Health in a post-pandemic EU

HEALTH IN A POST-PANDEMIC EU
After decades of efforts, recent years
have seen significant progress in research
and development (R&D) in the
field of cell and gene therapy. Following
approvals of several therapies in haemato-oncology
since 2017, developers
across the globe have now turned their
attention to opening entirely new treatment
pathways for a variety of diseases
beyond haematological cancers.
" Personally, I was always driven by
the vision to reinvent medicine
with new ways to tackle diseases
through cell and gene therapies."
DR. ERWAN GICQUEL
Stakeholder Article
The missing piece of
the puzzle
If proved effective, patients across Europe
living with a range of auto-immune
diseases, as well central nervous
system diseases such as multiple sclerosis,
could be set to benefit. To realise
this opportunity though, we must
ensure the European Union is putting
innovation, and the patients it serves,
at the forefront.
Against this backdrop, the announcement
of a revision to the European
Union’s general pharmaceutical legislation
was welcome news to European-based
advanced therapy medicinal
product (ATMP) developers and
marked a potential once-in-a-lifetime
opportunity for Europe to close the gap
with global pioneers in the field of cell
and gene therapy.
will support these European developers
to increase access to, and improve
affordability of, new, life-saving treatments
for European patients. The
Miltenyi Group is one such company
that has been at the heart of global
R&D in cell and gene therapy for many
years.
Miltenyi Biomedicine is a biopharmaceutical
company whose mission is to
bring treatments to patients living with
cancer and autoimmune diseases. The
company is building on the experience
of Miltenyi Biotec, founded in Germany
more than 30 years ago. Despite
this heritage in cell and gene therapy,
the company, along with other European-based
biotech companies, needs
more support to remain competitive.
process in order to advance treatments
that will help patients who fight serious
diseases every day,” he continued.
A particularly welcome aspect of the
new package for the development of
cell and gene therapies has been the
clarification of the decentralised manufacturing-related
requirements. This
has the potential to democratise access
to high-quality, effective, and vitally,
safe ATMPs for patients in European
countries that are typically forgotten.
Likewise, the introduction of regulatory
sandboxes could support the testing
and implementation of new innovative
technologies, such as point-of-care
manufacturing, to further increase access
to personalised ATMPs across the
continent.
A regulatory environment that values innovation will put
Europe at the forefront of global research in cell and gene
therapies
By DR. ERWAN GICQUEL, PHARMD, MSC,
HEAD OF EU GOVERNMENT AFFAIRS FOR MILTENYI BIOMEDICINE.
In the past, the European legislative
environment has been complex and
burdensome, putting ATMP developers
in Europe at a disadvantage compared
with those in other regions. Today, most
innovations in cell and gene therapy
are being pioneered in the USA or China.
The regulatory frameworks and authorities
in both countries have allowed
for faster development and commercialisation
of promising new therapies
for patients.
The good news? Europe already has
leaders in the ATMP field. A revision
of European pharmaceutical legislation
that includes long-term oriented
research funding dedicated to cell and
gene therapy products and a flexible
and risk-adapted legislative framework
“We are a highly specialised company
with truly world-leading expertise in
cell and gene therapy, and the potential
to bring personalised new therapies to
patients in need. While operating globally,
our roots are in Germany and we
have significant R&D operations in the
EU. In order to bring faster new treatments
to patients in need, we need a
more supportive regulatory en- vironment,”
said Stefan Miltenyi, CEO of
Miltenyi Biomedicine.
“In a complex and rapidly evolving scientific
field, innovative companies like
us need a European regulatory environment
that allows for improved interactions
with authorities by accelerating
and intensifying the mutual feedback
“Personally, I was always driven by the
vision to reinvent medicine with new
ways to tackle diseases through cell and
gene therapies. We are fully committed
at Miltenyi Biomedicine to making this
change happen, and fast, but we need
the legal and political environment to
do this from a European base while
ensuring we are competitive with companies
from the USA or China,” said
Stefan Miltenyi, founder and owner of
Miltenyi Biotec and Miltenyi Biomedicine.
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