Opinion, Berkeley Blogs

Lessons Learned in Therapeutics

By Steve Blank

This post is part of our series on the National Science Foundation I-Corps Lean LaunchPad class in Life Science and Health Care at UCSF. Doctors, researchers and Principal Investigators in this class got out of the lab and hospital talked to 2,355 customers, tested 947 hypotheses and invalidated 423 of them. The class had 1,145 engagements with instructors and mentors. (We kept track of all this data by instrumenting the teams with LaunchPad Central software.)

  • Part 1:  issues in the therapeutics drug discovery pipeline
  • Part 2:  medical devices and digital health
  • Part 3: described what we’re going to do about it
  • Part 4: This Will Save us Years – Customer Discovery in Medical Devices
  • Part 5: Value proposition and customer segments in Life Sciences
  • Part 6: Distribution channels in Life Sciences
  • Part 7: Revenue Streams in Life Sciences
  • Part 8: When Customers Make You Smarter: Customer Discovery in Digital Health
  • Part 9: We’ve seen the Future of Translational Medicine and it’s Disruptive
  • Part 10: Lessons Learned in Digital Health
  • Part 11: Lessons Learned in Medical Devices
  • We are redefining how translational medicine is practiced.

    Traditional view of translational medicineWe’ve learned that translational medicine is not just about the science.

    More on this in future blog posts.

    Lean view of translational medicine

    Vitruvian Therapeutics is one of the 26 teams in the class. The team members are:

    • Dr. Hobart Harris  Chief of  General Surgery, Vice-Chair of the Department of Surgery, and a Professor of Surgery at  UCSF.
    • Dr. David Young,  Professor of Plastic Surgery at UCSF. His area of expertise includes wound healing, microsurgery, and reconstruction after burns and trauma.
    • Cindy Chang is a Enzymologist investigating novel enzymes involved in biofuel and chemical synthesis in microbes at LS9
    • Karl Handelsman was the therapeutics cohort instructor. Julie Cherrington CEO of Pathway Therapeutics was the team mentor.

      Vitruvian Therapeutics is trying to solve the Incisional hernia problem. An incisional hernia happens in open abdominal surgery when the area of the wound doesnt heal properly and bulges outward. This requires a second operation to fix the hernia.Ventral Herniaincisional hernia

      Hobart Harris’s insight was what was needed wasn’t one more new surgical technique or device to repair the hernias, but something to prevent the hernia from occurring in the first place. Vitruvian Therapeutics first product, MyoSeal, does just that. It promotes wound repair via biocompatible microparticles plus a fibrin tissue sealant. So far in 300 rats it’s been shown to prevent incisional hernias through enhanced wound healing.

      Their 2 minute video summary is here.

      Two weeks into the class and interviews with 14 of their potential customers (surgeons) reality intruded on their vision of how the world should work. We happened to catch that moment in class in this 90 second clip.

      Watch and find out how talking to just the first 14 customers in the Lean LaunchPad class saved Hobart Harris and the Vitruvian Therapeutics team years.

      To see the clip, click here.

      The Vitruvian Therapeutics Lessons Learned Presentation is a real-eyeopener. Given that this product could solve the incisional hernia problem, Hobart and his team naturally assumed that insurance companies would embrace this and their fellow surgeons viewed the problem as they did and would leap at using the product. Boy were they in for a surprise. After talking to 74 surgeons, insurance companies and partners appeared that no one – insurance companies or surgeons – owned the problem. Listen to their conclusions 8 weeks after the first video.

      Watch the video and find out how they pivoted and what happened.

      Don’t miss Karl Handelsman comments on their Investment Readiness Level at the end. Vitruvian is a good example of a great early stage therapeutics idea with animal data missing and many key components of the business model still needed to verify.

      To see the video, click here.

      Look at their Lesson Learned slides below

      If you can’t see the presentation above, click here

      Market Type

      During the class the Vitruvian Therapeutics class struggled with the classic question of visionaries: are we creating a New Market (one which doesn’t exist and has no customers)? In Vitruvian’s case preventive measures to stop incisional hernias before they happen.  Or should we position our product as one that’s Resegmenting an Existing Market? i.e. reducing leakage rates.  Or is there a way to get proof that the vision of the New Market is the correct path.

      When Hobart Harris of Viturvian asked, “… what if you’re a visionary, and no one but you sees the right solution to a problem” we had a great in-class dialog. Karl Handelsman‘s comments at 3:15 and 4:16 and Allan May at 4:35 were incredibly valuable. See the video below for the dialog.

      If you can’t see the video above, click here

      Further Reading

      • Fibrinogen and fibrin based micro and nano scaffolds incorporated with drugs, proteins, cells and genes for therapeutic biomedical applications
      • Enhancement of incisional wound healing by thrombin conjugated iron oxide nanoparticles
      • Microparticles and their use in wound therapy
      • Lessons Learned

        • Principal Investigators, scientists and engineers can’t figure out commercialization sitting in their labs
        • You can’t outsource commercialization to a proxy (consultants, market researchers, etc.)
        • Experiential Learning is integral to commercialization
        • You may be the smartest person in your lab, but your are not smarter than the collective intelligence of your potential customers, partners, payers and regulators