In this Expert Insights interview, we sit
down with Jeffrey Wiese, Senior Safety Writer at MMS – to discuss safety
writing in the pharmaceutical industry, pharmacovigilance, Risk Evaluation and
Mitigation Strategies (REMS), and his future vision. In January 2019, Jeff
earned the inaugural Innovation in Life Sciences award at MMS, and prior to his
tenure at MMS, Jeff was a researcher at the University of Michigan, Pfizer, and
Purdue University. Below is an excerpt of our interview.
What makes a safety
writer successful and how have you applied this to your work?
writers have a unique niche within regulatory writing, in that we work on early
development and postmarketing documents alike. This breadth comes with
challenges, requiring safety writers to understand a wide variety of scientific
concepts that need to be applied to documents. In addition to a strong
scientific knowledge base, the safety writer must be aware of the regulatory
requirements for different documents from health authorities, like the FDA and
EMA. When you factor in the multiple regions and countries that have applicable
regulations, it can end up being a lot to track, along with a constant learning
curve to updated regulations. In my personal experience, I have relied on
various conferences, symposia, and seminars to stay
current with requirements.
How do you approach
FDA briefing documents and annual reports, such as the Development Safety Update
Report (DSUR) and Periodic Benefit Risk Evaluation Report (PBRER)? What tips do
you have for streamlining the preparation of these?
documents require input from a variety of functions within the development team.
For the DSUR and PBRER specifically, the regulatory requirements are very clear.
The best practice here is for the medical writer to assume the lead role for
the deliverable and to directly manage the development of the report,
requesting input from the team as needed. On the other hand, briefing documents
for the FDA and other health authorities can go in a variety of directions. The
best practice – in my opinion – for briefing documents is to engage the team in
a thorough discussion on the content and strategy and obtain a verbal consensus
for the document prior to beginning the first draft. This leads to a more
efficient process with early buy-in and minimizes major changes in strategy.
REMS have been in
the news lately, what do you believe are some of the biggest challenges that
sponsors face with these documents?
two REMS programs are alike – each program has different requirements and
challenges. The FDA has been active in addressing these challenges through its
stakeholder engagement. Towards the end of 2017, as part of the REMS
Integration Initiative, the FDA released a revised template for the REMS
document that helped stakeholders identify what the REMS requirements are and
who is responsible for the requirement. I think this has had a positive impact
on reducing the associated REMS burden on the stakeholders.
you had asked me this question a few weeks ago, I would have said the biggest
challenges with the REMS documents are in the REMS
assessment reports and REMS knowledge surveys, as there was little
information available on what the FDA expects. However, just recently, the FDA
released two REMS
draft guidances on these topics to provide input on how to develop a
REMS knowledge assessment and a standardized approach to report findings in the
REM assessment report. It will be interesting to see how the public discussion surrounding
these guidances unfolds, but nonetheless, this is a positive development for
all REMS stakeholders. At MMS, we write a large number of REMS and are
therefore able to bring this expertise to our sponsors who may not be involved
with REMS routinely.
Tell us about your
global team leadership style and how you keep colleagues engaged, valued, and
trained properly with new regulations.
am privileged to work with a very talented global staff of safety writers at
MMS. Our group has regular internal training sessions to stay current on the
regulations and guidances pertinent to our areas of expertise. When assigned to
a project, I proactively encourage colleagues to understand the intricacies of
the program that they support. Doing so allows our group to establish trust
with the sponsor team from the beginning, so that we can contribute our
expertise and deliverable-specific experience as a collaborative effort. I take
pride in knowing that quality work will help sponsors and their patients, and I
make it a point to remind teams of our end goal – helping patients.
What changes do you
see in the future of safety writing for the pharmaceutical industry in the next
Today, patients have access to an unprecedented amount of clinical trial information through transparency initiatives, such as clinical trial disclosures. This trend will continue, and in the next five to 10 years, I expect that technology advances will make it simpler to get accurate clinical trial information to patients in formats that are more easily understood by the general population. A large part of safety writing focuses on informing patients of the risks associated with a product; it will be interesting to adopt writing strategies to deliver the key messaging via the different media used in the future.