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0:00
Hello. Welcome to this talk.
I'm going to give an
advanced therapies update
in a changing regulatory
and access environment.
My name is Ana Hidalgo-Simon.
I am a medical doctor.
I have done research
and commercial work
in the Advanced Therapies arena.
I had spent 20 years in the
European Medicines Agency
in the last years, really
focused on the ATMP,
the Advanced Therapies
Medicinal Products.
For the last two years,
I have been a professor
at Leiden University
Medical Center.
0:39
In this presentation, I'm
going to give you a bit of
an overview of what is
the current picture
in the European Union.
We're going to have a look
at the challenges for
the future, and
especially looking at
this element of translation from
the academic origin to the
marketing authorization,
all the way to the patients.
All this is happening
in a changing world,
and we will be seeing what are
the major elements
of those changes.
I will leave you
with some thoughts
on a couple of issues
for the future.
1:11
This is an overview of what is
the current situation in Europe.
Those are the products approved
over the last ten years.
There were three or four
approved before that.
They are no longer
in the market.
Here we have all the
active therapies
classified into tissue
engineering, gene medicines,
and cell therapy
medicinal products.
This is not quite up to date.
It is the most recent
report from EMA.
But we know that one more of
the newly approved drugs
had been withdrawn
from the market.
The grey boxes you have
four, but it should be five,
are already out of the market.
This is a very important point.
Those are working, approved,
efficient, good therapies
that are not available
for patients anymore.
The reason for the delay in
the reporting is just that
when the company
announced that they are
withdrawing one drug
from the market,
it takes a few months.
It is a process,
it's not a switch.
It's a reminder that academia is
