Personalized medicine is the "wave of the future," says Husseini K. Manji, M.D., vice president of neuroscience and pain at Johnson & Johnson Pharmaceutical Research & Development. The pharma veteran believes that the approach of developing one drug for the largest population possible is unrealistic. "You don't have to deliver something for the entire population," he explained. "We really are at a very exciting time and moving into a more personalized framework." And J&J seems to be among those leading the way.
The company is one of nine large biotech and pharma members of the Personalized Medicine Coalition. We had a chance to speak with researchers from Johnson & Johnson shortly after the J&J's Paul Stoffels, Head of Global R&D Pharmaceuticals, led the Coalition's meeting in Washington. The pharma giant says its committed to integrating biomarkers and diagnostic tools at an early stage. By tailoring the process, you can avoid the trial and error cycle that comes with trying to deliver a drug that works for a large population and thus make the entire research and development process more efficient, Dr. Manji explains. "If we can do that, we can provide the optimal treatment for the optimal population."
How exactly will a drug industry built around personalized medicine differ from the industry as it operates today? As drug development will require large scale studies, resources will have to be pooled and intellectual property shared., says Manji. It will require biotechs, pharma companies, government entities and academics to collaborate and strategize before they go about developing their own molecule, drug or entity. Which presents some major challenges. For example, who owns the data and how will it be shared? Will it be available publicly? Will particular groups be given a period of exclusivity? If so, for how long?
Moreover, such large-scale collaborations may require new technological advances. "Conveying that data into practical knowledge will require a very sophisticated informatics approach to try and really understand what the data is telling us," explains Manji. "It's going to be trying to make sense of data you've generated form completely disparate sources. Somehow you've got to fuse those databases."
There are also regulatory challenges ahead. "From a regulatory standpoint you have to be cognizant of the fact that there are concerns about privacy and security," says Manji. "We as a society will come up with ways to make sure privacy is not an issue." Manji, who spent 15 years at the National Institutes of Health, says his discussions with the FDA have been very positive and the agency is taking personalized medicine very seriously.
And then there's the pricetag. Although it may not have deleterious effect on profits, it's enormously expensive to develop personalized drugs. It's a costly process to identify the appropriate set of biomarkers to predict a response, explains Nadine Cohen, head of pharmacogenomics for J&J's Pharmaceutical Research & Development unit. It's also difficult to quantify the return on investment upfront.
Given the pressures of the current economic climate, wouldn't such a drastic change in the development process be prohibitively expensive? "Most things are under pressure with the economic climate," explained Manji. "But I think this is something [Johnson & Johnson] views as imperative. This is something that's going to make us more efficient and bring value. This is something we're taking very seriously and something we view wholeheartedly as providing value."