Boehringer Ingelheim Implements One Medicine Technology Platform
By Ed Miseta, Chief Editor, Clinical Leader
Boehringer Ingelheim (BI) is the world’s largest, fully family-owned pharmaceutical company. Uli Broedl, the company’s SVP and head of global clinical development and operations, notes the firm’s guiding principle is “transforming lives for generations.”
“That vision is very important to us because every pill we produce has the family name behind it,” says Broedl. “We are always looking for ways to bring innovative drugs to patients faster. That speed is determined by our clinical development programs and the technologies we have in place. We have a patient-first mindset, and technology is the foundation of our clinical trial execution.”
“We had colleagues working on the interoperability issues,” states Broedl. “Those issues will create complex workflows that require a workaround for both internal stakeholders and our sites. The multiple passwords and user interfaces were not customer-centric. Also, working on multiple systems means you do not have a single source of truth.”
A New Mindset
BI knew if it wanted to transform patient lives for coming generations, it would need to take a big step to drive change in mindset, process, and technology. The technology change would be the most complicated and have a major impact on the company and its studies. After carefully evaluating the technology environment, the company decided to move from best-of-breed solutions to an end-to-end product development platform.
In making the shift to a platform approach, Broedl notes the company had just one definition of success: Improving patient outcomes and patient value.
“Everyone in our company has a patient-first mentality,” he says. “For that reason, we place a lot of emphasis on technology and process improvement. A big part of that is this end-to-end development platform which we refer to as the One Medicine Platform.”
Broedl notes there are several ways in which an end-to-end solution will benefit patients. The first is efficiency and speed. “Just two weeks ago I had the opportunity to meet with patient representatives from several different advocacy groups,” he says. “The message from them was clear: Patients cannot wait to receive life-saving drugs. Efficiency and automation will accelerate the clinical process, which will allow companies to get medicines approved and in the hands of patients faster. That will improve patient outcomes and their quality of life.”
On top of that, companies now have access to advanced eConsent and ePRO solutions. When incorporated into clinical trials, they help improve the patient experience. Both technologies are also part of BI’s One Medicine Platform.
New Technology Enables Innovation
Broedl notes that 10 years ago there were no end-to-end clinical platforms available. That forced sponsor companies to use a best-of-breed approach to technology implementation. Today, that end-to-end solution is available, and each company will need to decide if that approach is right for them.
“Every company will need to ask themselves what matters most,” says Broedl. “Technology should never be a self-serving purpose. For BI, that purpose is improving patient outcomes. I believe when you focus on patient outcomes, it is easier to understand the value proposition that this end-to-end platform delivers over best-of-breed approaches. The primary benefit is driving speed and value.”
Technology is also a big issue for research sites. One site executive I spoke to recently noted her employees struggle to deal with 10 or more logins and passwords due to the different systems in use. Broedl notes easing the technology burden on sites is another key value proposition for the company and an advantage of having an end-to-end solution rather than best-of-breed products.
The Right Solution
When BI began its search for a new platform, it considered solutions from several vendors. The company wanted a solution with a compelling value proposition and a product roadmap. The platform would need to have connected data flows to create efficiencies for the company. It would also need to enable the automation of processes. The user interface would have to be one with an intuitive look and feel, and the platform would also need to create better and easier communication with sites. BI also wanted a uniform data layer that would allow it to focus on innovation rather than maintenance.
“We conducted a very thorough search and felt the solution offering from Veeva was right to support our One Medicine Platform,” says Broedl. “There are three reasons for that. First, we felt that the product was the most advanced end-to-end solution. Second, we felt that solution had the most compelling roadmap. Veeva’s products focus on the needs of sponsor companies, but also on sites and patients, which aligns with our thinking. Finally, Veeva offers the opportunity to collaborate. As a sponsor company, we may see an opportunity to drive something that aligns with our patient-first philosophy. We have found Veeva is always open to and willing to listen to our ideas. In coming years, we will continue to advance our platform as Veeva products are updated and broadened.”
BI also has an interest in advancing its use of decentralized and hybrid trials and is working with Veeva to leverage and drive decentralized concepts. Broedl believes there are certain elements of decentralization that are here stay.
“We acknowledge that not every patient will want to have a fully decentralized trial,” he says. “I believe in the future we will most likely see hybrid solutions. We will arrive at a point where patients can choose what decentralized elements they want incorporated into their study. Companies can then offer a true patient-centered journey within a clinical trial.”
Change Management Is A Priority
BI’s shift to an end-to-end development solution began in 2020. Broedl states this entailed a transformation of mindset, process, and technology. He is quick to note this type of a change cannot happen overnight.
“A culture change is difficult, but it must happen if you want the technology transformation to be successful,” he says. “That culture change must be driven by a patient-first mindset. Employees must have the authority and courage to try something new, and making that change is a multi-year process. C-suite executives in the company must be behind the effort and believe it is necessary to achieve the goal of helping patients.”
BI worked out a clear transition plan, including how to deal with existing data, ongoing trials, and future trials. There is also a clear plan in place to manage the migration from BI’s previous systems to the new platform. Broedl does have advice for companies contemplating the implementation of a similar technology solution.
Before beginning any implementation, executives should clearly define the purpose of the technology. If everyone in the company does not have a clear vision of why the technology is being implemented, there won’t be a sense of urgency or understanding.
“Everyone at BI knows we are implementing the One Medicine Platform because it serves our purpose of bringing innovative drugs to patients faster,” he said. “Once you have that clear purpose, you need to implement change management activities. It’s important to move employees away from the status quo. Some employees will be early adopters but there will always be others who will resist the change. Change management is an essential function for getting all individuals on board.”