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TAKE Solutions Enabling Business Efficiencies Ram Yeleswarapu President & CEO Analysts Meet Mumbai September 18, 2008

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Page 1: TAKE Solutions Enabling Business Efficiencies Ram Yeleswarapu President & CEO Analysts Meet Mumbai September 18, 2008

TAKE SolutionsEnabling Business Efficiencies

Ram Yeleswarapu President & CEO

Analysts MeetMumbaiSeptember 18, 2008

Page 2: TAKE Solutions Enabling Business Efficiencies Ram Yeleswarapu President & CEO Analysts Meet Mumbai September 18, 2008

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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

Page 3: TAKE Solutions Enabling Business Efficiencies Ram Yeleswarapu President & CEO Analysts Meet Mumbai September 18, 2008

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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

Page 4: TAKE Solutions Enabling Business Efficiencies Ram Yeleswarapu President & CEO Analysts Meet Mumbai September 18, 2008

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Clinical Research Outsourcing

Clinical Research

Pre-clinical and Analysis

Page 5: TAKE Solutions Enabling Business Efficiencies Ram Yeleswarapu President & CEO Analysts Meet Mumbai September 18, 2008

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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

Page 6: TAKE Solutions Enabling Business Efficiencies Ram Yeleswarapu President & CEO Analysts Meet Mumbai September 18, 2008

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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

Page 7: TAKE Solutions Enabling Business Efficiencies Ram Yeleswarapu President & CEO Analysts Meet Mumbai September 18, 2008

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TAKE Life Sciences: Global Client Base

Clinical Operations + Regulatory Operations leading to effective & timely submissions

Page 8: TAKE Solutions Enabling Business Efficiencies Ram Yeleswarapu President & CEO Analysts Meet Mumbai September 18, 2008

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TAKE LS: Subject Matter Experts

Strength of Experts leading the business: Jonathan Seltzer, MD, MBA, MA, FACCPresident, 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.

Page 9: TAKE Solutions Enabling Business Efficiencies Ram Yeleswarapu President & CEO Analysts Meet Mumbai September 18, 2008

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TAKE LS: Subject Matter Experts

Mark WilliamsVice 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 GuinterMember 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.

Page 10: TAKE Solutions Enabling Business Efficiencies Ram Yeleswarapu President & CEO Analysts Meet Mumbai September 18, 2008

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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 PlayNiche Sector Play

Page 11: TAKE Solutions Enabling Business Efficiencies Ram Yeleswarapu President & CEO Analysts Meet Mumbai September 18, 2008

Thank You