Conveners
Panel: Mock Pre-Submission with FDA
- Christopher Dugard (FDA)
- Patrick Anibaldi (Abbott)
- Sreekanth Gutala (FDA)
- Mark Pasmore (Baxter)
- Clarence Murray (FDA)
- Stephen Anisko (FDA)
- Kristen Bozzelli (Baxter)
- Ryan Ortega (FDA)
Panel: Building Irradiators - Where Do We Go?
- Chad Rhodes (Sterigenics)
- Larry Nichols (Steri-Tek)
- Cody Wilson (IBA Group)
- Eric Beers (Steris)
- Jason Canaway (Steris)
- John Williams (Medtronic)
- Vu Le (Abbott)
Panel: Mock Pre-Sub Review and Regulators/Informed Bodies Interactions
- Patrick Anibaldi (Abbott)
- Clarence Murray (FDA)
- Sreekanth Gutala (FDA)
- Ryan Ortega (FDA)
- Stephen Anisko (FDA)
- Kristen Bozzelli (Baxter)
- Christopher Dugard (FDA)
- Mark Pasmore (Baxter)
Panel: Driving a “One Voice” Bioprocess Approach to Qualify X-ray as an Equivalent Alternative to Gamma
- Timo Neuman (Merck-Millipore)
- Ping Wang (Janssen Pharmaceutical)
- Matt Hammond (Amgen)
- James Hathcock (Pall Biotech)
- Thomas Kroc (FNAL)
- Ken Wong (SanoFi)