Pharmaceutical Outsourcing Q2 2024 - 34

SUPPLY CHAIN
reliable and timely delivery. The COVID-19 pandemic also highlighted
the pitfalls of this approach, with " just in time " becoming " just too late. "
Instead, an ideal strategy will encompass CDMOs building up their tolerance
stack - the accumulated individual tolerances of each aspect
of the supply chain - while capturing the essence of " just in time " and
applying risk management filters. As part of this strategy, they must
regularly examine every point in the supply chain to identify potential
vulnerabilities and implement continuity plans as standard practice.
Other factors that will be critical to ensuring reliable supply will include:
* Ensuring a diverse supply chain
Although it is common to have multiple API suppliers, the diversity
of a supply chain is often overlooked. If your suppliers are not spread
out geographically or they obtain their raw materials from the same
source, a supply chain will lack true diversity. Communicating with
suppliers to elucidate their networks and sources will help to identify
potential weak points before they become an issue. CDMOs can also
harness multiple supply sources to stay prepared for any unexpected
events that may affect suppliers in the same geographical region.
* Planning ahead and staying prepared
Many events are unpredictable; it is impossible to be fully prepared
for every possible situation. However, CDMOs must anticipate likely
scenarios, such as price fluctuations, and develop a plan accordingly.
Establishing a strategy to address acute shortages of ingredients is
essential to maintain supply continuity and absorb temporary price
increases. Having alternative suppliers or stockpiling critical materials
can contribute significantly to ensuring readiness for any eventuality.
By fostering collaboration, maintaining effective communication, and
gaining a thorough understanding of the supply chain, CDMOs can
effectively respond to disruptions and plan for contingencies.
* Keeping quality front of mind
In the face of market disruptions, prioritizing the maintenance of a
stable supply of high-quality APIs and intermediates is essential.
Integrating reliable and quality-focused suppliers into primary and
contingency networks can significantly enhance the security of
API supply, irrespective of wider market conditions. In addition to a
rigorous supplier selection process, implementing quality audits of
suppliers' facilities and processes can help to ensure they are meeting
the high standards required both for regulatory compliance and
patient safety. Failure mode effectiveness analysis (FMEA) for risk
management is also critical in identifying and assessing potential
issues with the quality of products and will enable the development
of suitable mitigation plans to address these risks.
By implementing effective supply chain strategies, CDMOs can
build supply chains that can " take a punch, " remaining strong in
the face of challenges to ensure a reliable supply of high-quality
APIs and intermediates.
Preparing for Trends on the Horizon
Having strategies in place that will allow CDMOs to de-risk their
supply chains and provide security for their clients will mean they are
well-positioned to face the challenges on the horizon.
This includes the impact of the BIOSECURE Act, a bipartisan bill
designed to safeguard U.S. biotechnology interests and protect
the sensitive genetic data of U.S. citizens from being accessed by
adversaries. If passed into law, the act could have a significant impact
on biotech and pharma supply chains, including potential supply
chain disruptions, increased costs, and increased scrutiny of suppliers.
The biotech and pharmaceutical industries are also facing an
increasingly complex and volatile geopolitical landscape that is
challenging the resilience of global supply chains. This includes
the conflict between Russia and Ukraine, which has caused supply
shortages, price increases, and transportation disruptions for supply
chains that rely on goods and services from the region. Additionally,
ongoing trade tensions between the U.S. and China have led to tariffs
on medical products, which could significantly disrupt supply chains
for companies relying on materials from China.9
The Future of Pharmaceutical SCM
Pharmaceutical SCM entails unique complexities. Recent trends
in drug shortages and demand for accelerated timelines have
highlighted the need for biotech and pharma companies to rely on
robust supply chains.
Relying on a CDMO partner that can secure sustainable supplies of
raw materials will be paramount in navigating these challenges as
well as those we can anticipate in the future. These CDMOs will have
adopted innovative strategies to enhance efficiency, quality, and
regulatory compliance. By implementing risk mitigation measures
and collaborating effectively with pharma and biotech companies,
these CDMOs will build a resilient and efficient supply chain to ensure
the timely and cost-effective delivery of life-saving medicines
to patients for years to come.
References
1. Four ways pharma companies can make their supply chains more resilient https://www.
mckinsey.com/industries/ life-sciences/our-insights/four-ways-pharmacompanies-canmake-their-supply-chainsmore-resilient
2.
https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages
3. https://www.abiresearch.com/blogs/2023/02/17/pharma-supply-chain-challenges/
4. https://www.bmas.de/EN/Europe-and-the-World/International/Supply-Chain-Act/
supply-chain-act.html#:~:text=The%20Act%20on%20Corporate%20Due,rights%20in%20
global%20supply%20chains.
5. https://www.api.org/news-policy-and-issues/news/2023/09/21/api-releases-methaneaction-plan
6.
IDC & TraceLink Inc. white paper on 'Solving the COVID-19 Pharma Supply Chain Struggle'.
7. www.tracelink.com-resources-resource-center-poor-visibility-tops-idc-list-of-6-obstaclesto-pharma-supply-chain-resilience.pdf
8.
https://www.gisreportsonline.com/r/supply-chain-risk-management/
9. https://valityone.com/en/auswirkungen-der-geopolitischen-risiken-auf-die-supply-chainin-der-life-science-branche
Tom
Wilson leads Pfizer CentreOne's global contract manufacturing
commercial business. Tom was formerly Vice President of
Contract Manufacturing Operations where he was the liaison
between the Pfizer Global Supply (PGS) and Pfizer CentreOne
organizations. He also led the Pfizer Optionality Program for
PGS, as well as the Integration Team for Hospira Device Operations, oversaw
management of Pfizer's Alliance External Suppliers worldwide, and provided
counsel on Pfizer's global manufacturing strategy. He joined Pfizer in 2010 with
the acquisition of Wyeth, where he was Vice President of Product Operations.
Tom is a former United States Air Force Captain, serving as a Command and
Control Officer. He holds a BSc in Physics from Saint Joseph's University and an
MSc in Administration and Management from Saint Michael's College.
Pharmaceutical Outsourcing | 34 | April/May/June 2024

Pharmaceutical Outsourcing Q2 2024

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