Accelerating Pharma time-to-market, cost effectively
Stem cell therapy clinical development capabilities D. A. Prasanna 15th March 2010 Presented at London at
Indian Stem cell Mission Seminar Organized by
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Service portfolio Reputed for quality, speed, competitive cost & personalized service
SERVICES
Phase II-IV Full Service. Multinational in Europe Monitors speak national language
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Central Lab ISO/CAP certified at Bangalore and Manipal Compatible with partner labs in USA and Europe
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CDM P Paper and d eCRF CRF Oracle O l Clinical Cli i lTM Biostatistics SASTM Medical Writing Functional services delivery center at Bangalore
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EU
No. of studies since 2005 5
Phase I 144 beds In India: offer First-in-Man, Phase I, BA/BE Audit by US FDA, HC, WHO for GCP/GLP compliance
INDIA
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86
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Ranked 3rd largest Indian CRO by revenue in 2009 2
Conduct studies meeting g regulatory g yg guidelines Of US FDA, EMEA, Health Canada, MHW, DCGI ….for marketing permission
Direct Coverage by EA Austria, Belgium, Czech Republic, France, Germany, India, Italy, Netherlands, Poland, Russia, Slovakia, Sri Lanka Switzerland, UK, Ukraine, USA Covered through Partners Australia, Brazil, Bulgaria, Cambodia, Denmark, Hungary, Ireland, Israel, Indonesia Japan, Korea, Malaysia, Portugal, Romania, Singapore, Spain, Sweden, Taiwan, Thailand, Vietnam
Optimal combination of G8 and new economy countries in submission studies
Full Service CRO with a 23 year track record Breadth for end to end study management, depth as functional service provider
Pre-study
Study Setup Ph II-IV IV
Study Conduct
Strategic Consulting
Post-study Strategic Consulting
CDP, Pre-IND Meeting Regulatory
Regulatory Clinical Operations Clinical Data Management Laboratory Services Protocol Development
Statistical Analysis Study Report Writing
Medical /Safety Monitoring, PV Quality Assurance 4
Regulatory Pioneer Contributing to guidance documents and Schedule Y1
Rescue study for allogenic stem cell: For a Ph II rescue trial for US sponsor, worked with Indian regulators ICMR and DCGI. Involving reputed investigators and sites, helped evolve draft guidelines. Permission was given to recruit 30 patients from 3 sites. Reputation: Dept of Biotechnology chose Acunova as CRO to monitor 3 trials and generate data acceptable to global regulators. First Indian allogenic stem cell study: Safety concern of regulator was addressed by study redesign and constituting a DSMB (Data safety Monitoring Board) First Malaysian study approval: Malaysian regulation was evolved in obtaining approval to conduct stem cell therapy trial on stroke patients. Experience: Experienced in multi national study set up and conduct which includes USA.
India Health Authority process: Stem cell product Application
Timeline
Clinical Trials (1st Response)
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Test license
30#
Referral to Expert committee
+60
IEC / IRB
20 to 60#
*Working days; #Parallel processing Takes 5-8 months
Well trained team managing stem cell studies
All Measures Taken to Ensure Patient Safety
Study conduct, conduct Site selection and Set up Process Special Points apart form other Site Selection process
9 Designing appropriate endpoints for the conduct of the study 9Last Line of Therapy – Super-Specialty Centers with High Clinical Excellence 9 Investigators having extensive experience in Clinical Research 9 Infrastructure – For Bone Marrow Aspiration (Autologous), Clean Room facility for isolation/preparation of Stem Cells etc… 9 Scientific Committee formation - Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) 9 Formation of Independent Data Safety Monitoring Board (DSMB) 9 Qualified and working with 30 sites
Site Initiation/Training and Study Conduct S Special i l Training T i i - Apart A t ffrom routine ti Sit Site Training T i i - GCP and d Protocol P t l etc, t Training of Study Team
• Basics of Stem Cell therapy and its clinical applications p Indication • Protocol Specific
IP Management – Shipment, preparation, Handling, Administration
• Protocols/SOPs for all procedures • Bone Marrow Aspiration training • Training of sites - Mock Run during site initiation visit 9 9Demonstration of IP preparation, handling with safety precaution 9 Hands on Experience to study team
Stability, Viability, Stability Viability Contamination
• Training on Good Clean Room Practices and precautions • Viability testing of IP • IP supplied in Dry Shipper containing liquid nitrogen vapor phase
S f t off P Safety Patients ti t
• Higher Hi h frequency f off follow f ll up and d monitoring it i visits i it • Safety monitoring by medical monitors and DSMB • Special Lab Investigations •Immunological Markers – Cytokines etc.
Ecron Acunova Stem cell clinical trial Experience Trial
Indication
Source
Sponsor
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GVHD
Allogenic
US
2
CLI
Autologous
3
AMI
4
Phase
Patients
Sites
II
30
3
US
II
60
1
Autologous
Indian (Govt)
II
250
5
Stroke
Autologous
Indian (Govt)
II
200
4
5
AMI
Allogenic
Indian
I/II
20
4
6
CLI
Autologous
Indian (Govt)
II
200
4
7
CLI
Allogenic
Indian
I/II
20
4
8
CS
All Allogenic i
M l i Malaysia
I/II
78
7
9
AMI
Autologous
US
II
26
3
10
CLI
Allogenic
Indian
III
100
7
11
COPD
All Allogenic i
I di Indian
II
30
3
12
DCM
Allogenic
Indian
II
30
3
13
LC
Allogenic
Indian
II
30
3
14
OA
Allogenic
Indian
II
30
3
15
DM
Allogenic
Indian
II
30
3
Stem cell therapy py trial experience p • Autologous and Allogenic • India, Malaysia, USA (for trial conduct and marketing authorization) • CLI, AMI, GVHD, Stroke,….. • PoC, Ph II, Ph III • 10 studies recruiting/follow up, +5 awaiting health authority permission • 23 sites in India and 7 in Malaysia • Enrolled >400 patients in last 3 yrs • Private, Government funded sponsors • DBT, Harvest, Osiris, Stempeutics 11
Qualityy Data From Studies Studies found GCP & GLP compliant by WHO, Health Canada & US FDA
CSV & 21 CFR Part 11 Compliance certified by CSV & 21 CFR P t 11 C li tifi d b Lachman Consultants NY
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Keyy Shareholders EA combines domain knowledge, patient access & financial strength
AcuNova Life Sciences
Manipal Group
World’s largest healthcare fund
Pharma & Medical Technology Professionals
Asia’s #1 Medical University
With $5B assets under management
Stem cell Advisory Board includes Dr. K. Vijayraghavan, Director NCBS, Bangalore Dr. Dinesh Patel, Founder vSpring Capital, Salt Lake City
Manipal p Ecosystem y Medical University & Hospitals give access to researchers, talent and patients
Manipal University Life sciences center for multidisciplinary research National Center for Pharmaco Genomics AERB center for cancer research Levers center for oral health Philips center for low cost diagnostics
M i l Health Manipal H lth System S t GE global IDC for molecular imaging agents Global Center of Research Excellence for a leading $50B Pharma co Remote radiology reading for MGH and NHS Transplant medicine-Univ of Minnesota
Manipal Institute of Regenerative Medicine Manipal Course in CDM, CDM Statistics, Statistics CR
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Contact us www.ecronacunova.com We accelerate Pharma time-to-market cost effectively
To accelerate your stem cell therapy solution to market cost effectively, with no compromise on safety and quality, choose Ecron Acunova as your clinical development partner.
ASIA
EUROPE
AMERICAS
SJR I Park, Mobius EPIP,, Whitefield Bangalore – 560 066 India
Hahnstrasse 70 D-60528 Frankfurt Germany
502 Carnegie Center Suite # 100 Princeton NJ 08540, USA
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+91 80 6691 5725
+49 69 6680300
+1 973 396 2742
Thank You
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