rors, early and often engagement
of my regulatory staff occurring
plan line items for claim support
How early should regulatory be
involved in the marketing/sales
process, and to what extent?
LISA GRANEY: Again early in
the process, when messages are
being crafted, will help a great
deal to improve the efficiency of
reviews;of;collateral.;Understand-ing the entire campaign and the
key messages is critical. Even if
this is so early that the key mes-sages;haven’t;been;defined;fully,
regulatory might be able to suggest that a particular message is
easier to support than another, or
another. It’s informal at this point,
and regulatory must have an open
mind and listen.
ANDREW STOREY: Absolutely.
Right from the beginning. The real
should commercial get involved in
varies from company to company and product to product, but
in general, the earlier the better.
study designs are critical for obtaining the most valuable commercial asset upon approval.
ROBERT GUZMAN: Yes. The
earlier the better, because only RA
presumably have never worked
to bring in RA as soon as we start
discussing claims and the indica-
tion for the product. It is in this
phase where we know what test-
development of claims presents its
own challenges, as a simple dele-
tion or addition of a word may
have a serious impact on the regu-
latory submission or prescription
for the product. These changes
could represent millions of dollars
in product launch strategy due to
additional clinical trials or testing
if not carefully evaluated.
GARY BARRETT: Cost is in-deed;a;major;factor.;Regulatory
submissions are dictated by what
sales and marketing wish to sell.
The process of feasibility should
include a consideration or market
potential in direct comparison
to the costs of registration. For
instance, a simple registration
depending on the desired claims. If
a pediatric market, the difficulty
of registration changes dramatically. It is important that all groups
involved are aware of the implica-tions;of;the;claims;matrix.
How can regulatory help ensure
that launches are planned and
timed to allow for proper regulatory review, so that changes can
be made in sufficient time?
GARY BARRETT: The design
process needs to include a consideration of all aspects of product
development. Regulatory is only a
part of the process, research and
development, sales and marketing,
quality,;etc.;should;all;be;consid-ered and factored in to the process.
ANDREW STOREY: Right. It is
a company-wide effort to ensure
that launches occur with success.
Regulatory needs to ensure that
they have the right people with the
right talent on the program.
LISA GRANEY: One: setting up
a claim support process with sales
and marketing; Two: being highly
engaged in the early planning pro-cess,;Three:;knowing;when;major
product launches, academy meetings, and other critical opportunities to the business are occurring,
so that they can block and priori-tize time for reviews in the weeks
leading up to the meetings.
ROBERT GUZMAN: Most regulatory submission processes have
a statutory cycle or impose a
response time by the regulatory
cycle may be interrupted when
regarding the submission. When
there is not an established cycle,
the regulatory agency may be
able to provide an answer on how
long some processes may typically take. The RA function may
be able to provide time input to
the agency continuously. We have
what is called pre-meetings. These
These meetings may not be limited
to RA, and other key functions
could be invited. Certainly, these
meetings are a forum to discuss
approval timeliness and the minutes can be shared with management once back in the office. The