Venture Partner Perspectives: Maya Hardigan (Director of Clinical Innovation at Pfizer)

Welcome to FundRx Venture Partner Perspectives, where a FundRx team member conducts a brief interview with a FundRx Venture Partner, with the aim being to share the knowledge and opinions of a diverse array of healthcare clinical and industry experts. Subsequently, we hope these interviews spur further thought and potential innovation and action in the areas discussed.

This interview features Maya Hardigan, the Director of Clinical Innovation at Pfizer. She oversees the advancement of 30+ innovation initiatives across the clinical development lifecycle. Maya previously established and co-led Pfizer’s mClinical platform, an innovation center of excellence driving the development and adoption of mobile and digital solutions for Pfizer’s clinical trials.

Maya also serves on the board of Kangu, a crowdfunding platform for safe births. Prior to joining Pfizer in 2009, Maya was a healthcare management consultant at Booz & Co. (now PwC’s Strategy&), serving pharma, payer, and healthcare services companies in defining adjacent business growth strategies. To chat digital health, connect with her on LinkedIn.

Megan Beck: At Pfizer, you have helped shape the patient experience during clinical trials by bringing innovative solutions into the patient journey, which helps ease workflows and improve compliance. What have been some examples of successful integration of digital tools into the execution of clinical trials?

Maya Hardigan: The past decade has been an exciting time for innovation in clinical development, with several digital solutions finally beginning to come of age. Informed consent can now be collected electronically in many geographies, mobile-based retention and compliance tools are keeping participants engaged in studies to completion, and electronic patient-reported outcomes and wearable sensors provide more continuous monitoring of study participants between clinic visits.

Across the industry, we are seeking and moving a bit closer to attaining the “holy grail” of clinical trial conduct, where we are able to optimize both the participant experience and the collection of robust, high-quality data. By leveraging mobile, digital, and data innovations, we hope to design studies that are more targeted, more convenient for participants, and more seamlessly executed.

A few trends have been working in our favor:

• The global proliferation of smartphones, and a willingness by study participants to use them as data collection and communication tools in clinical trials
• Increasing consumer familiarity and comfort with wearable sensors and personal tracking devices
• The availability of ‘big data’ sets, and a growing understanding of how to apply modeling & simulation capabilities to make the best use of them

Of course, as these trends evolve, so does the nature of how we’re innovating. As devices and sensors are deployed, we find ourselves interacting with vast quantities of new types of clinical data. Our continuing challenge is to tease out what inferences can be made based on using this data to further optimize study design and execution.

Megan: In this same context of clinical trials, what do you think are the key challenges to adopting new technologies? With so many stakeholders involved in the successful execution of a trial, so how do you get folks on board?

Maya: Innovators in the pharmaceutical space need to know how to navigate the complex regulatory framework that governs clinical trials at each step in the process. New approaches are dead on arrival if they may possibly compromise patient care, data privacy, or the quality of the data we will ultimately use for regulatory submission.

I tend to be pretty analytical in my approach to advancing innovation, so I always begin with a sound business case. For an executive audience, this would clearly articulate why the proposed capability or innovation is worthwhile: does it improve the experience of the participant or our site partners? Does it speed our clinical trial cycle time? Or does it have the potential to reduce protocol deviations and consequently, our downstream audit burden? These benefits would then be translated into a portfolio-level impact and ROI. Executive-level endorsement and communication of support to the clinical trial operators is critical to successful change management.

For the operators, it is important to engage early and often, and in my experience, it’s worked well to provide a degree of ‘white glove’ support to the earliest adopters. Finding operators who are genuinely excited to shake things up and improve the process are the best partners (and they’re not hard to find).

Once you have a successful deployment under your belt, it becomes much easier to showcase the value of a new approach and socialize it broadly to speed the pace of adoption. Consider crafting case studies that illustrate the improved speed or quality of a particular process, compared to previous baselines, and share them as often as you can, until it becomes the new expectation.

The degree to which the pharmaceutical industry has banded together to move the needle is really encouraging.

The Clinical Trials Transformation Initiative (CTTI), as an example, has released guidance and resources supporting the use of mobile technologies in clinical trials for improved data capture and participant engagement. TransCelerate BioPharma, similarly, has leveraged experts across its member companies to move the industry forward in several areas, including eSource, electronic informed consent, standardization of investigator technologies, and collaborative data sharing to support more informed site selection.

Generally speaking, we have the technology and looking across the industry, we also have the know-how. What we don’t always necessarily have, is an understanding of how regulators and ethics committees will respond to a proposed change in how we’ve traditionally conducted our studies. Sometimes it can also be challenging for any one company to take the risk of pursuing such changes as a first mover. So, for those reasons, the value of collaborations like CTTI and TransCelerate is immense.

Megan: What do you see as the greatest white space opportunity for digital innovations in clinical trials?

Maya: It’s difficult to choose one! The potential to conduct fully virtual trials is particularly fascinating.

Verily recently announced its Project Baseline, in partnership with Pfizer, Novartis, Otsuka, and Sanofi to establish what they refer to as a “Connected Research Ecosystem”. This integration of technology, devices, and analytics is designed to provide a foundational infrastructure for engaging study participants in the ways they deem most convenient and appropriate. This seems like a step in the right direction. Such an approach, I hope, will also help us access and engage a more diverse and representative population of clinical trial participants (something I am particularly passionate about).

Another very exciting prospect is to incorporate artificial intelligence more meaningfully into clinical trials. There is an obvious operational benefit to leveraging AI in traditional data processing and analytics. As we continue to see more adoption of devices for continuous monitoring, AI will be essential to help process this vast array of signals and translate them into actionable insights.

I led a platform of work for several years that was focused on mobile innovation, and we were able to drive improvements in protocol compliance with the use of app-based alerts and gamification tools. Similar approaches are used on the commercial side of the business to encourage medication compliance for marketed products.

Another immediate impact is leveraging digital and data approaches for study design. Making things like Model-Informed Drug Development more standard across portfolios has great near-term potential to help us design more efficient trials, and the industry is adopting this more broadly today.

The use of real-world data sets to supplement and eventually replace control arms in full is a longer-term area of opportunity that is beginning to have traction, particularly in oncology and rare diseases. The FDA has expressed support for the approach where a traditional control arm isn’t feasible, but I’d expect to see this used more broadly in the coming years, alongside 1) specific regulatory guidance being issued, 2) the validation of real-world data-based endpoints, and 3) growth in the data curation market (players like Flatiron Health).

Ultimately, I see clinical trials to be supplemented with real-world, data-driven insights, resulting in more targeted, smaller, and faster studies.

Megan: It can be daunting for entrepreneurs to approach a large pharma company. If an entrepreneur was to come to you with a solution that they think could benefit a business unit within Pfizer, what would be your advice to them?

Maya: I think my most important piece of advice is to be prepared to clearly articulate potential value, in a way that will resonate with decision makers. Put some thought into your audience’s portfolio of studies, and make the conversation relevant. And finally, show us how the sausage is made. Demo’ing a working prototype goes further than PowerPoint slides alone.

The industry is intent on solving for long-standing challenges in clinical development relating to our ability to execute trials faster and more cost-effectively while remaining laser-focused on quality and patient care. If a startup can communicate how they’ll help a sponsor optimize study design or execution, and the ROI is clear, most pharmas will give it a try.

Megan: In order to stay up to date in those areas and just health care, in general, what are some of your go-to resources?

Maya: I’ve already mentioned some of the fantastic publicly available resources published by CTTI and TransCelerate Biopharma. A favorite conference is DPharm Disruptive Innovations, which is held every September in Boston.

I also make an effort to stay in close touch with my Clinical Innovation peers across the industry, former Pfizer and consulting colleagues who are now in the start-up world, and other interesting folks I meet on the conference circuit. It’s the best way to spark new ideas and partnerships.

Megan: Outside of your career, how do you give back to at-risk communities?

Maya: Over the past several years, I’ve served as a strategic advisor and on the board of Kangu, which provides a platform for individuals to contribute to the funding of safe births for expectant mothers in underserved markets. Kangu has funded over 2,000 births to date through microdonations. I have three young daughters, and I’m extremely proud to support an organization that brings access to the same high-quality medical care I received when I had my daughters to other mothers and babies in need.