Updated on 23 January 2013
So, LCT's first goal is to bring Diabecell to market which will significantly reduce the risk to life in people who need intensive insulin treatment to normalise their blood glucose. To that end we are aiming to complete clinical trials in this indication by the end of 2015, with the goal of commercializing Diabecell in 2016.
Ntcell is a treatment we are initially developing for Parkinson's, although it is likely it will be useful in a range of neurodegenerative disorders. We have a phase I clinical trial of Ntcell in Parkinson's starting this year, and our R&D team has been tasked with getting Ntcell ready for clinical development in at least two additional indications by the end 2015.
You have experience of leading R&D teams into clinical trials in various countries. How do you find the regulatory environment of Asia Pacific countries?
The regulatory standards in New Zealand and Australia are recognized worldwide. Over the years, the clinical trial regulations in China have become more aligned with international standards. I am aware that many CROs and pharmaceutical companies are conducting trials in Asia. I would expect that as clinical trial centers in the Asia Pacific region continue to demonstrate the quality of data coming out of their centers, it will be clear that new therapeutics may be developed in this region earlier and even enter the Asian market earlier than in Europe and the US.
Do you think the regulatory environments of the countries need improvement? If so, how can the governments streamline the process?
It would certainly boost clinical trial activities in the region if there is some bilateral or multilateral recognition of the process so that clinical protocols approved in one country get a more rapid passage through the approval process.
You are the chair of NZBIO. How do you find the clinical trials industry in NZ and Australia? What are the challenges in bringing research to the market in these two countries?
The Australian clinical trial industry received a major boost from the Australian government with very favorable tax laws and rebates for companies doing research, including clinical trials, there. There is nothing like that in New Zealand.
In New Zealand, there has been a shift from clinical trials that are mostly all phase III and even post registration trials to more earlier stage, phase I and phase II trials. New Zealand is known for excellent centres for early trials of medical devices especially in cardiovascular disease. New Zealand's clinical trials sector has to leverage its small size as an advantage and position itself as a cost effective stepping stone in a larger plan for product development and market entry. This has worked well with LCT's unique product with no competitor cell therapeutic in close range.