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Science with Ethics Micro Therapeutic Research Labs Pvt. Ltd.

MTR - Clinical Trials-Presentation

22Science with Ethics

Market Overview


Clinical trial a major business in India.

Over 100 companies are currently conducting theclinical trials in India. Top MNC like Pfizer, Eli Lilly,Roche. Indian companies like Dr. Reddys, NicholasPiramal, Cipla and Lupin.

Clinical trials are conducted by MNCs are more than75% of the total trials.

Eli Lilly: The global pharmaceutical giant has 17 largeand small clinical research projects.

Pfizer's cumulative investment on clinical research inIndia is believed to be $13 million.

Roche's future clinical trials involving new drugs andtherapies for treatment of different variants of bloodcancer and colorectal diseases.

Phase Trial – in India

Phase I5%

Phase II

20%

Phase III

63%

Phase IV

12%


Phase Trial – in India

An estimated that in 2005 only1% of global clinical trials wereconducted in India. Thispercentage is projected to growto 15% of global trials by2011.

McKinsey projects that withinfive years, 1,500 to 2,000 GCPstudies will be conducted inIndia

IndiPharm projected that aninvestment of less than $ 100millions dollars in 2006 will be$2500 millions dollars.

The charts below illustrate the effects of such rapid growth,projecting that by the year 2013 over 400,000 patients will beenrolled in clinical trials in India.


Myths / Reality of Clinical Trial in India

Perception RealityGCP awareness absent or low Sites participating in global studies are

trained in GCP

Data integrity in question In house and sponsor audits of everyStudy Studies conducted have beensubmitted for global registration

Different languages cause confusionand escalate costs because of need oftranslation

English used for healthcare relatedactivities in most parts of AP. Patientrelated documents usually needtranslation

Telecommunication & connectivity notappropriate

EDC studies possible, electronictransmission of ECG/images frequent,IVRS frequently used

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Advantage India

Science with Ethics

EXPENDITURE ON HEALTH

6%OF GDP

(1.2% Government Spend)Fourth largest economy in the world

Second fastest growing economy in the world

India has diseases of the tropical world plus diseases of the developed countries.

LIFE EXPECTANCY68 YEARS

Large no. of ICH/GCP compliant Investigators / sites with 600,000 Eng. Speaking physicians.

URBAN LITERACYMALES 82%FEMALES 64%

Second largest population in theworld, having 6 out of 7 genetic varieties.

BIRTH RATE 27 per 1000DEATH RATE 8 per 1000INFANT MORTALITY 77 per 1000

Trial cost in United States $150 million.Similar drug could be tested in India at a 60% reduction cost.

In short -India Advantages • “Western” disease distribution • High patient numbers available • Many tertiary care and specialty hospitals • Large number of medical specialists • Patients generally “therapy naïve” • Low cost • No language barriers • IT-based advantages

Overall Clinical Trials in 2007- (1.4%) of world trial was 10% in 2010 and will be 15% by 2012


Clinical Trial – Positioning MTR in India Scenario

INDIA MTROut of 1500 Clinical Trials -500+ Trials are on Oncology (33%)

MTR has vast experience of trials on Oncology Products .

Most of the PK trials are on cancer patients .

MTR is specialist in patients PK study for oncology .We have more than 20 oncology sites across India

Phase trials percentage wisePhase IV-12%Phase III -60%Phase II-20%Phase I-5%

We are expert of phase III Trails. We have done many phase IV Trials.

Number of trials State wise 350 trials in Bangalore (23%)370 trials in New Delhi (25%)200 trials in Chennai (15%)

We have our sites at Gurgaon(NCR)-7 Km from New Delhi Airport. Bangalore & Chennai .


Country IRB/IEC Approval

Regulatory Average period for the Start of a Trial

India Simultaneous Sequential 3-4 Months

China Sequential Sequential 9-12 Months

Korea Parallel Parallel 30 Working Days

Taiwan Parallel Parallel 2-8 Months

Singapore Sequential Sequential 2-3 Months

Hong Kong First Sequential 3-4 Months

Thailand First Sequential 4 Months

Malaysia Parallel Parallel 2 Months

Regulatory Timeline at a Glance

Faster Regulatory approvals Faster Regulatory approvals

MTR has branch in Malaysia


Company Overview

• MTR was founded in 2005, in Chennai, India. • MTR is engaged in clinical research for Phase I to IV. • MTR offers clinical research services (CRS) such as clinical trials and data

management, biostatistics ,clinical pharmacology and investigator site services.

• MTR having a dedicated team of around 50 staff for Phase trials.• Principle Investigator –8• Project Manager-6• Clinical Research Associate-20• Research Nurses & Coordinators -17

• MTR’s contract research services primarily focus on oncology, cardiology, infectious diseases and, cosmetology therapeutic areas. MTR operates in 8 locations in 2 countries across Asia.

Specialized in conducting Clinical Trial on Oncology.


Services offers

Clinical Monitoring

1. Medical Monitoring (including 24/7 Medical Monitor coverage)2. Enhancement of regulatory compliance.3. Clarifying inclusion/exclusion criteria with the investigator.4. Providing consultation for potential safety issues or medical concerns

Regulatory Affairs

1. Clinical trial registration/licensing2. Regulatory submissions3. Safety reporting

Clinical Trial - Project Management

1. Frequent and timely reports to our sponsors.2. Training for CRA-s and site personnel on the protocol, CRF-s, SOP's, ICH- GCP.3. Constant review of CRA-s work to assure highest standards and consistency4. Management of Budget and Project Timelines


Quality Assurance

Investigative Sites Audit-Covering:o Trial master file audits o System audits o Site auditso Central laboratory audits o Data base audits o Final clinical report audits

Therapeutic areas of expertise

Oncology

Hematology

Dermatology

Obstetrics and Gynecology

Neurology/Neurosurgery

Endocrinology and metabolic Disorders

Diabetology

Gastroenterology

Psychiatry

Orthopedics

Cardiology

Radiology

We are specialists in conducting Oncology , Diabetology & Dermatology

Services offers


Clinical Data Management

• 21 CFR Part 11 compliance.

• SAS 9.2,WinNonlin 5.2.1,CDISC Standard.

• Report formats (full eCTD / Partial eCTD)


Molecules--ExperiencePivotal Studies:

S.No Molecules No. of Subjects Indications Submission

1. Doxorubicin Injection 24 Patients MULTIPLE MYELOMA EU Submission

2. Doxorubicin Injection 24 Patients OVARIAN CANCER US FDA Submission

3. Capecitabine 500mg 44 Patients

CANCER PATIENTS1. Ca.Breast2. Ca.Rectum3. Ca. Colon

EU Submission

4. Capecitabine 500mg 54 Patients

CANCER PATIENTS1. Ca.Breast2. Ca.Rectum3. Ca. Colon

US FDA Submission

5. Temozolomide 250 Mg 24 PatientsHIGH GRADE

GLIOMA PATIENTS

US FDA Submission

Phase III Trial

6. Moist Exposed Burn Ointment (MEBO) 200 Patients

MILD THERMAL BURN INJURIES

PATIENTSDCGI Submission


Molecules- ExperienceS.NoS.No MoleculesMolecules No. of SubjectsNo. of Subjects IndicationsIndications

1.1. Temozolomide 250 mgTemozolomide 250 mg 12 Patients12 PatientsGLIOBLASTOMAMULTIFORME GLIOBLASTOMAMULTIFORME or or

REFRACTORY ANAPLASTIC REFRACTORY ANAPLASTIC ASTROCYTOMAASTROCYTOMA

2.2. Capecitabine 500mgCapecitabine 500mg(Fast condition)(Fast condition) 18 Patients18 Patients

CANCER CANCER PATIENTSPATIENTSCa. BreastCa.RectumCa. BreastCa.RectumCa. ColonCa. Colon

3.3. Capecitabine 500mgCapecitabine 500mg(Fed condition)(Fed condition) 18 Patients18 Patients

CANCER PATIENTSCANCER PATIENTSCa.BreastCa.BreastCa.RectumCa.RectumCaCa. Colon. Colon

4.4. GOODLYFE in control blood sugarGOODLYFE in control blood sugar 10 Adult Patients10 Adult Patients TYPE 2 DIABETESTYPE 2 DIABETES

5.5. GOODLYFE in controlling blood pressureGOODLYFE in controlling blood pressure 10 Adult Patients10 Adult Patients MILDLY ELEVATED MILDLY ELEVATED BLOOD PRESSUREBLOOD PRESSURE

Bio Marker studiesBio Marker studies

6.6. Collection of specimen (serum) Collection of specimen (serum) 200 subjects200 subjects TYPE I TYPE I DIABETES MELLITUS DIABETES MELLITUS PATIENTS PATIENTS UNDER FASTING/FED CONDITIONSUNDER FASTING/FED CONDITIONS

200 Patients200 Patients METASTATIC METASTATIC BREASTCANCER BREASTCANCER PATIENTS PATIENTS STAGE IVSTAGE IV

100 Patients100 Patients METASTATIC BREAST CANCER PATIENTS METASTATIC BREAST CANCER PATIENTS STAGE IVSTAGE IV


Oncology experience

• Successfully completed 11 oncology trials.

• Specialize in handling difficult and risky molecules

• Ongoing (Clinical Trial - Oncology) -Leuprolide 7.5 mg with prostrate cancer patients 60 Leuprolide 7.5 mg with prostrate cancer patients 60 SubjectsSubjects

•• MTRMTR is a full service global CRO specializing in the earlyclinical development of drugs. With state-of-the-artfacilities in India & Malaysia and Belgium, we provide a fullrange of services in phase I and IV clinical research onOncology products.


Clinical Trial (Oncology) Sites

1.1. Dr. Kamakshi Memorial Hospitals (KMH ), Chennai Dr. Kamakshi Memorial Hospitals (KMH ), Chennai

2.2. Dr. Rai Memorial Medical Centre, ChennaiDr. Rai Memorial Medical Centre, Chennai

3.3. Sri Rama Chandra Medical Centre, ChennaiSri Rama Chandra Medical Centre, Chennai

4.4. Associates in Clinical Endocrinology Education & Research, ChennaiAssociates in Clinical Endocrinology Education & Research, Chennai

5.5. Right hospital, ChennaiRight hospital, Chennai

6.6. Abhijay Hospital, Chennai Abhijay Hospital, Chennai

7.7. Julian Nursing Home Julian Nursing Home –– Chennai Chennai

8.8. Erode Cancer Centre,ErodeErode Cancer Centre,Erode

9.9. Kovai Medical Center and Hospital, CoimbatoreKovai Medical Center and Hospital, Coimbatore

10.10. Lovanya Hospital Lovanya Hospital –– CoimbatoreCoimbatore Cont…Cont…

…………

MTR oncology Investigators (total 21) are experienced in conducting oncology trials


Clinical Trial (Oncology) Sites

11. Kanyakumari cancer Hospital, Nagarkovil 11. Kanyakumari cancer Hospital, Nagarkovil

12.12. MAPIMS MAPIMS –– Melmaruvathur Melmaruvathur

13.13. BG Hospital, ThirichanthurBG Hospital, Thirichanthur

14.14. OM Sakthi Nursing Home, Dharmapuri OM Sakthi Nursing Home, Dharmapuri

15.15. G.V.N Specialty Hospitals G.V.N Specialty Hospitals -- Oncology, TrichyOncology, Trichy

16.16. Deepen Nursing Home, TrichyDeepen Nursing Home, Trichy

17.17. IPGMR, KolkataIPGMR, Kolkata

18.18. Ratkal Speciality Hospital,Ratkal Speciality Hospital,BangaloreBangalore

19.19. NRR Hospital,BangaloreNRR Hospital,Bangalore

20. Manu Hospital and Research 20. Manu Hospital and Research –– JaipurJaipur

21. Sitha Devi Hospital 21. Sitha Devi Hospital -- Jaipur Jaipur


Values in MTR that Sponsor Looks For

Main reason is that MTR has prior experience in conducting Oncology BA/BE

studies

All the study related activities will be performed by MTR staff

MTR will use its own instruments like Infusion pump, ICU equipments etc..

MTR has close association with the investigators which is mandatory for

smooth conduction of studies as well as audits.

MTR QA person will be available for all Dosings

Well trained experienced staff available

Very good project management team


Values in MTR that Sponsor Looks For

Well equipped Bio analytical lab

MTR medical person will be available during P I dosings

Sponsor will be informed about the study progress periodically

Shipment of samples to BA site can be organized by MTR

MTR has already faced USFDA audit for Temozolomide trial conducted at

the sites and cleared with out any 483

Ethics committee

MTR will be using the services of site IRB.

All the sites where MTR conducted the study have GCP compliant Ethicscommittee formed as per ICMR/Schedule Y guide lines.


Advantage of MTR

Dedicated Clinical Trial team under professional leadership.

Conducted 14 clinical trials for both international & domestic sponsors.

Clinical Trial for various regulatory body. Successfully complete USFDA-2011

audit with Nil 483.

More than 30 ICH/GCP compliant Investigators / sites with 60physicians.

Tie-up with major hospitals/nursing home across India.

Submission and approval from DCGI for trials in India

MTR is having huge voleenters data bank -12000 males and 3000 female

including special population .

Patients from multiethnic background , 6 out of 7 genetic varieties of

world.


Strategy for Pazopanib Study

MTR plan for conducting Pazopanib Study and MTR responsibilitiesMTR will use 5 sites for conducting the study

Each site will provide 3 to 4 patients per month

Total of 40 patients will be recruited in 3 to 4 months

MTR responsibilities for Pazopanib study will be

Sending the Quote for the study

Sending the project contract

Preparing Clinical trial agreement

Site feasibility/Site selection

Site initiation/shifting equipments from MTR

Calibration of instruments

Getting consent and undertaking from Investigators

Submission of documents for IRB


Strategy for Pazopanib Study-Cont

MTR responsibilities for Pazopanib study will beSending the IRB approval documents to sponsor

SOP training to MTR staff

Protocol training to MTR and Site staff

Investigator training/Meeting

Identifying patients as per inclusion criteria

Screening and consent from patient

QA audits of the critical activities

Monitoring

Check in, Dispensing, Dosing of the patient

Sample collection, centrifugation and storage

Post study Investigations

Check out

Payments to Hospital and Investigators


Strategy for Pazopanib Study-Cont

MTR responsibilities for Pazopanib study will be

Patient compensation

Sample analysis at site

Sample shipment to MTR

AE/SAE reporting to IRB/Sponsor

Periodic updates to sponsor

Compilation of documents, SMF,TMF

Sample analysis at MTR BA lab

Documents scanning to aid eCTD formatting

PK and statistical reporting

Final reporting

Study close out

Archival of the documents


Contact US

Head Offices

Regional Offices

MICRO THERAPEUTIC RESEARCH LABS PRIVATE LIMITED THERAPEUTIC RESEARCH LABS PRIVATE LIMITED Rajam Bhavanam, Door No.6, Kamarajar Salai, Selaiyur, East Tambaram, Chennai – 600 059.Tamilnadu, IndiaTel: (91 44) 22390070,71,72 & 64625721

Coimbatore Door No.29 A, Krishna

Madura VanamVellakinar Pirivu,

ThudiyalurCoimbatore – 641 029

Tel: (91 422) 2642491 / 2642249

Gurgaon

N-295,2nd .FloorMayfield Garden

Gurgaon-18Haryana

Tel: 91-893 9998 703

Bangalore

No-87,8th CrossBFW Layout

LaggereBangalore -58

KarnatakaTel: 91-893 9998 703

Madurai

12A , Alakappa Nagar Siva Shiva Street

Madurai-03South Tamilnadu

Tel: 91-950 0195 986