KCR: Post-Authorization Study Develops Into Crucial Part of Drug Development Design

BERLIN–(BUSINESS WIRE)–
Post-authorization safety studies (PASS) are becoming an integral part
of the medicines development. Planning the design of PASS in the early
phases of a clinical trial will translate into significant time- and
cost-efficiency of pre-approval research. Supporting this trend, recent
regulatory requirements and recommendations are to assure the highest
level of quality, transparency and credibility of real-life data
collected.
Increasing significance of PASS was one of the topics at the recent DIA
EuroMeeting 2016, which took place in April in Hamburg. Magdalena
Matusiak, Pharmacovigilance Team Lead at contract research organization
KCR, highlighted the direction of recent changes in the PASS concept
during the presentation, which was a part of the Session entitled
“Assessing the benefits and risks as the basis of the benefit-risk
management.”
“PAS studies are becoming a vital part in drug development, especially
for biological medicinal products,” said Magdalena Matusiak. “Currently,
biological drug development is the fastest growing segment in the
healthcare industry. For the vast majority of biopharmaceuticals the
long-term observation of post-authorization is the essential condition
for marketing approval.”
A post-authorization safety study is conducted after the drug marketing
authorization to collect further information on the medicine’s safety
and to assure that benefits of the therapy outweigh the risks. Each
marketing authorization holder (MAH) is obliged to set up and maintain
the safety management system for the purpose of monitoring, collection
and assessment of adverse events reported during the clinical
development of the medicinal product as well as during the
post-authorization studies.
“The significant value of real-world evidences has recently been
recognized and well understood by regulatory authorities and
manufacturers,” added Ms. Matusiak. “Only additional monitoring in
real-life cycles allows for observation of the long-term safety and
immunogenicity, interactions between products, effects of switching
between similar therapies, as well as safety and efficacy assessment in
other types of population not observed during clinical research.”

Current flexible regulatory approach facilitates fast and effective
marketing approval. The tendency to streamline and shorten the time of
the pre-approval development phase for the benefit of post-approval
observation is becoming more and more prevalent. Decreased time and
lower costs of the pre-approval research allow for accelerated  and
wider patients’ access to advanced therapies.

PASS should be considered an integral part of the medicinal product
development, not only for biopharmaceuticals. “There is a growing role
for scientific consulting services to provide creative and smart design
of pre- and post-authorization studies, and this discussion starts at
the beginning of the cooperation with a client,” added Mr. Matusiak.
“The process of collecting and assessing real-world evidences remains a
broad area for innovative solutions, however advanced ideas are of great
value only when translated into successful outcome,” she summarized.
Ms. Matusiak’s presentation entitled “Is the ongoing surveillance a
blessing or a curse?” is already available here.
If you would like to contact Ms. Matusiak directly, please send your
request to Joanna Lewandowska, PR & Marketing, at joanna.lewandowska@kcrcro.com.
Please include your full contact details in the query.
About KCR
KCR is a Contract Research Organization (CRO) providing strategic
clinical development solutions for the pharmaceutical, biotechnology and
medical device industries. More than 300 professionals support clients
with full-service capabilities across our three main service areas:
Trial Execution (TE), Functional Service Provision (FS) and Late Phase
(LP). Focusing on knowledge, quality and innovation, KCR offers high
value solutions customized to clients’ needs. The company’s geographical
set up suits perfectly to deliver optimized trial execution
strategies. Headquartered in Berlin, Germany, KCR operates across 19
countries in Europe as well as the U.S. For more information visit www.kcrcro.com.
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