cadila cro presentation
TRANSCRIPT
8/3/2019 Cadila CRO Presentation
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Clinical Research
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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
comp iance with good science, accurate techniques,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
• ase –
• Data Management
• Medical Writing
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• os a s cs
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Salient Features of Existing Animal Unit.
• Total Area – 518 Sq.m with 8 Animal rooms & 1 Laboratory room.
• Double corridor facilit .
• 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 ServicesWe have completed more than 780 studies and developed followingcapabilities in Toxicological studies.
– Single dose or multiple dose in single day, acute toxicity, acute eyeirritation 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 earswelling test (MEST)
– In Vivo Efficacy Studies, Antifertility test, Antidiabetic, Analgesics,Anti-hyper lipidemic and Pharmacokinetics.
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Pre Clinical Expertise
pec a stu es
• Genotoxicity
» Micro Nucleus Test (MNT)
» One generation• Toxicokinetics
Allergenicity
• Guinea pig maximization test (GPMT)
• Mouse ear swellin test MEST
In Vivo Efficacy Studies
• Antifertility test.
• Antidiabetic.• Analgesics.
• Anti-hyper lipidemic.
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• armaco net cs.
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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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Clinical Pharmacology Unit
• Two separate identical 46 bedded units (total 92 beds) with well equippedICUs.
Ca abilities
• o unteer ata poo o approx , ea t y vo unteers nc u ng
female volunteers and 400 geriatric volunteers database.
• Protocol development and Study designing.
• Conduct of a range of BA/ BE studies:
Fasting /Fed / Steady state studies.
¤ Dose proportionality and
erapeut c equ va ence stu es.¤ Open-labeled / blinded studies.
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, ,
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 duringAE 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 in new Fixed Dose Combination (FDC) compared withindividual reference products
– A novel POLYCAP (First time in the world a Fixed Dose Combination, , ,
coated Aspirin) compared with its single individual reference products to evaluategain or loss in bio-availability and drug-drug interaction in five different twoperiod two way cross over studies.
– -
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,
asma extractors,
Milli Q-Water system.
• Team of 25 well qualified and
experienced scientists.
• A list of 91+ validated methodswhich are rugged and reproducible.
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Your advantage on Bio equivalence
ro ec me nes
o. o o un eers o. o er o s as ou er o s ra epor
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 faci ity by MoH, Tur ey.
• MCC South Africa - Certification for the Dossier submitted..
• - .
• 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 mana ement team.
• Robust experience in various therapeutic areas.
• Extensive network of hospitals and medical institutes through out India.
• 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.
– a s ca na ys s an an epor .
– Regulatory Support.
Site Development & Management
– Investigator and Site Identification, selection, initiation, monitoring & contracts with Investigators andsite close outs
– Site staff and Investigator’s training
– Randomization, repackaging, coding & labeling of Investigational Products.
– Site Supplies.– Medical monitorin & uer mana ement.
Project Management & Site Monitoring
– Clinical development plan.
– Steering committee meetings.
– ra n ng eve opmen .
– Quality systems Implementation.
– GCP Audits at Investigators Site.
– SOP Management.
– Clean & locked data and corrective measures management.
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Therapeutic Expertise
• Oncology - (Phase 2 & 3)
• Endocrinology - (Phase 3 – Anti diabetic)
• Anti-infective - (Phase 3)
• ro ogy - ( ase
• CVS - (Phase 1, 2 & 3)
The Team also has experience in working in the following Therapeutic areas:
• GI - (Phase 3)• euma o ogy - ase
• Immunology - (Phase 1, 2 & 3)
• Neurology - (Phase 2 & 3)
• Dermatology - (Phase 3)
• Women’s Healthcare - (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, Querygeneration, resolution and tracking , Data Analysis, Transfer and Archiveand Generation of statistical report.
• Offers protocol review and Preparation of statistical Analysis Plan and
con uc s a s ca ana ys s or , rec n ca an n ca r a s
Compliance : ICH – GCP, Company’s SOPs and 21 CFR part 11
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Oncology Case Study on Efficient Patient Recruitment
Nov Dec an Feb Mar A r Ma un ul Au Se Oct NovNSCLC
08
08
09
09
09
09
09
09
09
09
09
09
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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
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
. x aust ve te
Staff Training, 162
220
Interim Analysis
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(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
Refractory14 20 US FDA, DCGI Enrolling
,
Pulmonary Tuberculosis
Category -12 600 US FDA, DCGI Active; recruiting patients
Pulmonary Tuberculosis
Cate or -27 1024 DCGI Enrollment completed
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Why Cadila CRO…
ecause we r ng oge er…• State of the art infrastructure.
• Highly competent team led by globally experienced and renownedscientists to ensure validit 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.
• .
• Large pool of volunteer databank enabling fast selection & recruitment.
• Respect to Client’s IPR
• Excellent track record.
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our re a e oca partner or g o a ontract esearc requ rements.
Dr. Sailendra Kumar Goswami
ce res en –
Cadila Pharmaceuticals Ltd. - CRO
Jasmeet Bagga
Business Develo ment – CRO
Cadila Pharmaceuticals Ltd. - [email protected]
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