"Industry doesn't have a way to test its products without us, and few if any universities are developing their own compounds. Working through these issues is not direct or simple. It's complicated. But we're always searching for a fair, equitable middle ground that protects both sides."
The legal and financial details – and the necessary negotiations by attorneys and financial experts on both sides – can delay the start of research projects and frustrate academic and industry-based scientists who want to explore innovative ideas together and make a difference for patients.
"If you have a potential breakthrough that may help cancer patients, you don't want to spend a year talking about whether and how you can work together, – you want to get right to the science," said Jeffrey Hanke, Ph.D., vice president for cancer research at Astra Zeneca, which has recently enhanced its partnership with Vanderbilt-Ingram.
To streamline and simplify their marriage, the company and the cancer center have developed their own version of a prenuptial agreement, called a Master Alliance Research Agreement, to help navigate many of these issues on the front end. "We've developed a strong framework that will help us move forward more quickly," said Carlos Arteaga, M.D., Vice Chancellor's Chair in Breast Cancer Research and director of Vanderbilt-Ingram's Specialized Program of Research Excellence in Breast Cancer.
It is one of a handful of such agreements that AstraZeneca has developed, including a similar one with M.D. Anderson Cancer Center that was announced earlier this year and a long-standing one with Baylor University that has narrowed its focus to cancer research in recent years, said Steve Strand. Strand is global director of external scientific relationships for the pharmaceutical company, which has corporate headquarters in London and research & development headquarters in Sweden.
"AstraZeneca is conducting intensive preclinical discovery and performs clinical trials in a variety of locations," Strand said, "but there are a select few centers where we feel we really have to get it right.
"Internally, our desire to develop these alliances is driven by our own strategic review. We have a variety of strategies and capabilities that we are building internally, but there is expertise or technology that is important to our work and that we can access much faster through collaboration. For instance, with Vanderbilt, we're focusing on areas like genomics, proteomics and the development of biomarkers. We need to collaborate in these areas, and we need to work effectively and efficiently together over a long period of time."
Details of these agreements are confidential. They provide a basic framework that covers the basic
financial, legal and similar contractual issues that would be common to any mutual research project. Separate,
specific research plans are then developed that can move forward more quickly under the umbrella of the Master Agreement.
"We (the pharmaceutical industry) do a lot of transactional R&D work with academia," Strand said. "A single transaction, that's the traditional model, to come in and do 'Project A' with 'Drug X,' and when it's done, it's done. There's no institutional memory on either side. Every time we want to pursue
a new project with an investigator at that university, we have to re-invent the wheel. Now, we don't have to renegotiate everything. We've got those tough issues hammered out in the Master Agreement."
The initial Master Agreement between the company and Vanderbilt-Ingram involves preclinical research (basic and "translational" research not involving human patients); however, a similar pact to guide interactions in clinical research has recently been completed.
"We're Studying Cancer Biology, Not Drugs"
The "AZ Alliance," as it's become known in the hallways of Vanderbilt-Ingram's Preston Research Building, is similar to a marriage in another way – it was built upon a relationship between individuals at the cancer center and the company. Only later did that relationship grow to include the "families" on both sides.
In this case, it initially developed out of the relationship that the company had with Arteaga, who is known internationally for his research involving the epidermal growth factor receptor (EGFr) and its "cousin" receptors. He had done considerable work with AstraZeneca's drug gefitinib, which targets EGFr. "Steve Strand approached me about AstraZeneca's desire to partner with individual centers of excellence," Arteaga said. "They wanted to identify projects of mutual interest at a thematic level – in our case, research into novel combinations of new cancer therapies and identification of molecular biomarkers to assess and predict response to treatment with these novel agents and/or combinations."
The teams met in late 2003 and in early 2004, Arteaga recalled. The final agreement was completed and signed in late 2005. Not unlike a future groom introducing his family to his bride-to-be, Arteaga acknowledged some nervousness once Vanderbilt's legal and financial teams got involved and the process moved beyond his own personal relationship and reputation with the company. "These alliances grow out of the individual relationships at the investigator level," he said. "I and others in the oncology division at Vanderbilt didn't meet AstraZeneca yesterday."
Once the scientist-to-scientist relationship blossomed into a full-fledged alliance, however, it involved multiple investigators in oncology, cancer biology, biochemistry, mass spectrometry and other areas. "You can see the value added for the company," Arteaga said.
Now that the Master Agreement has been finalized, Arteaga is optimistic that specific projects can move forward quickly. Two projects involving small molecules that modulate cell signaling and cell cycle checkpoints are under way and others are in review.
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