Launching the next life saving therapy

Healthcare is a broad field.  It could apply to digital health that is sold directly to the consumer, medical devices (both physical as well as software) that are sold to hospitals and physicians, and drugs and therapies that fall into the “life sciences” vertical.  While there are some overlapping commonalities: regulated industry, longer time to market, and payer is not the user, there are many different considerations for drug launch compared to device launch.  Today I’m excited to interview Yaa Bruce who has been a part of many commercial launches for therapeutics and drugs to hear her perspective.

Lusi: Your expertise lies in therapeutics and drug launches, a distinct path from medical devices or digital solutions. Could you share your background with our audience?

Yaa: My experience primarily revolves around therapeutics, and managing product launches in both large and small companies. Recently, I led the US commercial launch of the first gene therapy for hemophilia A, overseeing marketing and overall launch strategy.

I've worked with companies spanning from small (e.g.80 people) to giants like Genentech, involving launches for products like multidrug-resistant antibiotics. I've also launched line extensions, meaning a product that is already on the market, but launching a new indication. This broad experience in marketing, sales, market access, and more has equipped me to navigate different aspects of launch planning and execution.  I've also partnered closely with other groups outside of commercial like regulatory, clinical, and manufacturing, to help think about things like filing strategy or negotiation strategy, lifecycle management (what other indications we want and when) to help bring the product to more people.

Lusi: Given the diverse companies you've worked with, at what stage do companies typically start planning for a drug launch, considering the unique challenges posed by regulatory processes?

Yaa: The timing varies based on company resources, risk tolerance, and priorities. Larger companies may initiate launch preparations even years before anticipated FDA approval, allowing for a more rapid uptake post-launch. Smaller or risk-averse companies might wait until closer to approval for more certainty, potentially causing a delay in full market penetration. Commercial considerations, such as understanding market dynamics and formulating launch strategies, also play a crucial role early on.

Lusi: I understand you’re an industry advisor for SPARK at Stanford, which involves interaction with students, professors, and industry partners. How does your experience inform early-stage companies about the market landscape, regulatory pathways, and the lengthy drug launch journey?

Yaa: Even though most people participating in SPARK are very early in their company journey, I help them assess the market viability of their discoveries. Even though you may not have a launch team, it is important to consider commercial inputs during drug development and trial design, understanding competitive landscapes, unmet needs, potential positioning strategies, regulatory pathway, and reimbursement strategy.

Lusi: Speaking of considerations, what are the key factors that companies in this industry must weigh when planning a launch?

Yaa: Several critical considerations come into play.  Clinical efficacy is paramount, ensuring the drug works and is safe. Regulatory factors, market dynamics, pricing, and reimbursement are also vital. Understanding the patient journey, from diagnosis to therapy, and addressing manufacturing complexities are significant aspects that need careful consideration.

Clinical efficacy is the foundation: the drug has to work and it has to be safe, the benefits have to outweigh the risks. However clinical effectiveness alone is not sufficient.  

Regulatory is another big one. There has to be a viable path to approval, and it needs to be clear to the company that they can achieve that path, understanding whether that's a shorter path or a long path, do you need large studies or can you do smaller ones? Do you need just one pivotal study? One needs to understand what's involved in it and make sure that resources are in place for that. 

Market dynamics are next, including market size, competitive landscape, and understanding who the customers are, and that can include patients, physicians, and other healthcare practitioners. It can include advocacy groups, so understanding who they are, what their current beliefs are, what the unmet needs are, and how this new product will address those needs is key as well. 

Pricing, market access, and reimbursement are huge.  I'm sure your readers know, that it's different than any other industry where the person using that drug is not always paying for it, and not necessarily always paying the full price.  So just understanding whether there's reimbursement potential or what the distribution channels will be, like how the drug will get to patients, and often physicians before patients, is important.

What does the patient's journey look like?  How short or long and easy or difficult will it be for patients to get your therapy? Sometimes even identifying people in the diagnosis stage with this condition can be long and complex. Is there testing required before therapy?  

If it's like a big departure from how things are done today, it could be harder to get uptake.  If previously someone could just easily take a drug at home, but now they have to go into a clinical setting to do it, they may not opt for your therapy even if it’s better, or it may take longer than you might expect for people to switch. 

Finally manufacturing, understanding how complex or simple that process is. Who's going to do the manufacturing? Can it be done in-house? Do you have the capability to do that? Do you need a contract organization? Those are some considerations as well.

Lusi: Is there a matrix to help smaller companies make decisions about drug launches (e.g. faster but smaller indication vs long but larger broader ones?)

Yaa: Decisions depend on trade-offs and objectives. This may depend on the company’s overall strategy, for instance whether it wants to get acquired quickly or go a bit further on its own.  For the latter, showing that there is a sizable market, and selecting a quick regulatory pathway is important.  If you don't have a ton of resources, you want to at least be able to generate some revenue early. Sometimes people do that by licensing an early product to a larger company, to generate revenue, while continuing to develop other molecules in the pipeline. For more rapid uptake, picking a market that has a clear unmet need and is not crowded may help.

Lusi: What lessons have you learned through your various drug launches? Are there instances where things went better or worse than expected during a launch?

Yaa: The key lesson is to remember the clinical impact and patient outcomes, as drug launches can be lengthy and complex, and remembering this overarching impact can be an important guiding light. External factors, such as unexpected regulatory news or unexpected data from competitors, can significantly impact plans. 

Multiple times I have been at companies that experienced unexpected regulatory news, perhaps there's an indication that you think is likely but then you end up not getting approval. Or perhaps the timing, maybe you were expecting a shorter time to approval than what ultimately ends up being the case. 

Expecting the unexpected and having a plan B in place is crucial.  For example, If you don't get approval, what is going to be required afterward (for example, more studies)? Do you have the cash or the ability to raise the cash to do that? 

There could be a change in the financial environment. And I think as an industry we've seen this a bit in the past year or so. And so for earlier stage companies it might be harder to raise capital, and so I think when you're raising capital thinking about how far this can get us and being conservative in those estimates could be helpful too. 

You could also have unexpected data, your own or a competitor’s. Early on in the launch process, you look at the competitive landscape, and can you try and predict what it will look like so you can have the appropriate positioning and messaging.  Sometimes that competitor doesn't get the data they want. And that's the good news for you. For one of my products, an early competitor petered off because their data simply wasn’t that strong so they became less of a threat. At the same time, others generated really strong data and became more of a threat.

Try not to get too swayed by the unexpected news that will certainly come and focus on what you can do to adjust your plan. It's essential to focus on what can be controlled and to understand that clinical effectiveness alone may not guarantee success; other factors play pivotal roles in a drug's overall launch and market uptake.

Lusi: Wow that’s a highly complex and long launch process.  As you mentioned, healthcare is one of those fields where the user is often not the buyer; then there’s distribution, the patient journey, regulatory, and competitors.  It's not for the faint of heart.

Yaa: It’s not, but the impact is so big.  In the midst of it all, when you see what potential therapies could mean for people, it balances out all that effort.

About:

Lusi is a partner of The Thirteens, a start-up consultancy of fractional executives covering multiple functions and industries, supercharging your start-up to the next level.

Yaa Bruce is a network advisor with the Thirteens.  If you’re an early stage drug company and want a commercial perspective on the most important aspects of your launch, feel free to reach out.