Medica InnovaMedica Innova

Siriporn Nonenoy, B.N.S.Kingkamol Kaenkratoke, M.Sc. Pharm

Promporn Jumnongtanachot, M.Sc. PharmAriya Khunvichai, Ph.D.

May 21 st , 2008

Medica Innova is the First Thai Own “Contract Research

Organization (CRO)” providing services to Thai and International

pharmaceutical industries in

1.1.Pharmaceutical Product Development Pharmaceutical Product Development

2.2.Pharmaceutical Product TestingPharmaceutical Product Testing

3.Clinical Trials/Clinical Research especially in

Bioavailability/Bioequivalence studies

..

Medica Innova

Overview: Clinical Research Development

� Strong management team with Full Service of Clinical Trials�A highly understanding of the requirements of the design, conduct, analysis and protocol/report writing for regulatory submissions�Licensed and well equipped laboratories in accordance with GLP practices�Studies are performed according to the GCP guidelines�Valuable Databases: clincal trial sites, investigators, and participants�Fast enrollment of subjects�Services with confidentiality and credibility�Accountability and accurate results�Favorable price/quality ratio and timeline

3. Bioanalytical Manager Ms. Kingkamol Kaenkratoke, B.Sc. Pharm., M. Sc. Pharm, Experiences – M. Sc. Pharm. :Pharmaceutical Chemistry, Chulalongkorn University

QC manager : Chew Brother Co., Ltd.QC manager : Nakorn Pattana Pharm Co., Ltd.

1. Clinical Pharmacology ManagerDr. Ariya Khunvichai, B. Sc. Pharm , Ph.D.

Experiences – Ph. D. :Pharmaceutics (Pharmacokinetics/Pharmacodynamics), University of Florida Pharmacokineticist in drug discovery & preclinical: Hoffmann-La Roche Inc, Nutley, NJSenior Clinical Pharmacokineticist : Vertex Pharmaceuticals Inc, Cambridge, MA

2. Senior Clinical Research AssociateMs. Siriporn Nonenoy, B. S.N.Experiences – B. S.N. :Thai Red Cross College of nursing, Chulalongkorn university, Bangkok, Thailand

Clinical Trial Monitor of HIV-NAT, Bangkok Clinical Research Associate, Novartis (Thailand) Limited.

Key Management Personnel

���Quality Assurance ManagerMs. Promporn Jamnongtanachot, B.Sc. Pharm., M. Sc. PharmExperiences - M. Sc. Pharm. :Pharmaceutical Chemistry, Chulalongkorn University

Analyst in Division of Drug Stability : Department of Medical Sciences, Ministry of Public Health

Plant ManagerQA & QC Manager : V. S. Pharma (1971) Co., Ltd.

Key Management Personnel

Full Time Staffs in Clinical Research

There are 19 staffs in Clinical Research Development:

� 3 CRAs� 6 Bioanalysts� 2 Medical writers, 1 Pharmacometrician (PK/Statistician)� 3 QAs� 2 ITs� 2 Officers

- Area : 1,200 sq m. facility (will be 2000 + sq. m. in mid 2008, 3 floors)

- More than “80 million Baht” investment in analytical

and bioanalytical laboratory facilities and equipments

- Laboratory -“State of the Art” equipments and facilities “OECD-GLP”

- Clinical Study -“ICH-GCP”

**** Bioequivalence Center must get GLP Certified and GCP monitoring

by the beginning of 2009

Our Facilities and Standards

� Controlled and secured logistic storage room

� Investigation products storage room (for clinical study)

� Controlled specimens storage room (such as plasma or urine)

� Weighing room

� Biological sample preparation room

� Instrumentation room

State of the Art Facilities: Analytical Site

Instruments: Analytical and Bioanalytical Laboratories

� 18 HPLC Systems (UV, Fluorescence, ECD, ELSD)

� LC/MS/MS (Applied Biosystems)

� UPLC/MS/MS (Micromass, Waters)

� -80°C/-20°C Freezer (with online monitoring�

� Stability chamber (with online monitoring)

Instruments: Analytical and Bioanalytical Laboratories

� 6 Dissolution apparatus with autosampler (Distek and Vankel)

� 15 stations Franz cell apparatus

� MilliQ DI water treatment (Waters)

� Power generator

Software:

� WinNonlin (Version 5.2)

Bioequivalence

4 Clinical Sites (ICH-GCP)�Subject service room for 24 persons�Overnight stay rooms for 24 persons�Sampling collection room �Controlled sample storage room�Physical examination and consultation rooms�Qualified clinical staffs

Medica Innova

Clinical OperatingDepartment (CRA)

Clinical PharmacologyDepartment

Bioanalytical Department

Sponsor

Good Clinical Practice (GCP)

Protocol Healthy Volunteers/Enrollment

Good Laboratory Practice (GLP)

Biological Samples

Bioanalytical Analysis

Report

1. Conduct Clinical Trials From Phase I-IIIBioavailability and Bioequivalence StudiesDose Escalation, First-in-Human and Food Effect StudiesDrug-Drug Interaction StudiesSpecial Population StudiesEfficacy/Proof of Concept Studies

Development & Validation of New AssaysAnalysis of Drug in Biological Fluid using HPLC (UV, Fluorescence), UPLC/MS, LC-MS/MS

Investigative Site AuditStudy Documentation AuditPreparation for Regulatory Inspection

2. Bioanalysis

3. Quality Assurance

Services: Clinical Reserch

Bioequivalence Studies: we provide

Protocol Development�Study design, sample size,

and power calculation �Case report form �Informed consent form

Study Management

�Regulatory Document Collection�Preparing Clinical Supplies�Site management�IRB and regulatory Submissions�Regulatory Document Processing

Clinical Monitoring

�Pre-study & initiation visits�Monitoring visits�Close out visits

Bioanalysis�Development & Validation of Assays�Analysis of Drug in Biological Fluid

Clinical Pharmacology and Safety Data Analysis�Statistical analysis�Pharmacokinetic (PK) analysis

�Data management

Clinical Study Report Development�PK and evaluations�Efficacy evalutaions�Safety evaluations

Bioequivalence study: Bioequivalence study: TimelineTimeline

Case 1: No protocol (s)Time line = 25– 32 Weeks (7-8 months) + 3-4 months (FDA submission)

Case 2:Standard protocolTime line = 19 – 26 Weeks (5-7 months) �

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Our current activities

Projects

o 8 bioequivalence studies (PK) in human

o 3 efficacy /clinical studies (PD, DMPK)

o 1 bioequivalence study for veterinary product

““To be Trusted and Recognized by Our Clients To be Trusted and Recognized by Our Clients

as an Innovator in the Development of Novel as an Innovator in the Development of Novel

Drugs and to Accelerate our ClientsDrugs and to Accelerate our Clients’’ Molecules Molecules

to Market Efficientlyto Market Efficiently””

Our Vision

ContactAriya Khunvichai, Ph.D.Tel 0-26934201 – 4 ext 520E-mail : ariya@medicainnova.com

A list of Protocols

o Cetirizineo Loratadineo Ticlopidineo Gabapentino Candesartano Valsartano Azithromycino Amlodipineo Finasterideo Amlodipineo Meloxicamo Donepezil HCLo Fexofenadineo Felodipine

o Risedronateo Rabeprazoleo Olanzapineo Rivastigmineo Sertaline