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
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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."
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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.
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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.