INNOVATION MODELS IN THE BIOPHARMACEUTICAL SECTOR - Innovation in the Biopharmaceutical Industry - page 7

MONOCLONAL
ANTIBODIES

PHARMA
APPLICATIONS

CHEMICAL
APPLICATIONS

PLANT
BIOTECH

ANIMAL
BIOTECH

DIAGNOSTIC
KITS

Genetic Engineering

THIRD GENERATION BIOTECHNOLOGY

MOLECULAR
BIO. & DNA

Vaccines Single Cell

Protein

Antibiotics Enzymes

Microbiological Revolution of late 19 th & early 20 th Century

SECOND GENERATION BIOTECHNOLOGY

Use of
Enzymes

Alcohol
Fermentation

INCREMENTAL
KNOWLEDGE
OF MICROBIO.

Cross
Breeding

Stone Age Empiricism

FIRST GENERATION BIOTECHNOLOGY

Fig. 2. Long waves of bioscience innovation. Source : After Sharpe M. et al . (1994)

The second of these factors, namely the constant upgrading of government
agency standards to ensure the safety and efficacy of new products, has had a major
impact on the pharmaceutical innovation process. The changing regulatory envi-
ronment, with more stringent safety and efficacy requirements, has prompted the
pharmaceutical industry to respond with sophisticated strategies for managing the
R&D process more efficiently, and submitting final dossiers for new products in time
for regulatory approval. These strategies include the development of new capabili-
ties based on interdisciplinary teamwork, as well as highly specialised competences
for managing the innovation process across an international array of contributors.
This approach exemplifies a progression towards Rothwell's (1992a) “four genera-
tion” model. However, despite the efficiency gains that have been achieved, the time
from conception to market has changed little over the past 20 years (8-12 years),
while the costs of development have continued to escalate (Di Masi, 2003).
There is now a trend towards more sophisticated links to external suppliers and
customers. “In-house” pre-clinical and clinical development activities now involve
clusters of external research contractors, clinical research management organisa-
tions and clinical research units in hospitals.
Advances in the fundamental understanding of bioscience at the molecular level
in recent years have all the hallmarks of a “technological revolution”. Sharpe et al.