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January-February 2010


 
 

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  Visionaries 2020

Reinventing the Pharmaceutical Industry, without the Industry

By Andrew Hessel

The founder of the Pink Army Cooperative is bringing the open-source development model to breast cancer therapies.

If I were to tell you that volunteers working out of garages and bedrooms could play as big a role in the elimination of breast cancer by 2020 as a multibillion-dollar big pharmaceutical company, would you believe me?

I’m convinced it’s possible. That’s why I founded the Pink Army Cooperative. The Cooperative is not your average biotechnology startup. It’s an open source biotechnology venture that is member-owned and operated and not-for-profit. It’s working to create individualized therapies for breast cancer. The mission is to build a new drug development pipeline able to produce effective therapies faster for less money, without compromising safety.

Big Drug Makers versus Co-Op: Why Small Is Better

About six years ago, I realized that the cooperative model could change the future of medicine. I’d just spent years working inside a well-funded scientific playhouse where R&D should have moved forward at breakneck speed, but somehow it hadn’t. Technologies are changing fast, and drugs frequently fail in development.

It costs hundreds of millions, or even billions, of dollars to bring a drug to market, and the costs are still growing faster than inflation. Even the largest pharmaceutical companies are struggling. The bottom line? Making a new drug is an adventure with no guarantee of success at any cost. The question I asked myself was, why hasn’t the pipeline been scrapped and replaced with something that can accommodate development done faster, better, and cheaper?

There is no public route for drug development; virtually all development is industry-backed. I wondered, if open-source software could effectively challenge multibillion-dollar software franchises, could scientists and drug developers work cooperatively to compete with a product from a big pharmaceutical company? To my mind, breast cancer therapies were the obvious choice, since many people already give time and money toward finding a cure.

Perhaps the single most powerful tool for accomplishing this goal is openness, which allows everyone, amateur or professional, anywhere, to peek under the hood of the company, understand what is being done, and add his or her ideas or comments. I personally believe it’s lack of transparency and inability to share information easily that has held back the biopharma industry compared to the IT industry.

Overall, as biology becomes more digital, there is potential for massive change. Open access will make it easier to share ideas, publish protocols and tools, verify results, firewall bad designs, communicate best practices, and more. Individualized medicine development will be built on this open foundation, which will only help developers be more successful and lower risk.

It also permits a novel funding model — i.e., directly approaching those who would benefit from any breakthrough. Whereas traditional funding models require attracting a few individuals or groups able to make large investments, for which they expect a financial return, we can deliver our message widely, asking people to invest $20 in a membership, in exchange for sharing our data with the community. Finding people to support us and running the cooperative itself is made easier because of social networking sites like Facebook and Twitter.

In the short term, I don’t see open-source drug development having a large effect on the U.S. health economy. The $2 trillion–plus system includes many products and services beyond just drugs. But there is room for a few examples to exist, make a real and measurable difference, and inspire others to experiment with nonprofit development. If Pink Army can treat even a single individual, I will consider the project a tremendous success, although I hope it will grow to treat millions of people with medicines that only get better and cheaper over time.

Personal Cures: From Individuals, For Individuals

The idea of cures or therapies that are unique to the individual is a critical component of the Pink Army Cooperative vision. A few years ago, the notion of cancer treatment that was specific to a person’s genome was seen as a fantasy. But thanks to rapidly moving technologies like synthetic biology, the prospects are very different today. This is a powerful new genetic engineering technology founded on DNA synthesis that amounts to writing software for cells. It’s the ideal technical foundation for open-source biotechnology. Moreover, synthetic biology drops the cost of doing bioengineering by several orders of magnitude. Small proteins, antibodies, and viruses were amenable to the technology and within reach of a startup.

Readers familiar with Wired editor Chris Anderson’s The Long Tail will recognize individualized medicine as the very end of the tail — a future of one product sold only to one person. I don’t think any company had seriously considered making these types of drugs before Pink Army. Most people accept that drugs cost hundreds of millions to make. Who could pay that much for a custom medicine, other than a few billionaires?

But individualized drugs could lower the cost of drug development across the entire spectrum of the development chain. Only very small-scale manufacturing capability is necessary. Lab testing is simplified. And clinical trials are reduced to a single person: No large phased trials are necessary, so there’s no ambiguity about who will be treated, and every patient can be rigorously profiled. This shaves money and years off development. Moreover, with the client fully informed and integral to all aspects of development and testing, the developer’s liability approaches the theoretical minimum.

My interest in breast cancer is personal and professional. Because it affects so many women — roughly 12% — almost everyone has been touched by breast cancer either personally or through someone they know. But cancer has always been central to my work as a genetic scientist, and I’m lucky to have been involved with several breast cancer–related projects during my time in biopharma. Curing cancer should be straightforward: It’s about making a better antibiotic, but the search for a cure seems to have stalled. It’s time to see if open-source drug development can reboot the process. That’s why Pink Army is important.

About the Author

Andrew Hessel is a geneticist and founder of the Pink Army Cooperative in Alberta, Canada. Web site www.pinkarmy.org.

 

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