Pande & Conde on: Players and Paths for Healthcare Startups | Summary and Q&A

TL;DR

The complexity of the healthcare landscape requires a careful understanding of the process involved in developing therapies, diagnostics, and tools for human healthcare.

Key Insights

• ❓ The healthcare industry is a complex landscape that requires careful navigations through various stages of development, approval, payment, and adoption.
• 💁 Therapies and diagnostics can take different forms and technologies, each with its own challenges and regulatory requirements.
• 🔨 Entrepreneurs in the biotech industry can choose between developing their own drugs/diagnostics or providing tools and technologies to empower the industry.
• 🪚 Successful market entry in healthcare often involves strategic partnerships and transformative technologies that offer broad applicability.
• ❣️ Understanding the go-to-market strategy from the beginning is crucial for tech-heavy founders in the biotech industry.

Transcript

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Questions & Answers

Q: What are the main steps involved in developing therapies or diagnostics for human healthcare?

The process includes discovering something relevant for human health, obtaining regulatory approval, figuring out payment options, educating the healthcare system, and getting patients to use the technology.

Q: What are the challenges in developing therapies compared to diagnostics?

Therapies require extensive clinical trials and proof of efficacy, starting from cells and animals, whereas diagnostics have a slightly simpler path, with options for laboratory-driven testing or FDA approval.

Q: Is it advisable for entrepreneurs to develop their own drugs or diagnostics?

It depends on the technology and its potential impact. Entrepreneurs can choose to empower the industry by providing tools and technologies, or they can develop their own drugs/diagnostics, which requires a groundbreaking solution to secure a share of the market.

Q: Are there examples of successful tool companies in the biotech industry?

Yes, companies like Atomwise and Illumina have become successful by partnering with other companies in the industry and offering transformative tools and technologies.

Summary

In this video, the speaker discusses the complexities of the healthcare industry, particularly in relation to developing technologies and tools for human healthcare. They explain the different players involved, such as regulatory agencies, and the various paths to take when developing therapies or diagnostics. The speaker also explores the concept of engineering as a way to empower the industry and shares examples of successful companies in the bio space. Overall, the video highlights the importance of understanding the go-to-market strategy and considerations for entrepreneurs in the field.

Questions & Answers

Q: What are the three main categories when developing technologies or tools for human healthcare?

Generally, there are three main categories: tools, therapies, and diagnostics. These can range from chemicals, proteins, genes, and even apps. The development process for these categories can be complex, but it follows a general chronology of discovery, regulatory approval, payment, and education.

Q: Who are some of the key players in the healthcare industry that entrepreneurs need to navigate?

One of the key players is regulatory agencies, particularly for therapeutic developments. To bring a therapy to market, entrepreneurs need to go through human clinical trials and gain approval from these agencies. Additionally, diagnostic developments require compliance with the FDA's regulations. Another player in the industry is the healthcare system, which needs to be convinced of the value of the technology for patients. Finally, patients themselves play a crucial role in adopting and using the developed technologies.

Q: What is the difference between developing a diagnostic that is a box to test something and one that can be tested in a lab?

When developing a diagnostic that is a box to test something, entrepreneurs need to seek FDA approval. However, if they develop a diagnostic that can be tested in the lab, they can utilize the Laboratory Developed Test (LDT) path. This path requires meeting basic processes and adherence to reproducibility standards. The LDT approach is considered less risky and allows for a quicker market entry.

Q: What is the process for developing a therapeutic technology?

Developing a therapeutic technology involves a more complex process. After the discovery stage, entrepreneurs need to prove its efficacy in tests using cells and animals. Subsequently, they must go through traditional clinical trials, which follow the phases of phase 1, phase 2, and phase 3. This process can be lengthy but is essential to gaining regulatory approval.

Q: Can entrepreneurs choose to develop technologies that empower the industry rather than creating their own drugs or diagnostics?

Absolutely. One path that entrepreneurs can take is to develop technologies that can be sold to the research and development industry. This approach allows them to slice and dice the technology, selling it to multiple players in a non-aggressive manner. This path can be beneficial as the industry itself has a significant annual spend. However, to pursue this route, entrepreneurs must have a truly transformative and widely applicable tool that can attract industry players.

Q: Are there any examples of companies that have taken the path of empowering the industry successfully?

Yes, one notable example is a company called Atomwise, which focused on designing monoclonal antibodies more effectively. They partnered with multiple companies involved in developing therapies and, by proving the effectiveness of their approach, were able to secure a share of the economics. Atomwise is currently a privately-held unicorn company valued at over a billion dollars. Another example mentioned is Illumina, which made itself indispensable in genomics research by enabling the sequencing of genomes at scale.

Q: How should entrepreneurs think about the healthcare space in terms of their go-to-market strategy?

Entrepreneurs should approach the healthcare space by aligning their go-to-market strategy with their technology. If the technology is broadly applicable, such as in diagnosing diseases, the path of Laboratory Developed Tests (LDT) can be a wise choice. On the other hand, if the technology enables the development of drugs or therapies in a unique way, becoming a drug development company might be the way to go. Lastly, if the technology elicits disease biology insights, partnering with established players in the industry can be a viable route.

Q: What is the key consideration for entrepreneurs in defining their go-to-market strategy?

It is crucial for entrepreneurs to understand what needs to be proven, how to obtain regulatory approval, and who will pay for the technology. By addressing these factors, entrepreneurs can shape their go-to-market strategy and align their company and products accordingly.

Takeaways

Developing technologies and tools in the healthcare industry requires navigating complex landscapes. Entrepreneurs must consider regulatory agencies, the healthcare system, and patients in their development process. They can choose to create their own drugs or diagnostics or empower the industry in developing better solutions. Going to market strategy should be aligned with the technology's scope and applicability. Understanding the requirements for regulatory approval, proof of efficacy, and payment models is crucial for success in the healthcare space.

Summary & Key Takeaways

• Developing technologies for human healthcare involves going through a complex process of discovery, regulatory approval, payment, and education.

• Therapies and diagnostics can take various forms, such as chemical compounds, proteins, genes, or apps.

• The healthcare system involves multiple players, including regulatory agencies, and successful market entry requires a thorough understanding of the industry.