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CADILA CROClinical Research

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Objective & Goals

Our Goal:

To be a leading CRO in the world using committed resources & to achieve 100% quality and compliance with good science, accurate techniques, prompt delivery and utmost Customer satisfaction.

Our Objective:Taking life sciences to new horizons through innovative research, high quality, ethics & commitment.

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Cadila CRO Services

• Pre-Clinical and Toxicology studies.

• Bio-availability / Bio-equivalence studies.

• Bio-analysis

• Clinical Trial Management [Phase II – IV]

• Data Management and Biostatistics

• Medical Writing

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Salient Features of Existing Animal Unit.

• Total Area – 518 Sq.m with 8 Animal rooms & 1 Laboratory room.• Double corridor facility.• Automated Illumination – 12 hr. lighting in 24 hours cycle.• 100% exhaust facility. No recirculation of air.• Animal house walls painted with epoxy non-toxic washable paints.• Species Propagated in-house breeding unit : NZW Rabbits, Wistar Rats, Guinea Pigs, Swiss Albino Mice,

C57BL/6ByJ Mice, F1 C57 & DBA, DBA/2J Mice, BALB/C Mice

Accreditations : a. DSIR, Govt. of India.b. ISO 9001 and ISO 14001.c. Animal House is Registered With CPCSEA

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Pre Clinical and Toxicology Services

We have completed more than 700 studies and developed following capabilities in Toxicological studies.

– Single dose or multiple dose in single day, acute toxicity, acute eye irritation and acute dermal irritation

– Repeated Dose, sub-acute (28 Days) and sub-chronic (90 Days)

– Special studies, genotoxicity, reproduction toxicity and toxicokinetics

– Allergenicity, Guinea pig maximization test (GPMT) and Mouse ear swelling test (MEST)

– In Vivo Efficacy Studies, Antifertility test, Antidiabetic, Analgesics, Anti-hyper lipidemic and Pharmacokinetics.

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Pre Clinical Expertise

Special studies • Genotoxicity

» Micro Nucleus Test (MNT)• Reproduction toxicity

» One generation• Toxicokinetics

Allergenicity • Guinea pig maximization test (GPMT)• Mouse ear swelling test (MEST)

In Vivo Efficacy Studies • Antifertility test.• Antidiabetic.• Analgesics.• Anti-hyper lipidemic.• Pharmacokinetics.

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In – House Pathology Laboratory

• The pathology laboratory is equipped with¤ HITACHI-902 - biochemistry analyzer¤ ADVIA-120 - haematology analyser¤ CLINITEK STATUS - urine analyser¤ Electrolyte analyser

• External quality control programme for biochemistry.

• Well equipped histopathology laboratory.

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Capabilities

• Two separate identical 45 bedded units (total 90 beds) with well equipped ICUs.• Volunteer data pool of approx 5,500 healthy volunteers including 500 female

volunteers and 400 geriatric volunteers database.

• Protocol development and Study designing.

• Conduct of a range of BA/ BE studies:

¤ Single dose /multiple dose ; Fasting /Fed / Steady state studies.

¤ Dose proportionality and

Therapeutic equivalence studies.

¤ Open-labeled / blinded studies.

Clinical Pharmacology Unit

Successfully completed approx. 180 studies, which includes Intravenous Anesthetic BE study, Early phase exploratory vaccine trial, Drug interaction, female volunteers, and more….

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Experience in BE (conducted more than 180 BE studies)

• Intravenous Anesthetic bioequivalence study, which involved Frequent sampling every 2 minutes interval from each subjects and Critical care of each subject during AE by Physician, Anesthetics and emergency equipments and drugs.

• Early phase exploratory vaccine trial on healthy volunteers. • Conducted concurrently male and female volunteer studies • Bioequivalence studies on large numbers of volunteers, n=80 • Drug-drug interaction studies

–Drug-Drug interaction in new Fixed Dose Combination (FDC) compared with individual reference products

–A novel POLYCAP (First time in the world a Fixed Dose Combination containing Atenolol, Ramipril, Hydrochlorothiazide, Simvastatin and enteric coated Aspirin) compared with its single individual reference products to evaluate gain or loss in bio-availability and drug-drug interaction in five different two period two way cross over studies.

–Result of this study was very well co-related with result of TIPS (The India Polycap study) study and has approved the concept of POLYCAP

–Anti-retroviral and Anti-tubercular drug-drug interaction studies.

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Bio-Analytical Services

Features:• Well equipped with latest detection methodologies. • Instruments : LC-MS/MS, Automated HPLCs, UPLCs, Deep freezers,

Refrigerated Centrifuges, N2 Evaporators, Plasma SPE extractors, Milli Q-Water system.

• Team of 20 well qualified and experienced scientists.

• A list of 80+ validated methods which are rugged and reproducible.

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Your advantage on Bio equivalence Project Timelines

No. of Volunteers No. of Periods Washout Period 1st Draft Report

24 2 1 week 1.5 months

24 3 1 week 2.0 months

24 4 1 week 3.0 months

24 2 2 week 2.0 months

• Timelines considered after the receipt of study drugs• All study reports are as per ICH E3 guidelines

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CRO Regulatory Accomplishments

Accreditations & Certifications :

• DCGI certification for the BA/BE centre.

• Audited & approved by WHO Geneva

• Approved BA/BE facility by MoH, Turkey.

• MCC South Africa - Certification for the Dossier submitted..

• MHRA - Dossier submitted & accepted.

• TGA Australia – Dossier submitted & accepted.

• ANVISA, Brazil.

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Clinical Research ( Phase II – IV )

Cadila CRO offers complete package for conducting Phase II-IV Clinical Trials.

Unique Features:

• GCP trained Clinical Trial management team.

• Robust experience in various therapeutic areas.

• Extensive network of hospitals and medical institutes through out India.

• Large database of investigators

• Proficient Patient Recruitment strategy.

• Timely and scientific delivery of projects.

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Clinical Trial Services

Medical Writing & Protocol Development – Protocol Development, designing of Screening form & CRF – Expert review & reports of Safety data. – Statistical Analysis Plan and Report.– Regulatory Support.

Site Development & Management– Investigator and Site Identification, selection, initiation, monitoring & contracts with Investigators and

site close outs – Site staff and Investigator’s training – Randomization, repackaging, coding & labeling of Investigational Products. – Site Supplies.– Medical monitoring & Query management.

Project Management & Site Monitoring– Clinical development plan.– Steering committee meetings. – Training & Development.– Quality systems Implementation.– GCP Audits at Investigators Site. – SOP Management.– Clean & locked data and corrective measures management.

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Therapeutic Expertise

• Oncology• Endocrinology• Anti-infective• Urology• Cardiovascular

The Team also has experience in working in the following Therapeutic areas:• GI• Rheumatology• Immunology• Neurology• Dermatology &• Women’s healthcare

Recently we had signed a Joint Venture with an international vaccine company which has a number of molecules in pipeline, for that we will be conducting a series of vaccine trials

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Data Management & Biostatistics

Soft wares :• WinNonlin® Professional Version 5.0.1 (Pharsight Corporation, USA) • SAS® Statistical Software Version 9.1.3 (SAS Institute Inc., USA ) • Automation of all trial activities by using Oracle Clinical 4.5.1 and Thesaurus Management System 4.5.2

Related Services :• Sample size determination, CRF designing, Patient Randomization, Query

generation, resolution and tracking , Data Analysis, Transfer and Archive and Generation of statistical report.

• Offers protocol review and Preparation of statistical Analysis Plan and conduct statistical analysis for BA/BE, Preclinical and Clinical Trials

Compliance : ICH – GCP, Company’s SOPs and 21 CFR part 11

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Oncology Case Study on Efficient Patient Recruitment

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Sites 8 8 8 17 17 17 17 17 17 17 17 17 17

Patients 24 47 59 17 105 136 162 220        

        PATIENT IN               

  24                        

220 total patients to be recruited   47                      

No. of sites targeted 17     59                    

Strategy : 1. Govt. hospitals,

      71                  

2. CRCs placed at the site,         105                

3. Non metro cities targeted,            136              

  4. Exhaustive Site Staff Training,             162            

                220          

                 Interim Analysis

(77 Pts.)  

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Current Clinical Trials Experiences & Status

INDICATIONS SITESSAMPLE

SIZEREGULATORY STATUS

Erythropoietin Agent 4 101 DCGI Completed

Lipid Lowering 6 180 DCGI Completed

NSAIDS 6 320 DCGI Completed

Cardiovascular 55 2000 DCGI Being closed out

Anti Infective 8 120 DCGI Completed

Bladder Cancer-STCC 13 120 US FDA, DCGI Enrolling

Prostrate Cancer-HRPC 20 176 US FDA, DCGI Enrolling

Lung Cancer-NSCLC 17 220 US FDA, DCGI Recruitment completed

Bladder Cancer-STCC – BCG Refractory

14 20 US FDA, DCGI Enrolling

Tubercular Pericarditis 31 600 US FDA, DCGI Enrolling

Pulmonary TuberculosisCategory -1

2 600 US FDA, DCGI Active; recruiting patients

Pulmonary TuberculosisCategory -2

7 1024 DCGI Enrollment completed

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Why Cadila CRO…

Because we bring together…• State of the art infrastructure.• Highly competent team led by globally experienced and renowned

scientists to ensure validity of all scientific work.• High confidentiality standards.• Utmost professionalism harmonizing with ethical practices.• Strict adherence to GCP,GLP and in-house SOP’s.• Rapid turn-around time.• Strong commitment to responsiveness and timely delivery.• Expert review & resolution of queries.• Excellent project management practices/tools backed by dynamic and

creative project tracking system.• In depth Regulatory knowledge, support & expertise.• Flexibility and Multi specialty.• Large pool of volunteer databank enabling fast selection & recruitment.• Respect to Client’s IPR • Excellent track record.

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Your Reliable Indian Partner for global contract research requirements.

Shruti Shukla - Vice President, Cadila CROshruti.shukla@cadilapharma.co.in