How to Prepare for a Successful NDA | Tips for Medical Writer - Pepgra

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TOP TIPS FOR A MEDICAL WRITER TO PREPARE A
SUCCESSFUL NDA
An Academic presentation by Dr. Nancy Agnes,
Head, Technical Operations, Pepgra
Group www.pepgra.com Email pepgrahealthcare_at_gmai
l.com
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Today's Discussion
OUTLINE In-Brief Introduction Tips for a Medical
Writer to Prepare a Successful NDA Conclusion
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In-Brief

• Medical writers must be subject matter experts of
  the regulatory control inside and out and know
  the drug under study in clinical research. To
  prepare a successful NDA, a medical writer
  should know all the basics of regulatory
  submissions. Pepgra provides you with essential
  tips for a medical writer to prepare a
  successful NDA and provides r egulatory writing
  services.

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Introduction
Medical writing includes writing scientific
documents of different types, with regulatory
and research- related papers, disease or
drug-related and promotional literature,
publication articles like journals, manuscripts
and abstracts, essential content for healthcare
sites, health-related publications or news
articles. The scientific data in these documents
need to be accessible to suit the target
audience's level of understanding, namely,
patients or the general public, physicians or
the regulators.
Contd...
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Medical writers require an understanding of the
medical concepts and terminology, knowledge of
relevant guidelines regarding the structure and
contents of authentic documents, and good
writing skills. They also need to be familiar
with searching medical literature, understanding
and presenting research data, document reviewing,
and editing and publishing requirements. Many
resources are now accessible for medical writers
to regularly get vital training in the science
and art of medical writing and regularly upgrade
their knowledge and skills.
Contd...
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The demand for the medical report is growing
gradually in pharmaceutical and healthcare
communication marketplace.
Medical writers can work individually or active
as full-time professionals.
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IT'S NEVER TOO EARLY TO START YOUR NDA
PREPARATION
Tips for a Medical Writer to Prepare a
Successful NDA
It would help if you began to think about your
eventual NDA(New Drug Application) from the
moment you start planning for your Pre-IND
meeting and IND submission, and well before you
have dosed a single patient. For instance What
is the most suitable regulatory path? What are c
linical trials needed for the NDA and product
label to be supported?
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Do you plan to seek expedited growth and
expedited review? What is production information
needed for the NDA? To help your application, do
you need long-term toxicology/carcinogenicity
studies? What needs to be outsourced? All these
questions should be front and centre as early as
possible in your mind. Even though your NDA
submission seems far off shortly, early
preparation will make the difference between
smooth sailing and rough seas.
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START ASSEMBLING YOUR NDA Far too often,
sponsors wait to start compiling their NDA until
late in production, which can place undue
pressure on resources and timelines. Note, each
piece of the NDA you can finish and "put on the
shelf" is one bit less that you have to think
about later. You can relax a little better as
the submission date approaches by knowing what
elements can be accomplished early and then
proactively completing those assignments during
medical writing in clinical trials.
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In most cases, by the time the drug reaches the
clinic, a significant portion of the nonclinical
program will be completed. All of this
information can be explicitly pulled into the
NDA's related modules and incorporated as other
studies become final. On the clinical side, as
soon as you can, you should start reviewing your
data and preparing your clinical research
reports (CSRs). Before the research is complete,
you can even start on the report shell.
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You can then collect the rest of the components
and collect all the required approval signatures
until final data is available. Analyses have
been carried out using r egulatory medical
writing in clinical trials. When the time comes
to colonize the NDA clinical overview pages,
completing these activities would also encourage
performance. KNOW THE RELATED LAWS AND
REGULATORY GUIDELINES The FDA review division
must manage your application, and for NDAs in
general, to understand the applicable laws and
regulatory guidelines that relate to your
specific program.
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Although rules are legally binding, documents of
advice are not in r egulatory writing. However,
guidance documents include the regulators' latest
thinking who will review the NDA (and hopefully
approve it). Therefore, it should be done with
caution, reason, and consultation with the FDA's
relevant review division to deviate from these
guidelines. USE STANDARDIZED TEMPLATES When you
start writing your IND, make sure you use uniform
models and that a standard style guide
regulates all authorship.
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To put together a masterful submission, you don't
have to have a fancy eCTD template kit, but you
can make sure your submission documents conform
to a standard format and style wherever
possible. The same grammatical, punctuation,
numbering, abbreviation, and text conventions
should be practical by all writers working on the
submission and should understand how to preserve
the dignity of the underlying document's
formatting and styles. Because of all the data
and scientific weight in the submission, this may
seem like a minor detail.
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Still, a polished, well-written, regularly
formatted application package that conforms to
current regulatory document requirements goes a
long way to the success of a submission. ENTER
YOUR STUDY DATA To get all your early-phase data
entered, queried, cleaned, and locked, do not
wait until Phase 3. It will save many
headaches, later on, to get an early start on d
ata management and free up time to emphasis on
other tasks as the NDA submission date approaches.
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If the data is locked, you can start producing
study-specific tables, listings, and figures to
help study reports and summaries inside the
NDA. REQUEST A PRE-NDA MEETING Your primary
late-stage opportunity to get feedback from the
FDA on your request is the Pre-NDA meeting. As
such, you must put a lot of thought into the
topics of discussion you want to raise and
ensure that the questions you pose are
straightforward, well-supported, and placed to
allow the FDA to make a meaningful response.
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Suppose any particular elements of your program
or submission may affect successful filing or
review and have not been addressed through
previous interactions. In that case, it is now
time for the FDA to discuss them. Prepare your
claims and your "Plan B" well in advance and
consider the possible impacts of both of these
on your submission's content and deadlines from m
edical w riting solutions.
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ESTABLISH REALISTIC TIMELINES FOR EVERY
ASPECT Communicate deadlines and obligations, and
follow-up stakeholders and participants.
often, to all relevant
The overwhelming amount of information that needs
to be obtained, processed, interpreted, and
shared inside the NDA should be careful in the
timelines. Establishing an NDA "tracker" is one
of the easiest ways to do this. The most
important thing if the tracker is part of a
sophisticated software package specifically
designed for regulatory submissions, a simple
spreadsheet, must contain some crucial and
actionable submission information.
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It requires listing constituent documents with suf
ficient granularity, the parties involved, each
document's current status, and the due dates.
ALLOW AT LEAST A MONTH FOR PUBLISHING YOUR
SUBMISSION Publishing timelines are often
looking at as something that can be dense if
"more critical" tasks such as authoring or
scientific review take longer than
planned. However, it can sometimes cut to publish
timelines, mainly if study reports and
different NDA parts are being firm up as you go.
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It is important not to underrate the vast amount
of effort and time involved in setting up a
proper submission. Even with leading-edge
technologies, publishing needs a considerable
amount of time, not to mention quality control
activities and final validation of the request,
to ensure consistent document formatting,
hyperlinking, bookmarking, and arrangement
within the eCTD system. Publishing timelines
should be compressed with care, prospectively
wherever possible, and in close contact with the
publishing team at all times.
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TAKE THE BIG PICTURE TO GUARANTEE A GOOD
SUBMISSION Take a minute to consider the picture
of what it takes to confirm a good proposal,
whether this is your first NDA or just one of
many that you've done. Pulling an NDA together
is a vast undertaking that takes considerable
time and effort to complete an
investment. Consider your organization or
institution's resources and skills and the
internal ability to execute the necessary tasks
in your desired timelines, and then make a
reasonable assessment of whether additional
support is required.
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Conclusion
Pepgra offers several scalable services to help
our clients yield high-quality, compliant NDA
submissions. Suppose you are thinking of
outsourcing your whole NDA. In that case, you
need a partner to assist with publishing and
submitting. Even if you have just one or two
papers that may benefit from an accomplished
clinical pharmacology expert's examination,
Pepgra will help regardless of your need along
with R egulatory Writing Service in Clinical
Research.
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