| Project Scope |
|---|
| Develop a BIMO Frequently asked Questions Forum to be posted on the PHUSE Advance Hub, following the same format as the SEND FAQ forum. This forum will utilize questions brought forward by the pharma/CRO community via public review, presentations, PHUSE BIMO team members, etc... |
| Problem Statement |
|---|
FDA drafted the initial Bioresearch Monitoring Technical Conformance Guide in December 2017, with an updated version published in July 2020. Reference: Bioresearch Monitoring Technical Conformance Guide - https://www.fda.gov/media/85061/download The guide provides specifications for preparing and submitting the following components in electronic format that are used by FDA for planning of Bioresearch Monitoring (BIMO) inspections.
NDA, BLA, and supplemental submissions to FDA require BIMO as a critical part of the electronic application. Pharma companies and CROs have individually developed BIMO standards based on the recent guidance from FDA. A coordinated approach to responses to Frequently asked BIMO questions can benefit sponsors as well as FDA. |
| Problem Impact |
|---|
| A coordinated approach to BIMO Frequently Asked Questions can benefit sponsors as well as FDA. It was apparent during the creation of the PHUSE Bioresearch Monitoring Data Reviewer's Guide (BDRG) that organisations implementing BIMO Submission packages have outstanding questions. The BDRG team captured a lot of those questions in our Communication Tracker (repository of questions and team responses). While most questions were directed at the BDRG effort, there were many general questions that came up during review, presentations, etc... |
| Project Leads | |
|---|---|
Julie Maynard (Johnson & Johnson) | jmaynar1@its.jnj.com |
Sopan Kaith (Cytel) | sopan.kaith@cytel.com |
Katie Warren (PHUSE Project Assistant) | katie@phuse.global |
CURRENT STATUS Q2/3 2022 |
|---|
Project approved Q3 2022. |
| Project Members | Organisation |
|---|---|
| Chunying Yin | Johnson & Johnson |
| Dyuthi Yellamraju | Genentech |
| Jack Field | AstraZeneca |
| Jean Mulinde | FDA |
| Kanaeko Ravenell | CBER |
| Kantish Chowdhury | IQVIA |
| Kirsty Wall | GSK |
| Mathura Ramanathan | IQVIA |
| Meng Li | AstraZeneca |
Phyllis O’Hara Smetana | UCB |
Rashed Hasan | FDA |
Sai Ma | Bayer |
Santosh Lingala | Gilead |
Srinivasan Ramasubramanian | Abbvie |
Triet Tran | FDA |