Queensland Life Sciences Industry Report 2012 (PDF, 3.5MB)

Queensland Life Sciences Industry Report 2012
30
4.3.3 Queensland Companies with Products
in Clinical Development
Development of new therapeutic products and devices is
a heavily regulated process that involves a clinical phase
of development during which product safety and efficacy
are assessed. The Australian New Zealand Clinical Trials
Registry (ANZCTR; www.anzctr.org.au) is one source of
information on clinical trials conducted in Australia.
The registry includes trials involving pharmaceuticals,
alternative and complementary medicines, medical devices,
treatments and rehabilitation therapies. Across all the
relevant sectors (Table 15) at least 32 clinical stage
products were identified as being under development
by QLS companies.
For pharmaceuticals, vaccines and biologics the
development process is lengthy (10 – 15 years), expensive
and heavily regulated. The expense is related to the
capitalised cost of new drug approval, including the cost
of all failures, which is estimated to be $1.3 billion. 11
Regulation can occur through regulatory bodies, such as
the Therapeutic Goods Administration (TGA), United States
Food and Drug Administration, and the European Medicines
Agency. Discovery and preclinical stages are followed by
three distinct pre-market clinical trial phases (Phase I,
II and III). Based on data from the survey, at least seven
therapeutics under development by Queensland companies
are currently in clinical development. Six of these had
reached clinical proof of concept stage (Phase II, III). An
analysis of ANZCTR identified a further two clinical trials of
pharmaceuticals/vaccines or biologics being undertaken by
Queensland companies in 2011/2012.
TABLE 15: Number of products in clinical development by Queensland companies
Complementary medicines undergo clinical development
to demonstrate efficacy. ‘Registered’ complementary
medicines have been evaluated by the TGA Office of
Complementary Medicines for quality, safety and efficacy.
‘Listed’ complementary medicines require only that the
sponsor hold evidence to support efficacy. While survey
respondents nominated six products in clinical development,
an analysis of ANZCTR identified a further seven clinical
trials of alternative or complementary medicines being
funded/sponsored by Queensland companies in 2011/2012.
Medical devices are regulated by the TGA Office of Devices,
Blood and Tissues. Medical devices require appropriate
clinical evidence to demonstrate the device conforms to the
applicable provisions of the essential principles of the TGA.
Survey respondents developing medical devices identified
five medical device products at the clinical trial/testing stage
of development. A further three products from Queensland
companies are in clinical development in 2011/2012,
according to ANZCTR.
Animal health products, including veterinary health
products and veterinary chemical products, are regulated
in Australia by the Australian Pesticides and Veterinary
Medicines Authority. Regulatory requirements differ
depending on the type of product, target species (companion
animal vs. food producing animal) and whether the active
ingredient is new or already registered. The regulations
regarding the manufacture of animal health products
and their preclinical development (preclinical safety and
toxicity) have considerable overlap with those for human
pharmaceuticals. Although much less extensive than human
clinical trials, veterinary clinical trials also examine safety
and efficacy in target species. Two veterinary products were
reported by survey respondents to be in clinical development
in 2011/2012.
Sub-sector Survey data Registry data Total
Pharmaceuticals, vaccines and biologics 7 2 9
Complementary medicines/ Functional Foods and Nutraceuticals 6 7 13
Medical devices 5 3 8
Animal Health products 2 0 2
Total 32
11 Tufts Centre for the Study of Drug Development. http://csdd.tufts.edu/news/complete_story/pr_outlook_2011; accessed 10.12.12