to other clinical investigations that may have impact on the
safety and well-being of human subjects
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CFR
Code of Federal Regulation (미국 연방규정집)
 미국 연방등록사무소(OFR)에서 발행하며, 50개 분야 (Title) 로 나누어져 있는
미국의 대표적인 규정집

Title of 21 CFR : Food and Drugs
- Chapter 1 : Food and Drug administration, Department of Health and Human
Services
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21 CFR Part 11 – Electronic Records and Electronic Signature
21 CFR Part 50 – Protection of Human Subjects
21 CFR Part 54 – Financial Disclosure by Clinical Investigators
21 CFR Part 56 – Institutional Review Boards
21 CFR Part 312 – Investigational New Drug Application
21 CFR Part 314 – Application for FDA approval to Market a New Drug
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Regulation of Korea
LAW
• 약사법 (제34조)
• 약사법 시행규칙 (제 31, 32, 33, 34, 75조)
ENFORCEMENT
GUIDELINE
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임상시험관리기준(KGCP)
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임상시험이상반응 보고지침
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임상시험실시기관지정에 관한 규정
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의약품 임상시험계획승인지침
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의약품 등의 품목허가, 신고, 심사 규정
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임상시험평가지침
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Business Prospect
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Business Growth and Prospect
1980
1990
건강보험 시행, 국민소득증가
1987, 물질 특허제, 연구개발 투자 증대
2000
의약분업, 처방증가
약가인하 압력, 노령화 가속
2010
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Business Growth and Prospect
IMS Korea, 우리 나라 전문의약품 성장 현황, 2010
IMS Korea, 향후 10년간 세계의약품 시장 전망, 2010
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Business Growth and Prospect
KFDA Report_연도별 임상시험 승인현황분석자료, 2009
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Competitive Pressures for CROs
Small CROs serve niche requirements; large CROs, the global trial portfolio needs.
How can the mid-size CRO differentiate?
Publish date: Nov 1, 2010
By: Lisa Henderson
Source: Applied Clinical Trials
Trends over the past five years have indicated the changing relationships between the pharmaceutical sponsors and the CRO.
Historically, the CROs have always indicated they wanted to use their brains, and be a more strategic partner to pharma.
But the complaint was that they were the arms and legs, just doing what the pharma said. These "mindless" activities
translated into a high number of transactional relationships that are still prevalent in the industry. Increasingly,
the transactional relationship is giving way to the strategic relationship. The strategic relationships allow pharma
to take advantage of the brains and mine the capabilities of a limited number of CROs, to hopefully bring efficiencies
to the process.
This trend has been borne out by both industry surveys and recent headlines. In the June 2009 issue of Applied Clinical Trials,
an article based on the results of a global CRO usage survey indicated plans by large and mid-size sponsors to use fewer than
five CROs in that year. The authors wrote that significant differences in relationship structure are determined by the sponsor's size.
Large and mid-size went more strategic, while the small pharma chose transactional. The authors based this on the smaller
project size where task-oriented outsourcing best met their needs, as well as a belief that they couldn't compete with the larger
sponsors financially or for attention.
Most recently in the headlines are deals that clearly reflect this trend toward fewer outsourcing partners. For example, reports that
GlaxoSmithKline was entering into strategic relationships with Parexel and PPD, following its mid-year announcement to whittle
its current roster of 30 CROs it was working with down to a few.
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Competitive Pressures for CROs
Small CROs serve niche requirements; large CROs, the global trial portfolio needs.
How can the mid-size CRO differentiate?
Publish date: Nov 1, 2010
By: Lisa Henderson
Source: Applied Clinical Trials
On its side, Parexel has announced similar deals with Eli Lilly and Bristol-Myers Squibb. Covance too entered into a strategic
agreement with Sanofi for lab-related business.
An article in the Wall Street Journal, posted after the GSK-Parexel-PPD announcement, forecasted that these large CRO-pharma
deals will squeeze the mid-size CRO.
Research and analysts interviewed for the article noted that mid-size CROs suffer from being too small to be considered a broad global vendor,
and too big to be a niche player. These industry observers noted that the best thing to do was to get big quick via M&A or capital infusion,
or find a way to differentiate in a specialty that allows them to stand out.
Large CROs have 50 percent of the global market and revenues above $500 million. These CROs include (in no particular order)
Parexel, PPD, ICON, Quintiles, and Covance. Mid-size CROs feature revenues below $500 million, with Kendle coming close at $475 million
for 2008 revenues. PRA, PharmaNet, INC, RPS, and Medpace also fall in the $100 million to $500 million range.
In the coming months, we will feature news and articles on these and other competitive pressures faced by all sized CROs. In the meantime,
this issue features an article based on the results of our Salary Survey. These results show that the competitive pressures faced by the CROs
and pharma in regard to M&As and global trials, trickle down in a big way on individual workload.
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Company Introduction
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45 50
PAREXEL HAS SUPPORTED NEARLY ALL OF
THE TOP FIFTY DRUGS ON THE MARKET
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PAREXEL International
Vision
Strives to be the premier provider to the bio/pharmaceutical
and medical device industries for development and
commercialization of new medical therapies worldwide.
Mission
Combine the strength of our expertise, experience
and innovation to advance the worldwide success of
the bio/pharmaceutical and medical device
industries in preventing and curing disease.
Think Globally, Act Locally
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Milestones:
+ 25 Years of Biopharmaceutical Industry Progress
2009 Product Line Strategy Award, Frost & Sullivan Awards
2009 Best Performing CRO, BioSingapore Awards
2008 Most Innovative Patient Recruitment Strategy, GCPj Awards
2008 Best Contract Research Organization, Script Awards
2007 Asia Pacific Healthcare Best Practice Award, Frost & Sullivan Awards
2007 APEX Full Acquisition by PAREXEL
2003 Alliance between PAREXEL & APEX
1999 Foundation of APEX In Taiwan
1995 PAREXEL expands operation in Japan
1982 Foundation of PAREXEL
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Product Development Continuum
Pre-IND
IND/
CTA
Clinical Research
Phase
I
Phase
IIa
Perceptive Informatics
Phase I-IV
Medical Imaging
Project Management
Site Management
IVRS/IWRS
Patient & Investigator
Recruitment
Integration Services
Data Management
Biostatistics
Phase
IIb
EDC
CTMS
ePro
Bioanalysis
Phase
III
PAREXEL Consulting
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Peri-Approval/
Phase IV
Medical Communications
Product Development
& Regulatory Affairs
Medical Education
& Communications
Strategic Compliance
& Risk Management
Meetings/Events/Exhi
bits
Clinical &
Manufacturing
Reimbursement/Patie
nt Assistance
Programs
Quality Process
Consulting
Educational Services
Scientific Publications
Medical Services
Process Expertise
NDA/MAA
(CTD)
Technology Expertise
Product Development
Expertise
Communication
Expertise
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PAREXEL Global Reach
PAREXEL has more than 9,500 employees worldwide
Belgium
Czech Republic
Denmark
Finland
France (3)
United States (17)
California
Connecticut
Illinois
Maryland
Massachusetts
New Jersey
North Carolina
Pennsylvania
Virginia
Germany (3)
Hungary
Italy
Lithuania
Netherlands
Poland
Romania
Russia (2)
Spain
Sweden
Israel
Ukraine (2)
United Kingdom (6)
Japan (2)
Mexico
India (3)
Argentina
Brazil
Chile
Peru
South Africa (3)
China (4)
Hong Kong
Indonesia
S. Korea
Malaysia
Philippines
Singapore
Taiwan
Thailand
Vietnam
Australia
located in 79 offices throughout 44 countries.
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Job Opportunities
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CRA
Clinical Research Associate
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Essential Function
 To perform all clinical monitoring / site management activities
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the ownership of investigator sites
the selection of investigator/sites
collating Regulatory Documentation
initiating and monitoring of sites
performing site documentation verification
data collection
drug accountability in accordance with ICH GCP guidelines
Education
Educated to degree level (biological science, pharmacy or other health related discipline
preferred) or equivalent nursing qualification/experience.
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Language Skills
Competent in written and oral English.
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Minimum Work Experience
Substantial monitoring experience in clinical research.
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Local Monitoring Force (CRA)
July 2010
China (81)
- Beijing
- Shanghai
- Guangzhou
- Chengdu
Hong Kong (13)
Thailand (18)
India (54)
- Hyderabad
- Bangalore
Vietnam (2)
Malaysia (14)
Total: 653
South Korea (51)
Japan (305)
- Tokyo
- Kobe
Taiwan (34)
Philippines (21)
Singapore (14)
Australia (40)
Indonesia (6)
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More than 25 CRAs in Korea have oncology experience
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COL/PL
Clinical Operational Leader/Project Leader
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Essential Function
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Coordinating the functional team members and their activities across all geographies
liaising with project leadership and the sponsor to ensure that the Global Research
Operations deliverables (timeline, quality, productivity) are met
Overall accountability for the execution of the clinical operations strategy on the project
Education
Educated to degree level (biological science, pharmacy or other health related discipline
preferred) or equivalent nursing qualification/experience
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Language Skills
Competent in written and oral English
•
Minimum Work Experience
Substantial experience in clinical research including relevant experience as a team Leader in
Clinical functions or proven experience in coordinating clinical trials.
Relevant Work experience in clinical research Experience in Coordination of Clinical Trials –
Preferably relevant working experience as an Associate Clinical Operations Leader or proven
experience in a similar role
Individuals should have a strong understanding of the cross functional activities
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Project Leads / Clinical Leads in Asia
July 2010
Total: 110
China (9)
South Korea (6)
Hong Kong (9)
Japan (43)
Thailand (1)
Taiwan (11)
India (11)
Philippines (1)
Singapore (8)
Malaysia (1)
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6 PMs/COLs in Korea have oncology experience
Australia (10)
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CTS/CMA
CTS(Clinical Trial Specialist)
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Essential Function
Conduct and facilitate specific start-up activities such as
 Site identification
 Feasibilities
 SRP collection
 Review and approval
 ICF customization and approval
 EC and RA submissions
 Preparation and negotiation of Clinical Site Agreements (CSAs) at a site level
CMA(Clinical Monitoring Associate)
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Essential Function
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to perform remote clinical monitoring tasks and remote visits for designated projects in
accordance with relevant SOPs, study specific procedures and regulations.
to include managing/coordinating/supporting clinical monitoring activities remotely
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Issue resolution
Patient enrollment management
Handling protocol- and/or ICF- and/or contract amendments
Drug / supply management
Ensuring timely data entry at a site level
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Study Start Up Unit (SSU)
July 2010
Total: 45
China (2)
Hong Kong (1)
South Korea (5)
Thailand (1)
Taiwan (10)
India (7)
Philippines (1)
• Shorten overall start up timeline
• Earlier site initiation
• Achieve project targets regards start up deliverables
• Develop stable relationship with site reviewers
Australia (18)
• Familiarize with site regulation and clinical policy changes
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Other Role
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Quality Management
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Consultant
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Data Specialist
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…
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Major Distribution
of Parexel Korea Employee
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Major distribution of Parexel Korea Employee
간호학
약학
수의학
자연과학
인문사회
인문사회
자연과학
간호학
약학
73 of 90 employees replied, 06 Dec 2010
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Open Discussions & Questions?
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Thank You
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Pharmaceutical Market Synopsis
Key drivers of Korean Pharmaceutical market
 Market Magnitude (source: OECD, 2006 )
10000000
9000000
8000000
10 Year Growth Rate: 11.3%, 5.6% of GDP in 2004
Gradual increase of national Income
Health Insurance coverage expansion
7000000
6000000
5000000
4000000
3000000
1.8 %
13.5 %
1
2003
2
2004
14.6 %
11.7 %
2000000
1000000
0
3
2005
4
2006
 Fast aging population, prevalence of adult disease: 7 Mil. HTN, 3 Mil. Diabetes Patients
 Drug Expenditure Rationalization Policy
 FTA
• MNC’s growth expected: Patent protection strengthened
• Domestic company estimated decline as generic launch will be tougher
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