Productivity Roundtable Notes

- Suzanne Cordovado, Centers for Disease Control & Prevention
- Petia Shipkova, Bristol-Myers Squibb
- Mark Arnold, Covance
- Bernhard Nemec, Prolab Instruments

Potential Solutions

• Increased use of “black box” automation – collected sample to “black box” to result, e.g.
  • Thermo Cascadion
  • Quanterix Simoa
• Standardised FDA approved assays
• Pharma quantitative BioA end to end automation
  • Abbvie
  • UCB
• LabCorp Pixel
• Standard methods / approaches
• Point of care analysis

Why aren't we doing this?

• Standardisation
• Concerns over job security
• Data quality concerns
• AI – humans no longer understand
• Hard to troubleshoot
• ROI and overhead
• Regulatory concerns
• Political environment and external culture
• We limit ourselves too quickly

Solutions

• Example of TB & Gates Foundation
• Know what intent of data is – fit for purpose
• How do we change?<
  • Regulators say so!
  • Corporate culture change from short to long term vision and investment
  • Seek out passionate individuals
  • Allow people to fail and learn from this
  • Give managerial support
• Demonstrate financial gain
• Only generate the samples and data we need
• Be better at integrating disparate data
• Share in the pre-competitive space
• Standardisation of data formats
• Broaden the conversation to include people that don’t look like us – non-analysts
• Consider the overall reward
• Consider change to non-centralised approaches
  • Portability
• Publish

Performance Roundtable Notes

- Ganesh Moorthy, The Children's Hospital of Philadelphia
- Alla Kloss, Sanofi
- Carla Marshall-Waggett, New Objective
- Joe Siple, New Objective

Personalize Roundtable Notes

- Neil Spooner, Spooner Bioanalytical Solutions
- Rick Yost, University of Florida

Portability Roundtable Notes

- Enaksha Wickremsinhe, Eli Lilly and Company
- Jeremiah Tipton, BioTech & OMICSx Solutions, LLC

What is your idea of Portability for Patients (or General Wellness Testing), and how does this look in the future?

Initial Thoughts

• Patient Testing
  • Access - Bring testing to the patient?
  • Access - Bring the patient to the lab?
  • Access - Simply put samples in the mail?
• Why do we need to wait for results – just upload to a cell phone?
• Can everyone have personalized testing in home if they want?
• Live return and testing of wellness measurements?
• Was also - mentioned portability with regards to Outbreak Testing, i.e. the field.

Clinical Trial Centric

• Can patients enroll in clinical trials remotely, not having to travel across states, the US, or the world?
• Can we improve upon portability of sampling - when people need to have blood drawn once a week for a chronic illness or for clinical trial testing?

Concerns for the Future

• Accuracy of the test cannot suffer with the idea of portability.
• Centralized information transmission while protecting data – Think HIPPA.
• Similar to virtual Businesses, but how to protect information.
• Cost of portability needs to be kept low – think development of genetic testing the last two decades.
• In clinical trials, still need to control dosing of drugs.
• Still need access to an expert for Clinical Trials and Diseases. Can A.I. help diagnose?

Technology and Solutions

• Group saw portable as wearable.
• Group saw portable as digestible.
• Group saw portable as something that comes to your home.
• Request for a device or testing to be non-intrusive.
• The technology can be Long Term / Non-Invasive / Minimal
• Use our cell phones during the future – testing and transmission of data?
• Already have smart watches as well – can we use these sorts of devices?
• Swallow a device – Some sort of Biosensor that stays with you.
• Transponder that can be recovered.
• Cameras that go through your gut and takes pictures.
• A microsensor on the skin / microdevice - inject and collect data.
• Interchangeable/flexible device that can be re-programmed
• Measure drugs by light on skin or other?
• Personalized drone for drug dosing and testing. Robot surgeon to your Home?