ventria | Course Paper

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VENTRIA BIOSIENCE AND THE

CONTROVERSY OVER PLANT

MADE

I. Executive Summary

Ventria Bioscience was founded in 1993 by Dr. Raymod

Rodriguez, a biologist on the faculty of the University of

California-Davis. From the beginning, Rodriguez hoped to

incorporate the commercialization of his techniques for

producing pharmaceutical proteins extracted from rice.

The company wanted to create a medicine that could

combat the severity of childhood diarrhea, which is beneficial

for public health, mainly for those in the developing

worlds. Since then, Ventria have tried to implement their

efforts in proposing a plan to plant at least 120 acres to begin

commercial-scale production. But considering the regulations

made by the California Rice Commission and California

Secretary of Agriculture, the company faced multiple issues in

trying to move forward with this decision.

The major problems facing the company include the

concern made by farmers and food companies about the

contamination of their products with the company’s

pharmaceutical proteins and seeking the approval from both

state and federal regulatory. In 2004, the regulatory rules

covering plant-made pharmaceuticals were complex. The

overlap of the rules put in place by the Food and Drug

Administration (FDA), the Environmental Protection

Agency(EPA) and the U.S. Department of Agriculture (USDA), all

made the implementation of biopharming difficult to pursue.

To combat these issues, we recommend that Ventria

quit their current implementation plan and propose a new plan

that provides boundary-crossing departments, so the complex

demands of the external environment are answered. Doing this

will get the public’s opinion in favor of their position on

pharmaceutical crops and the benefits that come along with

them. As a company, it is also important to listen to the issues

that are raised by stakeholders because they are affected by

the organization’s actions, objectives, and policies. Ventria

should take the issues that are raised into consideration and

should provide a report answering all the issues raised by the

stakeholders to improve their company.

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INDEX

I.Executive Summary ___________________________________________ 1

II. Statement of the Problem ________________________________ 3-5

III. Causes of the Problem ___________________________________ 6-7

IV. Decision Criteria and Alternative Solutions ___________________ 8-10

V. Recommended Solution, Implementation and Justification______ 11-12

VI. External Sourcing _______________________________________ 13

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II. Statement of the Problem

Ventria is facing an array of problems as a company. They are an Agricultural BioTech

firm that is involved in two different industries which are causing them to face regulations

from different organizations. Additionally BioTech firms become profitable by spending

years on research and development and then hopefully being able to commercially produce

a product that can is useful to the masses. The industry as a whole creates an environment

that makes it hard for firms to remain in business because they can go years without

actually having any revenue. They can also face internal problems that arise from

management practices. This being because as a Biotech firm you have to choose very

specifically which drugs or medicines you’re going to focus on because it costs a lot to pay

employees and their time has to be allocated to the developments that have the best

chance of producing a commercially viable product. As a whole this company is facing a lot

of adversity, the main problems being regulatory blocks and financial solvency.

Agricultural regulatory agencies are very complex and it can take a long time to be

approved by them for a company to be legally allowed to experiment and study their own

research. Ventria is working on a plant-based medicine that they would create by

genetically engineering a rice plant. Designing plants to produce pharmaceuticals is

subjected to heavy regulation because companies are using crops that are also used for the

production of food to test their research. This can pose the risk of pharmaceutically active

plants becoming mistakenly commingled with or contaminate the human or animal food

supply. One earlier incident, in particular, had highlighted the potential risk. In 2001,

Prodigene, a Texas Biotech company had planted a test plot of corn that had been

genetically engineered to produce a pig vaccine, the following year the same field was

planted with conventional soybeans, which became contaminated by volunteer corn that

had sprouted from the previous season’s seeds. By the time this was discovered the

soybeans had been harvested and stored in a silo containing 500,000 bushels. The

genetically modified corn tainted an entire lot of soybeans which had to be destroyed and

Prodigene was fined 250,000 and had to pay for the cleanup. This can be a long term risk as

you may put years into a crop that could end up having to be destroyed and also cost your

company a fine.

Ventria could be subject to the FDA, the EPA, and the USDA. As stated in the case

study the coordinated framework for these agencies can be easy to describe. The FDA is

responsible for food safety. The EPA is responsible for microbes and pesticides. And the

APHIS is responsible for all plants. In practice, however, it can be very complex because

some products fall into multiple categories. For example, a corn plant that has been