As the pharmaceutical industry’s investment in personalized medicine leads to development of an increasing number of targeted therapies, particularly for cancer patients, some drug sponsors have shown greater commitment and more structure in their approach than others, according to a new report by consulting firm Diaceutics.

Roche and Novartis are poised to become leaders in the field within the next five to 10 years, according to the report, and could potentially dominate in specific therapy areas within five years based on the ability they have developed to capitalize on new discoveries in genetic biomarkers and translate them into personalized medicines. The report data shows Roche has developed both a great capacity and a robust strategy for growth in personalized medicine innovation. More recently, Novartis has built its internal molecular diagnostic unit and developed a clinical pipeline with a focus on personalized medicine.

Success in this space, according to the report, will be determined by how each company embraces personalized medicine, such as restructuring internal R&D to integrate the concepts and changing marketing strategies to become more highly specialized.

“Most pharmaceutical companies say they are ready for personalized medicine, and their development pipelines are filling up with personalized medicine opportunities, but they may not fully understand the commercial ramifications of this technological shift,” said Peter Keeling, chief executive officer of Diaceutics.

The report, called “Pharma Readiness for Personalized Medicine,” analyzed 10 leading pharmaceutical companies with at least one targeted therapy on the market and ranked them according to their potential for taking advantage of opportunities in personalized medicine. It also concluded that four other companies—AstraZeneca, Eli Lilly, Bristol-Myers Squibb and Pfizer—have made investments that give them the potential to market personalized medicine and are likely to accelerate activities for targeted therapies during the next two to three years. But whether they join Roche and Novartis as leaders in the field, said Keeling, will depend on the extent to which board members and senior management decide to move the organizations to an infrastructure based predominately on personalized medicine.

“R&D teams are committed to a personalized medicine future, but their commitment is generally not matched by the significant commercial investment required to optimize future targeted therapy portfolios,” said Keeling. “Many pharmaceutical industry boardrooms don’t prioritize personalized medicine as a future paradigm for organizational re-engineering.”

According to a recent Tufts Center for the Study of Drug Development (CSDD) Impact Report, between 12% and 50% of current clinical pipelines, depending on the drug company, involve a personalized medicine approach. The 21 pharmaceutical and biotechnology companies surveyed said they had increased investment in personalized medicine by a median of 30% from 2006 to 2010, and they plan similar increases from 2011 to 2015.

The report also found developing personalized medicines has led companies to change their R&D paradigms, including how to make go/no-go decisions throughout development.

“Early indications show that development of personalized medicines is commanding more resources and fomenting more organizational change than is generally appreciated outside the industry,” said Christopher-Paul Milne, associate director of Tufts CSDD and author of the study.

In order to move forward, personalized medicine developers face significant scientific, regulatory, commercial and practical challenges. At a recent personalized medicine conference in London, Sir Gordon Duff, chairman of the U.K.’s Commission on Human Medicine, said advancements must include an overhaul of clinical trials, which should take a more adaptive approach, along with more collaboration and data sharing in development.

Another obstacle involves a prediction from business experts that a personalized medicine approach could force drug companies to change their operating models. “The complexities of integrating personalized medicine into the pharmaceutical industry’s traditional operating model, along with a preference for the traditional ‘blockbuster’ approach to therapy development, is delaying the advent of personalized medicine at many companies,” Keeling said.

With a few notable exceptions, Keeling said most pharmaceutical companies are reacting to market events regarding personalized medicine rather than anticipating them and proactively shaping new markets for their products. In particular, the Diaceutics report said GlaxoSmithKline, Sanofi-aventis, Amgen and Merck have fallen into this category. “They have, so far, few commercial successes in this space and thus little commercial experience,” said Keeling. “These companies are more likely to strive to maintain their existing operating models rather than adapt them for personalized medicine.”

-- Karyn Korieth