Hello, my name is Lothar Tremmel.
I work at CSL Behring, which is a plasma-based pharmaceutical company,
and I work there as the Head of QCSR, which stands for 'quantitative clinical sciences and reporting'.
The topic of my talk today is: pre-marketing safety surveillance, a structured approach.
Here you can see some more details about myself in case you're interested,
I'm not going to read this for you, you can do this at your leisure.
What is important is that I'm a member of the DIA-ASA Biopharm Safety Working Group,
and it's important because a lot of the thinking I'm going to present comes out of this working group,
in particular, the thinking around the structured approach that we call A, S, A, P or ASAP.
Here is what we will talk about.
We will talk about key concepts in safety surveillance,
then about the difficult issue of assessing drug event-relatedness through increased frequency analysis,
in particular in the light of the FDA's 'final rule' concerning IND safety reporting.
The third topic is providing context and perspective to emerging suspected safety issues.
The fourth topic is the importance of interdisciplinary collaboration.
Finally, I will introduce a structured approach towards safety surveillance
in the pre-marketing setting, that we call the Aggregate Safety Assessment Plan or ASAP.
Let's talk about some key concepts in safety surveillance.
Many of you may be familiar with post-marketing surveillance,
this is the effort of collecting spontaneously reported adverse events once the drug is
in the marketplace, these data are then collected in databases,
we record evidence databases such as for instance, the class of RWE databases
that are joined together in the FDA's sentinel project.
These are very large databases, but the data quality can be problematic.
There is no denominator information available, no exposure information available,
and limited ways to query these databases.