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EXCLUSIVE LIFE SCIENCE FEATURE leaders LIFESCIENCELEADER.COM JULY 2014 30 According to Koester, a core element of any successful innovation engine is to always keep in mind that it is working within and for a larger organization. "We are a small group," he reiterates. "If we work independently, then we are merely a think tank with a bunch of smart ideas theorizing about implementation. Instead, we want to create solutions and be an implementation engine. We want to create a blueprint that can be expanded throughout all of Janssen R&D.;" With an organization name that includes the words clinical, trial, and innovation, Koester says some desirable attributes for potential CTI members were fairly obvious, such as finding folks knowledgeable with actually hav- ing run clinical trials internationally. "Since CTI would be based in the United States, we did not want it to become a U.S.-centric effort," he states. One less obvious team-member attribute was negotiation experience from both the vendor and sponsor sides of the busi- ness. In addition, Koester wanted people with the ability to ask very naïve ques- tions. "I was looking for a combination of people who were very knowledgeable and close to the space, but had not lost their ability for expansive thinking," he says. "I wanted people who had demon- strated a past willingness to collide with very streamlined rivers of thought when it comes to challenging convention and the running of clinical trials." In other words, if you want disruptive innovation, seek disruptive innovators — then turn them loose on a project. (For approaches on how to find and keep disruptive inno- vators, be sure to read the Editor's Note on page 6.) PROJECT SELECTION CRITERIA Koester says that when it comes to selecting projects for CTI, the first and foremost driver is seeking solutions that make clinical trials better for Janssen's most important stakeholders — patients and investigators. "Though individual solutions we work on may lead to future precompetitive, cross-col- laborative solutions such as the shared Investigator Databank (see sidebar The Investigator Databank – A CTI Success Story ), we are first seeking a competi- tive edge," he states. Project selection is one of Koester's most difficult tasks. "In our first year, we saw the drive and enthusiasm you might expect to see with a newly cre- ated group the likes of CTI," he recalls. "But the willingness to change things can result in the tendency to bite off more than you can chew." Thus, restraint became the key to successfully selecting projects. He applies five filters to selecting CTI projects. "First, let's try not to duplicate what someone else is doing outside or inside the company. We are very careful not to create any overlap. Next, does it benefit the investigators? Does it benefit the patients? Does it increase the overall efficiency of the clinical trial?" When these questions are answered positively, then he goes to those who are supposed to use the solutions and asks, "Is this something you really want?" Koester advises not getting caught in the trap of pursuing something because you think it's great from your perspective. You really need to talk to the key stakehold- ers that will use the solution. This is how CTI selected other projects such as eMeds (utilizes smart technologies to overcome the issues related to medi- cation and protocol nonadherence), electronic informed consent form, eICF (utilizes an iPad app to increase patient clinical study comprehension and improve participant retention), and a patient portal (the first website designed specifically for a patient participating in clinical trials). "We learned a lot during our first year," he admits. "Looking back, the Investigator Databank project, with all its complexity and industry coopera- tion, was such a moon shot. If you asked me today, I would say, let's go for ambi- tious, yet feasible projects. By taking this type of approach, you can show some type of tangible results within the first year. Otherwise, you risk losing even the most enthusiastic supporters," he concludes. L J&J;'S APPROACH TO CAPTURING DISRUPTIVE INNOVATION IN CLINICAL TRIALS By W. Koberstein How To Get The Gap Out Of Analysis There is an analysis technique which tends to be more organic and flexible than SWOT (strengths, weaknesses, opportunities, and threats) and, in my opinion, offers much more value. Gap analysis compares the gap between your organization's actual versus potential per- formance. The first step in conducting a gap analysis is to identify your company's current state. This is followed by identification of your company's desired state. In a column format, start by list- ing the attributes you'd like to see improved. For example, qualitatively your organization might lack diversity. Quantitatively, you might list how many orders you get a day, week, or month. The key is to be specific and factual. For the desired state, list highly specific goals, such as increase diversity by 50 percent, or more generic concepts, such as creating a more inclusive culture, in an adjacent column. Try to capture all the idealized attributes as they correspond to the current state. The dif- ference between these two states is the "gap" and thus, where the technique gets its name. Seeing the gaps, and then creating the solu- tions for these gaps, is the true calling card of every successful entrepreneur. Being able to successfully bridge the cap should be the successful calling card of every business as an ongoing concern. Begin the process of bridging the gap by creating a description for every element where a gap exists in another column. This should be followed by discerning the factors responsible for the identified gaps. Be sure to be specific, objective, and relevant. The final step is to list all of the possible remedies for bridging the gap. It is suggested that remedies should be action-oriented and specific. Though gap analysis can be very forward- looking, you may want to create phases of gap analysis, such as gaps for one, three, five, and 10 years. Not doing this can make bridging the gap feel impossible, especially if you are trying to move from where you are, such as a biotech start-up, to where you want to be in 10 years — a Fortune 500 company. Finally, I would advise applying SMART-ER (specific, measur- able, achievable, realistic, timely, and easily remembered) objectives as part of the creating remedies process. I think it is important not to forget the ER part. People can focus on fixing/ bridging gaps for a limited number of things (e.g., three) at any one time. If you have people focusing on too many initiatives, they might feel overwhelmed or worse yet, lose sight of current business initiatives responsible for keeping the lights on. 0 7 1 4 _ F e a t u r e _ J a n s s e n 3 . i n d d 5 0714_Feature_Janssen3.indd 5 6 / 2 0 / 2 0 1 4 1 1 : 5 7 : 3 7 A M 6/20/2014 11:57:37 AM