Show Notes
What does it take to launch a new class of medicine?
When launching a new therapeutic, many unknowns exist, but some principles remain constant. By looking to past experiences and staying lean, emerging biotechs can derisk their organizations while hitting milestones by taking an agile team-building approach.
Today’s guest is Adriana Valenciano, Senior Vice President at SSI Strategy. She is working closely with Oz from Empyrean to bring a new class of medicine to the neuro-psych market. Co-hosts Kim Kushner and Ramin Farhood discuss with Adriana some of the intricacies of getting a new class of medicine to the market, the intersection of neurology and neurosciences, and the importance of the agility and flexibility needed in the early stages of biotech startups.
Here are a few of the highlights from this episode:
Creativity and past experiences are crucial to launching new classes of medicine
Emerging biotech companies, especially ones pursuing new classes of medicine, are navigating the unknown. It can feel like there is nowhere to turn for direction. The good news is that experience is a great teacher. Even experience that isn’t directly related to the current situation.
Oz, the CEO of Empyrean, had a diverse background in Big Pharma and within start-ups. He leaned on his past experiences to know where to focus his attention to bring the most impact to his current venture early on.
Similarly, Kim, Adriana, and Ramin speak about how every new field they’ve worked in gives opportunity to be creative and try new things. Still, certain principles and frameworks remain the same across types of medicine and levels of innovation.
Even though there are similarities, it takes creativity to engage with regulatory bodies, tell the value story to engage early payers, and translate the clinical value to physicians and, ultimately, patients.
Whenever a team brings a new therapeutic to the market, there are things to hold to and things to let go of. That’s why it’s essential to have a team with diverse backgrounds and perspectives. These differing points of view provide a vital lens to look through when making decisions about what needs to be pulled from past experiences and where the team needs to pivot to new ways of approaching the science or the organizational process.
Because the intersection of creativity and experience is critical, it’s important to think through early-stage organizational structure and resource allocation. You have to layer in the challenges of identifying what team makes sense for you at that time and the pressure you're facing to meet milestones and deliver on commitments.
Agile and flexible team building
In Oz’s interview, he said leaders are for seasons, and teams are for seasons. It will not work if you try to build out your early-stage team with the same organizational style as a Big Pharma company. This is also true of the types of people that you hire. If you focus on hiring people from large orgs that manage functions, they won’t necessarily be the right phenotype for building a department from scratch.
Early biotechs need to balance the needs of the internal organization, the company culture, and the funding runway. It’s easy to over-hire early on, and when things shift in the market or a key milestone takes longer than expected, it can derail or even completely crash the company.
One way to de-risk is to determine the key differentiating factors for your therapeutic. Focus your full-time hires on those areas and find external partners to augment their work.
If the main differentiator is the science, like at Empyrean, bring scientific or medically focused full-time employees. If your differentiating factor is in manufacturing, focus there.
Ask yourself, what solutions do I need vs. who should I hire? Asking this question enables you to think more flexibly and with agility. Instead of trying to hire unicorns, hire the solutions you need.
Begin with the end in mind. What do we need to accomplish to reach a milestone on time, who do we need internally to make that happen, and how can we augment our team with the right external resources to make that happen?
Whatever route you choose, don’t go it alone. Seek out partners, mentors, and peers that can help you make better, more informed decisions.
What is The Emerging Biotech Leader?
Biotech—it's complicated.
A successful product launch requires grit, determination, and clear direction.
But let’s be real, the path to launch isn’t a straight one.
There are curves, hard turns, and dead ends.
Here’s the good news, you don’t have to navigate the complexities alone.
Welcome to The Emerging Biotech Leader, where we help biotech leaders maximize the value of their therapeutics from clinical development to product launch.