Transcript TAKE Life Sciences

TAKE Solutions
Enabling Business Efficiencies
Ram Yeleswarapu
President & CEO
Analysts Meet
Mumbai
September 18, 2008
The Global Life Sciences Markets
Eastern U.S. Corridor:
drugs, devices,
bio-medics
Western U.S.
Corridor: life
sciences,
devices,
therapeutics
2
European Union:
drugs, devices, life
sciences
APAC: generic
drugs,
therapeutics,
devices
Clinical Trials Market Trends
• $25.6b spent on nearly 10,000
•
•
•
•
3
clinical trials in 2006
Expected to increase to $32.1b for
nearly 13,000 trials by 2011.
10-15 years for a drug to move from
trials to FDA to market
Only 1 in 5 pass trials stage to FDA
doors
FDA requires 5 trial phases data
IDC report
on CRO,
2006
Tufts Center for
Study of Drug
Development
Report, 2007
Clinical Research Outsourcing
Clinical
Research
4
Pre-clinical
and
Analysis
Clinical Research Outsourcing
Clinical Phase I
Animal Toxicology and
Pharmacology
Clinical Phase II - IV
Data Management
and Statistics
Clinical
Research
Pre-clinical
and
Analysis
Central Pathology
Laboratories
Regulatory Affairs
Chemical and Bioanalysis
Quality Assurance
5
Electronic Data Capture and CRO
Judy Hanover,
Sr Analyst,
Life Science
Insights
"Pharma and biotech companies are increasingly making EDCBased trials a standard practice. They are reexamining the
operating costs of trials and asking [contract research
organizations] and other outsourcing providers to work with
them to introduce technologies that will add efficiencies to
trials."
“EDC software revenue was $300m in 2007, expected to touch $1.3b
in 2011”
EDC use to grow by 45% annually in the next 4 years
Chris Connor,
Health Industry
Insights, IDC
6
EDC use in Phase IV to fall off the charts, as FDA tightens inspection
of trial data
TAKE Life Sciences: Global Client Base
Clinical Operations + Regulatory Operations leading to effective & timely submissions
7
TAKE LS: Subject Matter Experts
Strength of Experts leading the business:
Jonathan Seltzer, MD, MBA, MA, FACC
President, TAKE Life Sciences
• Over 15 years of industry experience and co-founder of Applied Clinical Intelligence
(ACI), expert in drug safety
• Chaired many Data Monitoring Committees in multiple therapeutic areas
• Provided medical representation at the FDA
• Special expertise in the area of cardiac safety
Jeff Davidson, PhD
Senior Vice President; Biometrics and Scientific Communications
20 years of experience in the industry, former VP of Global Biometrics at Shire
Development, Inc, gained regulatory approval for five new therapeutic agents.
8
TAKE LS: Subject Matter Experts
Mark Williams
Vice President and Chief Information Officer
Former Senior Director of Integrated Business Systems at eResearchTechnologies
(eRT), Expertise in complex data analyses, Worked with clients and FDA medical
officers on over 50 New Drug Application submissions.
Ilango Ramanujam, VP - Clinical Operations
12 years of experience in the industry, former biostatistician at Purdue Pharma,
Kendle International, and Eli Lilly.
Thomas Guinter
Member of the CDISC SDS (Submission Data Standards) team that developed the
SDTM and Implementation Guide since 2001, and has personally led development of
numerous components of the SDTM.
9
TAKE Life Sciences: Growth Opportunities
Niche Sector Play
SMEs enable services differentiation
Data
abounds
at client
sites
• Robust industry
standard DMS/eCTD
created to FDA standards
now offered to clinical
operations clients—low
cost of sales conversion
• License plus services
revenue models
• Technology-driven
services lowers FTEs
Niche Data
Management
Services low
barrier entry
point to new
clients
10
Specialized
technologies
demand
lesser
number of
FTEs to serve
new client
base
Once Data is
normalized, analyzed
and taken to results
prediction, clients
need a system to
submit the data to
FDA
• Cross-sell clinical
operations to regulatory
operations clients
• Leverage India-based
services delivery models
Thank You