1. Maximizing 3 rd Party Vendor Relations For Medical Communications CBI 7 th Annual Forum on Dissemination of Scientific Information May 25, 2010

2. Evan Demestihas, MD, RPh: Chief Executive Officer The Medical Affairs Company Principal. Executive Management & Medical Director Founded Science Oriented Solutions (SOS) the industry’s first Contract Medical Organization 1997-2008 25-year pharmaceutical industry veteran Sandoz, BMS, Solvay

3. CMO CORE COMPETENCIES Outsourced Field based Medical TeamsMedical Communications Services Customized Programs: MSLs Clinical Specialists CTLs MCLs/MMLs FORMs Program Management & Support : Strategic Planning Capacity Analysis Territory Alignment/Mapping Management Structure SOPs/Processes Metrics/Analytics Stakeholder Mix/Customer Focus Recruitment : Profile/Role Development Sourcing TMAC/Client Interviews Training & Development: Core Competency Compliance Programs Administrative IT/Operations/HR/Finance i-MSL™ Call Center: Fully staffed by HCPs Drug Information Adverse Event Handling Product Complaint Handling 8 or 12-hour support Medical Writing: Standard Response Letters FAQs SOPs Abstracts/Poster Presentations Literature Surveillance : Proactive & Reactive Literature Retrieval & Analysis Copyright Clearance Management Knowledge Management : IRMS capability Searchable databank Customized Metrics/Reporting Tools Medical Meeting Support : Booth Support Competitive Intelligence Analysis Symposia/Poster Reviews

4. GOAL Optimize the relationship with the outsourced vendor to meet effective medical communications through compliant strategies

5. Outsourcing: Delivering Value Through Efficiencies  Capitalizes on heavy-lifting and expedient program implementation while limiting burden to organization  Provides greater versatility & enhanced flexibility addressing internal challenges  Optimizes headcount limitations  Mitigates financial risk  Utilizes internal resources more effectively  Expands infrastructure & resources  Engages strategic insight and focused expertise

6.  New company with no medical communications department presence  Established company with fully functional medical communications department

7. Assessment Steps / Needs Analysis  Current department assessment  Expected workload impact  Expected available resources  Outsourcing considerations

8. Company A  New Company  Medical Communications & MSL outsourced  Limited home office personnel

9. Company B  New Company  Launch only support to handle increased volume  Only consumer calls triage to vendor

10. Company C  Established Company – big pharma device division  Internal headcount constraints  Overflow only support directed by client

11. Company D  Generics Company  Rapidly expanding portfolio  Adverse Event only capture & processing  Decided not to build internal expertise in this area

12. Vendor Assessment & Selection  Finding the right vendors  Screening call  RFP process: standardize criteria

13. Typical RFP  Project specifications  Company background & experience summary  List relevant companies supported  Number of new clients added in the last year including volume/services provided  Experience and education of the professional & non-professional staff  Are they FT or freelancers / consultants  Overview of the operation  New program set-up; SOPs; staffing methodology  Describe management and QA process  Service level reports  Technology; validated?  Representative work samples (reports, SOPs)  Timeline  Detailed budge  References

14. Vendor Assessment & Selection  Finding the right vendors  Screening call  RFP process: standardize criteria  Vendor presentations  Reference check  Site visits

15. Vendor Training  Technical training  Corporate policies and procedures

16. Medical Information Standard Operating Procedures Customer Call Center Call Center Operations After Hours Coverage Emergency Procedures Medical Information Medical Information Operations Adverse Drug Reporting Product Complaint Procedures Training Training & Development SOPs SOP Revisions SOP Deviations and Change Requests

17. Vendor Training  Technical training  Corporate policies and procedures  Ongoing

18. Vendor Monitoring  Communication channels  Site visits  Audits

19. Hallmarks of a Good Vendor  Reachable  Understanding  Responsive  Flexible  Quality  Value