Presentation on theme: "TAKE Solutions Enabling Business Efficiencies Ram Yeleswarapu President & CEO Analysts Meet Mumbai September 18, 2008."— Presentation transcript:
TAKE Solutions Enabling Business Efficiencies Ram Yeleswarapu President & CEO Analysts Meet Mumbai September 18, 2008
2 The Global Life Sciences Markets Eastern U.S. Corridor: drugs, devices, bio-medics Western U.S. Corridor: life sciences, devices, therapeutics European Union: drugs, devices, life sciences APAC: generic drugs, therapeutics, devices
3 Clinical Trials Market Trends $25.6b spent on nearly 10,000 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
4 Clinical Research Outsourcing Clinical Research Pre-clinical and Analysis
5 Clinical Research Outsourcing Quality Assurance Clinical Phase I Clinical Phase II - IV Data Management and Statistics Regulatory Affairs Animal Toxicology and Pharmacology Central Pathology Laboratories Chemical and Bioanalysis Clinical Research Pre-clinical and Analysis
6 Electronic Data Capture and CRO "Pharma and biotech companies are increasingly making EDC- Based 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." Judy Hanover, Sr Analyst, Life Science Insights “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 EDC use in Phase IV to fall off the charts, as FDA tightens inspection of trial data Chris Connor, Health Industry Insights, IDC
7 TAKE Life Sciences: Global Client Base Clinical Operations + Regulatory Operations leading to effective & timely submissions
8 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.
9 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.
10 TAKE Life Sciences: Growth Opportunities Once Data is normalized, analyzed and taken to results prediction, clients need a system to submit the data to FDA Data abounds at client sites Niche Data Management Services low barrier entry point to new clients Specialized technologies demand lesser number of FTEs to serve new client base SMEs enable services differentiation 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 Cross-sell clinical operations to regulatory operations clients Leverage India-based services delivery models Niche Sector Play