FDA Regulatory & Compliance Symposium Cambridge, August 26, 2005

1. Drug Safety Strengthened by Technology and Data Integrity Lisa Olson, SEC Associates, Inc. FDA Regulatory & Compliance Symposium Cambridge, August 26, 2005

2. Agenda? • What's Going on Now? • Some Problem Areas • What's Changing? • How is Risk Manifested? • Important Focus • Business Value of Accurate Systems

3. What's Going On Now?

4. Current Environment • Product problems • Need to see early signals • Increasing interactions • Multiple chronic conditions • Insurance promoting the "quick fix" (drug) • Physicians are rushed

5. Current Environment • Pressures • Congress • Patient • Industry • Various organizations (trade, patient advocacy, disease research) • Need/want to look at safety from research through to manufacturing and use

6. Current Environment • FDA • Wants to partner with industry • Pressure to get drugs to market quickly • Yet, under scrutiny for not protecting the public • Industry • Economic and competitive pressures • Bad press • Changing the way we approach therapies (more individualized)

7. Current Environment • Move towards electronic health records • Almost too much information to analyze – large amount of data • Computer usage increasing – storage, capture, analysis • Reliance on automation is increasing • Safety measures change and may be electronic (ECGs, specialty labs)

8. Current Environment AGHGHG!! • Reduce risks or deal with appropriately throughout life cycle of the product • Want to be able to look at data cross-program • Increased interest in quick solutions

9. Some Problem Areas

10. Problem Areas • Wide variety of "solutions" • Systems don't talk to each other • Increased outsourcing • More information coming from multiple parties

11. Problem Areas in Research • Separation of drug safety data from clinical data management (reconciliation task) • We do QA of CDM – what about SAEs, PVG? • What checks are done on the data? • What about coding – is it accurate? • Versions of dictionaries? • Any check that periodic safety reports are correct?

12. Problem Areas • We focus on accuracy of collection – what about the analysis? • Need to ensure availability of data These problems are solvable, but you do need to address them

13. What's Changing?

14. Critical Path • FDA's Critical Path Initiative • Make right decisions based on reliable data • Need better assessment of safety early on • Use new technology, but take care with it • Look at data cross-company (need for standards) • Want to be able to analyze data quickly, but watch out for bias which could invalidate study

15. What's Different • Data mining will be critical • Ability to slice and dice • Ability to quickly aggregate • But must be accurate • Hard to mine, if in multiple places • Health (medical) records vs. clinical trial records – can they be the same?

16. What's Different • Importance of PAT – finding a process or measurement problem that might cross products • Consider infrastructure that is needed • Staff roles changing • QA staff vs. scientists • Computer security • Analysis tools – training!

17. How is Risk Manifested?

18. Risk • Wrong decisions based on bad data • Data being changed inappropriately • Misrepresented results (not necessarily an error message!) • Unavailability of data/records • Technology issues • Training

19. Risk To Patient? Or risk of getting caught?

20. Important Focus

21. Realize Impact of: • Inaccurate software • Incorrect use • Control over changes • Integrity controls • Security

22. What Else Is Important • Employing the right skills • Auditing/verifying suppliers – know what you're buying! • Compliance (this is implied, but maybe shouldn't be) • Clinical investigators • Compliance is everyone's responsibility • All uses • All analyses

23. Business Value of Accurate Systems

24. The "V" Word What does "validation" mean? Simply, is it working correctly? (And can you prove it?) Why is this a bad thing?

25. Validation • Arguments: • "It takes too long – let's just put it in and fix it later" • "I'm buying it – the vendor should ensure it's correct" • "Nobody else is doing this" • "We won't get inspected" • "We'll know if it's not working"

26. A Contradiction • We are tending to trust computers more at a time when: • Impact of software bugs is greater • Timelines are too short to build in quality • We are trying to link incompatible things together • Security exposures are increasing • We are using other companies (and their systems) to do our processes, without adequate investigation

27. Value • Get things right the first time (more expensive to fix and patch) • Decrease overall costs of system deployments • Avoid making wrong decisions based on incorrect data

28. Value • "Hidden" costs • Company reputation • Staff confidence • Partner with suppliers – get better products • Minimize risks – appropriate mitigation • React vs. prevent • Not an add-on; just part of your business

29. In Summary

30. In Summary • For safety, remember the importance of: • Accurate data • The right data • Availability / timeliness • Use technology, but make sure it's right!

31. Thank You! Lisa Olson Principal Consultant SEC Associates, Inc. 2100 Gateway Centre Blvd., Suite 150 Morrisville, NC 27560 Phone: (919) 532-1241 Fax: (919) 467-1109 lolson@SECAssociates.com