The term “microbiome” refers to the collection of microorganisms (or microbiota) – including bacteria, viruses and fungi – found in the human body. With 100 trillion microorganisms, the digestive tract (or gut) has the densest concentration of human microbiota.
For many years, understanding the role our gut bacteria play in health and disease was an impossible task. Many human gut microbiota can only grow in an oxygen-free environment, making it particularly difficult to grow bacterial cultures. Despite all the improvements made in anaerobic culture techniques, the key breakthrough was actually the development of sequencing methods and associated computational science, which have allowed the scientific community to explore the entire gut microbiome, track how it changes over a lifetime and study its role in chronic diseases.
The Microbiome: A New Research Frontier
Today, not a week goes by without a new scientific study on the microbiome. The human microbiome – especially the gut microbiome – is seen as a new avenue to cure many chronic diseases, and a growing number of biotech firms are working to develop therapeutic applications based on this cutting-edge basic research.
What does it take for biotech companies in the booming microbiome field to overcome challenges and successfully develop their innovations?
As I see it, there are 6 key factors in successfully bridging the gap between basic research and real-world applications that can cure patients.
The microbiome is undoubtedly one of the greatest scientific breakthroughs of the decade. Literature on the subject has clearly established its role in regulating our metabolism, immune system and central nervous system.
We’re starting to map out how this ecosystem works, and I believe the next key step is to fully understand the mechanisms of action of the different families of bacteria involved in order to de-risk the drug development phase.
The microbiome is a genuinely exciting source of innovation, but it’s important to remember that the value added by biotech firms lies in their ability to solve well-defined health problems using innovative technology. Technology platforms or solutions that lack a clear problem to be resolved generally don’t go very far. That means it’s very important to choose your microbiome-based therapeutic targets with care – and avoid the “one-size-fits-all” trap – by being highly methodical and adhering to pharmaceutical standards as closely as possible.
In terms of strategy, I strongly advise against putting all your eggs in one basket with just one product. All innovative products are subject to the inherent risks of clinical development, so spreading this risk across multiple products makes strategic sense and doesn’t prevent you from having a lead product candidate. Developing a portfolio can be hard if you don’t have extensive resources from the outset. You’ll need to be inventive and creative. Building pharma partnerships may help you meet this objective.
I don’t want to sound pessimistic, but quickly determining whether your project is viable based on strong scientific evidence is key. If you have to fail, it’s better to fail early on rather than running into problems later in the development process, after having used up your capital. It’s important to identify your key success factors, the different milestones you’ll need to reach, your main risks and what you need to do to address them as quickly as possible. This is easier to do if you have a strong pipeline and are able to prioritize your projects.
In order to turn a scientific innovation into a successful treatment, you’ll need to assemble a multidisciplinary team of experts who thrive on challenges. In addition to microbiome expertise, you’ll want to bring people on board with the business, development, operational, regulatory, clinical and medical skills to help you successfully meet the various milestones throughout the lengthy drug development process. Surround yourself with people from different backgrounds and reach out to expert advisory panels to get the constructive criticism you need for your project.
The best founders, leaders and CEOs owe their success not only to their ability to deliver excellence: they are also able to tell a convincing, inspiring business story. That’s because the best employees, partners and investors are looking for more than just assets. They want someone with ambitious vision. The microbiome is an emerging field. Biotech firms have brought complex technology to this area. That means it’s important to make this technology easy to understand for a wide range of stakeholders including VCs, healthcare professionals and patients. Good storytelling helps raise funds that fully meet your business needs, avoiding “drip-feed” financing that slows down progress on projects.
Once you have a clear strategic vision, you’ve built a strong team, you’ve mapped out a well-defined pipeline and you’ve secured your financing, the next step is to focus on establishing proof of concept in order to move toward the clinical phase. That’s what we’re committed to doing at LNC Therapeutics.
Georges RAWADI, CEO LNC Therapeutics
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