Living Cell Technologies, a cell implant company based out of Australia and New Zealand, appointed Dr Paul Tan as its chief science and medical officer (CSMO) in December 2012. Dr Tan, who takes over the role of CSMO from Emeritus Professor Bob Elliott, the co-founder and acting CSMO of the company since June 2012, will essentially lead Living Cell Technologies' clinical trial programs for Diabecell and Ntcell , proprietary treatment candidates for type 1 diabetes and neurodegenerative diseases, respectively.

Dr Tan, who has more than 18 years of experience in senior roles in the biotechnology industry, is also the chair of NZBIO, the bioscience industry organization of New Zealand. He has led R&D teams into clinical trials in the US, UK, New Zealand, Philippines, Brazil and Russia. He has managed relationships with regulatory bodies, including Medsafe of New Zealand, the US FDA and the Center for Disease Control, in the US. In both his executive and consulting roles, Dr Tan has secured substantial government and private investor funding for the research and development of therapeutic products and has successfully transferred multiple therapeutic products into a GMP manufacturing environment.

In an email interview with BioSpectrum, Dr Tan talks about his new role at LCT and his experiences in working with the regulatory bodies of various countries.

As the new chief science and medical officer of LCT, what will be your immediate focus?
My focus is to make sure the clinical targets for the two leading products, Diabecell for type 1 diabetes and Ntcell for Parkinson's, are met. There is much innovative research and technology transfer involved when a product moves from phase I/II towards phase III, especially in the upscale production of a novel product. The company has allowed me to hire new staff experienced in technology development.

The clinical and regulatory team is being expanded as later stage clinical trials in diabetes are conducted in multiple centers. As we have moved Ntcell from preclinical project into clinical development, the preclinical R&D team is excitedly selecting the next therapeutic candidate to develop.

Tell us about the Diabecell and the Ntcell clinical trial programs and how you plan to take them further.
Diabecell is the world's first product comprising pig pancreatic islets coated in alginate. It is implanted into the abdomen of people with severe type 1 insulin dependent diabetes. In the trials we have done so far, the patients have experienced some reduction in the amount of insulin they need to inject and their overall glucose control has improved, as shown by their HbA1c reducing. But the most dramatic improvement has been a reduction in the number of unaware hypoglycaemic events that the patients experience.

Unaware hypoglycaemia can be life threatening. It occurs when a patient's blood glucose falls to dangerous levels without the patient having any sign or symptom that this is happening. The patient suddenly loses consciousness, and if glucose is not given immediately, for example because the patient is on their own,they can die. For patients that experience them, unaware hypoglycaemic events are very distressing for themselves and their families. The patient tends to limit their activities for fear of an unaware hypo occurring, say, when they are driving, and their quality of life is affected significantly.