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Breakthrough Business Models. Drug Development for Rare and Neglected Diseases and Individualized Therapies

机译：突破商业模式。稀有和被忽视疾病的药物开发和个体化治疗

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The research and development process for new drug and biologic products has become extraordinarily expensive and time-consuming. Even for large pharmaceutical companies working to develop potential blockbuster drugs, many consider the current model to be unsustainable. While developing drugs to treat rare and neglected diseases can be just as expensive and time consuming as it is for blockbuster drugs, the products are often far less commercially viable to certain sectors of the pharmaceutical industry. Recognizing that patient advocacy groups can play a vital role in the development of new drugs to treat rare and neglected diseases, the Forum held a workshop in September 2007 entitled From Patient Needs to New Drug Therapies: Can We Improve the Pathway. The workshop featured the work of four patient-focused organizations: the National Breast Cancer Coalition, the Cystic Fibrosis Foundation, the Arthritis Foundation, and the American Diabetes Association. To better understand the innovative approaches being used by these organizations to help advance drug development, the Forum hosted a public workshop on June 23, 2008, titled Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies. Investors, policy makers, and companies seeking to develop therapies for smaller markets came together to discuss innovative strategies being implemented to expedite the development of products for these less commercially viable conditions. The intent of the workshop was first to raise awareness of these new models. Additionally, participants discussed approaches for reducing the risk of such investments by both filling critical funding gaps along the drug development pathway and pursuing highly targeted approaches to early-phase development. The workshop had several objectives. The first was to lay a foundation for the discussions by describing the changes that have taken place in the translational research process over the past 10 years, such as the 10-fold increase in investment by philanthropic organizations since 2000. The second objective was to discuss successful venture philanthropy models for funding translational research. Beyond new funding models, some philanthropic organizations and for-profit groups have undertaken innovative strategies to help expedite the development of safe and effective drugs for rare and neglected diseases by, for example, funding trials directly, supporting resources such as tissue banks, and negotiating intellectual property. A third objective was to explore whether such strategies are successful and could be implemented more broadly. Finally, workshop participants were asked to examine regulatory, legislative, and institutional policy tools currently in place to help advance the development of therapies for rare or neglected diseases. The workshop provided an opportunity for participants to share ideas and identify potential collaborative activities. It is our hope that this workshop summary will serve as a resource for all organizations interested in advancing the drug development process for rare and neglected conditions, as well as individualized therapies.

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