Biomedical Engineering Reference
In-Depth Information
final section will provide a brief sketch of the bench to bedside
journey for Ozurdex
®
(dexamethasone intravitreal implant
0.7mg;Allergan,Inc.)whichisapprovedforuseinboththe
US and the European Union (EU).
2 A Successful Drug Development Process
In general, the drug development process proceeds from explor-
atory analyses of new compounds, through preclinical and clinical
testing of promising drugs, to application for marketing approval
in one or more markets (Fig.
1
). Although the application for
marketing approval is the final step, drug developers should begin
familiarizing themselves with the requirements for obtaining
marketing approval and begin communicating with the relevant
regulatory agency(s) as soon as a compound is identified as
“promising” [
1
].
Both the US Food and Drug Administration (US FDA) and
the European Medicines Agency (EMA) provide detailed guidance
on the nature of the preclinical and clinical studies that should be
conducted during the drug development process in order to sup-
port a successful application for marketing approval. The specific
requirements differ depending on the type of therapeutic and may
change over time as regulations change, so it is important to
consult with the relevant agency(s) early and often as drug devel-
opment proceeds. This should start with a visit to the relevant
agency website while the candidate drug is still in preclinical devel-
opment [
2
,
3
]. In Europe, there are three pathways to marketing
approval (described in detail below) [
4
] and drug developers
should begin considering which will be the most appropriate path-
way for their drug long before the drug is ready for early clinical
testing, so that consultation with the most appropriate contacts can
begin as soon as appropriate.
In addition, the regulatory agencies in the US, EU, and Japan
have been working through the International Conference on
Harmonisation (ICH) to develop consensus guidelines (on drug
quality, safety, efficacy, and medical terminology) that are accept-
able across agencies so that developers can bring quality therapeu-
tics to market in a more resource-efficient manner [
5
]. The FDA
and EMA also offer the opportunity for drug sponsors to request
“parallel scientific advice”—in the form of a teleconference or video
conference with representatives from both agencies—on aspects of
study design that could be critical to achieving marketing approval
[
5
]. The importance of taking advantage of all available guidance
and opportunities for early communication with regulatory agen-
cies cannot be over-emphasized.
