Rejuvenation Biotechnology Applying a damage repair paradigm to developing technologies for the diseases of aging panel discussion #rejbio

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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