What to Do	How to Do It	Key Issues
I. Strategy Setting
- Overall	Brainstorming	Avoiding problems
- Clinical	Telecons	Fastest route to goals
- Regulatory	Written proposals	Regulatory acceptability
II. Planning
-What to do	Meetings	What can be eliminated
-When to do it	Proposals	What can be delayed
-Who to do it	Periodic reviews	Regulatory acceptability
-How much to do it	Due diligence	Can costs be cut
III. Implementing Plans
-Keeping on track	Weekly project meetings	Identify potential issues/problems
-Preventing tangents	Ad hoc meetings	Should activities be simultaneous or sequential
-Solving problems	Monitoring progress versus plans
IV. Preparing Documents
-White papers	Prepare a synopsis first	Other issues to address
-Final study reports	Develop shells/templates	How can we support our position
-Regulatory submissions	Create boilerplate
-Clinical protocols
V. Review Documents
-Are key messages included	Content experts	Are issues/problems transparent
-Is the discussion complete	Method experts	Is the interpretation complete
-Is the structure sound		Is the report logical
-Is the organization logical		Is the report supported by evidence
-Is anything missing

VI. Miscellaneous
Shorten drug development	Review documents, interview staff and make recommendations
Raise money	Contact my financial associates and others
Locate other experts	Contact my extensive network of independent Consultants