A philosophy for Opening Biotechnology Collaboration for Therapeutics

The pharmaceutical industry faces a host of worsening problems: Multibillion-dollar expenses and decade-long development times to bring new drugs to market, high failure rates for new drug candidates, and a patent system that is both expensive and uncertain. Demanding regulatory requirements and governmental pressures on prescription costs add yet more pressure on drug development. Although the situation does not yet constitute a crisis, its current trajectory is becoming increasingly untenable. While the industry itself has been resourceful in introducing technological advances and operating reforms such as increased collaboration through patent pooling, these efforts do not exhaust the possibilities for improvement. In particular, there has been an emerging, more agile and responsive alternative model in pharmaceutical research and development, namely open source synthetic biology – a rapidly developing and highly collaborative effort based on engineering principles involving the design and construction of biological systems using standardized modules of DNA. Synthetic biology began entirely open to those who wished to participate, provided that they agreed to share their results without restrictions. In its current and more mature state, it retains much of its open source character and is consequently less dependent on secrecy and patent protection than the pharmaceutical industry’s largely proprietary approach. The success of open source synthetic biology has inspired us to further develop that approach for research and development in Biotechnology and its pharmaceutical applications. Here, we reviewed the history and progress of open source science and technology.