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From Hunting To Farming, Medicines Development Takes A Big Leap Forward

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For human societies, transitions from early “hunting and gathering” to farming set in motion the much more rapid progress of civilizations.  As one of my colleagues suggested recently, the shift from hunting to farming is a good metaphor to help explain significant changes now underway in the discovery and development of medicines.  And I hope that the resulting acceleration of progress against diseases will be similarly profound.

Moving from hunting to farming meant that small tribes formed larger communities to share both the labor and the bounty of agriculture.  It led individuals within those communities to learn new, specialized skills but also to collaborate and trade with each other.  And it shifted the group’s mindset from taking advantage of fortunate accidents (the essence of hunting) to improving expected outcomes (the essence of farming).

Similar transitions are happening today in the biosciences.

First, the various “tribes” in biosciences R&D—including universities, government labs, small start-up firms, biotechnology companies, as well as large pharmaceutical companies—now increasingly behave like a “community” that strives to cooperate for the greater good.

This can be seen, for example, in the rise of public-private R&D partnerships at all levels.  In the European Union (EU), the Innovative Medicines Initiative focuses on large, unanswered research questions that no single entity could take on—bringing together large and small companies, universities, hospitals, regulators and even patient advocacy organizations with combined EU and industry funding.  And in my home state, we’re launching the Indiana Biosciences Research Institute to engage entrepreneurial faculty from leading research universities and enable them to collaborate with the state’s life sciences industry, with an initial focus on metabolic disease.

Second, old rules about who does what, with whom, are being broken down in the biosciences along with the tribal silos.  For example:

  • Big Pharma companies are overcoming intellectual property barriers to collaborate with each other in previously unheard of ways—such as agreeing on “master protocols” for joint recruitment into cancer clinical trials (a huge potential timesaver), standardizing clinical data and research-site qualification standards, and joining forces on the development of new molecules.
  • More and more universities are seeking peer-to-peer participation in R&D activities together with private companies—keeping more of the financial risk to develop their discoveries in exchange for shares in potential success, such as milestone payments and, eventually, royalties.
  • Even the patient-advocacy mold is being broken.  Witness the group Stand Up to Cancer marrying its fundraising savvy to the creation of interdisciplinary, multi-institution “Dream Teams” to pursue treatment-development leads.

Finally, the focus of our collaborations is moving earlier and earlier in the R&D cycle—to expand the number of leads and do better at predicting what will work rather than counting on accidents.

When it comes to encouraging new leads from as many sources as possible, an example within my company is the Open Innovation Drug Discovery Initiative (OIDD), a web-based platform that gives researchers entry to Lilly’s molecule-screening process.  Some 400 universities, research institutes, and small biotech companies from 36 countries—along with the National Institutes of Health (NIH) itself—have made use of it.

Affiliated researchers submit compounds to OIDD, and Lilly carries out in-kind biological screening.  In return, we retain first rights to negotiate an agreement with them.  If no such agreement results, then external researchers receive no-strings-attached ownership of the data report from Lilly to use as they see fit in publications, grant proposals, or further research.  And it’s the kind of data needed to determine a new molecule’s viability and its ultimate fate with regulators.

The biggest problem in biopharmaceutical R&D productivity is that nearly two-thirds of molecules in Phase 2 clinical trials fail to advance to Phase 3.  And in those projects not halted for strategic reasons, the failure is most often due to lack of efficacy.  The problem is not about the number of molecules but about basic understanding of disease and disease pathways.

And here we see the clearest analogy to the shift from hunting to farming in drug development.  While drug hunting remains a vital activity, we need to do more to cultivate the knowledge of disease that will bear fruit in the form of molecules.

Industry and academia must continue to work together to develop better understanding around diseases—with clinical observations, patient phenotyping, and good lab science—so that we find and pick the right targets and molecules to begin with, and minimize late-stage failures.

A good example is the Alzheimer’s Disease Neuroimaging Initiative (ADNI), a partnership between NIH, the Alzheimer’s Association, and industry. ADNI has played an important role in mapping out the natural history of the disease and identifying effective “biomarkers”—easy-to-read biological signals that can identify patients with the amyloid plaques or tau tangles in the brain that are hallmarks of Alzheimer’s.  That work, in turn, facilitates clinical trials with patients at earlier stages of Alzheimer’s disease—which we hope holds the key to validating effective treatments.

Taken together, these burgeoning changes in the biosciences do feel more and more like a major shift.  As a long-time drug hunter, I for one am delighted to take up the plow.  And may the harvest soon begin!