Biomedical Engineering Reference
In-Depth Information
Major changes in this modus operandi occurred between 1990 and 2000, leading
to the emergence of a post-2000 model, as illustrated in Fig. 6.
The key features of this model are:
1. A more complex pattern of international contractual relationships in the front
end research phase, and a widespread belief that even “in-house” research units
should be limited in size.
2. In research, signs that geographical clusters are giving way to open global
research networks.
3. The pressure to speed up development through parallel processes and pragmat-
ically outsourcing preclinical and clinical development have intensified, lead-
ing to more creative approaches to internationalising them to achieve greater
efficiency.
4. Despite the substantial international harmonisation of regulatory requirements
for market access, negotiating the content of dossiers and achieving actual
approvals remains an unpredictable and high-risk process.
5. Outside of the USA, effective market entry requires diverse and often opaque
forms of price negotiation and approval by state institutions or appointed surro-
gates. Particularly in Europe, downward cost containment pressure on prices has
Product
Development
Market
Approval
Market
Diffusion
Research
Clusters
& Networks
Higher Technical Demands
— bigger/better trials
USA
EU
Hospitals
Pre Clin .
FDA, EMEA
Approval
Package
Pre Clinical
Development
Clinical
Development
Asia
Pacific
Reimb/Price
Authorities
Contractors
CROs
Lat Am.
RoW
Universities
SOs/SMEs
Stronger Payer Cost
Containment Controls
Corporate Activities
Market Globalisation
Fig. 6.
The post-2000 model of pharma innovation.
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