Training Day Slides 2017 June
Program of EBF Training Day “Bringing ADC into Practice” June 20, 2017
PDF renditions of the powerpoint presentations can be viewed and downloaded from this page by clicking the specific point on the program. The program itself can be viewed and downloaded by clicking here.
Agenda
| 08:45 | 09:00 | Welcome and Introduction |
| 09:00 | 10:30 | Defining a bioanalytical strategy for ADCs or ‘what do I measure |
| for ADCs and why?’ | ||
| 09:00 | 09:30 | Complexity and inter-modality nature of Antibody drug conjugates |
| Speaker: Surinder Kaur (Genentech) | ||
| 09:30 | 10:00 | Development phase bioanalytical strategy approach to Bioanalysis of ADCs from Discovery to Late Non-clinical to Clinical support |
| Speaker: Boris Gorovits (Pfizer) | ||
| 10:00 | 10:30 | Analyte diversity required for appropriate description of ADC PK |
| Speaker: Surinder Kaur (Genentech) | ||
| 10:30 | 11:00 | Coffee break & networking |
| 11:00 | 12:30 | Technology or ‘how do I measure ADCs? |
| 11:00 | 11:45 | ADC BA: Challenges and opportunities when using Ligand Binding Assay platform, including assay development and validation |
| Speaker: Sarah Childs (GlaxoSmithKline) | ||
| 11:45 | 12:30 | ADC BA: Challenges and opportunities when using LCMS platform, including assay development and validation |
| Speaker: Rand Jenkins (PPDi) | ||
| 12:30 | 13:30 | Lunch |
| 13:30 | 14:45 | Does theory match practice? |
| 13:30 | 14:15 | ADCs, what is industry doing today? An overview. |
| Speaker: Joe Stanta (Covance) | ||
| 14:15 | 14:45 | Correlation between LBA and hybrid assay: BMS’s perspective on analyte and assay selection for ADC PK in Discovery and Development |
| Speaker: Jian Wang (BMS) | ||
| 14:45 | 15:30 | Coffee break & networking |
| 15:30 | 17:00 | Feedback from submissions and regulatory aspects |
| 15:30 | 16:00 | The regulatory space |
| Speaker: Matthew Barfield (on behalf of the EBF) | ||
| 16:00 | 16:30 | Case studies 1 |
| Speaker: Surinder Kaur (Genentech) | ||
| 16:30 | 17:00 | Case studies 2 |
| Speaker: Boris Gorovits (Pfizer) | ||
| 17:00 | 18:00 | Questions & Answers |
| Panel of presenters answering delegate’s pre-submitted questions | ||
| 18:00 | 18:00 | Adjourn |
