Genentech’s Thoughtful Approach to Innovation that Actually Solves Problems in Clinical Trials
Genentech’s Kimberly Barnholt, PhD, MS, outlines her approach to identifying tech and non-tech innovations that have real impact. As Sr Director, Evidence Generation Leader at Genentech, she is responsible for sourcing and integrating new innovations to modernize clinical trials.
What does innovation mean in your role?
I define innovation in clinical research as anything that can help us evolve our design and process to improve quality, experience, cost, or timelines. I think there is a trend to tie innovation with disruptive new technology, but this doesn’t have to be the case. Innovation can also be exploring new applications for existing tools, such as leveraging real world data to improve trial design and patient matching.
Innovation is also sometimes about doing less – removing complexity of unnecessary technology and focusing on how to streamline information flows. Developing new medicines is expensive, time intensive, and often fraught with failures. Innovation should help us improve on all of those areas to ensure we are doing the best we can for patients. Innovation requires both the evolution of thought and of practice, and I try to address both of these elements in my role.
How does that mentality manifest itself in your work?
Our first step is to define the challenge or the opportunity that we are trying to address. This keeps us focused on innovating towards something of high impact rather than just because something sounds interesting. We are in an exciting time today with so many new tools available at our disposal to overcome barriers to trial access, to reduce patient burden, to better match patients to the right trials.
Our team takes the approach of evaluating both internal and external solutions, weighing the different scenarios and tradeoffs, then partnering with our stakeholders to define the best path forward.
Innovation is also sometimes about doing less – removing complexity of unnecessary technology and focusing on how to streamline information flows.
How does your team support modernizing clinical trials in Genentech?
I am fortunate to lead an integrated team of biomarker operations, clinical innovation and technology leaders, data managers, and data engineers. Each of those areas alone play a large part in modernizing clinical trials, and by working together as a team, we have identified areas we can have an even greater impact as a collective. My team delivers the traditional output required for their roles in a study, and also serves as a bridge to innovative approaches for both operational design and data strategies. By being closely connected to studies, we stay grounded in the challenges and opportunities while we are actively engaging new vendors, technologies, and approaches.
What are the key considerations for you when assessing the value of any new innovative tech or process?
Two important considerations stem from revisiting the purpose of the study and the people who will be participating. First, we find it important to ground to what question is this particular study trying to answer, then we can explore what are the options for where and how the evidence should be collected to best answer that question (or set of questions) efficiently and effectively. Second, we also need to understand the people who will be in the trial – not just who they are as patients, but who they are as humans and what type of experiences, challenges, or barriers might they face while participating.
Genentech has a strong commitment to inclusive and representative trials, which means that we need to make our trials accessible to the broad US population and manageable for diverse schedules and situations. Digital tools, decentralized approaches, data sources and linkage capabilities broaden the possibilities for optimizing how we design and execute a study without overburdening our patients and sites.
We connect dots and share learnings so that study teams can build on past experiences to improve on future designs.
How do you advance to solution identification?
We try to balance a process of evaluation to implementation with keeping an eye on new and exciting trends. In our partnership model with trial teams, we help define the opportunity or problem to solve then propose categories of solutions that might be a good fit. From there, we recommend vendors in those categories that offer different suites of services. This approach keeps us focused following through with the defined parameters rather than getting too distracted by all the possibilities that we encounter in our horizon-scanning efforts.
Can you share an example of a trial you’re identifying innovative solutions for?
Our Health Equity and Inclusive Research (HEIR) team is partnering with our Evidence Generation team to run a dedicated Alaskan Native/American Indian non-interventional study that aims to understand referral patterns from primary to specialist care and barriers to healthcare access and engagement in a community setting.
We do not want geography to be a limiting factor to participation in this study and so can’t expect people to drive long distances to academic sites for assessments or to go outside of their trusted health network to participate. For this reason, we started to look at decentralized trial options, using a technology platform for direct-to-patient engagement, digital tools, and virtual services. It is still early, but we are seeing a positive impact on the study and for the patients with this hybrid decentralized approach.
What does Genentech’s Innovation Hub do for scaling and implementing innovation?
We connect dots and share learnings so that study teams can build on past experiences to improve on future designs. InnoHub includes three integrated elements – people, process, and product. The people are our Clinical Innovation and Technology Leaders and Data Engineers who are subject matter experts in different innovative areas and approaches. The InnoHub group partners with study teams to identify fit-for-purpose solutions, engage vendors, accelerate implementation, and then capture and share lessons learned to pull forward.
The team also defined an innovation process and framework that outlines what stakeholders should be consulted at what point, what type of questions should be addressed, what are the key steps that need to be taken for due diligence, etc. The InnoHub product includes a centralized repository of all the knowledge gained and vendor capabilities.
Doing something new or different requires work, so it should have some meaningful impact on the cost or duration of the trial, the patient or site experience, or the quality of the outcome.
Why was the Innovation Hub formed?
Given all the demands and time pressures on a study team, it is not always feasible to layer on additional elements required to explore new approaches or keep tabs on the evolving vendor landscape. We heard from our teams that they didn’t have an easy way to know what has been tried before or what types of innovations seem to be working well (or not).
We realized that innovating at the study level translated into lost knowledge, redundant due diligence steps, and sometimes a “stuck in pilot” approach. The InnoHub was created to provide a centralized and up-to-date knowledge repository and to build dedicated capabilities that will help us mature innovative solutions and remain aware of the next cutting edge opportunities..
What is ongoing work to explore how digital can expedite or enhance research?
In addition to the HEIR study, we are also partnering with a study team working with a rare disease population for long-term follow up. Rare diseases and long-term follow up both pose unique challenges to research and these are areas that I think digital and real world data can really make an impact.
In rare diseases, you are unlikely to find enough patients centered around any one site, and digital offers ways to bring the trials closer to patients where they are. We have seen this broader reach translate into more effective recruitment and better feasibility for enrolling enough patients to derive meaningful answers from the study. We are also exploring ways to link real world data to clinical data to reduce study duration and provide more holistic findings beyond the trial setting.
What is your approach to non-tech innovations to modernize clinical trials?
We approach non-tech similar to tech – first, what is the problem we are trying to solve and then what solution (tech or non-tech) might help? Doing something new or different requires work, so it should have some meaningful impact on the cost or duration of the trial, the patient or site experience, or the quality of the outcome.
Both tech and non-tech innovations offer ways to more effectively partner with patients, reduce the burden on sites, and accelerate the trial timelines. Tech and non-tech also have different pros and cons to consider. The InnoHub team tailors their innovation recommendations to be fit-for-purpose and fit-for-patients, while balancing trial budget or timeline constraints.
What are lessons learned from how Genentech approaches implementing innovation?
Two things: one is to focus on the opportunity and impact of the innovation and the second is that to be successful, we must work together.
For the first point – I appreciate the lure of new technologies (AI, digital, DCTs) that we all want to try in trials. These tools and approaches hold so much promise. My takeaway would be to explore them but use caution not to focus on a solution trying to find a problem. At the end of the day, we are engaging with people’s lives in trials and we need to balance the cool, trendy with the impact and experience.
For the second point – digital transformation in healthcare and trials isn’t easy. The innovative tools and approaches are the tip of the iceberg – there is an entire ecosystem under the waterline that needs to evolve and align to make those innovations happen. There will need to be new processes, regulations, roles, and mindsets that will have to shift. We can’t just tack on new ways of working to old structures and paradigms or we will get stuck between status quo and future potential. I’m a strong believer in collaboration and partnership to make this all happen in a cohesive and meaningful way.