11/30/2011

Welcome to the Open Day!

NUSAGE - PAREXEL Postgraduate Certificate

In Clinical Trial Management

Heidrun Bruchmann, PhD Director, PAREXEL Academy

© 2010 PAREXEL International | Confidential

Who we are

Dr Heidrun Bruchmann Director

Valerie Howarth-Gruender Course Coordinator Lecturers:

Dr Matthias Grossmann The Drug Development Process

Bettina Merz-Nideroest/ Regulatory Affairs Dr Edmund Leong

Claudia Richter Conducting Clinical Research

Dr Sabine Brunschoen-Harti Client Relationship Management

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Topics

1. PAREXEL International 2. PAREXEL Academy 3. Course Structure 4. Selection of Students 5. Module 1: The Drug Development Process 6. Module 2: Regulatory Affairs 7. Module 3: Conducting Clinical Research 8. Module 4: Client Relationship Management 9. Assessments/Marking System 10. Work Placement 11. Career Opportunities 12. Questions?

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South Africa (3)

Mexico

Japan (3) Israel

India (2)

United States (17) California

Connecticut Illinois

Maryland Massachusetts

New Jersey North Carolina

Pennsylvania Virginia

China (4) Hong Kong Indonesia S. Korea Malaysia Philippines Singapore Taiwan Thailand

Australia

Ukraine (2) United Kingdom (6)

Argentina Brazil Chile Peru

PAREXEL International

PAREXEL has more than 10,850 employees worldwide

located in 72 offices throughout 38 countries. (Figures as of Sept 2011)

South Africa (3)

Israel

United States (17) California

Connecticut Illinois

Maryland Massachusetts

New Jersey North Carolina

Pennsylvania Virginia

China (4) Hong Kong Indonesia S. Korea Malaysia Philippines Singapore Taiwan Thailand Vietnam

Belgium Croatia Czech Republic Denmark Finland

France (2) Germany (3) Hungary Italy Lithuania

Netherlands Poland Romania Russia (2) Spain

Argentina Brazil Chile

Colombia Peru

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PAREXEL Academy - Background

Founded: 2001 in Berlin (Germany/Europe)

Objective: To provide high quality training for newcomers and professionals in the biopharmaceutical and contract research industry.

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Postgraduate

Courses

Bachelor of Science

in Clinical Research

(BSc)

Training for the

Pharma- ceutical Industry

Tailored In-house Training for Pharmaceutical Companies

Validated by the University of Wales, since 2008

GCP-Training for

Site Staff

Japan Oncology Academy

Internal Training for PAREXEL CRAs

1. Study Nurse Training

2. Investigator Training

PAREXEL Academy

PAREXEL Academy – What we do

1. Clinical Research Associate/Clinical Trial Management, PAREXEL Academy Germany, since 2002

2. Certificate in Clinical Trial Management in cooperation with the National University of Singapore, Feb 2012

3. Cooperation with

Northeastern University Boston in process

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Who we teach

Over 1700 participants in all courses to date 680 Study Nurses 280 Investigators 443 Postgraduates 54 Undergraduates Several hundred professionals from pharmaceutical

companies

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Postgraduate Courses – Proven Success

443 graduates have completed our courses 92% of all graduates were placed 50% received job offers before the end of the course

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Postgraduate Courses

239 started work in these departments at PAREXEL Monitoring/Clinical Operations 118 Clinical Logistics 64 Data Management 42 Study Start-Up Unit 27 Project Management 13 Medical Services 22 Regulatory Affairs 17 Peri-Approval Studies 5 Proposal and Contracts 4 Perceptive Informatics 3 Quality Assurance 2 Biostatistics 1 Medical Writing 1

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170 graduates started work at other companies

Pharmaceutical Industry:

Contract Research Organisations:

Institutes:

Astra-Zeneca Bausch&Lomb Biotronik Bayer Boehringer-Ingelheim Boots Grünenthal Merck Novartis Pfizer Roche Pharma Sanofi-Aventis Solvay Schwarz Pharma/UCB Stada NovoNordisk

Quintiles Covance PRA Int. I3 Research Icon PPD Accovion Clin Research Cologne Ecron Entimo Berlin GSO Hamburg Omnicare Synarc Hamburg

BfArM Helios Kliniken Trial Coordinating Units in Hospitals or Universities University of Marburg

Postgraduate Courses

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COURSE OVERVIEW

Valerie Howarth-Gruender, BA, PGCE, RSA Dip

Course Coordinator Senior Trainer PAREXEL Academy

© 2010 PAREXEL International | Confidential

The Postgraduate Certificate Program Details

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Qualification Postgraduate Certificate in Clinical Trial Management Course structure 4 modules taught sequentially Delivery One week full-time face-to-face training (30 hours)

One week self-directed learning (30 hours) Academic value 4 x 4 Modular Credits (MC) = 16 MC (24 ECTS) Course length 10 weeks: 8 teaching weeks 1 revision week 1 examination week Assessment A 2-hour written examination for each module. Faculty Lecturers from PAREXEL Academy and NUS Venue Department of Pharmacy, Faculty of Science National University of Singapore

Course Structure

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Selection Procedure

Prerequisites Bachelor degree in Medicine, Pharmacy, Life Sciences or related major.

IELTS 7.0 or TOEFL equivalent* Application procedure Written application with complete CV to NUSAGE Deadline: Monday 5th December 2011 Selection procedure Assessment Centre comprising: Interview Aptitude test Communication skills test

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Course schedule

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Week 1 13 Feb 2012 Drug Development Process 30 hrs contact

Week 2 20 Feb 2012 30 hrs directed learning

Week 3 27 Feb 2012 Regulatory Affairs 30 hrs contact

Week 4 05 Mar 2012 30 hrs directed learning

Week 5 12 Mar 2012 Conducting Clinical Research 30 hrs contact

Week 6 19 Mar 2012 30 hrs directed learning

Week 7 26 Mar 2012 Client Relationship Management 30 hrs contact

Week 8 02 Apr 2012 30 hrs directed learning

Week 9 09 Apr 2012 EASTER

Week 10 16 Apr 2012 Timetabled Revison Sessions

Week 11 23 April 1 x 2-hour examination per day

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THE DRUG DEVELOPMENT PROCESS

Matthias Grossmann, MD, PhD

Clinical Pharmacologist Pathophysiologist

Vice President and Principal Consultant Trainer PAREXEL Academy

© 2010 PAREXEL International | Confidential

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History of Drug Development

Before 1800 use herbal remedies

After 1850 isolate the active principle understand symptoms of a disease

After 1920 recognize the cause of a disease (insulin, penicillin) discover putative target

After 1970 understand immunology and genetics produce human-specific compounds/biologicals

After 2000 an era of individualized medicines?

Drug Development: Success Rate

• Only 1 out of 50 drug candidates reaches clinical testing

• Only 1 out of 5 of these drug

candidates reaches the market

• Clinical development is twice

as expensive as candidate selection

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Learning Too Little Too Late

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Preclinical Phase IIb Phase III Phase IV Phase I-IIa

KNO

WLE

DGE

TIME / MONEY

Market Withdrawal!

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Learning Too Little Too Late

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Preclinical Phase IIb Phase III Phase IV Phase I-IIa

KNO

WLE

DGE

TIME / MONEY

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Orloff and Stanski 2009

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Drug Development

is expensive time consuming often fails time is limited due to patent expiration good planning is of paramount importance Good planning needs good understanding…

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REGULATORY AFFAIRS

Bettina Merz-Nideroest, MPharm

Pharmacist Senior Clinical Trial Specialist CTS

Trainer PAREXEL Academy

© 2010 PAREXEL International | Confidential

An Early Clinical Trial

Dr. James Lind and Scurvy Royal Navy Surgeon aboard HMS Salisbury Scurvy: disease caused by deficiency of Vitamin C

20th May 1747 12 scorbutic sailors divided into six pairs

1) a quart of cider daily 2) 3 x 25 drops of elixir of vitriol (sulfuric acid) 3) two spoonful of vinegar three times a day 4) half a pint of sea-water 5) two oranges and one lemon 6) a spicy paste (garlic) plus barley water

Group 5 experienced a remarkable recovery

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Conduct of Clinical Trials

Would it still be possible nowadays to conduct the study as Dr. Lind did in 1747?

What are the requirements for starting and conducting a Clinical Trial?

What guidelines and laws must be followed?

Who are the key players in clinical research?

What are their roles and responsibilities?

What documents are essential?

Regulatory Affairs Module!

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Clinical Research

Roles Responsibilities

Ethics Competent Committee Authority Investigator Sponsor CRO Trial Subject

Legal Framework Processes Documents 11/30/2011

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CONDUCTING CLINICAL RESEARCH

Claudia Richter

MSc in Medical / Nursing Education Senior Clinical Research Associate Senior Trainer PAREXEL Academy

© 2010 PAREXEL International | Confidential

Process of a Clinical Trial

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What Happens on Site?

We will discuss and answer the following questions: How are patient safety and data integrity assured in Clinical

Trials?

What does a Clinical Research Associate (CRA) have to do and why?

Why is it so interesting to work with site staff in Clinical Trials?

What are the challenges for a CRA in Clinical Trials?

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CRA - Responsibilities and Interactions

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CRA

Investigators and site staff

Client (Sponsor)

Other functional

groups Vendors

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CLIENT RELATIONSHIP MANAGEMENT

Sabine Brunschoen-Harti, PhD

Scientist Director Operations Process, Quality & Training

Trainer PAREXEL Academy

© 2010 PAREXEL International | Confidential

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Client Relationship Management

We will examine the following topics: Managing studies with special requirements

The importance of good communication

Good document practice requirements

Preparing for audits and inspections

Detecting and managing non-compliance and fraud

The Importance of Good Communication

During study visits Addressing quality issues Clarifying issues Good Documentation Practice Requirements Data, documents, signatures Advanced Monitoring Visit Report Writing Addressing the requirements of ICH/GCP Meeting client expectations Meeting regulatory requirements

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Quality Control

Identifying, managing and dealing with: poor performance non-compliance fraud

Audits and Inspections Preparation with site Communication with investigators Communication with inspectors Do’s and Don’ts… Common Findings

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Assessment and Marking

Assessment The course is assessed via 4 x 2-hour written examinations

at the end of the course (1 per module) during exam week. The exams are a mixture of multiple choice, short answer

and case study questions.

Marking The Postgraduate Certificate is marked according to the UK marking system: 70% and over Distinction 60% - 69% Merit 40% - 59% Pass

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Work Placement at PAREXEL

Optional All students guaranteed interviews Takes place at the end of the course Approx. 6 months May to October 2012 Paid at local rates APAC region Testimonial on completion Job interview in 5th month for full-time position

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Assessments and

Selection of Candidates

for the PG Certificate

Program in Clinical

Trial Management

Students complete the PG Certificate

Program

Students apply for

placements

Interns perform 6-month

Work Placement

Selection interviews during 5th

month

Hiring of

interns for full-time positions

The Work Placement Process

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Criterion: English speaking environment Suggested countries (others can be added):

Korea* China* Australia India Singapore Hong Kong Taiwan* Japan*

* Locations will need local language capability

Locations

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PAREXEL International: Monthly payment according to local pay practices

Students: Travel costs to/from placement Accommodation Visa fees (if applicable)

Who Pays For What

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Clinical Research Associate, Clinical Monitor, Clinical Monitoring Associate, Clinical Trial Monitor, Clinical Research Specialist, Clinical Research Assistant, Field Based Monitor, Medical Writer, Drug Supply Manager, Clinical Site Manager, Clinical Trial Assistant, Study Coordinator, Clinical Research Coordinator Clinical Study Manager, Clinical Manager, Clinical Research Manager, Director Clinical Research Management, Clinical Project Scientist, Project Management Assistant, Clinical Project Manager, Medical Field Manager, Clinical Trial Manager, Clinical Scientist, Drug Safety Manager, Data Entry Assistant, Clinical Writer, Manager Drug Regulatory Affairs, Regulatory Specialist, Head of Drug Safety, Regulatory Affairs Manager, Manager Drug Safety, Data Manager, Database Manager, Clinical Data Manager, Clinical Programmer, Clinical Data Associate, Database Administrator, Senior Clinical Data Coordinator, Line Manager, Medical Service Liaison Manager, Field Application Specialist Molecular, Clinical Trial Specialist

Possible Careers in Clinical Research

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Any questions?

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