In the pharmaceutical industry, gaps often exist between companies and internal working groups. Consider one of the industry’s largest players, Johnson & Johnson (NYSE: JNJ), which has more than 127,000 employees and operates more than 250 companies organized into several business segments in 60 countries.
J&J’s pharmaceutical segment consists of six Janssen pharmaceutical companies, including Janssen R&D, which contains the Janssen Healthcare Innovation (JHI) team. And while the R&D arm is focused on discovering and developing medicines for unmet medical needs, JHI’s vision is to help accelerate the transformation of J&J from a healthcare product company to simply a healthcare company.
To bridge the gap between the two, as well as facilitate external collaborative alliances with consumers and companies, J&J created Clinical Trial Innovation (CTI) — an organization integrated with JHI and Janssen R&D Operations. Headed by 20+ year R&D veteran Andreas Koester, M.D., Ph.D., CTI has some ambitious goals — develop solutions that will modernize clinical trials, improve data quality, and enhance the clinical trial process for patients and investigators. Having 13 new medicines approved in the last decade, J&J ranks at the pinnacle of the most productive pharmas, and perhaps is one of the most disruptively innovative. Koester, VP of clinical trial innovation and external alliances, shares what the CTI team is doing to keep it that way.
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 person. In actuality, CTI was the result of a collaborative effort which first began with a project. In the spring of 2011, executives 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, primarily due to increasing amounts of clinical 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 industry do clinical trials,” recalls Koester.
The goal of the workshop was to brainstorm 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), approximately 50 people representing internal Janssen Pharmaceutical segments (e.g., R&D operations, therapeutic areas, biostats, 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 impossible, 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 formation of CTI in early 2012 — nearly a year after the workshop had ended.
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 example, where will the head count come from? (Koester’s team has seven full-time members.) What about the budget? “Those are the first two questions that need to be answered so that you can integrate the team and its expenses into the overall 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 members? “These were the questions we were busy with during the months after the design workshop,” he says.
Though Koester is not able to disclose the budget amount allocated to the creation and running of CTI on an annual basis, he is able to share how it’s structured. “We set up the group to be independently funded,” he says. “The budget for every one of the pilot projects we are running is contained and preallocated specifically toward clinical trial innovation.” In addition, the CTI team is given the freedom (within budget) to run projects that don’t have full-blown business cases. “This is a key element to success,” he states. “Because we are venturing into the unknown, you can’t really create a business case. If we knew it, then it would not be innovation.”
According to Koester, how to get people on board without the ability to create a complete business case is one of the most frequently asked questions posed to him at conferences. “It is one of our biggest challenges,” he admits. “When dealing with a lot of imponderables, taking the approach that a project will only be undertaken if it has a positive business case doesn’t work because you cannot draw a line, make a linear expansion of the past, and then foretell the future.” If creating an organization similar to CTI within your company, Koester suggests setting funding aside so you can create projects without having to “pluck a business plan out of thin air.” Further, allow innovation teams the ability to run pilot projects so they can gather data toward the creation of a more thorough business case. “Avoiding months of discussions and negotiations before being able to start projects makes it is easier for the broader organization to see what you are doing, as well as to help you get it done,” he attests.
"Looking back, the Investigator Databank project, with all its complexity and industry cooperation, was such a moon shot."
Andreas Koester, M.D., Ph.D
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 having 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 business. In addition, Koester wanted people with the ability to ask very naïve questions. “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 demonstrated 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 innovators, 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 pre-competitive, cross-collaborative solutions such as the shared Investigator Databank (see sidebar The Investigator Databank – A CTI Success Story), we are first seeking a competitive 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 created 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 stakeholders that will use the solution. This is how CTI selected other projects such as eMeds (utilizes smart technologies to overcome the issues related to medication and protocol non-adherence), 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 cooperation, was such a moon shot. If you asked me today, I would say, let’s go for ambitious, 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.
The Investigator Databank – A CTI Success Story
"The Investigator Databank project was actually started before CTI was formed,” says Andreas Koester, VP 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 pharmaceutical 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 administrative burden of investigators.”
Research conducted by the Tufts group from 1999 to 2005 revealed that the average clinical 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 conferences and other forums. “Remember, this was pre-TransCelerate,” he reminds. Reducing redundant trainings would benefit pharma companies 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 advantage 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 collaboration 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 benefits, it is anticipated that the Investigator Databank will also improve investigator selection, and it holds the potential to improve clinical trial execution by enabling improved matching between studies and investigators. Most recently, the website investigatordatabank.org was launched, which allows investigators to securely log in and view the composite information held on file about them and to supplement it with additional information such as their CV and GCP training certificate.
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 performance.
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 listing 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 difference between these two states is the “gap” and thus, where the technique gets its name. Seeing the gaps, and then creating the solutions 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, measurable, 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.