About Us Cliantha Research Hill Top Research Inflamax Research Karmic Lifesciences

Transcription

1 Full Service CRO

2 About Us Cliantha is an independent global Contract Research Organization (CRO) providing integrated clinical offerings in Early Phase (Phase I/IIa), Late Phase (Phase II-IV), Bioequivalence (BA/BE), Clinical Endpoint Trials, Bioanalytical, Biosimilars, Dermatology, Respiratory, Allergy, Biometrics, Pharmacovigilance and Personal Healthcare services. Our services have science at its foundation that is developed through regular and systematic training of the Cliantha Team. Cliantha offers Biosimilar, Biotech, Cosmetic, Generic, Personal Healthcare and Pharmaceutical companies a comprehensive range of clinical research and support services. You will notice we use our legacy brand names: Cliantha Research, Hill Top Research, Inflamax Research and Karmic Lifesciences, however, we operate as one company Cliantha. We have added and enhanced the capabilities during the past 6 years in each of the companies to provide our sponsors with a single, global research network. 2

3 Cliantha locations CANADA Winnipeg Toronto New Jersey New Delhi INDIA St. Petersburg Ahmedabad Vadodara Mumbai EUROPE, SOUTH AMERICA AND SOUTH AFRICA THROUGH PARTNERS 3

4 Global Clients and Submissions Submissions > 90% for US (FDA) and the EU (EMA) Canada India Japan South Africa Russia Australia WHO GLOBALLY DIVERSE 4

5 Experience with Route of administration Injection Oral Tablet (IR, ER, DR, OD, EC) Capsule (Soft Gel, MR) Chewable Tablets Suspension Granules Sublingual Rectal Transdermal Vaginal Pulmonary 5

6 Accreditations & Inspections 6

7 Accreditations & Inspections Last inspection in March 2017 by USFDA (17 times) Inspected facility in Nov 2006 by ANSM Last Inspection in Nov 2015 by Austria (2 times) Last inspection in March 2013 by WHO (3 times) Inspected facility in Jan 2009 by MCC Inspected facility in April 2011 by Spain Last inspection in April 2017 by UK MHRA (2 times) Facilities inspected & approved by Ministry of Health of Turkey in April 2013 Inspected facility in July 2013 by Thai MOH Government of India Facilities inspected & approved by Drugs Controller General of India 7

8 Regulatory Inspections History India USFDA Inspections Date March 20 23, 2017 March 14 17, 2017 Nov 28 Dec 2, 2016 April 25 May 3, 2016 Jan 18 22, 2016 Mar 23 Apr 03, 2015 Aug 18 22, 2014 May 19 23, 2014 Jan 20 24, 2014 June 24 28, 2013 Oct 03 07, 2011 Oct 25 27, 2010 Oct 18 22, 2010 June 17 23, 2010 Sept 15 19, 2008 Sept 20 21, 2007 May 14 17, 2007 Inspection details Ahmedabad HQ (Clinical) Ahmedabad Sigma (Clinical) Vadodara (Clinical) Ahmedabad HQ (Bio-Analytical) Ahmedabad HQ (Clinical) Ahmedabad Sigma(Clinical) Vadodara (Clinical) Ahmedabad HQ (Clinical & Bio-Analytical) Ahmedabad HQ (Clinical) Vadodara (Clinical) Vadodara (Clinical) Ahmedabad HQ (Clinical) Ahmedabad Sigma (Clinical) Ahmedabad HQ (Bio-Analytical & Stats) Vadodara (Clinical) Ahmedabad HQ (Clinical, Bio-Analytical & Stats) Ahmedabad HQ (Clinical) All the four locations of Cliantha Research Limited Ahmedabad HQ, Ahmedabad Sigma, Vadodara & Noida are approved by Drug Controller General of India (DCGI) 8

9 Regulatory Inspections History India Other Inspections Date Inspection details April 24 28, 2017 Ahmedabad HQ and Sigma by UK MHRA (Clinical & Bio-Analytical ) Nov 03 05, 2015 Vadodara by AGES (Clinical) July 15 18, 2013 Ahmedabad HQ Thailand MoPH (GLP) April 09 11, 2013 Ahmedabad HQ and Sigma MoH Turkey (GLP & GCP) Mar 19 22, 2013 Ahmedabad HQ and Vadodara by WHO (Clinical, Bio-Analytical & Stats) Feb 25 Mar 01, 2013 Ahmedabad HQ and Sigma by UK MHRA (Clinical, Bio-Analytical & Stats) June 19 22, 2012 Ahmedabad HQ and Sigma by WHO (Clinical, Bio-Analytical & Stats) April 13 15, 2011 Ahmedabad HQ by AEMPS (Bio-Analytical & Stats) April 11 12, 2011 Vadodara by AEMPS (Clinical) Feb 09 10, 2011 Vadodara by AGES (Clinical) Oct 18 20, 2010 Ahmedabad HQ by WHO (Clinical, Bio-Analytical & Stats) Jan 12 13, 2009 Ahmedabad HQ by MCC (Clinical, Bio-Analytical & Stats) Nov 06 11, 2006 Ahmedabad HQ by ANSM (Clinical & Bio-Analytical) All the four locations of Cliantha Research Limited Ahmedabad HQ, Ahmedabad Sigma, Vadodara & Noida are approved by Drug Controller General of India (DCGI) 9

10 Regulatory Inspections History India Date Jan 2018 Oct, 2017 Sep, 2017 Oct, 2016 Sep, 2015 Sep, 2013 July, 2012 Aug, 2011 Aug, 2011 Sep, 2010 Sep, 2009 Sep, 2008 Sep, 2007 Clinical Lab Inspection details Noida by CAP Sigma by NABL Sigma and Vadodara by CAP Sigma by NABL Sigma and Vadodara by CAP Sigma and Vadodara by CAP Sigma by ANVISA Vadodara by CAP Sigma by CAP Vadodara by CAP Sigma by CAP Vadodara by CAP HQ by CAP Inspection of Clinical Lab in by ANVISA July, 2012 Last Inspection of Clinical Lab in Jan, 2018 Last Inspection of Clinical Lab by NABL in Oct,

11 Regulatory Inspections Clinical Trials Regulatory Agency Inspection Date Location Inspection Area USFDA Jan 16 18, 2018 Omaha, Nebraska, USA (Multicentric Clinical Trial) Clinical USFDA Dec 11 13, 2017 Mumbai (Multicentric Clinical Trial) Clinical USFDA Dec 04 08, 2017 Bangalore (Multicentric Clinical Trial) Clinical USFDA Nov 15 18, 2017 Ahmedabad (Multicentric Clinical Trial) Clinical USFDA Feb 20-24, 2017 Pune (Multicentric Clinical Trial) Clinical USFDA Jan 23-26, 2017 Junagadh (Multicentric Clinical Trial) Clinical USFDA Nov 7-10, 2016 Surat (Multicentric Clinical Trial) Clinical USFDA Aug 15-19, 2016 Pune (Multicentric Clinical Trial) Clinical USFDA Aug 8-12, 2016 Gandhinagar (Multicentric Clinical Trial) Clinical USFDA Aug 25-28, 2014 Vadodara (Multicentric Clinical Trial) Clinical USFDA Jul 28-31, 2014 New Delhi (Multicentric Clinical Trial) Clinical USFDA Mar 24-27, 2014 Madurai (Multicentric Clinical Trial) Clinical USFDA Feb 24-27, 2014 Nagpur (Multicentric Clinical Trial) Clinical 11

12 Our Global Services Early Phase & BA/BE Bioanalytical, Small & Large Molecule including Immunogenicity and cell culture lab services Late Phase/Multicenter Clinical Trial Management Pharmacovigilance & Medical Services Clinical Laboratory (Asia) Dermatology Specialty Testing Environmental Exposure Chambers Asthma, Allergy, Dry-eye syndrome Biometrics - PK, PD, DM, Biostatistics, Report Writing Biologic and Biosimilar Program Plan Development and Program/Project Execution 12

13 Clinical Trials Our Therapeutic experience: Oncology/Hematology, Dermatology, Psychiatry, Diabetology, Cardiology, Ophthalmology and Gastroenterology. Clinical Data Management & Statistical solutions for a wide range of Therapeutic areas. Key strengths: Experience in complex late phase (I-IV) clinical trials, PK studies in patients and clinical data management services Expertise in project management, site management, medical affairs, regulatory affairs, Clinical Trials Supply Management (CTSM) and Central lab services Robust working relationship with more than GCP trained investigators across various therapeutic areas Team members bring along combined experience of > 100 years Rich experience across various therapeutic areas with Paper and EDC studies We have strong presence in USA, Canada, Europe(through partner) and India 13

14 Clinical Trials - Our Services Clinical Operations Medical Affairs and Writing Supply Management Data Management Biostatistics Central Laboratory Training Regulatory Quality Assurance 14

15 Clinical Trials - Operational Experience Completed and Ongoing Trials 15

16 BA/BE Studies Conducted over 4000 studies 12 clinical units, 513 beds, 16 ICU beds and 20 doctors Central Lab accredited by CAP 55,000 healthy subjects database Infrastructure includes freezers, cardiac monitors, secured pharmacy, controlled archives, and power backup 16

17 Bioanalytical Facility in India is well-equipped with a Bioanalytical Lab focusing on method development, validation and subject sample analysis using validated analytical methods Over 250 analytical methods in biological fluids 32 LC/MS/MS (API 3000,4000, 5500) ICP-OES for elemental analysis Over 3 million samples analyzed 17

18 Dermatology Cliantha Research acquired Hill Top Research, which specializes in managing Phase I-IV clinical trials with focus on Dermatology Opportunity to execute studies in multiple locations with multiple climatic conditions in N. America and/or India Established Global Interscorer variability Expertise in: Transdermal/Topical Bioequivalence Contact Sensitization- Human Repeat Insult Patch Test (HRIPT) Cumulative Irritation (14 and 21 day studies) Wear studies Skin Blanching (Vasoconstriction studies) 18

19 PK, Biostatistics & Report Compilation PK parameter estimation using WinNonlin Statistical analysis using SAS software Well experienced team of Biostatisticians, SAS Programmer, Report writer and Report Compilator Experience in handling different crossover, Parallel, Partial replicate, Fully replicate, Steady state bioequivalence studies Study data submission in CDISC standards Report writing as per ICHe3 format. Centralize report compilation as per ectd standards. 19

20 Clinical Laboratory CAP accredited lab with state-of-the-art facilities for multi-centric Clinical Trials Complete range of specialized tests with a test menu covering Hematology, Clinical chemistry, Immunology, Clinical Pathology, Flow Cytometry Has stringent quality control programs in place and is strictly compliant with all applicable regulations. Automated system from bar coding to bilateral interfacing of results to minimize any kind of clerical error. 20

21 Biosimilar bioanalysis Team with expertise in method development and validation for Pharmacokinetic, immunogenicity and biomarker studies of Biosimilars. Validations are done as per GLP, FDA, EMEA guidelines. Assay platforms ELISA CMIA Clot based assays Flow cytometry End point kinetic assays With our knowledge and experience comes the ability to work de novo, transfer and fully develop a client initiated assay and transfer a fully validated client assay. 21

22 Immunogenicity and biomarker testing We have the capabilities of detecting anti drug antibodies by three tiered evaluation approach. Screening assay Confirmatory assay Neutralization assay (Cell based assay) Cell culture lab for detection of neutralization antibodies. Our biomarker offerings include a range of therapeutic areas to include: CVS CNS Metabolic disorders Inflammatory markers Oncology Numerous vaccine studies have also been conducted 22

23 Quality Assurance (QA) QA team independently monitors all activities ensuring compliance to Protocol, SOPs, GCP, GLP and other regulations: Confirms compliance to: Protocol, SOPs & Regulatory guidance System & vendor audits Ensures audit of each study s source data Revisions of Standard Operating procedures are scrutinized by QA Resolution of regulatory queries 23

24 Project flow Project inquiry followed by Feasibility Assessment Cliantha signs agreement Protocol preparation Client approval of protocol Sample analysis Clinical Phase: Subject housing, dosing, sampling, discharge, ambulatory samples Subject screening IEC/DCGI approval of protocol CDM, PK & statistical analysis Draft report to client Final report to client Archiving Set-up weekly calls for regular study updates 24

25 Typical Timeline chart (Assumptions: No. of subject: 36, No. of periods: 2,Washout period: 7 days; Delivery in < 113 days) Day Week W1 W2 W3 W4 W5 W6 W7 Project Confirmation Protocol finalization & EC Approval BE NOC/T- License MD/MV (if applicable) Day Week W8 W9 W10 W11 W12 W13 W14 W15 W16 IP Transfer Clinical Phase completion Bio-analysis PK/Statistics Draft report

26 Case study - 1 Flawless fastest ANDA First to File submission: Completed USFDA bio submission study within a week Meticulous coordination between the respective teams enabled to accomplish perfect study and deliver the data without compromising any ethical standards Milestones Fasting BE Study (n=36) Fed BE study (n=36) Clinic starts 04-Apr Apr-2012 Clinic ends 08-Apr Apr-2012 Bioanalysis starts Bioanalysis ends 08-Apr Apr Apr Apr-2012 Final report 10-Apr Apr-2012 This product is approved by USFDA 26

27 Case study - 2 Nitroglycerine study: (Tmax: 6-7 minutes) Extensive Planning and coordination with different dept for Manpower and Infrastructure. Challenges Sublingual administration of IP with observation up to 10 minutes to ensure proper dosing. Every minute blood sample collections till peak level of Cmax (10-15 minutes). Centrifugation within 2 minutes of sample collection Planning and Execution Dedicated doser and supervisor for each subject. Dedicated phlebotomist for each subject with standby phlebotomist. Dedicated centrifuge machines for each time point arranged near to collection area with standby. Plasma samples to be immediately shock frozen in a Ethanol/dry ice bath 75ºC ± 15ºC Specially treated glass tubes for plasma and overseas shipment Arrangement of racks containing dry ice / Ethanol with attached data logger for continuous temperature monitoring at the sample separation site. Procured from Bioanalytical facility and shipped in specially designed Armcool boxes and wrapped to avoid breakage. 27

28 Case study - 3 Potassium Chloride (KCL study): 17 days housing study with diet equilibrium period Extensive Planning and coordination with different dept for Manpower and Infrastructure. Challenges Planning and Execution 17 days housing duration Identification of specific pool of volunteers Diet equilibrium period with fluid intake Specific meal menu to meet the daily intake of Potassium, Sodium and Calories) and fluid intake (3,000 to 5,000 ml/ day) requirements Urine collection at different time interval Different size of urine pot, Jar, container with specific labeling Critical IP administration procedure (i.e Four/ Eight capsule administration with/ without apple sauce) Trained dosers and detailed discussion of IP administration procedure with volunteer 28

29 Why Cliantha? Steady core team since inception Robust e-learning system, only CRO with a dedicated and centralized training team (Get a sneak peek: Training process) International presence with extensive set-up in North America and India Facilities successfully audited and inspected by both national and international Regulatory bodies 29

30 Team Vijay Patel Executive Director 25 years Management experience Naveen Sharma President 22 years Research experience Anita Kaul Vice President, Operations 26 years Clinical experience Dr. Dharmesh Domadia Associate Vice President, Global Clinical Operations 13 years Clinical experience Hitesh Chauhan Head - Biometrics 16 years of Statistics & CDM experience Anshul Dogra Head, Bioanalytical Lab 15 years Bioanalytical experience Arpana Prasad Head, Quality Assurance 18 years Research experience Dr. Shaifali Gupta Head, Central Reference Lab 16 years Pathology experience Dr. Chirag Shah Director - Late Phase Trials 18 years of Research experience Rahul Nijhawan Sr. Director - Early Phase 16 years Research experience Nayan Prajapati Head, Training 9 years of Research / industry experience 30

31 Our Assets Cliantha team 700 and growing including 20 doctors Combined experience of over 50 years at leading pharma companies and CROs 31

32 Facilities - India Cliantha, HQ; Ahmedabad Cliantha, Sigma; Ahmedabad Cliantha, Vadodara Cliantha, Noida Go Back 32

33 Facilities USA and Canada Hill Top Research, St. Petersburg, FL Go Back 33

34 Facilities USA and Canada Inflamax Limited, Toronto, ON Hill Top Research, Winnipeg, MB Go Back Hill Top Research, Neptune, NJ 34

35 Thank You 35