Sept 15, 2005
| A recurring theme at this year's BIO meeting in Philadelphia was the need to understand the mechanisms by which drugs interact with the body. While this has always been critically important to drug efficacy, its impact on safety and surrogate endpoints is almost equally important. The increasing use of molecular imaging (MI) in drug development is providing direct insights as to how and where drugs act, highlighting both effective delivery to targeted areas and identifying potential adverse events through interactions elsewhere.
The ability to "see" specifically where a drug is interacting in a human being would be the ideal drug discovery tool. We would know that the drug was being delivered to the problem area and be certain that no other parts of the body were being affected. We could monitor the interaction and optimize the drug to provide only a limited degree of action and then observe the discharge of drug residue from the body. While somewhat idealized, this capability is emerging through technologies collectively known as MI. In a recent report*, we discuss how MRI, CT, PET, and other complex, noninvasive, 3-D imaging techniques - along with highly targeted, biologically well understood visualization reagents (i.e., contrast agents) - are providing valuable insights during all stages of drug development. These data are becoming an increasing component of new drug submissions and provide added assurances that the drug is doing what it is designed to do, and no more.
The potential of MI to improve drug development is not solely a technological innovation. The wealth of knowledge accumulated from basic research has been key to the opportunity. As research has uncovered the nature of specific interactions and processes, this knowledge has allowed for the development of targeted reagents that allow imaging equipment to noninvasively monitor the specific effects. Ideally, this imaging development process leverages scientific knowledge to directly monitor biological processes, including changes to processes as drugs or other therapeutic interventions are evaluated.
New technologies to improve and streamline drug development and the current high cost of drug development (more than $1 billion on average) provide tremendous incentives to adopt innovations. Technology solutions that shave one to two years off the time-to-market can save tens of millions of dollars in costs and produce hundreds of millions in earlier revenue. Opportunities to avert postmarket recalls offer potentially even greater savings. The expanding opportunity for MI technology to significantly improve drug development has not gone unobserved.Adoption on Track
Major drug development companies are beginning to recognize MI's potential. Several companies have added imaging capabilities to their arsenal of drug development tools, including GlaxoSmithKline's new $44-million Clinical Imaging Center in collaboration with Imperial College London, Pfizer's $35-million investment and collaboration with Yale University School of Medicine, and Millennium Pharmaceutical's new $3-million Imaging Center (see Imaging in the New Millennium,
May 2005 Bio-IT World,
page 1). Contract research organizations (CROs) are also developing capacity, including specialized imaging offerings from companies such as ABX-CRO, Beacon Bioscience, Certus International, MIR PreClinical Services, Synarc, and WorldCare Clinical.
Medical instrument manufacturers are expanding their imaging offerings to address the increasing opportunity. In establishing dedicated MI business units, the three major manufacturers (GE Healthcare, Philips, and Siemens) have demonstrated their commitment to applying imaging technologies to drug development, expanding their efforts with new instrument offerings, partnerships across the drug development process, and investments in new technologies. We anticipate that these efforts will continue to expand, including development of combined imaging (e.g., PET and CT), improvements in visualization software and data management, and development of new imaging contrast agents.
Building on a growing wealth of basic research, MI offers the potential to apply this knowledge to the intelligent development of drug and other therapeutic solutions to diseases. In addition, solid business drivers ensure that imaging will become an integral component of the drug development process.
Alan Louie is a research director with Life Science Insights. E-mail: firstname.lastname@example.org.
* Louie, A. and Sams, G. "Overview of molecular imaging technologies in the drug development process." Life Science Insights; July 2005 (www.lifescience-insights.com/LSI/getdoc.jsp?containerId=LSI1019).