21st Century Innovation

Where will the breakthrough drugs of tomorrow come from? It's a question I'm asked often by the media, academic colleagues, and folks in large and small drug companies. It's clear that the research-based pharmaceutical industry, the source of the vast majority of prescription drugs today, is being buffeted by economic, regulatory, legal, and competitive pressures. A simple fact emerges: the extant model of drug development is yielding too few new products to sustain industry growth. As a result, many companies have had to re-evaluate and restructure their research and development (R&D) processes.

A major shift is the transformation from fully integrated pharmaceutical companies to a network model that encompasses the major stakeholders in drug development: large and small bio/pharmaceutical firms, academic research centers (ARCs), patient groups, public–private-partnerships, and contract research organizations. In the new model of innovation, these stakeholders have a place at the table and share in the risks and rewards of innovation.

Industry's role

Key to this new model of innovation is the relationship between pharmaceutical companies and academic institutions. The commitment to a new level of partnership is reflected in the steep cuts in R&D spending by some of the larger pharmaceutical companies, such as Pfizer and Sanofi. It may seem counterintuitive to say, "We're going to boost R&D productivity while we decrease R&D spending." These and other companies, however, are simply diverting their early-phase R&D efforts to ARCs, where the company gains access to cutting-edge science, highly skilled investigators, and state-of-the-art equipment, thereby allowing the company to lower overhead and investment in expensive discovery tools and technologies.

Pfizer's commitment to an academic-partnership strategy is exemplified by its initiative to create five Global Centers for Therapeutic Innovation. The first of these centers was announced in late 2010 and included an $85-million grant to the University of California, San Francisco (UCSF) to develop new biological therapies. As part of the agreement, Pfizer is setting up joint laboratories on the UCSF campus to combine its knowledge of drug development with the basic-research expertise at UCSF. The deal allows the academic researchers to publish their research findings in academic journals and present at scientific meetings while the university shares with Pfizer the ownership rights to new drugs. The goal is to bridge the gap between important basic research discoveries and the commercial development of new medicines; in short, it supports translational science.

Government support

During the past decade, the US and European Union governments have developed programs to foster translational science. For example, in 2001, the US National Institutes of Health (NIH) released its NIH Roadmap, which was intended to invest in new pathways in drug discovery, support research teams of the future, and re-engineer the clinical research enterprise. In 2006, the Clinical and Translational Science Award (CTSA) program, which was intended to facilitate the transfer of knowledge between basic research and clinical medicine, was launched. With more than 50 CTSAs awarded to date and 60 planned by 2012, NIH has clearly signaled its support for academic institutions as active partners in bioinnovation.

In a similar vein, in 2004, FDA introduced the Critical Path Initiative (CPI) to improve the translation of basic research findings into safe and effective medicines. Mirroring the goals of the EU Innovative Medicines Initiative, a public–private partnership formed in 2007 between the European Federation of Pharmaceutical Industries and Associations and the European Community, CPI fosters precompetitive research by bringing together the respective capabilities of academia, industry, and government to identify new biomarkers and other tools to improve the selection of drug candidates and increase the likelihood of pipeline success.

Obstacles

Despite a shared commitment by both sectors and unequivocal government support, significant obstacles stand in the way of successful partnerships. These obstacles include language barriers (academics speak the language of science while industry speaks the language of business), misaligned reward systems (academics are rewarded by publication, promotion, and grants while industry is rewarded by pipeline success and regulatory filings), intellectual-property issues (academics try to retain ownership as much as possible while industry requires sufficient rights to make downstream investment worthwhile), and a heightened sensitivity to conflicts of interest in academics and a reluctance to align too closely with the private sector.

Despite these obstacles, there are many reasons for academic–industry partnerships. There is a financial imperative for both sectors as NIH grants have diminished and industry lowers its R&D spending. Industry gains access to cutting-edge science, and academics gain access to drug-development expertise. And both parties realize the benefits of translational science. Academic–industry partnerships may not be the perfect marriage, but they are definitely worth fighting for.

Kenneth I. Kaitin, PhD, is director and research professor of the Tufts Center for the Study for Drug Development at Tufts University.