BiopharmingInformed risk assessment

Joanna Goven

Talking Biotechnology, Wellington, 29 Nov-2 Dec 2005

Project home and funding

Part of the FRST-funded Constructive Conversations project (2003-2008) PI: Rosemary DuPlessis (2003-2005)

Joanna Goven (2006-2008)

Animal biopharming MA began March 05

Some other project research began as of July 05

Most will begin Jan 06

Runs until mid-2008

What is biopharming?

Expansive definition: growing plants and animals as vehicles (‘bioreactors’) to produce: Substances to be used in the medical treatment of

humans [and other animals?] This could be non-GM (bioprospecting), but most

is GM Extracted from (rH lactoferrin) or delivered by

(vaccine bananas) the plant or animal Can include organs for (xeno-)transplantation

Food that offers ‘extra’ health benefits (‘functional food’)

Distinction is blurry (‘health supplement’)

Why biopharming?

Heralded by biotech industry and associated scientists as: Moneymaker (get some of those pharma $)

Rests on assumption that using plants and animals as bioreactors will prove to be cheaper than lab-based production

‘Once commercial-scale expression is established in transgenic plants or animals, scaling up production is as simple as planting more crops or breeding more animals. …“If Enbrel were produced in corn, [Immunex] could have just planted more acres, which would have been much less expensive than building new, larger facilities”’

‘Thomas Newberry, vice president of Corporate Communications at GTC Biotherapeutics suggests that establishing a commercial production herd of the company’s transgenic goats could be done at around a tenth of the cost of building a commercial cell-culture facility, with companies able to assess market demand—and scale-up production appropriately—with each new breeding cycle.’

Why biopharming?

Heralded by biotech industry and associated scientists as: Moneymaker (get some of those pharma $)

Rests on assumption that using plants and animals as bioreactors will prove to be cheaper than lab-based production

Overcoming public resistance to GM crops Belief that resistance is due to ‘no consumer

benefit’ of ‘first-generation’ GM crops Belief that ‘cheaper’ drug production will be seen

as consumer benefit

Why biopharming?

Heralded by biotech industry and associated scientists as: Moneymaker (get some of those pharma $)

Rests on assumption that using plants and animals as bioreactors will prove to be cheaper than lab-based production

Overcoming public resistance to GM crops Belief that resistance is due to ‘no consumer

benefit’ of ‘first-generation’ GM crops Belief that ‘cheaper’ drug production will be seen

as consumer benefit Humanitarian

Vehicle to deliver medicine and extra-nutritious foods to 3rd world

Why biopharming?

Heralded in NZ as the way forward:

“There has been slow progress in agricultural biotechnology due to resistance to genetically modified seeds and biopesticides. Highest returns are likely to be in the use of crops in non-food applications such as pharmaceuticals.” –NZTE, 200?

“The development of transgenic animals for the production of pharmaceuticals …is a logical outgrowth of the country’s outstanding animal health status and vast experience in breeding… The use of transgenic animals to generate large amounts of human-protein-based drugs is a natural fit for New Zealand…The development of transgenic cattle represents an enormous opportunity for New Zealand.” –rept commissioned for Industry NZ, 2003

Why biopharming?

Definitely on the agendas of CRIs and science entrepreneurs in NZ, e.g., PPL sheep

AgResearch cows, machs I and II

Crop and Food potatoes

The Research: Grand goal

To enable improved risk-assessment decisions and decision-processes for 1/ plant biopharming; 2/ animal biopharming; and 3/ nutrigenomics and functional food.

Approach

Focused more on public’s knowledge than public’s views or values

Focus on importance of social practices for understanding risk

Social practices can be source of risk in conjunction with the technology and can be put at risk by the technology

Relevant social practices are widely distributed; knowledge of those practices is widely distributed

Most of this knowledge is not utilised in the regulatory (risk-assessment) process

Goal is to elicit knowledge of social practices implicated by biopharming

‘Method’

Scope the terrain: Where is it now and where is it going? What is driving it? What concerns have already been raised (here or elsewhere)?

Identify likely concentrations of knowledge of social practices relevant to key biopharming applications in NZ

Develop ‘translational’ materials: Explain socially meaningful aspects of technology briefly and

comprehensibly Suggest how their knowledge might be relevant (not what their

knowledge is).

In order to: Enable the interview participants to identify the knowledge they have (and we don’t) that is relevant to the subject (e.g., production of biopharm milk), particularly when the subject has not yet entered the public arena in a significant way.

Streams

Plant biopharming PMPs

Functional foods

Animal biopharming Pastoral

Aquaculture

Marine biopharming/Māori

Multidisciplinary approach; transdisciplinary aspirations

Social practices Political-economic and cultural context Key biosafety issues Trade impacts

Integrated transdisciplinary assessment of social, cultural, economic and biosafety risks associated with biopharming in the New Zealand context

Regulatory and governance implications

International collaboration

University of British Columbia, Centre for Applied Ethics: Democracy, Ethics, and Genomics Programme Indigenous communities’ experiences and strategies

(salmon/marine)

Social research and public engagement on biotechnology issues

BiopharmingInformed risk assessment