Scrip 100 December 2008

POLICY & REGULATION
The expert third party
Communication gaps between innovator pharma and the key European
medicines regulators created a need for a different type of consulting ﬁ rm,
Professor Kjell Strandberg, chair of the NDA Advisory Board, tells Pete Chan
Q.
submission strategies with the aim of securing
Why was the NDA Advisory Board
PROF KJELL STRANDBERG
quick and positive drug application assessments
established?
at European level.
Having Advisory Board members from
First off we recognised that there was no
industry as well as ex-regulators helps us
independent group of former EU regulators
to understand the pharmaceutical sector’s
available to provide the pharmaceutical
different pressures and to navigate a path
industry with advice on strategy and their
forward. In particular, the Board can help
development programmes. We decided that
clients to take a more objective view of their
such a group should comprise leading experts
own development projects. In this way the
in regulatory affairs who had previously
Board provides a forum that can deal with the
occupied senior positions in European
types of questions that clients can’t ask the
regulatory authorities, or alternatively in
regulators, as well as providing the answers
industry.
that the regulators can’t give them.
The diverse mix of European expertise that
The Board can also offer a highly qualiﬁ ed
we have created at NDA should be helpful in
second opinion on how best to handle
bridging the communication gaps that currently
sensitive issues with currently marketed
exist between regulators and the industry.
products and to give neutral advice at times of
NDA’s ultimate objective is to help its clients
to improve their drug development strategies
crisis management. Of particular importance is
such that they meet the needs of both
the internal quality assurance by non-involved
regulators and patients.
members of the Board of all project reports.
Q. When was this concept launched?
Q. What are your current expansion
plans?
NDA was established as a regulatory affairs
consulting ﬁ rm back in 1997. The ‘Advisory
Today we already have a client base ranging
Board concept’ was created around 2001 and
from start-up ﬁ rms and SMEs to 70% of
we went public with it in 2002. We started out
the world’s top 20 global pharmaceutical
small; in November 2003 there were just four
companies. The NDA Group is also expanding
of us on the Board, but we have grown steadily
its services with a particular focus on the types
since then into a nine-member team working
of areas that are of strategic importance to its
out of ofﬁ ces in eight European countries.
clients.
All Board members are experienced former
From an industry perspective, for
regulator and/or industry scientists, and as
instance, there is an increasing number of
such, are capable of giving strategic advice that
biopharmaceutical products in development,
reﬂ ects the latest thinking and decision-making advanced therapies are becoming more
practices of the various regulatory authorities established, risk management and quality
in Europe. The NDA Group, with its ofﬁ ces assurance have risen to the top of the agenda,
in Sweden, the UK and Germany, provides and in Europe, the paediatric medicines
additional regulatory, industry expertise and regulation is raising some major challenges
full regulatory functions. A network of external for companies and regulators alike. We have
experts located in both the EU and the US has responded to these trends, establishing
also been established. business units and recruiting expertise to the
Advisory Board to help us address these issues.
Q. What does the NDA Advisory
Board do? Q. What improvements would you
welcome in the regulatory environment?
The NDA Advisory Board represents an
independent third party that can objectively
We strongly support the EU Innovative
review clients’ projects, very often at phase Medicines Initiative and the US Critical
transitions. The Board effectively functions Path Initiative and look forward to the
as a strategic partner for clients wanting harmonisation of criteria for validation of, for
to optimise their development plans and example, biomarkers. We expect many more
70
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