Clinical Research

CADILA CRO

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Objective & Goals

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

Our Goal: To be a leading CRO in the world using committed resources & to achieve 100% quality and compliance with good science, accurate techniques, li ih d i h i prompt delivery and utmost Customer satisfaction.

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Cadila CRO Services

Pre-clinical and toxicology studies. Bio-availability / Bio-equivalence studies. Bio-analysis Clinical Trial Management :
Phase I Safety Studies Ph Phase II IV

Data Management Medical Writing Biostatistics

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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. y 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 780 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 S i l studies di Genotoxicity Micro Nucleus Test (MNT) Reproduction toxicity One generation Toxicokinetics Allergenicity Guinea pig maximization test (GPMT) Mouse ear swelling test (MEST) g ( ) In Vivo Efficacy Studies Antifertility test. Antidiabetic. Analgesics. Anti-hyper lipidemic. Ph Pharmacokinetics. ki ti
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In House Pathology Laboratory

The pathology laboratory is equipped with HITACHI-902 - biochemistry analyzer y y ADVIA-120 - haematology analyser CLINITEK STATUS - urine analyser Electrolyte analyser External quality control programme for biochemistry. Well equipped histopathology laboratory.

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Clinical Pharmacology Unit

Two separate identical 46 bedded units (total 92 beds) with well equipped ICUs. Volunteer d t V l t data pool of approx 6,000 healthy volunteers including 500 l f 6 000 h lth l t i l di female volunteers and 400 geriatric volunteers database.

Capabilities p
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. Th ti i l t di Open-labeled / blinded studies.
Successfully completed more than 209 studies which includes Intravenous Anesthetic BE study, studies, study Early phase exploratory vaccine trial, Drug interaction, female volunteers, and more.
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Experience in BE (conducted more than 209 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 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 Atenolol, Ramipril, Hydrochlorothiazide 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 co-related 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, Pl t t Milli Q-Water system. Team of 25 well qualified and f2 ll lifi d d experienced scientists. A list of 91+ validated methods which are rugged and reproducible.

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Your advantage on Bio equivalence Project Ti li P j t Timelines

No. f Volunteers N of V l t 24 24 24 24 No. f Periods N of P i d 2 3 4 2 Washout Period W h tP i d 1 week 1 week 1 week 2 week 1st D ft Report 1 t Draft R t 1.5 months 2.0 months 3.0 months 2.0 months

p y g 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 A Approved BA/BE facility by M H T k d f ili b MoH, Turkey. MCC South Africa - Certification for the Dossier submitted.. accepted MHRA - Dossier submitted & accepted. TGA Australia Dossier submitted & accepted. ANVISA, Brazil.

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Clinical Research ( Phase I IV )

Cadila CRO offers complete package for conducting Phase I-IV Clinical Trials. Unique Features: GCP trained Clinical Trial management team. g 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 Report. Regulatory Support. Site Development & Management Investigator and Site Identification, selection, initiation, monitoring & contracts with Investigators and site close outs i l Site staff and Investigators training Randomization, repackaging, coding & labeling of Investigational Products. Site Supplies. Medical monitoring & Q y management. g Query g Project Management & Site Monitoring Clinical development plan. Steering committee meetings. T i i & Development. Training D l t 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 U l CVS (Phase 2 & 3) (Phase 3 Anti diabetic) (Phase 3) (Phase 1 & 2) (Ph (Phase 1, 2 & 3)

The Team also has experience in working in the following Therapeutic areas: GI Rheumatology Rhe matolog Immunology Neurology Dermatology Womens Healthcare (Phase 3) (Phase 3) (Phase 1, 2 & 3) (Phase 2 & 3) (Phase 3) (Phase 3)

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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 p g g y 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 d t t ti ti l l i f BA/BE P li i l d Cli i l T i l Compliance : ICH GCP, Companys SOPs and 21 CFR part 11

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Oncology Case Study on Efficient Patient Recruitment

NSCLC Sites Patients Nov 08 8 24 Dec 08 8 47 Jan 09 8 59 Feb 09 17 17 Mar 09 17 105 PATIENT IN 24 220 total patients to be recruited No. of sites targeted 17 Strategy : 1. Govt. hospitals, 71 2. 3.
4. 4

Apr 09 17 136

May 09 17 162

Jun 09 17 220

Jul 09 17

Aug 09 17

Sep 09 17

Oct 09 17

Nov 09 17

47 59

CRCs placed at the site, Non metro cities targeted,

Exhaustive Site E h ti Sit Staff Training,

105 136 162 220 Interim Analysis (77 P ) Pts.)

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Current Clinical Trials Experiences & Status

INDICATIONS Erythropoietin Agent Lipid Lowering NSAIDS Cardiovascular Anti Infective Bladder Cancer-STCC Prostrate Cancer-HRPC Lung Cancer-NSCLC Bladder Cancer-STCC BCG Refractory Tubercular Pericarditis Pulmonary Tuberculosis Category -1 Pulmonary Tuberculosis Category -2 g y SITES 4 6 6 55 8 13 20 17 14 31 2 7 SAMPLE SIZE 101 180 320 2000 120 120 176 220 20 600 600 1024 REGULATORY DCGI DCGI DCGI DCGI DCGI US FDA, DCGI US FDA, DCGI US FDA, DCGI US FDA, DCGI US FDA DCGI FDA, US FDA, DCGI DCGI STATUS Completed Completed Completed Being closed out Completed Enrolling Enrolling Recruitment completed Enrolling Enrolling Active; recruiting patients Enrollment completed

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Why Cadila CRO

Because we b i together B bring t th State of the art infrastructure. Highly competent team led by globally experienced and renowned sc e t sts e su e va d ty o a sc e t c wo . 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 SOPs. 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 ll j i / l b k db d i d creative project tracking system. In depth Regulatory knowledge, support & expertise. specialty. Flexibility and Multi specialty Large pool of volunteer databank enabling fast selection & recruitment. Respect to Clients IPR Excellent track record.
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Your reliable l l partner f global Contract Research requirements. Y li bl local for l b l C R h i Dr. Sailendra Kumar Goswami (Vice P id t (Vi President CRO) Cadila Pharmaceuticals Ltd. - CRO s.goswami@cadilapharma.co.in

Jasmeet Bagga (Business eve op e ( us ess Development CRO) C O) Cadila Pharmaceuticals Ltd. - CRO bd.cro@cadilapharma.co.in

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