LS&HC Horizons 2023 - Flipbook - Page 5
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | Precision and Regenerative Medicine
5
Harnessing transformative technologies to enhance
vein-to-vein supply chain
Advanced therapy medicinal products
(ATMPs) have potential for truly personalized
medicine and viable treatments for diseases
which are currently near-incurable. ATMP
creation involves “donating” human tissue,
which is generally then modified, engineered
or manufactured into a bespoke therapy for
delivery to the same (autologous) or another
(allogenic) patient. As ATMPs become more
prevalent, this “vein-to-vein” supply chain
integrity will be of paramount importance.
Blockchain, meanwhile, offers the ability
to store and transmit data in a decentralized
and real-time manner. Blockchain could
help resolve many ATMP supply chain
challenges due to its inherent characteristics
of: (i) consensus; (ii) provenance and
immutability; (iii) finality; (iv) security
and reliability; and (v) decentralization.
Blockchain transactions are secure,
authenticated and verifiable. This
is relevant to ATMPs because:
• ATMPs are environmentally sensitive
Blockchain combined with other
technologies can be used to verify
temperature, geolocation, or other variables,
and provide real time updates to prepare for
scheduling and resource allocation while
ensuring compliance throughout the chain.
Penny Powell
Partner, London
• ATMPs are subject to complex
regulatory requirements
Regulation of ATMPs involves separate
regulatory bodies governing different
aspects of the entire supply chain; from
donated tissue through to resultant ATMP.
Integrating blockchain into the ATMP
supply chain could save time and expense
by enabling regulators to: (i) access the
blockchain platform; (ii) track products
and coordinate with stakeholders in real
time through the blockchain network;
(iii) assess compliance via publication of
zero-knowledge proofs; and (iv) have access
to a permanent and immutable regulatory
audit trail in the form of the blockchain
ledger itself.
• There are many players within the
ATMP supply chain
The lack of coordination and openness
of data encountered when using existing
technologies could be addressed through
implementation of a blockchain network.
Key considerations when implementing an
ATMP supply chain blockchain network will
include how to: (i) decide how the network will
be operated, and by whom; (ii) form contracts
between stakeholders; (iii) evidence regulatory
compliance; and (iv) ensure security and
privacy of data.
Alice Russen
Associate, London
Bea Watts
Associate, London
