COLD CHAIN
INDUSTRY
TRENDSPLANNING TIPS
TO CREATE A ROBUSTSUPPLY CHAIN

Introduction and overview

3Industry trends

4

Planning in the early stages

5

Strategy for a robust supply chain72

Introduction and overview
The maintenance of cold chain product integrity
across the entire supply chain demands rigorous
processes and cold chain expertise of the highest
calibre—from packaging, handling, storage &distribution of temperature sensitive Investigational
Medicinal Products (IMP), all the way to theinvestigator site. These eBooks outline industry trends
and reviews how Fisher Clinical Services solutions aremeeting the challenges of the cold chain distributionof clinical trial supplies all over the world.
COLD CHAIN INDUSTRY TRENDS provides an industry overview anda framework for discussion. The importance of a robust supply chain isaddressed. It includes planning recommendations for biopharmaceuticalcompanies preparing to scale up to global vaccine trials.
COLD CHAIN SHIPPING CONSIDERATIONS takes a deep dive into
passive shipping options and how they work, with information on theadvantages and disadvantages of various coolants.
EVALUATING & QUALIFYING TEMPERATURE MANAGED SHIPPERS
provides insight into how we qualify shipping options with a case study
example of a ‘return and reuse shipper pilot’ which delivered very
positive results.
MANAGING TEMPERATURE EXCURSIONS provides top tips on thebest course of action to take, and provides summary recommendationsfor Sponsors on how to handle cold chain or temperature sensitive IMP
across the supply chain, up until delivery to the investigator site.

3

Industry trends‘Cold chain management’ isundoubtedly a hot topic in theclinical research industry because
a rising percentage of the drugs inclinical testing today are biologics.
The percentage of pharmaceuticals
based on biologics and vaccines
has grown tremendously in the pastdecade. With hundreds of vaccines
in research and development
worldwide, vaccines are among thefastest growing segments of thebiopharmaceutical market today.
In 2016, biologics accounted for sixof the top-eight drugs, in terms ofrevenue. In fact, the global biologics
market size is expected to reacharound $319 billion by 2021 at
an annual growth rate of 9.6%2,more than twice the growth rate ofconventional pharmaceuticals.

The interest in vaccines is fuelled by a variety offactors. Among them: the impact of globalisation,technological advances in biotechnology, post
9/11 concerns about biological warfare, theemergence and re-emergence of diseases suchas Ebola, West Nile Virus and tuberculosis, andscientists’ pursuit of new vaccine targets suchas cancer and Alzheimer’s disease. Anotherkey contributor is the recognition by principal
vaccine purchasers—healthcare providers andgovernments, whose ranks have swollen toinclude those of emerging markets such as Chinaand India—of the ability of vaccines to reduce
healthcare expenditures and increase quality of life
through disease prevention.
New drug development is accompanied byformidable challenges, both for biopharmaceuticalresearch companies pursuing the next generationof products, as well as the clinical supply chainpartners. These partners often take responsibility
for packaging, labeling, storing and delivering
IMP for global clinical trials. In addition to theircost and complexity to develop and manufacture,
vaccines must be stored, transported andmaintained at controlled temperatures in a “coldchain environment.” Maintaining cold supply chain
demands planning, partnering and attention todetail; a single broken link can result in loss ofscarce resources and time, the twin currencies ofthe biopharmaceutical industry.

1. BIOLOGICS MARKET - GROWTH, TRENDS, AND FORECAST (2019 - 2024). Report by Mordor Intelligence
2. Biologics Market By Types, By Trends, By Regions And By Key Players - Global Forecast To 2021 Report byThe Business Research Company, March 2019

Biologics market
expected toreach around$319 billionby 2021
at an annual

growth rateof 9.6%2

Maintaining cold supply chain
demands planning, partneringand attention to detail; a single
broken link can result in lossof scarce resources and time,
the twin currencies of thebiopharmaceutical industry.

4Planning in the early stages
As the volume of cold chain shipments has increased significantly year on year, the Fisher Clinical Services
team has developed a proven model for use in crafting a robust cold supply chain. To begin at the outset—
by thoroughly understanding the protocol and what the sponsor wishes to achieve—is critical.

PROTOCOL

PLANNINGPRODUCTIONSDISTRIBUTION

Understand the protocol

Establish a budget (balance
between cost and risk)

Make sure the kit fits easily
into the site refrigerator

Ensure that enoughdepots and sub-depots
are available

Understand whatsponsors want

Anticipate and address
requirements for customs
and importation

Know when and how much
vaccine will be available

Know the temperature
requirements

5Planning in the early stages
Thorough understanding of the protocol enables us to craft a customized distribution strategy that addresses
the following key issues:

Considerations for distribution
Facilities, depots & sub-depots
A sufficient number of facilities/depots and sub depots ensures that product is delivered to clinical sites as needed.
Many prevalent diseases are in locations where there simply is no clinical trial infrastructure, the indigenous populations aretravelling 100s of miles for any type of treatment and the planning of supply routes requires imagination and dedication.

Vaccine supply
Since vaccine is frequently in limited supply during early development, knowing when and how much product will be available
is necessary for meeting tight clinical timelines

Kit sizeAn often overlooked and critical detail is the size of the kit, which must fit easily into the site refrigerators.

Temperature requirements
Temperature requirements impact the selection of appropriate packaging and monitoring, which ensure that product remains
safe and efficacious.

Customs imports requirements
Requirements for customs and importation vary widely from country to country; anticipating and addressing them early in theprocess is critical. Customs delays as a result of documentation errors are commonplace and can lead to increased costs.

6Our strategy forestablishing a robust
refrigerated supply chain
for clinical trials involves arigorous process of provendurability. Ideally, planningshould begin six to twelve
months in advance offirst patient enrollment,
especially for vaccines
when the trial needs tomeet a specific windowof infection. While clinical
trial timelines sometimes
get missed and the Fisher
Clinical Services team
can quickly accomodatechange, advance planningis always preferred.

Consider the need for andavailability of bio-repository
and bio services, sincelaboratory tests for study
subjects are standard protocol
requirements.

START

Strategy for a robust supply chain
Allow designers and engineers
to examine the entire supply
chain process for a specificstudy, making recommendations about adjustments andimprovements.

Incorporate critical Interactive
Response Technology (IRT)
to integrate the drug supply
chain of packaging anddistribution with the clinicalprocesses of patient enrollment
and treatment.

Double-check to be sure thatlabeling is correct andcontains all necessary
information for every region inwhich the study will takeplace. Countries differ widelyin their labelling requirements.

Address the need foranalytical and stability
testing, which are requiredby regulatory authorities.

Essential
Early Planning

Confirm differing temperatureand handling requirements
for comparator/concomitantvaccines. The surge inbiologics testing has prompted a tightening of regulations
around temperature control
and monitoring.

Evaluate the need for reverse
logistics during or after thestudy, along with destructionof unused trial supplies.

Identify secondary packaging
needs once decisions about
packaging and shipping havebeen made and IRT has been
incorporated.

Determine the need forancillary supplies, since
supplies taken for grantedin Western countries may not
be readily available in someemerging markets.

Ensure that storage anddistribution are sufficient inreceiving sub-Good
Manufacturing Practice (GMP)
hub and sites.

7

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Published 09/21