미국시간으로 내일은 FDA가 BLA 타운 홀 미팅을 합니다. 내일 저녁에 자료가 올라오면 내용을 분석해 드리겠습니다.
아래는 회사에 호재가 될만한 미래의 벨류체인을 그려봤습니다.
1. nVidia
-젠슨황은 PMWC25에서 아래와 같이 언급 (노란색 부분)
생물학은 차세대 반도체이다. 과학으로만 남기에는 아깝다. 즉, 엔지니어링 세계로 들어와야 한다는 발언.
-뒤에서도 서술하겠지만, 가장 확실한 방법은 nVidia가 회사에 투자하는것이다.
SAVE $1376 BY JUN. 4
The Dawn of Digital Biology: Jensen Huang’s (NVIDIA) Vision for AI in Healthcare at PMWC25
In a world where technology and healthcare converge, the visionary leadership of Jensen Huang, the CEO of NVIDIA is pioneering a revolution that could redefine our approach to medicine and biology. He has articulated a vision that is not just transformative but revolutionary: “Digital biology will be one of the biggest revolutions ever. For the very first time in human history, biology has the opportunity to be engineering, not science.” This bold assertion underscores the seismic shift that NVIDIA is driving in the healthcare industry through the application of artificial intelligence (AI).
We are thrilled to announce that Jensen Huang will be the Luminary honoree at the PMWC 2025 Silicon Valley track on AI and Data Science in Research and Development in Track 2 on February 7th (View the full February 5-7 Silicon Valley Program).
AI technologies like the BioNeMo foundation models, are decoding complex biological data, such as DNA sequences and protein interactions, which are crucial for advancing drug discovery and precision medicine. These technological innovations, including the H100 chips and specialized software, are empowering pharmaceutical companies to harness AI for drug discovery, significantly accelerating the pace of development and enhancing the accuracy of outcomes. This is not just about incremental improvements; it’s about redefining the entire drug development process. However, there remains skepticism about the oversimplification of complex biological processes and the potential risks of heavy reliance on AI, which are challenges that the industry continues to address. Yet, these concerns do not overshadow the substantial benefits and enhancements that AI technology brings to the table.
The role of AI in healthcare is not just about providing tools but about creating an ecosystem where biotechnology can thrive through AI integration. NVIDIA’s strategic partnerships with major pharmaceutical companies like Novo Nordisk, Amgen, and Genentech, its investments in AI-driven biotech startups, underscore its commitment to nurturing a tech-forward healthcare environment. A prime example is the collaboration between NVIDIA and Genentech, which aims to shorten the time-consuming process of drug discovery but also to increase the success rate of R&D efforts. Using AI to put “lab-in-a-loop”, Genentech and NVIDIA are creating a dynamic system where experimental data continuously improves computational models, leading to faster and more effective drug development cycles.
As we look forward to the advancements this collaboration will bring, it is clear that Jensen Huang’s vision is not just participating in the healthcare industry but actively driving its evolution. Join us at the PMWC Award Ceremony to hear more from Jensen Huang, our Luminary Honoree, about how AI is setting new standards in healthcare and opening up new frontiers in the digital biology revolution.
In addition, Matthias Troyer of Microsoft will highlight the integration of AI with quantum computing, discussing its potential to revolutionize fields like chemistry and biochemistry through hybrid classical-quantum supercomputing systems. Other sessions led by experts such as Ken Drazan from ArsenalBio, Gaddy Getz from the Broad Institute, Yasin Şenbabaoğlu from Chan Zuckerberg Biohub San Francisco, Peter Goodhand from GA4GH, Chris Lunt from AllOfUs/NIH, Karen Miga from UCSC, Philip Awadalla from the Ontario Institute for Cancer Research, Janusz Dutkowski from Data4Cure, and Paul Rejto from Pfizer, promises to provide deep insights into the cutting-edge technologies shaping the future of healthcare and biotechnology. With sessions ranging from precision medicine to quantum computing and panels discussing genomics, global health data sharing, and AI-driven drug development, attendees will gain a holistic understanding of how AI is revolutionizing the field.
2. 10x Genomics
- 10x Genomics 는 현재 전 세계 단일세포 분석(Single Cell Analysis) 분야의 사실상 표준 기업 중 하나.
이들과 협력하면 작품이 나올 것 같음.
- 이들이 갖고 있는 기술은 세포 100만개를 한꺼번에 분석 하는 기존 유전자 분석과 다르게 10x Genomics는
세포 1개씩 분석. 즉, 암 조직안에 있는 세포 하나 하나의 특성을 분석 가능.
- 만약 이들과 협력한다면, 예를 들어 조인트스템 투여전 환자의 염증세포 종류 분석, 투여 후 연골세포 변화
분석, 장기 추적 관찰을 통해 조직 재생 기전 분석이 세포 단위에서 가능할 것.
- 기존에는 VAS, WOMAC을 통해 통증이 줄었다라고 표혔했다면, 이제는 어떤 세포가 어떻게 변해서 통증이
줄었는지 보여줄 수 있을 것.
- 조인트스템 보다는 향후 미국 FDA시장에 진출할 알츠하이머 및 희귀질환 치료에 대단히 도움이 될 듯.
- 기전 분석 및 조직 재생 메커니즘 입증에 활용될 수 있기 때문.
- 비임상 연구 (동물 시험, 독성시험등)에도 활용 될 수 있을 듯.
3. FDA
- 아래 링크를 보면 , FDA가 AI를 활용하여 어떻게 RWD를 보고 의사결정을 할지에 대한 가이드라인임.
"FDA는 의약품과 바이오의약품의 전 생애주기(Product Life Cycle)에 걸쳐 AI 활용을 적극적으로 발전시키는 데 전념하고 있다."라고 언급
- 종합하면, 10x Genomics에서 세포 상태 분석, nVidia에서 AI모델 학습, FDA에서 AI기반 RWD심사.
- 말은 쉽지만, 아직 AI가 우주에서 가장 복잡한 시스템인 생물학을 단기간에 넘보기는 어려울 듯.
결국회사의 연구 및 전문적 지식 + 기존 통계학 + AI기반 분석의 3박자가 조율을 통해 줄기세포를 연구해야.
- BLA제출후 nVidia가 회사에 투자를 하고, 10x Genomics등과 협력하는 모델이 좋아 보임.
https://www.linkedin.com/posts/the-fda-is-committed-to-advancing-the-use-share-7467934874369146880-MhqL/?utm_source=share&utm_medium=member_android&rcm=ACoAAEQMegEBg8ZRrUHJUk6HRgBMInosw_WhyvI
The FDA is committed to advancing the use of Real-World Evidence (RWE) in regulatory decision-making across our product centers. In that spirit, today the agency updated its webpage “FDA use of… | FDA
The FDA is committed to advancing the use of Real-World Evidence (RWE) in regulatory decision-making across our product centers. In that spirit, today the agency updated its webpage “FDA use of Real-World Evidence in Regulatory Decision-Making” with a list of additional examples. https://lnkd.in/eRR...
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