Providing Clinical Leadership for Early-Stage IO Biotech Companies

This content was originally published in Women Leadership in Immuno-Oncology Issue 2023. Click here to read the original article.

What does Halloran Consulting do in immuno-oncology?

Our expertise is strategic program leadership, clinical development planning, regulatory affairs, and regulatory operations to early-and late-stage biotech and pharma companies with immuno-oncology assets. In some cases, we act as interim staff to alleviate a financial burden of the company who may not yet have the payroll or capacity to assume full-time hires. We’ve worked on numerous immuno-oncology products resulting in a bedrock of relevant and current thinking about how the FDA operates in this space.

We can save a company valuable resources and potentially costly mistakes by adding our insights to their regulatory process. For larger pharma companies, we bring the small company nimbleness, and we help them adopt what might be perceived as too risky. For example, if an organization is evaluating a risk-based quality management (RBQM) system, considering adopting technology for managing decentralized trials, or thinking outside the box organizationally, we’re able to add constructive value based on what has worked at other companies.

What are the areas you most help biotechs to supplement?

We provide senior-level executive thinking for biotech startups. Experienced industry players often are hesitant to join and commit to a small biotech until there is good clinical data because they don’t want to frequently change jobs due to uncertainty or potential company failure. There’s a real talent shortage for deeply experienced people which can be a huge impediment to a young company because they won’t necessarily get the senior-level thinking if they bring in more junior people. Critical thinking and planning early on are essential.

With the current funding challenges, small biotechs need to find a more efficient path. They want to save as much money as they can and be as laser-focused as possible. Time equals money in a drug development lifecycle. So, if they can bring on a person that commits five-to-twenty hours a week, it’s less expensive and they’ll ensure a deeper level of experience.

From Halloran’s experience, what is unique about early-stage IO biotech companies versus other biotechs, and the challenges they face?

One unique challenge to the IO biotechs is time. With lots of “me-too” products and similar targets under development, it is a race to the finish line of accelerated approval or traditional regulatory approval. Further, time impacts the patients for whom we are trying to impact their survival and treatment outcomes. That is why having a vetted strategic development plan with heavy considerations towards the competitive and regulatory landscapes is essential.

With respect to the regulatory landscape, early-stage IO biotech companies will need to closely watch the evolving programs and perspectives emerging from the FDA Oncology Center of Excellence including Project Optimus and Project FrontRunner. Project Optimus is beginning to reshape the landscape of early-stage clinical trials, particularly with respect to dose exploration and optimization, in oncology settings. Project FrontRunner is a more recent initiative and may create an opportunity for certain companies/products to explore efficacy in early-line settings much more rapidly than the traditional paradigm, where products must begin in a treatment refractory setting.

What should IO biotechs be aware of in regard to changes in the approval process?

Early-stage IO Biotech companies must be aware of the evolving landscape for accelerated approval. Historically, small biotechs would take products through a conditional approval through the accelerated approval process before initiating a confirmatory RCT. Often these small companies were not properly funded to support a large global RCT and this development approach was the only viable option. However, recent messaging from FDA (and the OCE in particular) suggests that the agency will expect a confirmatory trial to be fully enrolled by the time accelerated approval is granted.

This is a major change in regulatory expectations, but one that is focused on reducing that window of uncertainty between accelerated approval and standard/confirmatory approval to avoid continued distribution of products that do not demonstrate clear benefit and efficacy. In addition, identifying and implementing biomarkers in IO is a major challenge and given the increasing pressure that the accelerated approval is facing, the use of reliable biomarkers will become increasingly important for these programs.

What is your advice to early-stage IO biotech companies, to get through the hurdles facing early biotechs?

To successfully get through the many obstacles that early-stage IO biotech companies will face, the execution of the development program will need to be thoughtful and deliberate. Strong leadership and communication are a requirement, and this is not only internally facing, but also in collaboration with the FDA. Forming a collaborative and transparent relationship with the FDA will help to align expectations on the necessary data package to support a future marketing application and mitigate the risk of designing clinical trials that will not produce robust clinical data.

Before you got into helping early-stage biotech companies, how did you get into the industry?

I no longer wanted to be on-call as a nurse. I answered an ad because I needed a new car and it said “50% travel.” That’s it. When you take care of a patient, they either get better and go home, or they don’t. That was devastating for me, especially in the pediatric ICU.

I saw the opportunity to develop new products as a much bigger way to make a difference for patients. That’s what turned me on to it, and what still makes me passionate about this industry. I’m not interested in working on the second or third generation of an existing drug. We’re gravitating towards diseases with no treatments because this will change lives.

What experiences did you draw on to create your company?

When I was at Parexel, we went from 40 people to 5,000. I really learned a lot about what organizations are like at different sizes. The first biotech company I worked at had only five people in the U.S. and they eventually spun out and licensed off their lead product. The second company I worked at was a later-stage biotech; there was nothing put in place before I joined.

I realized you have to have big company thinking to put systems in place at an early-stage company because you can’t “fake it till you make it.” It just won’t work. You need quality and infrastructure every step of the way. If you don’t, you won’t have a high-quality product. You need senior people who know what they’re doing to save time and money. There’s a need for the right-sized process and discipline to be ingrained into a young company from the get-go. Our consultants, like me, come from the industry and have learned how to be better, and we take our collective knowledge and framework to a company with the confidence and understanding of having walked a mile in their shoes.

What is career advice that you find impactful?

My number one piece of advice would be: “If you want to, you can do it.” Women often think that they can’t do things or feel they need to be an expert at everything. That’s not true. Figure out what you’re good at, and then find somebody else who can be good at the things that aren’t aligned with your skills.

We see this with our clients – they believe they need to know everything – and we recognize a limiting mindset will be an impediment down the road. To be successful, you have to have a high level of self-awareness and not feel guilty about saying, “I don’t know this.”

How do we better support women in science careers, from those just entering and those rising the ranks?

For a lot of young women in science, they have to recognize that to grow within their career and ultimately get into a position of executive leadership, they have to give up some of the science because they have to be good at management. You can’t be down in the weeds, while also thinking about the vision and the future. That is where I’ve seen people face significant challenges because the person who gets stuck in the data will struggle to be the ultimate leader.

Dig deep to understand your strengths and weaknesses. Pick up skills to be a leader or find a mentor. The biggest part is recognizing that you have to grow.

To learn more about how Halloran can offer support to your immuno-oncology development, please contact us today.