Panel members discussing the feasibility of applying such a strategy
Richard Barker, center for the advancement of sustainable medical innovation (moderator)
Julie Allickson Director, Translational Research, Wake Forest Institute for Regenerative medicine
Stephen Minger, Chief Scientist, GE Healthcare life sciences, UK
Evan Snyder, Sanford Burnham Medical Research
Evan Snyder talk
Predicting
Predicting things hinges on personalized medicine.
How to get in going ?
Take the umbilical cords and turn them into iPS stem cells for those patients in the future
How to profile the banked cells ?
What happens with the iPS stem cells ?
They are young and immature cells
Vascular cells and neural cells develop together
Pure cells may not be the right way to go.
For ALS, get rid of toxic astrocytes,
Need to make grey matter, neurons and healthy astrocytes.
Relative transcript abundance and protein
Assay clinical meaningful predictors
Greatest challenge in disease modelling
molecular can opener strategy.
prying into a cell to reveal unknown pathosphysiological mechanism(s)
Preventing – intervention
describes a tumor intervention. A particular pathway target that was switched. change something to PAK6.
Protecting
Preserving a hNSC pathway
Restoring
Injuries of long standing established injuries.
How to find a way use tissue engineering to recreate organelles etc…
Replacing
Tough problem
why ? Very specific instructions.
Not just a neuron or a heart cell.
It is a particular cell in the floor plate of a particular part of the brain and it is the A9 type etc…
Stem cells are just one tool
Diseases are complex
stem cells may be glue
Biology is still a big hurdle, need to figure
Julie Allickson talk
How to streamline regulation for aging medicine.
Regulations for tissue engineering, diagnostic etc…
CFR code of federal regulations
CGMP current good manufacturing practice
CGTP Current good tissue practices
HCT/P human cells
FDA regulates almost all medical
Read guidance documents
Drugs
Devices
etc….
Regulatory considerations
Section 361 of the PHS act
Current good tissue practices
21CFR1271 subpart D
Need to be registered with 361, and provide an annual report and they do spot checks
Section 351 is everything else not in 361.
Japan is looking at a risk benefit system of regulation.
How effective versus the downsides.
Poor understanding of mechanism of action
Continuous dialog with FDA
Stephen Minger -GE- Innovative Preclinical Drug Development and Human Cell Therapy
GE Healthcare 53000 employees, $17 billion revenue. 1$ billion revenue
All the big medical machines (PET, MRI, XRAY etc…) Integrated IT systems, drug discovery and biopharm manufacturing tech
1000 people in San Ramon making the industrial internet.
GE makes 95% of the world’s insulin supply
GE becoming human embryonic stem cell company
Cardiomyocytes production
Make a continuous sheet of heart cells (with different cell types)
They grow 5 billion sheets
Cytiva plus cardiomyocytes (troponin, hoechst)
The evolution of biotherapy
Three generations of biotherapy
1. Cell therapy
2. Monoclonal antibodies ($40 billion in 2008)
3. replacement therapy
Cell therapy generic workflow
Bought a cellular production company (accelerex)
All automated cell production. Large vats
Continuous inline processing
Cells in one end and a lot of good cells out the other
Xuri 25 bioreactor system with automated perfusion system.
Do not need a GMP facility (Each GMP facilty costs $5 million)
Cell based immunotherapy with GE.
Targets for stem cell therapy
GE Blue Sky organization (what to do in 20 years innnovation wise)
Implantable electronic biological interfaces
tissue engineering
neural prosthetics
in vivo Dx regenerative medicine
3D bioprinting
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Brian Wang is a Futurist Thought Leader and a popular Science blogger with 1 million readers per month. His blog Nextbigfuture.com is ranked #1 Science News Blog. It covers many disruptive technology and trends including Space, Robotics, Artificial Intelligence, Medicine, Anti-aging Biotechnology, and Nanotechnology.
Known for identifying cutting edge technologies, he is currently a Co-Founder of a startup and fundraiser for high potential early-stage companies. He is the Head of Research for Allocations for deep technology investments and an Angel Investor at Space Angels.
A frequent speaker at corporations, he has been a TEDx speaker, a Singularity University speaker and guest at numerous interviews for radio and podcasts. He is open to public speaking and advising engagements.