Innovation

What does it actually take to turn a cell therapy idea into a viable therapeutic—especially when the hurdles are higher than ever and every experiment carries real consequences for your runway?

Dr. David Brühlmann

CMC Strategist

Innovation

What does it actually take to turn a cell therapy idea into a viable therapeutic—especially when the hurdles are higher than ever and every experiment carries real consequences for your runway?

Dr. David Brühlmann

CMC Strategist

Key Topics Discussed

The Bioprocess Brief — biweekly intelligence for CMC and manufacturing leaders.

Strategic takeaways on biologics, cell and gene therapies, and AI-driven bioprocessing — distilled from the Smart Biotech Scientist Podcast and 20+ years on the floor.

Manufacturing neural cell products is notoriously complex: the science is tough, the regulatory path even tougher, and the financial pressure is relentless. 

In this week’s episode, David Brühlmann is joined by Bilal Fares, co-founder of AzureCell. Bilal has charted the biotech frontiers across two neuroscience ventures and now faces the dual challenge of bringing an ambitious Parkinson’s cell therapy through preclinical development with a lean, cross-disciplinary team. His blueprint is equal parts scientific rigor, ruthless prioritization, and candid lessons from the startup trenches.

  • Strategies for prioritizing experiments and narrowing focus with limited resources [03:33]
  • How business opportunity validation programs helped define a product roadmap [04:08]
  • Integrating AI and synthetic biology into research programs—and where these tools do, and don’t, accelerate development [05:07]
  • Building a cell therapy platform for personalized approaches in neurological diseases beyond Parkinson’s [06:38]
  • Lessons learned in biotech leadership and why tackling big problems matters [08:08]
  • Key advice for aspiring biotech entrepreneurs: kill your own solutions quickly, and learn from others [09:27]
  • The importance of having a strong team and how a powerful mission attracts top talent [12:21]
  • AzureCell’s near-term plans and future goals, including upcoming fundraising and R&D milestones [13:30]

In Their Words

I would say ensuring that we can balance the fast pace of development and getting the key data that we need, while also keeping the end goal in mind. We need to ensure that everything we generate isn’t just for show or for a nice paper, but is actually a building block toward an IND package.

That’s very difficult when you’re working within academia. It’s also very difficult when you’re operating with limited funding and a team that comes from different backgrounds and areas of expertise.

At this stage, we’ve been lacking, to some extent, the ability to balance rapid execution with keeping the end goal in mind, and that has been our biggest challenge.

Podcast Transcript

David Brühlmann [00:00:41]:
Welcome back. In the first part, Bilal Fares walked us through the vision behind Azure Cell and what makes a cell therapy approach to Parkinson’s disease worth pursuing. Now we get practical. Manufacturing neural cell products presents some of the most demanding challenges in biotechnology. And if that isn’t enough, all of it has to be accomplished on a lean budget. We’ll also look at where synthetic biology and AI fit into the picture. Let’s continue.

Looking at your development journey so far, and where your company is today in the preclinical stage, what have been the biggest challenges?

Bilal Fares [00:02:33]:
I would say ensuring that we can balance the fast pace of development with generating the key data that we need, while always keeping the end goal in mind.

We need to ensure that everything we produce isn’t just for show or for a nice publication, but is genuinely a building block toward an IND package.

That’s very difficult when you’re working within academia. It’s also very difficult when you’re operating with limited funding and with a team that comes from different backgrounds and areas of expertise—all of them incredibly talented. At this stage, we’ve been lacking, to some extent, the ability to balance rapid execution with keeping the end goal in mind, and that has been the major challenge. I would say we’ve been able to mitigate that by bringing in the right experts to advise us along the way. At some point, we had to decide, “Okay, this is our R&D strategy for generating the data we need from this experiment.” At the same time, we began planning the longer-term roadmap required to build the complete package needed for the IND.

David Brühlmann [00:03:33]:
How do you decide which experiments are truly necessary to move you closer to your goal, and which ones might simply become distractions?
When you have limited funding and a limited runway, I imagine that can become quite overwhelming at times.

Bilal Fares [00:03:50]:
Absolutely. What we did was think backwards. Again, we started with the end in mind. We asked ourselves: This is what we ultimately want to achieve. This is the power of the platform. But how do we narrow it down into a first product that could realistically be approved by regulators and supported by investors?

We had to strike that balance. I would say we went through a very thorough business opportunity validation phase. We participated actively in several venture programs and interacted with leaders across different fields.

That process helped us narrow down which features we actually needed to incorporate into the first asset we’re developing, balancing the level of innovation we bring with the speed required to generate the first data package we need. That was the first step.

Then, once we had defined the target product profile for our first asset, we worked backwards from there, identifying the data packages we would need along the way. From there, we prioritized what we could realistically accomplish with the funding we had, while putting together a plan that would allow us to raise additional capital to fill any remaining gaps.

David Brühlmann [00:04:48]:
If we look further into the way you’re developing the science and your overall strategic R&D approach, to what extent are you benefiting from newer technologies like AI and machine learning? How has that changed the way you generate meaningful results?

Bilal Fares [00:05:07]:
I would say it has changed our thinking, especially now that we’re seeing practical use cases for AI that go beyond the hype and can genuinely accelerate R&D in biotechnology—and specifically in cell therapy. Our current lead program is largely independent of AI at this stage. We’re pursuing it through a more traditional development approach.

However, we’re now launching a second program where we intend to leverage both synthetic biology and AI much more extensively to accelerate research, create an even more powerful therapeutic asset, and really push the boundaries of what engineered cells can do within the brain.

I believe there’s a tremendous opportunity today for AI to accelerate this process. For example, AI-guided protein design is already proving to be effective, and there are numerous examples demonstrating its potential. I also think AI will significantly disrupt the pharmaceutical and biotechnology industries—not only in how innovation is generated, but also in how intellectual property is created and patents are filed. I’m a strong believer that AI is here to stay. It’s not going to replace scientists. But scientists who effectively use AI will, over time, replace those who don’t. That’s why we’re trying to integrate AI into our development strategy as early as possible.

David Brühlmann [00:06:21]:
Where do you see your company evolving over the next five—or even ten—years? To what extent do you see this technology becoming a broader platform that can expand into other neurological diseases? What do you think is realistic in that timeframe, and what remains part of the longer-term vision?

Bilal Fares [00:06:38]:
Yes. We’ve also integrated that thinking into our early development plan. We see the first asset we’re developing as a building block for future assets that we could potentially develop. We view the stem cell line we’re engineering as a chassis cell line, incorporating modifications that are relevant not only for Parkinson’s disease but also for other neurological disorders.

We’ve already developed a strategy for systematically modifying this cell line to incorporate additional features in a de-risked manner. That would expand the functionality of these cells, allowing us to address different diseases and, potentially, different patient subpopulations over time.

As I mentioned earlier, Parkinson’s disease is highly complex, and not all patients are the same. One advantage of our approach is that we can tailor specific cell therapies to match the pathogenic mechanisms occurring within different patient subpopulations.

That’s really our vision: develop a first asset that is sufficiently differentiated to make a meaningful impact, and then use it as the foundation of a broader platform that can expand into different patient populations and additional neurological indications.

David Brühlmann [00:07:48]:
Let’s shift gears a little. I’d love to talk about the lessons you’ve learned and the advice you would give as an entrepreneur. You’ve co-founded two neuroscience ventures, and now you’re building AzureCell. What has been the biggest leadership or business lesson you’ve learned so far?

Bilal Fares [00:08:08]:
I think the biggest lesson I’ve learned is something that may sound obvious today: building a biotech company is difficult. It’s very, very, very difficult. It doesn’t matter what type of biotech you’re building—it’s incredibly challenging. So, if you’re going to do something this difficult, you might as well choose a problem that’s truly worth solving.

Some people think, “Let me find a problem that’s relatively easy or straightforward,” assuming that will create a smoother path. In my experience, that path doesn’t really exist. That was something I learned from the previous company I was part of.

For this new venture, I asked myself: What could genuinely change the future of medicine for this disease? How can we address the root cause? For me, the answer was cell therapy. Then I realized that building a startup is difficult. Building a biotech startup is among the most difficult kinds of startups. Building a cell therapy company is among the most difficult types of biotech companies.

And building a genetically engineered cell therapy company for neurological diseases—one of the most challenging frontiers in medicine—is even more difficult. The challenges keep increasing. But that’s also why it’s worth doing. We’re working on a problem that’s so significant and has the potential to create such a profound impact that it continually gives us the motivation to keep moving forward despite all the setbacks and challenges.

So my first piece of advice would be: choose a problem that’s truly worth solving. Second, find a solution that you’re genuinely passionate about and that you truly believe can change the status quo. Third—and this is something we discovered almost by chance—try to kill your own idea as quickly as possible. Talk to experts. Talk to potential customers. Participate in competitions and venture programs. Seek out people who will challenge your assumptions. If they convince you that your solution won’t work, they’ll save you an enormous amount of time, money, and effort. Then you can move on to another solution or another problem where you can genuinely make an impact.

Finally, always start with the end in mind. Once you’ve identified the problem and developed a solution that you’ve validated, talk to people who have already done it. Make sure what you’re building isn’t simply an interesting research project, but something that truly puts you on a path toward making a real clinical impact.

David Brühlmann [00:10:08]:
What’s one piece of advice you wish someone had given you several years ago when you were just starting out?

Bilal Fares [00:10:16]:
It’s very much in line with what I just shared. For me, though, it wasn’t actually advice—it was a question. It’s an interesting story. I was part of a Venture Leaders Biotech program in Switzerland, where they assemble a group of Swiss biotech entrepreneurs and take them to Boston for a week to pitch to investors and meet industry leaders. I was sharing a room with another entrepreneur—now a very good friend—whom I had just met. We had both just arrived in Boston, were completely jet-lagged, and started talking. He’s a chemist by training, and he was trying to understand Parkinson’s disease. He kept asking me questions: What causes Parkinson’s? What drives the disease? Then, at one point, he looked at me and asked: “Bilal, if you had a magic wand and could do absolutely anything to cure Parkinson’s disease, what would you do?” That question completely changed the way I was thinking.

Up until then, my thinking had been constrained by what I had available: my budget, my team, my existing projects, and the practical limitations around me. For the first time, I allowed myself to think much more broadly.

My answer was: Cell therapy is the future—but we need to make sure the transplanted cells don’t die over time. We can’t simply put them back into the same fire.

He looked at me and said: “That’s actually a smart idea. Why aren’t you working on it?”

I replied, “I already have so many things going on.

But that idea stayed with me. I couldn’t stop thinking about it. I kept researching it, and I realized that very little work was being done in that direction. That became the spark that ultimately led to where we are today. So I would say: surround yourself with smart people who believe in you and who challenge your thinking. In my case, it wasn’t just the question—it was also his validation.

He’s a successful serial entrepreneur who has founded several companies. Hearing someone like him say, “This isn’t crazy. This is actually a good idea. You should pursue it,” gave me the confidence to explore it more deeply. That initial encouragement became the fuel that ultimately led to this company.

David Brühlmann [00:12:00]:
Excellent. I like that. I think that’s really good advice because, when you’re starting out as a scientist, you believe you can do everything by yourself. But the further I’ve progressed in my career, the more I’ve realized that, actually, no—I need a team. I need other people. And that’s exactly what you just shared: put yourself in a room with smarter people, learn from them, and collaborate.

Bilal Fares [00:12:21]:
Absolutely. I can’t emphasize that enough. I think we’ve been very fortunate at AzureCell to assemble a fantastic team. Every time I pitch, people tell me, “Wow, how were you able to bring all of these people together?” I think it’s because people are motivated by the potential of the solution and by how well it addresses such an important problem. To us, it feels like the logical way forward. We know what needs to be done—we just need smart people who can translate that vision into reality, continue developing it, and take it further. We’ve been very fortunate to build a great team that’s capable of doing exactly that.

David Brühlmann [00:12:54]:
You have a big “why,” you have a strong sense of purpose, and you also have a clear plan. I agree—that combination attracts high-caliber people. This has been great, Bilal. As we’re wrapping up, is there a question I should have asked but didn’t?

Bilal Fares [00:13:11]:
I can’t really think of anything. You’ve done a great job covering all the important topics. Typically, I enjoy giving back and offering advice to young entrepreneurs, and we’ve covered that quite a bit today. So, honestly, nothing else comes to mind.

David Brühlmann [00:13:24]:
Then tell us about your future plans. What are the next steps for your company?

Bilal Fares [00:13:30]:
Right now, we’re heavily focused on R&D. Our priority is generating the data packages we need to establish proof of concept for our lead asset while also beginning development of our second program. On the funding side, we’re well financed into 2027, and we’ve already received interest from potential investors. Those discussions are progressing well.

Our main objective is to launch our next major fundraising round around the beginning to the middle of next year. That financing would provide the resources needed to advance the program through IND-enabling studies.

David Brühlmann [00:14:00]:
Excellent. There’s clearly a lot of exciting progress ahead. With everything we’ve discussed today, Bilal, what’s the single most important takeaway?

Bilal Fares [00:14:09]:
I think the biggest takeaway is that building a biotech company is incredibly difficult. Make sure you’re solving a truly important problem. Make sure you’ve thoroughly validated the solution you’re pursuing. And make sure you have the right CMC strategy to move it forward, because in therapeutic development—and especially in cell and gene therapy—CMC is absolutely critical.

Finally, surround yourself with the right people who can help you accomplish your mission and keep you motivated through the inevitable challenges along the way.

David Brühlmann [00:14:40]:
This has been excellent, Bilal. Thank you for sharing your passion and the impact you’re working to create. Where can people connect with you? And perhaps, if there’s an investor listening today who would like to support your work, where can they reach you?

Bilal Fares [00:14:56]:
I’m fairly active on LinkedIn, so people are welcome to connect with me there. Unfortunately, I can’t reply to every single message, but I do my best. We also have a landing page for our website, and we’re currently developing the full website. People will also be able to reach us through the contact form there or via the company’s general information email.

David Brühlmann [00:15:15]:
There you have it, Smart Biotech Scientists. I’ll include all the relevant links in the show notes. Please reach out to Bilal. And Bilal, thank you very much for joining me on the show today.

Bilal Fares [00:15:24]:
It was a pleasure. Thank you very much for having me. I really enjoyed our discussion today, and I look forward to staying connected.

David Brühlmann [00:15:32]:
The hardest problems in CNS cell therapy aren’t only scientific. They’re also about deciding which experiments truly de-risk a program when capital is scarce. Bilal Fares’ perspective, shaped through multiple biotech ventures, offers a valuable roadmap for any scientist considering the journey from academic discovery to company building.

If you found value in this episode, please leave a review on Apple Podcasts or your favorite podcast platform. It really helps other scientists like you discover the show.

Thank you for tuning in, and I’ll see you next time.

Disclaimer: This transcript was generated with the assistance of artificial intelligence. While efforts have been made to ensure accuracy, it may contain errors, omissions, or misinterpretations. The text has been lightly edited and optimized for readability and flow. Please do not rely on it as a verbatim record.

Next Step

If you found value in today’s episode, take a moment to like, follow, and leave a review on Apple Podcasts or your favorite platform—it helps us reach and support more scientists like you.

Thanks for tuning in to the Smart Biotech Scientist podcast and being part of this journey toward bioprocess mastery. For more insights and practical tips, visit

www.smartbiotechscientist.com

About Bilal Fares

 

Bilal Fares is a biotech entrepreneur passionate about turning cutting-edge neuroscience into life-changing therapies. With a background spanning research, business, and leadership across three continents, he has spent more than 15 years developing regenerative medicine and antibody-based approaches for neurodegenerative diseases. He is the Co-founder and CEO of AzureCell, a University of Geneva spin-off developing next-generation stem cell therapies to transform the treatment of Parkinson’s disease and related disorders.

 

Connect with Bilal Fares on LinkedIn.

Further Listening

If you enjoyed this episode you might also like listening to:

Episodes 269 - 270: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo

Episodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee

Episodes 249 - 250: How T Cell Activation Redefines TIL and CAR-T Manufacturing (Boosting Success Rates to 95%) with Chantale Bernatchez

Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome

David Brühlmann is a strategic advisor who helps C-level biotech leaders reduce development and manufacturing costs to make life-saving therapies accessible to more patients worldwide.

He is also a biotech technology innovation coach, technology transfer leader, and host of the Smart Biotech Scientist podcast—the go-to podcast for biotech scientists who want to master biopharma CMC development and biomanufacturing.  

Hear It From The Horse’s Mouth

Want to listen to the full interview? Go to Smart Biotech Scientist Podcast

Want to hear more? Do visit the podcast page and check out other episodes. 
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The Bioprocess Brief — biweekly digests and deep-dives on biologics, cell and gene therapies, and AI-driven bioprocessing, written by a CMC practitioner.

Key Topics Discussed

The Bioprocess Brief — biweekly intelligence for CMC and manufacturing leaders.

Strategic takeaways on biologics, cell and gene therapies, and AI-driven bioprocessing — distilled from the Smart Biotech Scientist Podcast and 20+ years on the floor.

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