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NOTICE

This plan is a dynamic document integral to the development of our company, our business and research strategies, and our products.  Its purpose is to inform and to encourage participation and discussion.  See Appendix 1 for definitions of unfamiliar terms.  Except as otherwise indicated, all references in this document to “we”, “us”, “our”, the “Company”, the “Cooperative”, or “Pink Army” refer to the community that is, collectively, the Pink Army Cooperative.  

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TABLE OF CONTENTS

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If you know both yourself and your enemy, you will come out of one hundred battles with one hundred victories.
 -- Sun Tzu, The Art of War

OVERVIEW

Pink Army's goal is rethink cancer therapeutic development.

Damaged cells are a normal part of life and no amount of prevention, exercise, or dietary care will change the fact that at low frequency some cells will break.  Almost all will die, commit suicide, or be deleted by bodily defenses.  A few will have the right combination of errors to persist.  Some can become life-threatening.

Consider how medicine treats a bacterial infection:  A sample is taken, the organism is purified, and diagnostic tests are run to identify the organism and determine what antibiotics kill it.  The side effects are minimal because bacterial cells are substantially different than human cells; the antibiotics don't affect us much.

Cancer is like an infection with our own cells.  It is difficult to tell the difference between which cells should be killed and which should not.  Current cancer medicines mostly target fast-growing cells, but this is a poor differentiator.  The challenge, then, is to make better cancer antibiotics.  If this can be done, cancer should be as treatable as other infections.

Another challenge is that each cancer is really a different disease.  Cancers arise because the DNA of cell, which can be considered the "operating system", gets corrupted.  Because we all have different DNA, and because the corruption can be caused by many different factors, no two cancers are identical.  It's becoming increasingly possible to detect the differences between the cancerour and normal cells, opening the door to more personalized treatments.  Ideally, each treatment would be customized for each cancer.

This is a major stumbling block for drug developers big or small.   Drug development as it is done today can take over a decade and cost a billion dollars or more to go from initital discovery to a product that can be used by doctors.  That's why Pink Army is working to create a new path for developing cancer therapeutics.  There are four pillars to our strategy.

The first is to focus on individuals.  We intend to work with one person at a time, understanding their cancer as much as possible by performing comprehensive testing, including complete DNA sequencing of their cancer.

The second is to translate this data, plus our growing molecular knowledge of cellular metabolism, into a customized drug.  The therapeutic we will use is called an oncolytic virus.  Essentially, these are viruses that can only infect cancer cells.  They have the advantage that they are modular, so we can mix and match modules to tune for each cancer.  We're developing a process to do design and manufacturing of oncolytic virues that is very rapid and inexpensive, and can also be scaled for high throughput.  It's like an assembly line for customized drugs.

The third is to bring change to the regulatory architecture.  We don't intend to sell drugs to large markets.  Our drugs are meant for one person.  This means years of testing are eliminated because the clinical trial is reduced to one person (the person for whom the drug was designed) and because the Phase I trial is the treatment.  The drug is never mass produced.  Regulators like the FDA and Health Canada will need to establish new guidelines for approvals, so we intend to work with them closely.

The final pillar is economics.  Drugs made in this way have almost no commercial value.  Value comes from information, such as learning how well a particular design performs in laboratory testing and in the clinical trial.  This information is crucial to the design of the next drug for the next person.  We need to create an economic model that supports drug development as a service.

To accomplish our goal, we basically need to create an entirely new drug development pipeline.  This requires making fundamental changes to a large and complex system.  So we're taking a grassroots, open-source approach and organized Pink Army as a cooperative.  This allows us to be far more transparent and collaborative than other biotechnology companies, and to put the people we want to help ahead of profit.  The use of the cooperative structure allows Pink Army to operate in ways no other drug company can.

SECTION 1: CANCER

Cancer as infection

Cancer remains a significant cause of human illness and mortality despite decades of global R&D and billions of dollars aimed at eliminating it.  Why has so little real progress been made?
 
In fact, damaged cells are a normal, everyday byproduct of daily life.  Errors will arise in DNA code of all living things at low frequency, by countless means.  What isn’t common is the persistence of damaged cells in our bodies.  We have astoundingly effective mechanisms to eliminate malfunctioning cells, but over time a few cells inevitably slip through the net.  Although not operating perfectly, they aren’t broken quite enough to die or be eliminated.  Most of these cells are benign, but some continue to degrade and accumulate more errors.  Eventually, abnormal morphologies and growth dynamics will appear and can become life-threatening, particularly if the cells acquire the ability to migrate to other sites within the body.

Diagnostic technologies

In the past, cancer detection often relied heavily on self-identification.  Today, lifetime cancer risk can be estimated with genetic tests and routine screening is becoming both more sensitive and more affordable.  The advancements in diagnostic testing over the last decade has been dramatic and are still accelerating.  Today, the challenge is to translate diagnostic information into more effective therapies. 

Cancer therapies, therapeutics, and therapeutic development

Once a visible, palpable, or metabolically detectable cancer appears in the body, significant ground has already been lost.  When cancerous cells are found, they are usually described by the tissue or primary site they appear in, for example, breast cancer.  The cancer is staged, which involves assessment of how it has spread through the body, which correlates with how invasive it is, and graded, accomplished by microscopic examination of cells.  In general, the more visible damage there is cellular or DNA morphology, the more advanced the cancer.  Visual data and other test data is then compiled and used by oncologists to determine the best course of therapy and the odds of survival, determined by the statistical analysis of historical data.  At this point, the decisions about treatment is based on statistical models.

Surgery remains one of the most effective forms of cancer treatment, with the caveat that the cells must be in a cohesive mass to be removed in this manner.  Excision, when possible, is effectively a cure.  If cells were not in a mass to begin with (eg. leukemia), or are too small to excise, or have metastasized, a systemic (whole body) treatment must be used, such as a chemotherapeutic drug.  Typically, these are broadly toxic compounds that kill fast-growing cells.  They are nonspecific and cause substantial collateral damage to normal cells that grow or divide rapidly – like hair, bone marrow, and the linings of the gut and mouth.  It is often the treatment cancer, not the cancer itself, that can lower quality of life for those with a cancer diagnosis.

Targeting fast-growing cells is a differentiator that dates back to the earliest days of cancer treatment.  For decades, oncologists have longed for “magic bullets”, or antibiotics with greater specificity.  Yet few have entered the clinic, frustrating physicians and their clients alike.

The current drug development pipleline outlined in Figure 1, below.  The pipeline is meant to funnel potential drug candidates through an increasingly stringent set of filters and validation criteria that are meant to identify the safest, most effective compound for a given condition.  Without such filters, the risk is that the public would be sold ineffective or possibly even dangerous therapies.

By the time a compound enters human clinical trials, millions of dollars have been invested in research, pre-clinical studies, manufacturing, clinical trial design, and intellectual property protection.  For economic reasons, most drug developers can advance only a single lead molecule through the pipeline.  Accordingly, they must choose one that best balances the requirements of cancer sufferers, regulators, researchers, manufacturers and investors, while still demonstrating a therapeutic advantage over placebos or other medicines.  Most candidate molecules fail, usually taking the bulk of the invested effort and dollars with it.

One must also appreciate the role of the regulators.  The FDA is the main organization in North America responsible for overseeing drug development and granting approval to developers for the commercial sale of their products.   Its authority is based on the Food, Drug, and Cosmetic act that signed into law in 1938 by Franklin Roosevelt.  This act mandated a pre-market review of the safety of all new drugs, regulated labels, and created inspection and enforcement powers.  Although amended extensively, it remains the foundation of the FDA regulatory authority today.  Other countries have similar organizations to ensure the safety of drugs.  In Canada, therapeutics are regulated by Health Canada.

The economic success of companies (and, often, their continued existence) is directly linked to the outcome of FDA assessments.  Indirectly, FDA decisions affect a significant fraction of the US economy.  Finding a balance between access to medicines, scientifically proven efficacy, and the protection of public good is very difficult.  Technological changes in diagnostics, genetics, and drug manufacture create additional complexities.  The FDA is now under almost continuous reform in its effort to find the best risk-benefit balance in a social and technological environment that is changing almost daily.  Overall, this has led to regulators becoming more conservative and requiring increasingly comprehensive testing before approvals are given.

Overall, the current drug development pipeline has few positive attributes.  Developers must consider drugs mainly for large markets, and portray these in the best light possible to regulators – possibly to the point of obfuscation of data.  It tends to reinforce monopolies, since small developers often sell products in development to established companies rather than face total loss should they fail.  It is also expensive, supporting only a small number of drugs in development globally.  And, finally, it’s slow, typically requiring a decade or more from start to finish – necessary because human tests cannot easily be accelerated or scaled.

Economics of Current Drug Development Pipeline

Drug development is so risky and so expensive that only the biggest companies bring a drug from discovery to market.  With so much at stake and so many stakeholders, only a few molecules per year are approved by the FDA.  Industry data shows the number of drugs produced per R&D dollar over time is at best a flat line.  Using inflation-adjust dollars, the number actually trends lower, indicating pharmaceutical development has actually become less efficient over time.

Significantly, the current development pipeline makes no allowance for market size.  Finer discrimination does nothing to reduce development costs, which drives up the final cost of drugs proportionally.  A drug that can be sold to only 50% of a disease group must be sold for twice the cost to recoup costs.  This makes the development of personalized medicines economically impossible.

Legal trends further cloud the economic outlook.  Regulatory approval does not typically shield developers from legal action if the drug is found to have negative consequences for its users.  If the drug is approved for sale, developers risk class-action lawsuits and loss of revenue in addition the writedowns of past R&D investment.  Because of these dynamics, companies are required to charge the maximum the market will bear for their drugs, to fund future R&D and to create reserves for possible legal action.

Company Management

Founding Directors

The company will be incorporated with three founding directors:

Andrew Hessel.  Mr. Andrew Hessel is an independent biotechnology consultant.  He has broad experience in academic science, the biotechnology industry, synthetic biology, and scientific laboratory operations.  Following incorporation of the cooperative, he intends to take the role of interim CEO and focus on promoting and attracting resources to the enterprise.

John Carlson

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Jayson Tymko

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Directors

A complete board of directors, consisting of nine people, will be elected following the company's first annual meeting.  The initial board will bring vision, business experience and contacts, and community and social awareness to the company.  The board will be create and be advised by a number of committees and panel with scientific and drug development expertise.

Company Location

Pink Army is a new Canadian biotechnology enterprise.

Canada strongly supports research innovation.  Canadian researchers and facilities rank among the best in the world, and the Canadian public are generally open to new technologies, particularly health technologies.  Also, the Canadian biotech industry is, relative to the US, economically underdeveloped.  Pink Army's business is not expected to economically disrupt existing enterprises.

Pink Army will be based in Edmonton, Alberta.  The provincial government is keen to broaden its bio-economic base.  Alberta is also very progressive on health issues – for example, they are the first province in Canada to implement electronic health records – and it has proven receptive to biological engineering ideas and concepts, evidenced by strong support for nascent synthetic biology initiatives.

Funding, compensation, and dividends

Pink Army intends to grow to become a sustainable, revenue-generating enterprise through organic growth.  Seed investment for Pink Army, if any, should be minimal. At no point will venture funding be solicited.