APR Sept/Oct 2023 - 91

« ROUNDTABLE
Considering the diverse pharmaceutical industry
segments, how does your company envision the
future outlook for drug delivery technologies in
each segment (e.g., oncology, central nervous
system disorders, immunology)? Are there
specific areas where you see substantial growth
potential or heightened demand for innovative
drug delivery solutions?
Morgen: There is tremendous diversity in terms of therapeutic
areas, but this diversity extends to modalities, targets, delivery route,
and even regulatory hurdles. These all contribute to a challenging
environment. Taking oncology as an example, a substantial fraction
of small molecule NCEs require the application of formulation
technologies to achieve acceptable oral bioavailability.
Oncology programs are typically on accelerated pathways, but
meeting rapid timelines has become even more challenging with the
introduction of Project Optimus, the FDA's dose optimization initiative,
where a maximum tolerated dose approach is no longer acceptable
for oncology INDs. Dose optimization studies are required, and a
model-informed approach to predict drug absorption and determine
the first-in-human dose has become critical. Here at Lonza, we use
tools such as solid form screening and selection, combined with
physiologically-based pharmacokinetic (PBPK) modelling, to select
the optimal technology to meet target product profiles.
In the CNS area, there is the additional issue of the blood-brain barrier.
Nasal delivery is one route that might prove beneficial, and it also has
potential in immunology. Dry powder nasal vaccines avoid the need
for cold chain storage, too. Advanced spray drying technology is now
enabling dry powder pulmonary delivery of biologics for respiratory
and oncology applications.
In light of the changing global healthcare
landscape, how does your company collaborate
with stakeholders such as pharmaceutical
manufacturers, healthcare providers, and
regulatory authorities to ensure the successful
adoption and integration of your drug delivery
technologies? How do you address the unique
needs and requirements of different markets
and regions?
Morgen: For a CDMO,
especially one that
frequently employs
innovative and enabling formulation and delivery approaches, it is
important to have good collaborative working relationships not only
with the pharma or biotech client, but with the relevant regulatory
agencies as well. On our experience, working closely together in,
essentially, a single integrated cross-organizational team that includes
both the client and the regulatory body is important for achieving a
successful outcome, while also meeting aggressive timelines.
Early and frequent communication with all stakeholders is one key
to success, as it helps ensure there is a common understanding
of approach, requirements, and challenges. We have had several
cases in the past few years where we have commercialized delivery
technologies with novel characteristics, and had very positive and
comprehensive interactions with both the client and the regulator. This
has allowed us to address the unique aspects of these technologies,
and thus facilitate the advancement of the client's program.
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