Publications in launch and lifecycle

1. Publication is a critical part of the scientific process,

• It is important to communicate the results

• Peer review still adds credibility to research

• Important for further steps

• Need to have transparency - refer to clinical trials .gov

• History of not publishing data in the past

2. Helps establish credibility with various stakeholders,

3. Enable scientific discussions in the field,

4. Advance science in that disease and in general

A. Types of publications:

1. Presentations

2. Abstracts

3. Posters (original and encore)

4. Papers

1. Methods characterization (to the standard of reproducibility)

2. Results presented accurately and in a balanced manner

3. Clinical and statistical conclusions are consistent