Info Kinetics Sdn Bhd / Clinical Research Centre Connecting Research & People

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May 2010

Phase 1 Study

BA/BE Study

Protocol Development

IRB / IECApplications

Pantai Hospital Penang

Bioanalytical

Regulatory Applications

Data Management& Reporting

Subject/Patient

BE StudyPhase 1 Study

Full Services Under One Roof

Accreditation

Facility

Timelines

Cost

Request for Information (RFI)

Market Authorisation

R&D StrategiesStandards

2001-2002 2003-2004 2005-2006 2007-2008 2009-2010

• Company Established

• First BE Study performed.• Complied with ICH-GCP• First CRO to obtain ISO 9001:2000

• Inspections from NPCB and HSA• Achieved ISO/IEC 17025 accreditation.• Quality manual aligned with ASCLD

• First Asian CRO to obtain OECD GLP accreditation• Inspected by German Federal Bureau

• GCP Inspection by French regulatory authorities (Afssaps)• GCP Inspection from NPCB (renewal)

Quality Milestones

Info Kinetics is the first CRO is Pan-Asia to achieve ISO9001:2000 and OECD GLP accreditation

• Migration to ISO9001:2008

36-bedded facility

Large Database ofsubjects

Pantai Hospital PenangLimited Access

Drug Storage area

Phlebotomy Stations FreezersRefrigerated Centrifuge

Clinical Pharmacology Unit

Full safety supportICU & 24-hr emergencyRFID Subject

Tracking System

Bioanalytical Laboratory

Over 70 validated methods (plasma)

Over 40 validated methods (pharmaceutical)

LCMS/MS (2)GCMS (2)RRLC / UPLC (6)

Agilent OpenLab® Platform

Pre-Study Timelines

2 d

1 - 2 wks

4 - 6 wks

Timelines Financial & LegalOperationsSponsor

Request for Information (RFI)Feasibility Studies

(Facility Audit)

Accepts Proposal

Protocol WritingInform Consent FormsCase Report Forms

IEC Application(Approval)

TCECDA

Regulatory Application

(CTIL) / (NMRR)

Study AgreementIndemnity

Provide Technical Dossier

Provide Working Stds Method Development & Validation (if not validated)[4-6 weeks]

1 - 2 wks

Study Timelines

2 wks

2 - 4 wks

4 - 6 wks

2 - 3 wks

2 - 3 wks

Timelines FinancialOperationsSponsor

Ship IMP to Site Subject Screening & Recruitment

12-16 wks

Monitoring Visits Study Period 1(washout period)Study Period 2

Safety Follow-up

Bioanalysis

Data Management & Statistical Analysis

Report Writing &Study Closure

Application

• Applicant must be Malaysian Registered Organisation, with appropriate personnel

• Parallel submission to Drug Control Authority & National Medical Research Register

• Language: English• Dossier Format: Common

Technical Dossier

Review

• Monthly Meeting• Safety & Quality aspects• Ethical aspect is the

responsibility of Ethics Committee.

• First in Man: New Chemical Entity (NCE) is acceptable

• First in Man: New Biological Entity, slower process

Approval

• A Clinical Trial Import License is provided. Valid for 2 years.

The Malaysian Govt. is very supportive of Translational Research. Day 1Day -21 Day 7

Regulatory Applications

IRB / IEC Applications

Application

• State ethics committee – accepts application from Penang State

• Parallel submission with regulatory

• Language: English• All forms available online, and

JPEC has its own set of SOPs, under ISO9001

Review

• Monthly Meeting• 12 Member (9 Medical

Professional, 3 layperson)• Registered with OHRP, hence

able to review trials for US NIH.

Approval

• A decision is made known to the applicant within 1 week from meeting date.

• Approved protocol to commence within 18 months.

Independent Ethics Committee (JPEC) – ICH GCP standardsDay 1Day -21 Day 7

Accreditation

Facility

Timelines

Cost

Request for Information (RFI)

Market Authorisation

StandardsR&D Strategies

Market Authorisation

• Which market / regulatory agency is the study intended for?

• Choice of Reference / Comparator

• Narcotics / Psychotropics

Standards

• Local authorities

• EMEA

• TGA

•US FDA

• GLP vs non-GLP

R&D Strategies

• Pivotal Study

• Pilot / Exploratory Study

• What developmental stage? Comparative Dissolutions Stability Studies Bio-batch production

Request for Information (RFI)