LSHC Horizons Brochure 2024 - Flipbook - Page 46
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Transactions
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Manufacturing relationships underlying transformative technologies
Cell, tissue, and gene therapies (CTGT)
have for years offered the potential for
truly personalized medicine for many nearincurable disease indications. In addition,
radiopharmaceuticals and custom and
customizable medical device deliverables
have recently shown to have great promise for
individualized patient care. All of these new
technologies leave little margin for error due to
the time-sensitive nature of their manufacture
and delivery. Manufacturers face tough choices
on how much of the delivery process can be
centralized or brought in-house, often at a very
high cost, versus partnering with a specialist,
which may increase logistical hurdles.
Additionally, the potential geographical
location of manufacturing/distribution
facilities requires careful analysis; for example,
with respect to radiopharmaceuticals and
autologous cell therapies, close access to high
population regions and hospital and treatment
centers, in addition to robust transportation/
distribution/logistics systems is essential.
Increasingly, many of these steps are carried
out by one or more specialty contract
manufacturing or contract development and
manufacturing organizations (CMO/CDMO)
creating or utilizing distribution and treatment
centers in close proximity to large patient
populations (e.g., near major hospital systems),
raising important considerations and logistical
challenges with respect to the relationships
between the “legal” product manufacturer
and these partners, as well as the contractual
Penny Powell
Partner
London
challenge of ensuring safety in unique point
of service supply chains, which require
an integrated approach to distribution
and manufacturing.
Additionally, these processes and relationships
can raise tricky contractual issues, resulting in
greater complexity in core license terms and
potentially greater challenges in diligencing
investment opportunities. The end result is
greater scrutiny and intense negotiations around:
• what is being licensed;
• what are the potential costs associated with
manufacturing, distribution, and possible
commercial scaleup;
Capacity, materials shortfalls, and delivery
logistics continue to impact the bottom line for
partners across the supply chain. Ultimately,
planning for every eventuality and building
controls and contingencies for every step are
the key to successfully being able to deliver
transformative therapies to patients. Early
consideration of nuanced contract terms
and planning at the development/clinical
stage of an agile and efficient framework
for commercial manufacturing/logistics
arrangements is advisable as is careful
construction of a trigger to negotiate an
early exit on satisfactory terms if a suitable
outcome ceases to be achievable.
• what is the available manufacturing and
distribution capacity and geographical
footprint and what impact will this have on
the relationship with the contracted partner;
• how comfortable are the regulators with new
methods for manufacturing and distribution
in all applicable jurisdictions;
• what impact possible regulatory delays
(including product approvals and/
or facilities inspections) may have on
manufacturing and distribution planning;
• how to balance centralized versus
decentralized delivery models; and
• how best to partner with administering
health care providers (HCPs) who ultimately
have access to patients.
Jodi Scott
Partner
Denver
Andrew L. Strong
Partner
Houston
