CLINICAL
TRIAL
PACKAGINGINNOVATIVE,FLEXIBLE AND
TIME-SENSITIVE
SOLUTIONSClinical trials: A constantly changing landscape3

Case study:
Packaging innovation enables breakthrough results

4

Case study:
Creative design delivers flexibility and time savings

5

Case study:
Remaining nimble allows rapid respond to unexpected needs

6

Case study:
Project management experience is essential for quality results

72

Clinical trials: A constantly changing landscape
Medicine is an everchanging field. As ourknowledge increases andbecomes increasinglyrefined, new treatments
are developed that benefit
more patients.
Standards of care change as alreadyapproved medicines are used in
new ways and new medicines areapproved at increased rates, owing
in part to the FDA’s BreakthroughTherapy, Priority Review, and Fast
Track designations.
Oncology drugs, for example,
have seen approvals at record
rates in recent years.1 To succeed,
pharmaceutical companies mustremain vigilant, attending to every
detail of the process, as well as thelarger landscape around them.

Creativity and adaptability are key
to successfully developing andcommercializing new treatments.
Companies must be flexible enoughto anticipate and avert pitfalls
and shift direction according toenrollment progress, trial results
and releases by competitors. Thesechanges often impact outsourced
services, which requires suppliers
remain equally flexible e.g. changes
in dosage, increases/decreases inpackaging volumes, expiry datechanges, addition of new countries.
And time is of the essence: patientsare eager to receive treatment
sooner, and companies stand to losefinancially with each day of delay inreleasing a new treatment.

For the large pharmaceuticalmanufacturer, outsourcing
non-core activities is a
key strategy in support ofstreamlining operations.
They need suppliers that can beresponsive, held to high standards,
with a demonstrated ability to work
across their organizational silos inorder to get job done. At the otherend of the spectrum, emerging
biopharma companies simply do
not have the internal resources andexpertise to manage the range ofactivities required in support of aclinical trial. They need a trusted
advisor that can walk them throughthe process, demonstrating proactive
approaches to solve problems withexcellent communication & project
management skills.

Whether large or small, clinical trial
sponsors must have the assurance
that their selected suppliers canmeet their needs. Given the rapidlychanging landscape of today’s trials,
timelines, flexibility and innovation
are essential. Equally important is theproject management expertise thatties everything together and keeps
things on track.

A delay in launch can cost a company anaverage of $15 million per drug, per day. 2
1. Zupnick, Andrew. “The Impact of Faster Drug Approvals on Oncology Clinical Trial Design.” Applied Clinical Trials Home,
2 May 2018, www.appliedclinicaltrialsonline.com/impact-faster-drug-approvals- oncology-clinical-trial-design.
2. Noffke, Tim. “No Time To Delay.” Pharmaceutical Executive, March 1 2007, www.pharmexec.com/no-time-delay

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Case study: Packaging innovation
enables breakthrough results
Developing new drugs is a complex process,but challenges at each step offer opportunities forcreativity and innovation. A large pharmaceuticalcompany was planning to conduct an infectious
disease trial for the treatment of Hepatitis C.
The global trial would cover over 40 countries
and require the labeling and distribution of morethan 250,000 pre-filled syringes over the courseof the study.

The investigational drug also required strict 2°C to 8°C temperature andhandling protocols. Only one comparator drug was suitable for use in thestudy, and it was available as a pre-filled syringe in four dosages and included
a needle-stick protection device. The sponsor faced 2 significant challenges:
the comparator had to be blinded using a label that met the exact dosage
specifications of the branded product, and the sponsor had to match its own
investigational product packaging and labeling to the comparator, including
the same size syringes and labels with similarly precise dosing regimens.
Having completed an extensive study of supplier capabilities, they found none
had existing capabilities that would meet their needs.
Having previously worked with Fisher Clinical Services, the sponsor engaged
their project management team to discuss solutions. A global team of engineers
was assembled to design a solution to include high-precision labeling
equipment and labels that would meet the exacting dosage requirements ofthis trial, as well as future trials that required precision dosing graduation.
In collaboration with the sponsor, acceptable precision standards weredefined and extensive testing was conducted to ensure compliance. The
complete system was ultimately qualified according to the co-developed
precision standards. Working with the sponsor to meet stringent requirements,
the Fisher Clinical Services team was able to develop a first-in-industry
capability that is now available to all sponsors requiring varying levels of
precision dosing graduation on labels.

Innovative design yields high precisionlabeling solution for pre-filled syringe
within +/- 0.7mm tolerance level, withintegrated automated quality assurance
to ensure exceptional results.
4Case study: Creative design delivers
flexibility and time savings
Product packaging is a detailed task that requires both creative thinking and flexibility to realize the greatest
gains. Designing with an eye toward versatility, involving the right experts and completing appropriate testing
can result in time and cost savings, and lead to success far beyond the original project.
A small, emerging biopharmaceutical company
developing an oncology Investigational Medicinal
Product (IMP) had been working to blister-packcapsules in a 12-pack strip. Over the course of
3 to 4 months, the requirements changed multiple
times, impacting production scale and the packaging
process. The team saw that they needed a solutionthat provided greater flexibility to meet the changing
needs and avoid waste. The supplier’s project
manager pulled together a team of experts fromoperations, engineering, design, and quality tocreate a package design that was scalable as needschanged through various phases of the trial.
Their CAD team created a 3-dimensional proofof-concept which was used to further refine theirsolution—a blister pack with perforations in stripsof 3 with a single outer wallet. Adopting perforated
blister packs offered the flexibility required to support
multiple dosing strategies

Using one wallet design across all studies
reduced storage and costs; only the inside cardneeded to be changed

Applying a single-panel label with multiple
languages enabled small batch print on demandruns vs. the more costly booklet production

Packaging re-work was eliminated delivering
time and cost savings

Design was fully scalable through all phases of
the trial

Flexible design results in decreased waste and, due to the scalable
approach, eliminates re-design throughout multiple phases of trial.
5Case study: Remaining nimble allows
rapid respond to unexpected needs
From drug development to production to patients,
there are a host of stakeholders, experts, processes
and requirements that come into play. Successrequires the ability to communicate across all of thesegroups to build collaboration, communication andconsensus that guides swift action. Proactive project
managers are trained to leverage their years of clinical
trial expertise to anticipate and prevent errors fromoccurring. Unfortunately where multiple suppliers areinvolved, issues can arise that require swift action tosave a trial that might be in jeopardy.

Sometimes a small error can have a significant impact on clinical trial timelines
and even patient safety. This was the case for a small biopharmaceuticalcompany as it prepared to begin a trial. The study preparation had runsmoothly but, during the final stages before the clinical trial, the sponsor
realized they had made an expiry dating error. The sponsor had inadvertentlysubmitted the wrong expiry date for a particular lot of investigational drug. Asa result, the labels had been approved with a shelf life of 48 months instead of30 months. This required immediate attention as there was a significant risk tomeeting dosing timelines.
Realizing they could not remedy this issue on their own, they turned to thesupplier their consultant recommended to facilitate an emergency relabelingprocess. Reaching out to the relevant teams, the supplier’s project manager
saved time by simultaneously requesting a quote for relabeling the drug withthe correct expiry date, conferring with the packaging site to facilitate speedy
relabeling, and requesting permission to start the re-work pending quotesignature by the customer. The project manager received the green light tobegin the relabeling at risk because patients were at risk of not getting theirrequired dosage. Ultimately, the customer was able to complete all required
documentation prior to the start of relabeling. The teams were able to work
closely, communicate effectively across all parties, and respond with speed
and flexibility in order to keep the trial on track and keep patients safe.

Quick action and clear communication
allows emergency relabeling due
to sponsor error to commence within
5 days of quoting the job.

6Case study: Project management experienceis essential for quality results
Having a dedicated partner with the expertise tohelp guide your team can mean the difference
between making it to market first and having to takea step back or begin again. There is a methodology
to addressing client packaging needs that includes
gathering information, setting timelines, presenting
options and delivering quality results. Suppliers thatcollaborate with sponsors and engage their own
internal subject matter experts can deliver the best
outcomes for trial sponsors and their patients.

A large biopharmaceutical company had an injectable drug in the field, but inlimited supply, which placed a heightened focus on minimizing or eliminating
rejects. They requested an unconventional packaging process: instead of
applying a plunger rod to a syringe before snapping on the backstop, they
requested that operators apply the backstop first, then push the plunger rod
through the backstop while ensuring minimal movement to the rubber stopper.
The supplier’s project manager gathered a team of subject matter experts
from engineering, packaging, operations and quality to brainstorm and createcustom tools that would facilitate the assembly process while ensuring
optimal quality. Team leads from each discipline worked to prepare a batchrecord, which was then tested in a simulated packaging room. Test operators
were briefed on the client’s expectations and given the draft batch record toguide the process. Gowns and gloves on, the team proceeded to assemble
the syringes, working to refine the process and procedures as they worked.
A process engineer was a key member of this initiative, revising the batchrecord in a way that was easily understood by those performing the work.
When the production job was ready to run, the client came on-site to observe.
Because the team had conducted a detailed simulation in advance, theproduction run was completed with no delays and with minimal rejects. By
creating a clear timeline and engaging the right experts, the project manager
was able to deliver a solution that exceeded the client’s expectations.

Project Management leadership delivered aproactive timeline and plan that eliminated changeorders, provided a solution that minimized waste,and avoided costly downtime or delays due tocomprehensive advance testing.
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Published 09/21