Here's how you can effectively scale a biotech venture.

Para llevar tu empresa de biotecnología al siguiente nivel, necesitas la pasta. Pero no cualquier pasta, necesitas convencer a los inversores de que tu tecnología es el futuro. Presenta tu caso de manera clara y convincente, destacando qué hace que tu tecnología sea especial y por qué tu equipo es el indicado para llevarla adelante. Además de buscar inversores tradicionales, como los de capital de riesgo, considera otras fuentes como las subvenciones gubernamentales o asociaciones estratégicas. Asegúrate de que tu plan financiero esté bien alineado con tus objetivos comerciales y de que tengas claros los hitos que harán que los inversores sigan apostando por ti.

Securing-funding is not the main objective. To get funding to scale, you need to show why it is worth scaling. It is meaningless to scale something that does not make commercial-sense (although it has been done numerous times in biotech, but those companies fail sooner or later).

Invest in technologies and processes that can grow with your business, such as automation and high-throughput screening. Scalable technology ensures that as demand increases, your operations can expand efficiently without compromising quality. Collaborate with academic institutions, research organizations, and industry leaders. These partnerships can provide access to cutting-edge research, additional resources, and new markets, accelerating your venture’s growth. Secure a mix of funding from grants, venture capital, and strategic investors. Diversified funding not only provides the necessary capital for scaling but also brings in a network of advisors and supporters who can offer valuable guidance and open doors to new opportunities.

Hazte amigo de las agencias reguladoras desde el principio y mantén una comunicación constante para entender qué necesitas para que tus productos sean aprobados. Puede ser una buena idea contratar a expertos en regulación para que te guíen a través de este laberinto normativo. Recuerda que cumplir con las regulaciones no es solo un deber, sino una forma de ganar credibilidad y confianza en tus productos.

Well, your regulatory strategy will be a very large part of your funding strategy, so it's good to see this at the top. But your reg strat doesn't start with your product development plans (here is where AI thinks biotech is developed like software <wink>); your reg strat begins with understanding how you're meeting an unmet need and who benefits from use of your products. If you're developing medical biotech (which could include devices and digital health) or biopharma (medicinal), your regulatory strategy will start with your patient population and perhaps a Target Product Profile. From there, you develop your product plans, which heavily rely on how you will research, develop, and manufacture (eventually at scale) in a compliant way.

Para hacer crecer tu empresa de biotecnología, necesitas más que solo científicos brillantes. Busca personas con habilidades comerciales que complementen su experiencia científica. Busca talento en desarrollo de productos, ensayos clínicos, marketing y ventas. Además, crea una cultura de empresa que fomente la innovación y la colaboración. A medida que tu empresa crezca, asegúrate de que tu equipo esté listo para enfrentar los desafíos que se avecinan.

Team build is very strategic and time-based in the Biotech industry. There are certain functional expertise you will always need in order to be competitive, but perhaps not at 100%. There are expert needs likely to grow with time and are certain to phase-out (depending on your portfolio). Think outside the box - 1. Leverage AI tools to re-adjust job descriptions so 2. Virtual assistance is a great to explore 3. Hire fractionally when needed which could ramp up or down with time. It will help you pick potential hires, while budgeting your expenses wisely 4. Explore the ecosystem of possibilities that also increase your network. The most effective C-Suite executives in Biotech have an expanded aperture of possible resources

OK, for starters let's call this R&D vs "product development." We are testing and learning as we develop, which is why the "R" is so important. It's also a heavily regulated process (especially during "product development"). And it should be efficient and adaptable to changes-- but we can't do that the same way other "tech" companies do. Efficiency comes with the investment: if your investors care about efficiency (which means reduced waste and NOT "faster"), they will pay for it. But "adaptable to changes in technology and market needs"? Nope-- we don't have that luxury because our R&D is regulated and based on an approved experiential design via your IND, so you better get as close to your tech and market needs well ahead of R&D.

Imagina que estás desarrollando un nuevo medicamento basado en terapia génica para tratar una enfermedad genética rara. Tu equipo ha identificado un gen específico que se sabe que causa la enfermedad y está trabajando en desarrollar un vector viral para entregar el gen correctivo a las células afectadas. Durante el desarrollo del producto, se enfrentan a desafíos técnicos para optimizar la eficiencia de la entrega y la expresión del gen terapéutico. Mediante pruebas rigurosas en modelos celulares y animales, logran mejorar significativamente la eficacia del vector viral. Este avance les permite avanzar hacia estudios clínicos con una mayor confianza en el potencial terapéutico de su producto.

Communication is key. As a CEO or a C-Suite of a Biotech firm, your job is 80% communication - what is the value of your Biotech, how will you circumvent negative speculations, market headwinds, and competition? Keep it simple and know how to convert science into an easily relatable topic. Most important - could you show us reasons to believe? A good analog is to go back to the news publications of successful Biotechs such as Ryze Bio, Cellares, Rev Med and most recently Fusion. An important component is communicating your value and differentiated position through the right channels and in a relatable manner.