Collaborating for the Future Developing effective CRO, Site and Sponsor relationships in a changing healthcare environment

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1 Collaborating for the Future Developing effective CRO, Site and Sponsor relationships in a changing healthcare environment Jean Chitwood Senior Vice President, Corporate Strategy INC Research

2 Faculty Disclosure In compliance with ANCC Guidelines, I hereby declare: I do not have financial or other relationships with the manufacturer(s) of any commercial service(s) discussed in this educational activity. Jean Chitwood Senior Vice President, Corporate Strategy INC Research

3 The current environment Almost $2.6 billion The estimated cost to get a new drug to market, according a 2014 Tufts CSDD study* In 2003, Tufts CSDD estimated the cost per approved new drug to be $802 million $312 million Tufts estimate of the average cost of post-approval R&D The study found the full product lifecycle cost per approved drug of $2.87 billion Cost to develop and win marketing approval for a new drug increased by 145% between the two study periods CAGR of 8.5% * Cost of Developing a New Drug, Briefing, November 18, 2014, Tufts Center for the Study of Drug Development, Joseph A. DiMasi, Ph.D.

4 An ever-changing landscape Healthcare environment Patient focus Clinical research care option Technology advances Wearables Microchips Data Management Access Sharing

5 Healthcare

6 Shifting focus Enhance the patient experience Protocol designs that incorporate sites and patients voice Patient at the center Improve the efficiency of clinical research sites Legislation, insurance factors impact choices

7 The future of research Leadership Research as a Care Option Physicians Highly engaged and supported by the system Staff Educators and ambassadors of the value of research within an organized system of care Patients Empowered and more accountable for choices in their care

8 A viable option 2014 GuideStar/CenterWatch survey of 183 U.S. healthcare professionals. Among respondents: 92% 86% 73% believed that clinical research programs contribute to medical science. said trials deliver cutting-edge therapies to the community. said they enhance a hospital s image. Top-level hospital executives said clinical trials can help them attract and retain high-quality physicians who are interested in research. Results published in Tapping community hospitals for clinical trial volunteers, by Karyn Korieth, CenterWatch Monthly, March 2014

9 Competition increasing for high-performing sites The ability to recruit and retain motivated, informed, protocol-eligible patients starts with sites 74-80% of global sites perform one clinical trial and never perform another Over the last 15 years, 86% of studies failed to recruit on time In 2014, 65% of sites surveyed have less than 3 months operating cash Most prevailing reasons enrollment fails from the sites perspective 85% I/E Criteria 54% Study Design 33% Amendments after we agree Created a Call to Action Data and research from Society of Clinical Research Sites, 2014

10 Data

11 Evolving role of data Impacting our daily lives Major advances in the amount of data we generate and collect Constantly changing and adapting Multiple categories of data Fragmented Big data in clinical research Enhanced selection of patients to enroll Improved, easier and more reliable tracking of patients and sites Detailed genetic information to fuel personalized medicine Mining data for previously unavailable information Fighting epidemics by predicting possible outbreaks

12 Creating a solution INC initiative Uses targeted, high-volume data to inform decision making Moves patient ID from step three to step two in the clinical trial process Need to prove the viability of using external data sources and new technology to create maps of where potential protocol-eligible patients might be locate The danger of venturing into uncharted waters is not nearly as dangerous as staying on shore, waiting for your boat to come in. ~ Charles F. Glassman

13 Collaborating with key stakeholders INC working with DrugDev First CRO worldwide to integrate with and implement DrugDev s SiteCloud platform Same system used by the TransCelerate Biopharma Investigator Databank Provides a collaborative platform for the visualization of investigative site data Enhances access to and management of critical investigator and site data between sponsor/cro and sites Facilitates more efficient feasibility, site selection and study start-up processes

14 Technology

15 Rapid technology advances Continuous evolution Across the pharmaceutical industry Major technology players Regulators Developing a wristband to vital signs and other data of clinical trial participants ResearchKit: Open-source platform for creating iphone apps that collect healthcare research data, can bring together personal data from a large cross-section of the population HealthKit: Central platform for health information, developed in conjunction with the Mayo Clinic and Nike

16 Personal technology Wearable devices Digestible sensors Microchip implants

17 What s next? Pace Partnerships Patients Paths We can define a better future together.

18 Thank you