CPSA USA 2019
Clinical and Pharmaceutical Analysts United:
Human Wellbeing is Our Responsibility
Building Tomorrow Today
October 29, 2019
6:30 pm - 9:00 pm
The Imagine Summit is inspired by three ongoing and interrealted events - the Merck Imagine Talk, New Objective Town Halls, and CPSA Meetings.
This unique event is celebrated annually in London, Boston, and Philadelphia at the CPSA Europe, CPSA Analytics, and CPSA USA respectively.
Welcome and Introduction
Emily Ehrenfeld, New Objective
Neil Spooner, Spooner Bioanalytical Solutions;
Kevin Bateman, Merck
Tim Olah, Bristol-Myers Squibb
Neil Spooner, Spooner Bioanalytical Solutions
Enaksha Wickremsinhe, Eli Lilly and Company
Imagine - dreams, hopes and visions for the future imagined!
Interactive Breakout Session - Four Pillars!
Productivity Roundtable Notes
- Suzanne Cordovado, Centers for Disease Control & Prevention
- Petia Shipkova, Bristol-Myers Squibb
- Mark Arnold, Covance
- Bernhard Nemec, Prolab Instruments
Why aren't we doing this?
- 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
- LabCorp Pixel
- Standard methods / approaches
- Point of care analysis
- 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
- 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
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?
Clinical Trial Centric
- 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.
Concerns for the Future
- 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?
Technology and Solutions
- 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?
- 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?