Gaspar, Rogério Sá --- "Therapeutic Products: Regulating Drugs and Medical Devices" [2010] ELECD 722; in Hodge, A. Graeme; Bowman, M. Diana; Maynard, D. Andrew (eds), "International Handbook on Regulating Nanotechnologies" (Edward Elgar Publishing, 2010)

Book Title: International Handbook on Regulating Nanotechnologies

Editor(s): Hodge, A. Graeme; Bowman, M. Diana; Maynard, D. Andrew

Publisher: Edward Elgar Publishing

ISBN (hard cover): 9781848446731

Section: Chapter 14

Section Title: Therapeutic Products: Regulating Drugs and Medical Devices

Author(s): Gaspar, Rogério Sá

Number of pages: 30

Extract:

14 Therapeutic products: regulating drugs
and medical devices
Rogério Sá Gaspar


14.1 TRENDS AND TENDENCIES IN DRUG
DISCOVERY, PHARMA PIPELINES AND
STRATEGIES

The forward march of innovative technologies is changing the context for
pharmaceutical development. Integration of diagnostics and therapeutic
approaches is raising new possibilities in medical treatment, along with a
number of innovative medicinal products for clinical use, including mono-
clonal antibodies (and their fragments), targeted chemical entities and new
drug delivery systems including nanopharmaceuticals (liposomes, nano-
particles and macromolecular or polymer-conjugates) (Duncan, 2003a,
2003b; Duncan et al., 2006; Peer et al., 2007; Bawarski et al., 2008).
Scientific integration between emerging technologies and the ability to
benefit from converging sciences raises the possibility of bringing better
medicines faster to the market and looking at improved ways to solve pre-
viously unmet clinical needs (European Science Foundation (ESF), 2005).
At the same time, a wave of scientific optimism is facing obstacles
arising from late developments in the organization and business models
of the pharmaceutical industry. Difficulties arise from limited financial
support aimed at savings in copayment systems (public or private) which
increase the pressure for generic drugs. Additional pressure originates
from the need for proof in adequately established pharmacoeconomics
research studies looking at comparative therapeutic added value of new
medicines and new health technologies (National Institute for Health and
Clinical Excellence (NICE), 2002).
In recent years major trends in drug discovery have looked at the
complex networking of research organizational and strategic options. The
classical approach, followed ...