In the interview — part of our Women in Pharma and Biotech series, Waters provided insights on an array of subjects, from adopting the IT-based agile framework to cell-and-gene therapy to the art of hiring and weighing hard and soft skills in the biotherapy domain. She also provided advice on approaching data-driven decisions, and offered perspectives on team leadership, patient prioritization, and the future trajectory of the field.
Be open to the unexpected
Waters’ initial inclination was towards academia. Graduating in 2008, in sync with the “Great Recession,” she decided to get a Ph.D. with an aim of becoming a college professor. At the University of Minnesota, she dove into molecular, cellular, developmental biology, and genetics. “I enjoyed getting an opportunity to do research every day,” she recalled. “Getting to work with other colleagues in graduate school postdocs, and other PIs attending conferences, there was always an opportunity to learn about very specific subjects.”
A twist of fate occurred when she attended a job fair sponsored by the university. Recently learning that Be The Match was headquartered in the Twin Cities, Waters met with some of their representatives. “I met with a couple of people who also had their doctorate degrees, many of them from the U, who now worked at Be The Match,” Waters mentioned. When getting ready to defend her thesis, Waters found a job listing for Be The Match as an immunogenetic specialist that resonated with her background and interests. Fast forward to today, and she has worked for the organization for close to 10 years.
Invest in biotherapy leadership
Waters noted that Be The Match invests in leadership through training opportunities, “especially for new and emerging leaders.” The organization offers mentorship and sometimes taps external experts. The organization also has a program known as Leadership Lab that is focused on hands-on leadership training and peer-to-peer coaching with an external consultant. “That was a really great experience to learn from my peers across the organization that I wouldn’t normally work with on a day to day basis, as well,” Waters said. Getting an outside perspective on the leadership skills that are important can keep organizations competitive.
Waters highlighted that guiding teams to make the best decisions in their respective domains is a core dimension of leadership. Those domains could encompass roles as varied as physicians tasked with pivotal clinical decisions to drug developers deliberating on intricate manufacturing processes.
Prioritizing patient well-being while balancing the needs of other stakeholders
The focal point in the biotech realm, especially with biotherapies, revolves around “always bearing in mind there is a patient at the end of this story, whose life needs to be saved,” Waters said.
This patient-centric approach is a theme that extends across a complex landscape composed of an array of stakeholders, including physicians and drug developers. Waters underscored the importance of providing physicians with the necessary information to help guide clinical decision-making. This ambition requires a balancing act, equipping drug developers with the needed services and resources to optimize their manufacturing decisions while also meeting the needs of internal staff. “All of this is done working within a complex regulatory structure as well, trying to make sure that we are following the regulations that authorities like the FDA set for us and for these drug developers,” Waters said.
The process of biotherapy development frequently involves “taking in a lot of information, hearing a lot of different needs from all different parties,” Waters said. Sometimes the process involves making decisions on imperfect or less than complete information based on “what you have available to you at that time — that will be the least disruptive to operations but still getting what you need or come the closest to providing exactly what is being asked for.” The goal is to minimize disruption to operations while ensuring the utmost patient care and meeting the specific demands of the project. That involves supporting physicians with information to help guide their decisions while providing services or resources to drug developers to optimize their manufacturing processes.
Embrace agile decision-making, even when faced with incomplete information
In a quickly-moving field like biotechnology, flexibility and adaptability are paramount. To help streamline processes and foster rapid decision-making, Waters has found success in adapting the agile methodology and its focus on iterative product development. “It just happens to be that our product is nine times out of 10 human cells and not software,” Waters said.
She further explained that the roles within Be The Match echo those found in a traditional software development framework. “My team in particular are called ‘solution owners’ and they’re very analogous to ‘product owners’ within an IT landscape.” Waters said. In the agile framework, product owners prioritize feature lists, define user stories, and ensure that the development team delivers value to the business. At Be The Match, solution owners “represent the voice of the customer.” They ensure that the biotherapies in development are “what the customer is asking for,” she said.
Additionally, Be The Match has teams focused on daily operations who fulfill a role similar to software developers in the agile methodology. But instead of coding, their tasks, however, are distinctively biological. Their focus could be to ensure cells are transported correctly or to confirm that cell donors undergo appropriate testing and meet all requisite standards.
Ultimately, the agile approach has empowered Waters’ team to be more autonomous, make faster decisions, and better serve their clients. “We wanted to understand how to work in a way that is faster and allows more independent decision making by the individuals who are working with clients every day,” Waters said. She explained that the agile format provides structured timelines for client tasks. “It also gives them the autonomy to make decisions that are in the best interest of their clients without necessarily getting bogged down,” she said.
Hiring advice in biotherapy: Weighing hard and soft skills
As a veteran in the biotherapy domain who regularly hires employees, Waters provided some pointers on hiring criteria in the biotherapy space. “I do obviously look for and value experience,” Waters said. Thankfully, many applicants in the field have a wealth of relevant expertise. But beyond just professional experience, Waters also seeks out a candidate’s potential. Here, soft skills can be decisive. She emphasized the importance of adaptability, a willingness to take risks, and the capability to unite different teams toward a common goal. “How do you bring everybody together, move in the same direction?” she asked. Effective communication and collaboration are other considerations. “Do they have the ability to influence without authority?” she asked. Ultimately, it’s crucial to have team members who are constantly seeking improvement, comfortable with making mistakes, and possess a growth mindset.
For Waters, hiring is more than just ticking boxes. It’s about identifying candidates with an innate drive for continuous improvement. “Are they always looking for better ways to do things and not just settling for the status quo?” she pondered.
Equally important to Waters is a candidate’s ability to own their mistakes and learn from them. “Is the candidate comfortable with the idea of occasionally being wrong?” Waters questioned, stressing the importance of resilience. She advocates taking a scientific approach to making mistakes — treating them as experiments. “Are they willing to take risks, even if it means making a mistake, and then learn from it for future challenges?”
In the rapidly changing world of biotherapy, adaptability is crucial. Waters values candidates who can adapt to changing scenarios and uncertainties. “The direction of the field can be unpredictable, and we need people who can navigate those changes,” she concluded.
Diving deep into data without drowning in it
Professionals in the biotherapies industry should be able to demonstrate a willingness to process large amounts of information swiftly and effectively to aid decision-making. Waters emphasized the significance of data in the operations of Be The Match, stating, “We do use as much data as we can.”
The data-driven mindset took time to cultivate, Waters acknowledged, as the organization had to invest in gathering baseline data before it could begin to understand performance metrics, like meeting client timelines and delivering quality services from a data-driven perspective.
One of the ways Be The Match uses data is to measure product quality. “When I talk about the product itself, I usually am referring to cells derived from a healthy donor in a bag — cells in a bag,” said Waters. Here, data plays a pivotal role in optimizing the collection process to meet manufacturing needs — for instance, how many cells to collect at the end for manufacturing. “Based on the data we’ve gathered and analyzed from our collections, we can advise on the optimal total blood volume to process to achieve the desired cell count,” Waters said.
“The one piece of advice I have around data-driven decisions is that you have to start with quality data,” Waters stressed. When it comes to data, less is sometimes more. “It’s really easy to just get really excited and to say, ‘give all of the data to me,” she observed. A thoughtful approach to data gathering and analysis can make all the difference. Waters emphasized the need for clarity in understanding the kind of data required, stating, “You need to know if you’re collecting, storing, and analyzing the right data.”
On data-driven planning
Be The Match uses data for strategic planning, using data to plan for the evolution of the industry. “We take a look at what the data tells us and then try to improve those outcomes,” she said. Partnerships are an important part of the data puzzle. “We rely on vendors and partners for some of our services,” she said. “And we really want to understand how well they are performing according to the contracts that we have with those organizations.”
Highlighting a transformative moment for the organization, Waters recalled, “I think we saw sort of the biggest leap in our ability to use data to drive business decisions once we started working with our data analysis people who helped us form those questions and then therefore form the data gathering structure to actually answer them.” This collaboration streamlined their approach, ensuring that they were not just collecting data, but collecting the right kind of data to drive meaningful change.
Envisioning the future of biotherapy and CGT
Waters is excited about the trajectory of cell and gene therapies (CGT). Reflecting on the decades of development and the setbacks experienced, she notes that the industry seems to have reached a sweet spot, harmonizing research insights with advancements in technology, especially in targeted genetic manipulation. “Our ability to make induced pluripotent stem cells (iPSCs), to manipulate stem cell lines, and to help treat disease in patients… it’s all just coming together in a very cool way,” she remarked.
Blood cancer has been a prominent focus for many cell therapies, but Waters sees the horizon broadening. “What’s really exciting to me is the expansion of cell and gene therapies outside of blood cancers, and into orphan diseases,” she shared. The ripple effect of this expansion is profound. Waters elaborated, “Suddenly, patients who had absolutely no options might have significant options that can save or drastically improve their life.”
Recalling the impact of the gene therapy Zolgensma (onasemnogene abeparvovec-xioi), for instance, on spinal muscular atrophy patients, Waters emphasized the transformational effect of potential treatments. “Something that was a really scary situation may be a little less scary now, with the promise of further improvements to come,” she said.
She’s eager to see cell and gene therapies branch out even further. “The movement into autoimmune diseases and neurodegenerative diseases is very promising for cell and gene therapy,” she mentioned. Waters, however, doesn’t shy away from acknowledging the challenges that lie ahead. As the biotherapy domain continues to evolve, scalability becomes crucial. Waters emphasized the significance of cost considerations during development and manufacturing processes. She said, “We have to bear in mind the cost of goods, ensuring that these therapies remain accessible to all.”
Filed Under: Cell & gene therapy, Data science, Drug Discovery, Women in Pharma and Biotech