(photo: kisforkate/Flickr)
In almost every conversation I have these days with potential industry partners, I hear what seems to be the new buzz phrase: “Clear path to clinic.” A molecule with a “clear path to clinic” can become a medicine quickly, by virtue of a well-defined patient population, clear endpoints for clinical trials and measurable biomarkers.
Industry is increasingly recognizing that investigators at academic research centers know this path to clinic best. This has brought a shift in how industry interacts with academia, and new and equitable partnership structures are poised to facilitate joint therapeutic development like never before.
Pharma companies have a strong incentive to change. It’s been well reported that pharma pipelines are drying up, that it costs approximately $1 billion to get a drug to market and that there is approximately a 95 percent failure rate throughout the process, with expensive failures in phase II and phase III being disappointingly common. Key patents are expiring over the next few years and profits are shrinking.
Declining R&D productivity: New Molecular Entities (NMEs) vs. R&D spending (source: FDA.gov; click to enlarge)
These pressures are forcing industry to view research and development differently. Companies like Sanofi and Johnson & Johnson have engaged in public soul-searching about how to reorganize research models to support more innovation, with a special emphasis on sourcing new ideas from outside the organization. Some proposed R&D solutions tread on ground that was previously considered off-limits in pharma, like sharing rights to composition-of-matter patents covering the molecular structure of the drugs themselves — the same patents that drove profits for decades.
The new approaches include updates to academic partnership arrangements. In the old model, a short-term project would be proposed, generally by the academic investigator. An industry sponsor would fund the project or supply reagents, and the end result would be a publication. It was never clear to the academic side how the project fit into the company’s strategy, since it was not discussed, nor was such information shared. The end of the project tended to mean the end of the relationship, at least for that academic investigator.
While these projects are very important, they don’t truly capitalize on the value that each party brings to the relationship. The academics bring deep knowledge of the biology of a specific pathway or disease process, the tools necessary to study it and the continuity of focus built upon long careers in a given field. Investigators at a research hospital can also provide access to human tissue samples and access to patients for ultimate clinical trials. The industry partner brings the molecules themselves, the critical ability to optimize a starting molecule to make a viable drug, and deep expertise in the long process of developing a drug — including the ability to bring it through regulatory review and to market.
These strengths, when brought together under the right alignment of incentives, can lead to robust therapeutic development partnerships. Pfizer’s Centers for Therapeutic Innovation, GlaxoSmithKline’s Discovery Partnerships with Academia, J&J’s Corporate Office for Science and Technology programs, Bayer’s Grants4Targets initiative and Eli Lilly’s PD2 program are examples of novel partnership structures that are arising. Though I don’t know the detailed terms of all of these arrangements, most have terms that explicitly acknowledge the value of the academic investigator and the institution in unprecedented ways.
Even more striking than the terms are the open attitude and commitment. Programs like Pfizer’s and GSK’s are specifically designed to support a discovery from lab through early clinical trials with the same academic team. While this may sound subtle, it’s a dramatic shift. For the first time, it puts the academic investigators – those closest to the patients – in the lead during early therapeutic development. That’s a major change from when industry was the sole driver of drug development and academia was a supporting contributor.
It’s early yet, as these programs have only recently launched, but my hope is that these new partnership structures will support projects that are more patient-focused than market focused. That could bring drug development back from primarily being profit-driven to its fundamental purpose: enhancing human health.
Tomorrow, I’ll describe these opportunities further.
Nurjana Bachman, PhD, is Business Development Manager in the Technology & Innovation Development Office (TIDO) at Children’s Hospital Boston.
