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Biospecimen procurement can be challenging,
but technology, planning and new procurement strategies can make it easy and
efficient. Many companies run into issues when trying to procure samples, from
difficulties finding enough to documentation challenges and everything in
between. How can mistakes and delays in biospecimen procurement be avoided?
By Emily Newton
Prioritize Biospecimen Procurement Planning
Many of the most common mistakes in
biospecimen procurement are simply due to a need for adequate planning. This
may be because the R&D team is unfamiliar with biospecimen procurement or
because a project started hastily. Whatever the reason, poor planning can
cripple the procurement process and potentially jeopardize the entire project.
To minimize the likelihood of any procurement
issues, plan out as many factors as possible as far in advance as possible.
R&D teams should have a detailed kit and training process for sample
collection, especially if the samples require special care, such as a
temperature-controlled environment or rapid delivery to the lab. A clear kit
and advanced training for collection personnel will streamline the acquisition
process and minimize the risk of improperly collected samples disrupting
research processes.
Similarly, R&D teams need to take a
critical look at the timeline they have in mind for their procurement process
and project as a whole. Project timelines are more likely to be overly
optimistic, setting unrealistic expectations about how quickly a certain
quantity of samples can be collected. Bioprocessing 4.0 innovations — such as smart analytics programs and remote
sample monitoring — can help make the R&D process as a whole more
efficient.
Unfortunately, there are countless possible
delays research teams can face when trying to acquire biospecimens. They might
need patients with particular traits or an exceptionally large quantity of a
certain biospecimen. Even collecting plasma and blood samples takes time when more
than a handful of samples are necessary. Planning for delays and a lengthy
procurement process allows everyone to use their time and funding efficiently.
Consider Direct-to-Patient Procurement
A lack of adequate information on the origin
of samples can pose a particular risk of R&D mistakes. This is especially
true if certain patient information is necessary for accurate results, such as
info on a patient’s race, ethnicity or any environmental factors they might
have.
Unfortunately, brokers may be reluctant to
share this information, creating issues for researchers. Rather than go through
a broker, companies and researchers should consider forming direct
relationships with hospitals and biobanks. Some industry leaders are even building directories for biobanks and research
companies to connect directly with one another. This saves time and money and
ensures R&D teams have all the necessary information concerning sample
origins.
Direct-to-patient biospecimen procurement is
also another option. Patients are the ones providing biospecimens, so why not
go directly to them? This method requires highly detailed planning, but it can
be far more efficient than conventional procurement methods.
Direct-to-patient biospecimen procurement
proved highly effective early in the COVID-19 pandemic when labs worldwide
worked to develop vaccines as quickly as possible. Platforms like the popular
LabCorp Patient Direct network connected labs directly to patients willing to
provide samples and participate in clinical trials. Since then, more broad
platforms like iSpecimen Marketplace have launched to help companies connect
directly with specimen providers, indicating the high potential for this procurement method.
Direct-to-patient biospecimen procurement
helped make the COVID-19 mRNA vaccines the fastest developed in history. It is
important to note that part of why direct-to-patient procurement methods worked
so well for COVID-19 vaccine development was patient awareness.
When large numbers of samples were necessary,
everyone was aware of the COVID-19 pandemic and the urgent need for a vaccine.
This awareness likely played a role in the number of patients who volunteered
for sample collection campaigns and clinical trials.
Any company or research group can employ
direct-to-patient biospecimen procurement, but it requires comprehensive
planning and marketing efforts to raise awareness of the project’s goal.
Patients will need highly detailed kits instructing them how to collect and
handle samples properly. Companies will also need an efficient process to
obtain samples from patients.
Digitize Procurement Processes
Digitalization is becoming increasingly
popular in the biotechnology and pharmaceutical industries. IRB approval and
documentation are among the most common procurement issues companies and
research groups face. It isn’t always possible to speed up IRB approval, but
organizations can streamline document collection and processing.
Moving documents to digital platforms makes
them easier to deliver to patients and collect once signed. This streamlines
documentation and compliance audits. However, companies and research groups
need to ensure they follow IRB
electronic documentation guidelines. Electronic signatures are
legally binding, but the way electronic signatures and documents are obtained
and collected is vital for patient privacy.
Similarly, HIPAA compliance regulations apply when using
digital documentation. The platform used to deliver, obtain and collect
electronic documents from patients needs to follow specific security and
privacy regulations. While verifying compliance may take some time, electronic
documentation ultimately saves time.
With a digital documentation platform, the
startup could email patients a link to a patient portal where they can type in
their e-signature and submit the forms, a process that takes a matter of
minutes from start to finish. This method is especially useful when paired with
an at-home collection method where the patient can complete the entire
collection process without needing to visit a physical collection facility.
Simplifying Biospecimen Procurement
Effective planning, technology and patient and
biobank outreach can help companies avoid the most common biospecimen
procurement mistakes. By simplifying the procurement process with a few key
strategies, samples are less likely to be damaged, lost, improperly collected
or processed without crucial information. The procurement process can be
frustrating at times, but a little innovation can go a long way toward making
it easy and efficient.
Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
