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Exclusive Life Science Feature Some may think sending a man to the moon to be difficult. However, discovering the cure for cancer or Alzheimer's is more difficult. Otherwise, it would have already been done. Many are skeptical if we will ever find cures for these kinds of diseases. Skepticism proved to be one of the biggest roadblocks to TransCelerate gaining liftoff. "The history of these kinds of not-for-profit, precompetitive collaborations has yielded mixed results, at best," he asserts. According to Gill, the key to overcoming skepticism is getting results. "As TransCelerate quickly started to produce and publish tangible, pragmatic, actionable, deliverables (e.g. its risk-based monitoring paper at the end of May 2013), some of the initial skepticism started to dissipate. Next came the announcement of a plan for a common clinical-site qualification and training initiative. This was followed by TransCelerate delivering on other successful initiatives. Thus, the key to overcoming the initial skepticism was delivering results. But none of that would have been possible without an organizational structure that encourages and enables its members but also holds them accountable for delivering results. importantly, when results and deliverables are released, these individuals have the ability to drive implementation as opposed to having a nice white paper that people can pin up on their bulletin board." In addition to having the right leadership, Gill Founding Companies stresses the importance that prioritization has AbbVie played in TransCelerate's success. For example, AstraZeneca once the organization gains approval to comBoehringer Ingelheim mission a project, it is treated within member Bristol-Myers Squibb companies like any other internal project. "We Lilly look for project leadership that makes sense, GSK staffing the team with people from the member Johnson & Johnson companies who fit with the right subject-matPfizer ter expertise," he states. From there, the team Roche drafts its time line, deliverables, and budget, Sanofi refining the project from the original proposal. "These folks are held accountable to deliver to New Members In 2013 TransCelerate," Gill explains. "These projects Astellas should not be secondary priorities." Biogen Idec Gill recognizes that maintaining prioritizaBraeburn Pharmaceuticals tion of TransCelerate projects is challenging for Cubist member employees, since they have their day EMD Serono jobs to contend with, too. That's why part of Forest Laboratories the budgeting process includes assigning fullOnyx Pharmaceuticals time equivalent (FTE) contributions to indicate UCB RESULTS ORIENTATION the necessary member-employee workload for a REQUIRES THAT FORM project. In some cases, the FTE is as high as 100 FOLLOW FUNCTION percent being dedicated toward a TransCelerate TransCelerate's organizational structure, which had been put in project. "Twenty-five to 30 percent is at the bottom end of the place prior to his arrival, was one of the reasons Gill was attracted FTE commitment allocation," Gill shares. TransCelerate employs to the position. "A big contributor to why consortiums fail is only two full-time employees; the rest of the work is completed by because they often don't have leadership at the right level," states member-company personnel who define problems and come up Gill. In his experience, consortium projects are frequently manwith solutions. This strategy not only creates buy-in and accountaged and run by consultants and third-party providers. As a result, ability, it prevents projects from languishing. "We don't get calls company people do not get deeply involved, and initiatives never saying, 'Hey, this project slipped by for three weeks, and we are really take off. To prevent this from happening at TransCelerate, sorry about that,'" Gill says. "People realize that's not an acceptthe configuration was set up to involve member-company leaders able response, and they will have to justify these things to me and at the highest levels and in a structure similar to a pharmaceutithe entire operations committee." cal company. For example, Gill reports to chairman of the board THE SCIENCE OF PROJECT SELECTION Paul Stoffels, CSO and worldwide chairman of pharmaceuticals At its core, TransCelerate was created to cut through the red for Johnson & Johnson. The organization has a board of directors tape and duplicated work so often associated with skyrocketing representing each member company. "At the board level, we have R&D; drug development costs. But the scope of such an endeavor some very senior-level leaders, some responsible for multibillionwas daunting, with potential projects including everything from dollar R&D; budgets," he affirms. "They have accountability within improving efficiencies in collaborations, clinical/preclinical data the TransCelerate organization and need to be on board with sharing, and target validation. The initial potential-project list how we operate, the projects we pick, and progress being made." numbered 30. From there, TransCelerate leadership began the According to Gill, they are consulted regularly through board process of narrowing the focus to a more manageable number. meetings and other interactions. The operations committee, which To do this, member companies sent some of their best people to also consists of senior-level people from member companies, apply a tactical approach to project selection. "Initially we wanted handles the day-to-day running of the business. to pick doable, tangible, quick-hitting projects that had enormous "When you have these two layers of top-level support, you value and a return on investment from multiple perspectives (e.g. have the ability to move projects along quickly," says Gill. "More 26 LifeScienceLeader.com TransCelerate: From 10 Members To 18 January 2014