Our March seminar on Emerging Bio-technologies was organised by CETC Chairman, John Read and featured 3 speakers from 2 companies active in the area of stem cells.

Wesley Randle, Business Development Associate of Novathera Ltd – Novathera is a spinout from Imperial College (2003) and specialises in regenerative medicine.  They are a developmental company in Biomaterials and Stem Cells and are about to start generating commercial revenues.  Wesley took us through the list of products that Novathera are developing within its two ranges-Biomaterials and Stem Cell Technologies. TheraGlass is an anti-inflammatory antibiotic that incorporates glass-like particles that can be used to repair wounds and bones as well as for cosmetic regeneration and as a tissue scaffold. Stem cell products are difficult to culture in a robust manner. NovaThera leads a £3.2M DTI funded program to demonstrate proof-of-concept for industrial scale-up with the Theramachine which allows for automatic feeding and monitoring of stem cells, thereby reducing the amount of skilled human resource required.  The products are used for such applications as lung regeneration and in the creation of fibreblasts (Dermal fillers or regenerators).

The largest problem they have found is defining the cellular products for the purposes of approval.  Efficacy, Indication, Active Substance, Mode of Action, Delivery, Toxicology, Manufacturing and IPR freedom, are some of the categories under which new products are judged, and in many cases this is increasingly difficult to define given the novelty of the product.

George Schlich, UK and European Patent Attorney for Stem Cell Sciences plc. (SCS) – George explained how important it was to ensure that companies such as SCS had their Intellectual Property Rights (IPR) protected by Patents as they are the primary means of gaining funding in the initial stages of a development but also a means of generating income through licensing and important for cross-licensing to obtain rights to use technology from other companies.  George took us through a number of patents that had been obtained by SCS, starting with the ‘Edinburgh Patent’, filed in 1994, which patented globally a method of stem cell selection.

There are various problems in obtaining patents relating to human stem cells. The EU does not allow patents for human embryonic stem cells nor for cells derived from such cells and insists that all patents comply with the EU Biotech Directive.  The human body itself is not patentable, but if a substance can be isolated from the human body then this can be patented.  However there are overriding provisos.  The product will be unpatentable if it is immoral – i.e. if it involves the cloning of humans, the modification of germ-line identities, the use of embryos for commercial purposes or involves the modification of the genetic identity which could cause suffering.  A fundamental hurdle that needed to be crossed by SCS in the very early stages was convincing the patenting authorities that stem cells existed in all animals, as the basic proofs for the patent applications were made from testing on mice.

It was clear from George that the creation and defence of IP is an integral part of the commercial success of SCS, and any other company in this area.

Tim Allsopp, Chief Scientific Officer for SCS – Tim gave us a brief history of SCS, as the only global stem cell company, having offices in Edinburgh, Japan (Kobe), Melbourne and recently San Francisco.  He felt that SCS was different because of its fundamental stem isolation and growth technologies, its broad diversity of ethically sourced human stem cells, its integrated discovery and innovation process and its quality lab and assay production speciality.

The company has 4 main business units; SC Proven (direct sales of cell media culture), SC Licensing of its IP for drug discovery, SC Services for contract production of customised cells for pharma R&D and SC Therapies for the development of cell-based gene and tissue therapies.  SCS has found that involvement in collaborative research, as in the EuroStemcell Project, is highly appropriate for the growth of the companies products, as it provides the company with value and flexibility.  The research within the EuroStemcell Project involves the creation of multi-potent, self-renewing and homogeneous cells that can produce neurons and other key cells.  The hope is that they could be used to treat Parkinson’s Disease, Epilepsy, Cerebral Ischemia among others.

The challenges for SCS, relate to patentability of discoveries and inventions, commercialisation of their various products, processes and developments, the adoption of public and private partnership to mitigate risk, enhance value and deliver economic benefits, monitoring society and patient groups in addition to developing flexible products and revenue generating strategies. Lastly that it will be important to educate the public of the benefits of stem cell technology to change perceptions and improve the profile and market value of such companies.

The evening finished with a lively and informative Q&A panel session and our thanks are due to all of the speakers for their contributions.

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There are also other companies who give us generous help with specific meetings and services.

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