The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute
Issue link: https://lifescienceleadermag.epubxp.com/i/338402
EXCLUSIVE LIFE SCIENCE FEATURE leaders LIFESCIENCELEADER.COM JULY 2014 28 are the first two questions that need to be answered so that you can integrate the team and its expenses into the over- all organization and budget." Next, who would be the right person to lead such a group? What would be the appropriate profile and background of group mem- bers? "These were the questions we were THE KEYS TO CREATING A CLINICAL TRIAL INNOVATION ENGINE According to Koester, at every company there are key questions to answer before undertaking such an initiative. For exam- ple, where will the head count come from? (Koester's team has seven full-time mem- bers.) What about the budget? "Those THE IMPETUS FOR CREATING CTI Like most ideas, the creation of CTI was neither derived from a "Eureka, I've got it!" epiphany nor driven by just one per- son. In actuality, CTI was the result of a collaborative effort which first began with a project. In the spring of 2011, execu- tives at J&J; sat down to tackle a growing problem — inefficiencies in clinical trials. Everyone knew that drug development costs were spiralling out of control, pri- marily due to increasing amounts of clini- cal evidence needed to obtain regulatory approval. Furthermore, it was understood that Phase 3 clinical trials represent about 40 percent of pharmaceutical company R&D; expenditures. "Essentially we wanted to have a fresh look at how we in the indus- try do clinical trials," recalls Koester. The goal of the workshop was to brain- storm on what the future of clinical trials might look like in five to 10 years — given not much had changed in the previous 20. Utilizing various tools and techniques, such as gap analysis (see sidebar — How To Get The Gap Out Of Analysis ), approxi- mately 50 people representing internal Janssen Pharmaceutical segments (e.g., R&D; operations, therapeutic areas, bio- stats, data management) and external organizations (e.g., CROs, IBM, Oracle) were involved in the workshop. "During this three-day meeting, we came up with a number of actionable items we thought we should do to prepare and shape Janssen for the future," Koester says. For example, the group identified a fair number of ongoing improvement projects which could benefit from an increased focus. "We realized that more follow-up and follow-through were needed to move projects more quickly from concept, to pilot, all the way through to implementation," he shares. "We also concluded that it is difficult, if not impos- sible, to change the way you are working on a broad scale while still executing on the highest priority — the development of your own company portfolio. We needed a different group which had the 'luxury' to focus only on innovation while not being tasked with executing on the pipeline." It was this conclusion that led to the forma- tion of CTI in early 2012 — nearly a year after the workshop had ended. The Investigator Databank – A CTI Success Story "The Investigator Databank project was actual- ly started before CTI was formed," says Andreas Koester, VP and head of CTI (clinical trial innovation) and external alliances at Janssen. The idea was to create a repository of key information (e.g., infrastructure, GCP training records, site profile forms) about investigators and clinical trial sites for multiple pharmaceuti- cal companies. Previously, if Janssen trained an investigator on GCP, and the person wanted to serve as an investigator for another company, they would have to complete very similar GCP training for every single company. "Everybody hates it," Koester attests. "This redundancy does not improve the quality of the trial and only serves to further increase the administra- tive burden of investigators." Research conducted by the Tufts group from 1999 to 2005 revealed that the average clini- cal trial staff work burden had increased by 67 percent. Further, studies have shown that 70 percent of investigators drop out after one or two trials. "Can we reduce the administrative burden for the investigator by not asking them the same questions at the initiation of each clinical trial?" Koester laments. Though the project was under way prior to the formation of CTI, it became the responsibility of the group to see it through to completion. The project team members within Janssen began reaching out to other companies through informal contacts made at conferenc- es and other forums. "Remember, this was pre- TransCelerate," he reminds. Reducing redun- dant trainings would benefit pharma com- panies by lowering trial costs. Investigators might be inclined to participate in more trials, thus further reducing pharma costs related to recruiting clinical trial investigators. But there were a number of hurdles which needed to be overcome to make the Investigator Databank a reality. For example, they needed to find a place to store the information outside the walls of one particular pharma company to avoid the perception of a competitive advan- tage or restricting access. Another hurdle was getting buy-in from internal legal departments that this was okay and beneficial to do, as well as to create language so the activity would not be perceived as collusion. Privacy laws, how many companies to involve — the list of hurdles seemed endless, and the task of overcoming, daunting. Yet the creation of the Investigator Databank via col- laboration between Janssen, Lilly, and Merck proved successful. In late 2013, Pfizer joined the initiative, and in May 2014, Novartis did as well. Hosted by DrugDev (www.drugdev.org), the Investigator Databank includes nearly 180,000 investigators, 50,000 sites, and 7,335 studies, making it four times the size of the dataset utilized in the 2013 Tufts analyses of clinical trial sites. In addition to the previously mentioned ben- efits, it is anticipated that the Investigator Databank will also improve investigator selec- tion, and it holds the potential to improve clinical trial execution by enabling improved matching between studies and investigators. Most recently, the website investigatordata- bank.org was launched, which allows investi- gators to securely log in and view the compos- ite information held on file about them and to supplement it with additional information such as their CV and GCP training certificate. J&J;'S APPROACH TO CAPTURING DISRUPTIVE INNOVATION IN CLINICAL TRIALS By W. Koberstein 0 7 1 4 _ F e a t u r e _ J a n s s e n 3 . i n d d 3 0714_Feature_Janssen3.indd 3 6 / 2 0 / 2 0 1 4 1 1 : 5 7 : 0 6 A M 6/20/2014 11:57:06 AM