GMW:_Pharma_plants_for_UK_and_Europe!

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> GMW:_Pharma_plants_for_UK_and_Europe!

> " GM_WATCH " <info

> Mon, 12 Jul 2004 16:19:39 +0100

 

>

> GM WATCH daily

> http://www.gmwatch.org

> ------

> Here comes the latest variant of the bad idea virus.

>

> Just when you thought you'd seen off genetially

> engineered food crops, here comes the next line of

> attack - pharma plants!

>

> Even the players are familiar: Phil Dale who worked

> so hard to bring us GM food plants, Paul Christou

> who was at the forefront of the attacks on Ignacio

> Chapela over his maize contamination research, and

> Julian Ma who has been at Peter Lachmann's shoulder

> in the attacks on the BMA etc.

>

> 1.Medical Experts Plan GM 'Pharming' Project

> 2.JIC info on pharma project

> 3.Pharma-Planta Consortium - the players

> -------

> 1.Medical Experts Plan GM 'Pharming' Project

> By Tim Moynihan

> The Scotsman, July 12, 2004

> http://news.scotsman.com/latest.cfm?id=3192422

>

> Scientists across Europe, including Britain, are to

> explore the possibilities of producing

> pharmaceuticals grown in genetically modified

> plants, it was announced today.

>

> The European Union has awarded 12 million euros

> (GBP8 million) to a network of experts in 11

> European countries and South Africa and they aim to

> begin human trials of the drugs within the next five

> years.

>

> The aim of the " pharming " project is to use plants

> to produce vaccines and treatments against major

> diseases including Aids, rabies, diabetes and TB.

>

> The consortium, called Pharma-Planta, will develop

> the concept from plant modification through to

> clinical trials.

>

> Its scientific co-ordinator, Professor Julian Ma,

> from St George's Hospital Medical School, London,

> told reporters: " We recognise that this is

> contentious technology, but I think many of the

> fears are unfounded.

>

> " We want to address these issues and show that we

> can overcome them in a safe manner. "

>

> And he added: " There is a cost to not doing

> anything.

>

> " Millions of people are dying from what are

> essentially preventable diseases every year. I'm not

> aware GM crops have ever caused anyone to be

> unwell. "

> ------

> 2.JIC info on pharma project

> [this was obtained from the john innes centre]

>

> The European Union has funded research by a

> consortium of scientists from academic and

> industrial institutions in the area of " Plant

> platforms for immunotherapeutic biomolecule

> production " , under the Framework 6 programme

>

> This consortium aims to build a plant based

> production platform for pharmaceuticals and to enter

> the first candidate pharmaceuticals into human

> clinical trials. The programme will develop robust

> risk-assessment and risk-management practices based

> on health and environmental impact,

> and will work with EU regulatory authorities to

> ensure safety and acceptance.

>

> Plants have enormous potential for the production of

> recombinant pharmaceutical proteins as they are

> inexpensive and versatile, amenable to rapid and

> economical scale-up. The use of GM for the

> production of pharmaceuticals has precedents, such

> as human insulin and hepatitis B vaccine, but plant

> derived materials used in humans have not been

> formally addressed within the EU. A major goal will

> be to address the necessary biosafety and regulatory

> requirements for the use of plant derived

> pharmaceuticals through a process of engagement and

> consultation with regulatory bodies involved in GM

> plants as well as new medicines.

>

> The consortium partners represent many of the major

> laboratories in Europe focusing on the creation of

> transgenic plants that express important

> pharmaceuticals for human health. Collectively, the

> consortium has a wide range of expertise spanning

> the areas of molecular biology, plant biology,

> immunology, recombinant protein expression

> technology, vaccinology, plant biotechnology, risk

> assessment and IP management. This proposal is a

> unique opportunity to make an impact on global

> health through the responsible development of plant

> biotechnology.

>

> JIC's role in this project is to develop and improve

> methods for protein expression in plants and to

> assist in exploring biosafety issues associated with

> responsible production of pharmaceuticals in plants.

> ------

> 3.Management and Organizational Committees in the

> Pharma-Planta Consortium

> http://www.pharma-planta.org/committees.htm

>

> The size and complexity of the Pharma-Planta

> Consortium means that efficient management is very

> important. The Coordinator of the entire project is

> the Fraunhofer Gesellschaft in Munich, Germany. This

> oversees two management bodies, the Administrative

> and Scientific Coodinators, the former handling

> legal, contractual, financial and administrative

> aspects of project management, and the latter

> handling scientific developments and decisions. The

> administrative and scientific

> management staff form the Executive Committee, which

> meets on a regular basis to discus progress and

> plant the future direction of the project. The

> current members of the Executive Committee are:

>

> Professor Julian Ma, St George's Medical School,

> London, UK - Scientific Coordinator

>

> Professor Rainer Fischer, Fraunhofer IME, Aachen,

> Germany - Adminstrative Coordinator

>

> Professor Paul Christou, Fraunhofer IME, Aachen,

> Germany - Training Coordinator

>

> Professor Philip Dale, JIC, Norwich, UK - Biosafety

> Coordinator

>

> Professor Philip Dix, National University of

> Ireland, Maynooth, ROI

>

> Professor Chris Hawes, Oxford Brookes University,

> Oxford, UK

>

> Professor Mario Pezzotti, University of Verona,

> Verona, Italy

>

> Dr Richard Twyman, University of York, York, UK -

> Project Manager

>

> Dr Kerstin Müller, Fraunhofer Gesellschaft, Munich,

> Germany - Legal Counsel

>

> Dr Max Steiert, Fraunhofer Gesellschaft, Munich,

> Germany - Financial Controller

>

> Other committees, reporting to the Executive

> Committee, deal with specific areas of project

> management. These are listed below with a brief

> explanation of their functions:

>

> Science and Technology Committee. Reviews scientific

> progress, plans future direction of scientific work.

>

> Training Committee. Oversees the PhD programmes and

> training days arising from the project.

>

> Biosafety Committee. Discusses biosafety aspects of

> the project work and advises the Scientific

> Coordinator on biosafety matters and regulatory

> compliance.

>

> GMP Committee. Oversees the production of

> plant-derived pharmaceutical proteins under good

> manufacturing practice (GMP) conditions, essential

> for regulatory approval.

>

> IP Committee. Handles intellectual property issues

> arising from the project and has the impotant role

> of ensuring freedom to operate in developing

> countries.

>

>

>