Thank you all for being here tonight.
It's really exciting to be here for what I
think has become a wonderful community event
every year, now we're doing this.
And it's so in keeping
with the Knight Campus mission
to better connect the amazing research going
on at the University of Oregon with our community.
So people know what's going on and a partner
better with our medical
and industry experts so we can better translate
what's going on at the university
into technologies that help people.
And that says the president mentioned that's
what we call the impact cycle.
And I'm going to tell you some stories tonight
about how
we've been successfully able to get around
that impact cycle
and move some technologies into patient care.
But before I do that I'd like to introduce
my family
at least the part of my family that moved
with me here to Eugene.
This is my wife Tina who I met in an engineering
class
at the University of Michigan.
Yes.
30 years ago 30 plus years ago .
We have two college aged kids who I'll introduce
to you
a little bit later on in the story,
but I think the simplest way I can explain
what an amazing opportunity
we felt this was was that we literally abandoned
our two children
in Georgia because they're both in college
at Georgia Tech.
This is Panda here on the bottom as you can
see Panda loves Oregon
as I think all dogs must.
And the picture on the right from a few weeks
ago of Panda
and I Spencer's Butte is now part of the standard
package
we send out to faculty and student that we're
trying to recruit
to Eugene to let them know as all of you know
that it's always sunny in Eugene.
All right.
So in science we often take inspiration from
observations
in nature and so can we regrow or regenerate
organs and limbs.
That sort sort of the holy grail of the field
of regenerative medicine
and the answer is that you can if you're a
newt
or a few other special organisms.
Unfortunately you can't if you're a human.
And if we look at how the newt is doing this
it's actually really fascinating right that
a newt
within 20 days is able to completely regenerate
a lost limb down to everything's perfectly
organized the bone,
the skin, the cartilage are all exactly organized
the same way that they were before.
And so that raises a lot of really interesting
questions
"How does that happen, what are the cells involved
in making that happen?"
"How do they know what tissues to make and
where?"
and "why can a newt do it and we can't?" Right,
lots of great questions.
And these are questions that biologists are
often thinking about
and trying to answer in their research.
But sometimes the biologists in a place say
like the Knight Campus
might be working next to a bio engineer like
myself
interested in regenerative medicine and perhaps
we have a conversation
with a clinician and we all get together and
say,
"OK now that we know that this is not science
fiction that this can really happen,
how can we use that information to help patients?"
Maybe we can't completely regenerate a limb
right now
but maybe we can regenerate parts of that
limb.
Maybe we can regenerate the bone or the cartilage
or the blood vessels or the nerves.
And if we could do that maybe we could help
get away
from using metals and plastics
that have a limited lifetime or perhaps a
prosthetic.
I don't know if we'll ever be able to regenerate
like a newt does
but there's advances going on in biomaterials,
3D printing, stem cells,
molecular biology that are making their way
into patients
and I going to tell you about some of those
stories tonight.
All right so one great example is cell therapies.
And you've heard a lot about cell therapies.
There are cell therapies being developed
for just about every unmet clinical need that
you can think about.
There's a lot of clinical trials going on.
I'll show you later clinical trials across
the entire world.
And how many there are a great example of
this
and not all those clinical trials are working.
And in fact most of them probably will not
work.
You shouldn't expect them to work because
it's very rigorous
to get through the clinical trial process.
But there are some that are working and and
we're coming up with cures now for things
that previously seemed incurable.
A great example of this is cancer immunotherapies.
So cancer immunotherapies are basically when
you take it
to a patient's T cells and they're being trained
it's a patient's specific technology the T
cells are being trained
to recognize their cancer and being implanted
back into the patients.
When you think about the history of cancer
and all the effort and money and time has
gone
to cures it's absolutely amazing that we're
living
in a time now when there are cures being developed
at least for some forms of cancers.
There's still problems associated with this.
The blood cancers are much easier to attack
than solid tumors.
Some patients don't respond well to the treatment.
And the cost of these treatments are absolutely
exorbitant
up to a million dollars a patient.
And that's one thing that before I left Georgia
Tech
we had started a national consortium on cell
manufacturing.
Now the University of Oregon is part of to
address that problem
to develop manufacturing technologies
to bring down the costs of these therapies.
Another area of cell therapies that has been
the news recently and you can see the dates
here are very recent is for macular degeneration.
How many people in the audience have macular
degeneration
or know somebody that has had macular degeneration.
So these are very common problems that are
very difficult to solve.
But cell therapies are often offering a lot
of promise.
You may have also noticed some on the flip
side
negative stories in the news that raised concerns
about fraud.
About potentially unproven or even unsafe
therapies
such as the clinic a few years ago that injected
stem cells
in patients eyes and blinded them. To medical
devices
that do more harm than good.
And even to the level of very severe ethical
breaches
such as the reports out of China of gene editing
babies
even though these are very rare and
outlier
situations they understandably cause a lot
of concern
in the public distrust if you will
and even cause some people to think well
maybe there isn't value in doing science.
But in fact in all of these cases
it was the science that was missing.
And the vast majority of entrepreneurs and
scientists
and engineers and clinicians that went into
the biomedical field
did so not for fame and fortune which unfortunately
to our regrets
is very rare but they did it to help people.
And so these are the best
way
to avoid these situations is really to have
rigorous science
done that's under strong ethical guidelines.
And one of the hallmarks of doing ethical
research is open transparent disclosure of
your potential conflicts of interest.
So I'm showing here the companies and foundations
that we currently work with and some of whom
we've worked with
to form ventures that have actually been
able
to move some of our technologies out of the
lab and into people.
And I'll talk about some of those.
On the right is another example of why it's
really important
for academics not to be isolated
and actually to be working with industry.
And that is because business is now supporting
a larger amount of their research and development
in the United States as federal funding levels
have continued to decline. All right,
So I'm going to talk about both medical devices
and regenerative medicine the first half
will be on advances and in medical devices.
And the second half will be on regenerative
medicine.
So I'm showing here some traditional medical
devices
that some of you may actually have very common
hip implants in knee implants.
These were designed originally to be bio compatible
in other words to have to not have
a negative reaction in the body.
They are intended to have a limited.
They do have a limited lifetime.
So if you have one of these you probably had
a conversation
with your clinician that went like this
"I know you're in pain."
"I want you to put up with it is long as you
can...
because we don't want to do surgery...
before we have to because these tend...
to last maybe about 15 years
before they'll have to be replaced.
They're also not customized to the patient
other than being available in a few different
sizes.
They're not customized to the anatomy of the
patient.
This is a rather old hip implant design
but it illustrates that our implants actually
do respond
in the body and you get reactions such as
at the base
of the stem and this is down in the bone.
You can see there's a densification of the
bone
whereas up underneath the implant you can
see
that there's bone that's been taken away.
And so it turns out the bones just like muscle
actually respond to exercise by getting stronger
and to not being used by getting weaker.
And so you can imagine is the bone underneath
this implant is shielded and goes away.
This implant is likely going to loosen and
have to be replaced.
So the new generation of medical devices
in contrast
are actually designed with a better knowledge
of the biology
to interact and cooperate with the body and
integrate
in ways that give you better performance.
They're also designed increasingly to be adapted
and customized
to the patient through for example 3D printing
and I'll show you some examples of that.
And then finally there's sometimes designed
with materials
that actually are intended to go away.
So not like metal which is intended to be
there for as long
as it'll last, but actually a material that's
intended to resorb away
and allow the natural tissue to grow.
So imagine for this implant for example
if that implant surface was made of a material
that would slowly degrade and allow the cartilage
to reform and the patient could have
a living cartilage natural joint again.
Wouldn't that be a much better solution?
And that's really regenerative medicine.
All right so I'm going to start with a story
that's a very personal story
and it's it's actually one that even many
years later
is still a difficult one to tell.
But it has a good outcome
and resulted in a medical device that is helping
people.
So this is our daughter Sophia who at age
14 was a nationally competitive
tennis player and she played a tournament
and came home and said, "You know my back's
hurting a little bit."
Not a lot but a little bit.
And so she went in and she had some rehabilitation
and she played some more and then she felt
some pain going down her leg.
And we said oh so we need to get this thoroughly
checked out.
And the doctors did an x ray and discovered
to our shock that she had a degenerative spine
condition
in which one of her vertebra was actually
slipped
almost 80 percent off of another.
So she had a very unstable spine that she
probably
had since birth and somehow had adapted to
and so it wasn't discovered until very late.
And the doctors told us there really
was there was no choice that she needed
to have surgery in order to stabilize her
spine.
And so Sophia went through a seven hour surgery
to fuse two levels of her spine and her lower
back.
You can see her here her radiograph
and what they basically did is they put in
screws
and rods and stimulated the bone to form
between two adjacent vertebral segments.
And the idea is to stabilize it and remove
her pain.
And it was,
It was a scary experience.
I'll tell you.
And she came out of it
and was in a lot of pain it was a difficult
recovery.
But she did everything the doctor said she
worked very hard.
She went into high school with what she called
her turtle shell
and a brace for her back.
But she was very brave
and did a great job got back to full recovery.
About nine months later she turned over
in bed and she felt the rods in her back break.
What had happened was the fusion part
of this the biology part of it had failed
and the rods and screws are not
intended
to work without the biology working.
And so we had the second shock of her having
to go through a second seven hour surgery.
Fortunately the second surgery went much better
her recovery was much much better.
She bounced back much more quickly.
She never did compete again
at singles tennis but she made her way
back in doubles and won two state championships
in doubles after that.
And there's Sophia now she just is graduating
next month from undergraduate school at Georgia
Tech.
And she's committed to go to graduate school
at UCSF.
So a great story, ending story for Sophia.
But that really led a colleague of mine and
I to think about you know isn't there a better
way of doing this so that patients don't have
to go through multiple surgeries like this.
And so it turns out this is a very common
procedure it's not common in children like
my daughter.
But it's very common particularly in older
adults.
About 400,000 spine fusions per year.
And the idea behind the spine fusion is again
to stabilize the implant and to restore the
disk height.
Sophia was actually an inch and a half taller
coming out of her first surgery at which there
was one positive thing about it.
In heels she's taller than her dad but it
also was to remove pain and decompress the
pinched nerves.
And so one of the ways of doing this is to
implant what's called a spine fusion cage
and that cage can be made of metals, metals
have some positive and negative aspects or
it can be made of a really strong plastic
called Peek about half the cages are made
of this Peek material.
And what physicians like about Peek is that
it can do
an image of the patient and actually verify
that fusion has occurred but unfortunately
Peek also has some disadvantages and that
is that bone doesn't like to grow up right
up next to it.
And so you can see that here the bone on the
top is in blue that the peak, the strong plastic,
is in brown and in between is forms this orangey
stuff that is a soft fibrous layer of tissue.
And so what happens a lot of times is that
that implant will loosen and come out and
migrate.
So, we set up, we set out to design a
better spine fusion cage using what the doctors
like to use which is this really strong plastic.
And the idea was to make it integrate better
and so we thought well how can we do that.
And we basically took this peak material and
we designed into it a surface porous layer
about 500 microns or about half of a millimeter
in thickness.
And when we did that and we did all the research
behind it you can see here we published 10
peer reviewed papers on this technology along
the way.
We found that instead of getting this orangey
stuff in between the implant in the bone
all of a sudden we could see the bone growing
into all these pores that we had created.
And it more than tripled the integration strength
for the implant.
And then we realized well OK,
This is great science but the only way we're
going to get this into people is this if we
form a company and we start working with clinicians
to see if they like it.
And so we did that we formed a company called
Vertera Spine and we began working with clinicians
and we began working with the FDA because
the FDA makes you go through rigorous testing
to show that your devices are both safe and
efficacious.
And so we did that we received approval from
the FDA for the upper spine which is the easier
application in October and did our first implantation
in March 2016.
We then continue to work on the technology
and cleared now the lower back which was the
harder the harder one to clear through the
FDA.
And at that point two very large medical device
companies NuVasive and Medtronic came
and started competing for our little startup
company which was a nice thing to happen.
And NuVasive ended up acquiring it.
And that was a great outcome for us but it
also was a great outcome for patients because
now they were able to expand this and it's
now going into tens of thousands of
patients.
So if you think about what we went through
to do this and we went through
a basically a typical innovation cycle to
make this medical device.
It started with an unmet need with not having
a good spine fusion device.
We then had an idea to improve it.
We did a lot of science behind it.
We began working with the FDA to clear products.
Once those were cleared and there was a company
you have to go through the expense of building
an inventory then you have to develop a sales
network.
And then work with hospitals and surgeons
and patients and so forth.
This is a long long process.
On average it takes over 10 years and 30 million
dollars to bring a new medical device to the
market.
And so you can imagine there's a number of
good technologies that are discovered in labs
that actually never make it into the marketplace
because of the timeline and the cost associated
with doing this.
So the problems arising from this innovation
structure are the design cycle is expensive
and takes a long time.
I showed it for a medical device.
If you're talking about a new drug it's actually
longer than that and probably 10 times the
costs hundreds of millions of dollars.
The implants are also not tailored to the
individual because when you're working with
the FDA this is the way the process works
you have to fix the design and work with that
design you can't change it as you're going
through all your testing so that's a 10 year
period and you can imagine there's new improvements
going on during that 10 years.
You can't change that design.
You've got to stick with the original design.
And building up this implant inventory is
costly and inefficient.
And so in emerging technology for making medical
devices is 3D printing.
And 3D printing I'm sure you've heard about
it really started as a prototyping technology
where you could make a prototype of something
before you actually built it.
And then it actually moved into surgical planning.
So surgeons would use this to 3D print something
they intended to do in the body and that's
still done.
It's a very useful application.
But it's now moved to the point that we can
use 3D printing to actually make devices out of
medical grade materials that have enough
good mechanical properties that they can implanted.
They can be implanted into patients and they
will address all of these problems.
So let me give you a couple examples.
This is a clinical example where you've got
an airway that's obstructed airway can be
obstructed because of growth of something
on the inside or or potentially something
that's on the outside of the airway.
It can happen in adults.
I'll show you an example of this.
This actually commonly happens in newborn
infants and can be very life threatening.
The current solutions for this are medical
devices that come in a range of sizes and
shapes but you can imagine there's a great
variability in the anatomy of people's airways
right.
And so it's never a very good match.
And because of that you have problems with
migration irritation and plugging.
So here's a 3D printing solution.
For airway implants.
And it's going to start out at real time speed
and then it's going to speed up.
And this is made out of a medical grade plastic
material so this is something that's an FDA
approved material.
The process is called fused deposition modeling.
And there you can see the implant that's been
made and you can see it has excellent mechanical
properties and it can be handled quite well
by the surgeon.
So let's think about this process.
How did this happen.
We had a patient image so a C.T. image of
the patient.
There was then a design meeting with the clinician
and a computer model that was made in this
case of a stent which means it was on the
inside of the airway.
The the stents were then printed.
They were printed in a couple different ways
in case the surgeon had a preference for having
little nodules on it or a smooth surface.
And then it was delivered for surgery.
So how long do you think this process took.
Four days.
Four days from the initial time that the image
came in all the way through delivery for
surgery so not ten years.
Four days.
And it's customized to to the patient.
Here's another example that's even more intriguing.
This was really the first example.
This was not the previous example was a new
company that I'm working I'm part of called
Restore 3D.
This is,
This was work done by Dr. Scott Hollister
who is actually one of my advisors at the
University of Michigan.
And then I had the chance to recruit him down
to Georgia Tech.
Many years later.
So when Scott was at Michigan though he was
working with a clinician called Dr. Glenn
Green and Dr. Green had a patient who was
born with a collapsed airway, a baby, and was
on a ventilator and in the very severe cases
these babies will die.
There's just nothing that they can do that
can't leave them on the ventilator indefinitely
and there's nothing they can do to correct
it.
So Dr. Green had a patient like this he called
Scott and he said is there anything you can
do.
So Scott said "Well let me let me see what
I can come up with."
And he designed the implant that you can see
up there which is now called a splint because
it's on the outside because the baby's
airways too small to do a stent.
And he designed it to be C shaped so it could
grow with the child and out of a material
that would go away over time.
And so that that implant was then printed
and there was some testing done.
This had never been done before so they contacted
the FDA and the FDA said this is a humanitarian
exemption because this baby is gonna die in
one day the FDA cleared it to go ahead and
do an implantation.
So this is Kaiba, the first child that received
this treatment in 2012.
And you can see the pre-op image here
with with the collapsed airway.
And there's the post-op image showing Kaiba's
open airway.
And there's Kaiba.
On his second birthday enjoying cake.
And notice this is 2012.
So Kaiba is now seven years old.
That material was designed to be in the body
for two or three years so it's now completely
gone.
And Kaiba's own tissues have taken over and
the airways kept open.
OK so just an incredible story.
This has now been applied to babies all over
the world.
My friend Scott got a call from Saudi Arabia
and he had to fly in and treat a baby there.
So it's going through a clinical trial now.
Great example and again very quickly done.
I'll give you one more example in 3-D printing
because this is a different material.
This is made out of metal now.
So you can imagine in foot fractures or foot
deformities it's very complex very complex
bones a large number of bones can have complex
fractures.
The current solutions involve taking bone
from your hip which if you've ever had that
done is very painful and transplanting it
or non customized implant devices like those
shown here And so again they don't fit perfectly
and they're prone to failure.
So here's an example and this is back to Restore
3D.
The company that's based in North Carolina
where we have a complex foot fracture
and we designed for that a wedge implant.
That you can see has a lot of complexity to
it.
You can see the outside surface is complex
fitting the geometry of the foot.
And we've also designed into it an interior
surface that has porosity sort of similar
to the spine implant that I showed you.
Again the timeframe for this.
This happened just last fall September 14th
was a design meeting a week later it was printed
and two weeks later it was implanted for surgery.
So a three week time period for this innovation
cycle.
So this is I think the future we're going
to see these types of, this type of technology
be applied in all kinds of different implant
areas.
You'll actually see 3D printing I
think and all kinds of markets and as it continues
to evolve and continues to come down and cost.
I also just want to emphasize that there's a
whole lot of basic science research that goes
into this that you don't see.
You know you see one with the end of it where
we're putting it into patients.
But there's a lot of basic science research
to figure out.
Well how do we design this architecture so
that that bone will grow into it most optimally.
And how do we make the interior of it so that
it has good mechanical properties and won't
fail in the body.
And even as you zoom in and you look at the
surface of it it turns out the texture and
the topography of the surface make a big difference
in whether the cells are going to adhere and
actually make bone.
And so there's a tremendous amount of science
that goes into it before it actually even
gets to the FDA.
And what that allows us to do is to really
customize other aspects of it it's not just
the shape you can imagine if you have a young
athlete and they've got very dense strong
bone that's very it's a very different implant
that you need for an older osteoperotic patient.
And so we can design now and manufacture processes
that are appropriate for the patient and then
anything that ranges from very strong dense
bone down to thinner bone that's that's less
strong.
And just the last slide on 3D printing because
I love this one.
It's the technology for this is just advancing
so incredibly fast and there's many different
types of 3D printing now.
This is the this is a pencil and we're zooming
in on the tip of this pencil.
And as you get getting closer you can see
that there's been a castle that was 3D printed
on the tip of this pencil.
Just incredible resolution.
All right.
So let's transition now to talk about regenerative
medicine and we already talked about regenerative medicine
a little because I've talked about the
materials that resorb and go away and allow
the tissues to form.
That's one aspect of regenerative medicine
but more broadly what we're talking about
here is combining cells and biomaterials and
biological signals to try and restore function
within the body in a biological way rather
than putting in a synthetic material.
What's shown here in this sort of circular
thing is what the original paradigm was for
regenerative medicine where we would take cells
from the patient and we would combine those
with a bio maternal maybe incubate them and
something called a bioreactor and then implant
them back to that into the patient.
In reality this hasn't happened very often
in a few rare cases this has happened successfully
but it's a very complex approach that it turns
out probably is not entirely necessary.
What's been much more common is for
taking cells either from the patient or in
some cases from other patients and implanting
them directly or using the materials themselves
to be implanted and to cooperate with our
own endogenous reparative capacity.
And I'll talk about that a little bit more.
And that's been much more likely to get into
clinical use.
So over the last decade I've had the honor
of being involved in this field in a very
special way and that is through a Department
of Defense funded effort called the Armed
Forces Institute for Regenerative Medicine.
And this is a very large national consortium.
Sixty projects 37 institutions involved 18
clinical trials have come out of this work
and so there's been a huge impact for our
wounded warriors who you can imagine have
severe injuries at a much higher rate than
the standard clinical standard civilian population.
My role has been to lead one of the five clinical
areas so the particular clinical area that
I co-lead actually with a professor up at
OHSU is the extremity regeneration area.
So we work on the arms and the legs.
And it turns out that's the most commonly
injured tissues in soldiers because their
heads and their bodies are really well protected
and that means that there's their limbs get
injured badly.
So we work on, we have projects focused on
regenerating bone and muscle and cartilage
nerves and in blood vessels.
And you can see the types of injuries that
the soldiers can have usually from explosive
devices.
And some of the statistics from this are extremely
daunting.
Only about 20 percent of these individuals
will get back to full active service duty
and the one that always gets me is that one
out of seven of the wounded warriors that
are wounded like this.
Will opt for a late stage amputation
and that means that after a period of maybe
one to two years after they've been through
many painful procedures they decide to have
an amputation because they're going to get
more function out of a prosthetic than we've
been able to give them through, through our
treatments.
And so we need to do better for these individuals.
So this is an example.
This is some of my own work where we're working
on repairing function to really large bone
defects that won't heal on their own.
So this is a typical type of injury that you
might see.
I've avoided the gory bloody images.
I'm just showing you radiographs.
But this is a complex fracture to the lower
limb where there's been damage to the muscle
and it's an open fracture.
That means that there's a high probability
of infection.
And so what the surgeon would typically do
in this case is implant a material that's
loaded with antibiotics to help ward off the
infection.
They'll then at a short time later, two weeks
later.
Take that out and implant a material that's
intended to maintain the space of the injury
stabilize it.
You see there's a lot of instrumentation that's
in there as well.
And then that spacer is removed at six weeks.
And the clinician will typically take bone
graft again from the hip transplant it down
and then hope that it heals.
And you could see in this individual even
though it's a young 24 year old male six months
out the the injury didn't heal.
And there had to be a revision surgery.
And so we set out to develop a technology
to repair bone in these really complex cases
more consistently.
And here's what we came up with and that we've
we've tried a lot of different approaches.
This is our most successful approach.
If you have a big injury like this in the
bone it normally would go on like this and
this is called a non-union.
So it has not healed.
Well we developed was a nanotechnology where
we would spin nano fibers sort of like a spider
onto onto a surface using an electrical gradient
and then form that into a tube and the nano
fibers the cells like to attach to and the
tube gave us an area that was defined by the
injury that we could inject into a hydrogen.
Hydrogen is a material that's made mostly
of water but also some other components.
And that was used to deliver a very potent
protein called DMP2 that attracts cells
attracts blood vessels and actually instructs
them to make bone.
And so when we do that you can see here the
blood vessels growing into the defect.
This is an imaging technology that we developed
in our lab a few years ago.
And if you look at the healing we can
achieve complete healing of these massive
bone defects and if we take them out and test
how strong they are they're just as strong
as actually the original intact bone.
So this is in animal testing right now and
we're moving it towards the clinic we're also
working a lot on trying to be able to predict
which patients are going to heal well and
which ones are not because it turns out there's
a lot of variability in the patient responses.
So at two weeks you might see a radiograph
like you see here and one of them goes on
to heal wonderfully and another it goes on
and doesn't look doesn't heal at all.
And so we'd like to be able to know which
patients are going to heal and which ones
are not.
And so for that what we've been doing is collecting
blood early on we can collect blood at one
week and measure a whole host of proteins
in different cells it turns out the immune
cells play a big role in this and develop
predictive models where we can predict how
well at one week how well we're going to we're
going to see healing at 12 weeks.
And the idea would be to give sort of the
orthopedic surgeon a weather report and what
we'd like to be able to give is a Eugene summer
weather report and not a Eugene winter weather
report but even if it is a winter weather
report that's really important if the clinician
can know at one week that this patient is
likely to go on and not have a good healing
outcome they can change their strategy up
front and be much more aggressive.
And so this is this is another technology
that I think will be translated actually much
quicker than some of the others that we're
working on.
OK so I've mentioned a couple of times regenerative
capacity one of the reasons that we see differences
between patients is because we have differences
in our regenerative capacity.
None of us are as good as newts but some of
us are better than others.
And it turns out as you might expect when
we were younger our regenerate capacity is
better than more older or younger we've got
lots of stem cells relatively speaking and
those stem cells produce a lot of factors
that are pro healing as we age the number
of stem cells that we have declines and they're
less functional.
But it turns out that we can influence our
regenerative capacity through lifestyle choices
so smokers for example have fewer circulating
stem cells.
And if you exercise you will have more.
And and the good news is that if you change
lifestyle choices you can affect your regenerative capacity
So what are stem cells?
You know even with improving lifestyle
choices you may need some cell therapies.
And so that's where stem cells come in.
Really stem cells can be defined by two definitions.
One is that they can make more of themselves
so they can replicate in stem cells make more
stem cells.
The other is that they can differentiate and
make different types of tissues in the body.
And so the different types of stem cells that
you hear about like embryonic stem cells or
adult stem cells differ in how many of themselves
they can make.
And how many pathways they can form as they
differentiate.
That's the term we use.
They differentiate into nerve cells and muscle
cells and bone cells.
So an embryonic stem cell can make any cell
in the body whereas the cells that are in
all of us that commonly reside on the surface
of blood vessels and you can see them here.
Have a limited capacity to only make certain
types of tissues.
So the way I often think about this is when
you're young.
And this is our son Michael when he was young
you could be anything you wanted in the world,
right?
Michael wanted to be,
I can't remember it was either a brain surgeon
or a neuroscientist and a major league baseball
player.
Which one was it.
Right so, I think was a brain surgeon
and a baseball player.
Now he's studying engineering now in college.
So it's pretty unlikely he's gonna be a brain
surgeon.
He's a pretty terrific college baseball player
though so maybe the major league baseball
thing is still still possible.
So that's how I like to think about this as
you're going through and differentiate it
turns out we've learned now over the years
that these pathways are not completely
irreversible.
And it turns out you can actually, the cells
can actually jump between pathways to be sort
of like you and I.
Changing careers or taking on a second career.
And then most excitingly in 2006 it was discovered
that we could take plain old adult cells just
your skin cells or any cell.
And reprogram it to turn it back in time biologically
into it.
What was very similar to an embryonic stem
cell.
Have you noticed the embryonic stem cell debate
has largely disappeared?
The reason is that is science.
So in 2006 that discovery basically removed
the need for the most part of even needing
embryonic stem cells.
And I'll show you an example of that at the
end of how it's being used.
So these are these are the stem cell trials
going on all the time.
I just looked the other day I did this search
on the 18th and there was over 5000 stem cell
clinical trials around the world about half
of them in the United States.
As I said for all kinds of different clinical
trials are all kinds of different unmet clinical
needs.
And you know one of the main challenges that
I mentioned earlier was the cost of these
therapies basically in making cell therapies
we are where we were with making automobiles
back in the early nineteen hundreds.
Everything is one off and everybody has their
own little protocol and it's not very efficient.
And so while we were, right before I left Georgia
Tech, we formed a national consortium funded
by the National Science Foundation focused
on cell manufacturing technologies.
And now you can see there's a link to the
University of Oregon where we're working on
that here as well.
And the idea is to bring down the cost of
these cell therapies to the point that they're
available to everybody because.
Of course you'd spend a million dollars to cure
a child with cancer but that's not something
that's sustainable for our health care system.
And the hope is that we'll see something similar
for cell manufacturing that we saw for the
cost of the human genome.
You may recall back in 2001 the cost to sequence
the human genome was hugely expensive,
a hundred million dollars.
And with investment from the federal government
that cost came down over the first 10 years
about an order of magnitude 10 million.
And then there became to be a commercially
viable marketplace and investment from industry.
You can see how quickly it then declined
and over just the course of 16 years it went
from the cost of one hundred million dollars
per patient to about eight hundred dollars.
So I want to finish with just one last example
that I think is really cool and it's just
to give you the idea that cell therapies don't
necessarily have to be something that's implanted
into the patient.
OK.
This is work from 2004 using embryonic stem
cells from discarded embryos.
It's not my work.
It was from someone at Stanford in which they
were very excited because they showed they
could take these stem cells that have the
potential to become any different type of
tissue and give them the signals to make
them into beating heart cells.
They couldn't do it very efficiently there's
only about 5 percent efficiency but you can
see that it's beating a little bit.
So fast forward now to 2019 and this is worked
by a friend of mine Dr. Joseph Wu at Stanford.
And.
Now you can see there's 90 percent efficiency.
And these are no longer being done from embryonic
stem cells.
They're being done from what's called Induced
Pluripotential Cells.
And this is what I was telling you about that
that invention in 2006 where you can take
your own cells any plain old adult cells
and turn them back biologically in time.
And so now we've completely removed the ethical
debate these, and more importantly well,
just as importantly, these are patient specific
so they can be from the same patient.
So what is he using these for.
You can not look at all the
details here but basically this is taking
cells from patients say from the skin reprogramming
them into induced pluripotential stem cells making
them into these beating hearts and then basically
you have a model in a dish of that patient.
And what can that be used for.
Well say you have a heart patient which you
have maybe six different drugs.
The clinician is trying to decide whether
to give to the patient.
You could do testing of those different drugs
not on an animal model not on another patient
but actually on a model of the actual patient
you intend to treat.
Through this technology creating creating
the beating heart of their own cells in a
dish.
So very exciting stuff.
All right.
So lastly I just want to spend a couple of
slides.
That's the end of the science.
But I want to spend a couple slides on the
Knight Campus because as the president talked
about this is the incredibly exciting initiative
and it's why I'm here in Oregon.
The mission is science advancing society of
course and the idea is through building these
world class research training and entrepreneurship
facilities that we can dramatically shorten
the amount of time between discovery and societal
impact.
And so some of the things that we're working
on are building a spectacular building which
I assume you've seen over on Franklin Boulevard.
We finish next year recruiting outstanding
scientists and bio engineers and the president
mentioned we've hired our first three faculty
already.
Forming new partnerships across the state.
And he mentioned the Oregon Health Sciences
University partnerships engaging with industry
more effectively because as I showed you tonight
and several examples if we don't partner with
industry and don't partner with clinicians
A you don't know what you should be doing
and B you can't move these things into patients.
And finally promoting a culture of entrepreneurship
in Eugene.
And if you remember one thing from my talk
tonight I hope you remember that I think
what we can create in Eugene is very special.
We don't have to be doing.
We can do cutting edge research.
We can do 3D printing we can be making devices
that go into patients without having some
huge industrial complex.
And I think Eugene is the perfect place to
have such a nimble innovative ecosystem.
And with that sort of intentional vision in
mind my hope is what we'll create is a place
where all this innovation is going on we can
educate our students and they'll have places
to work on leading edge technology right here
in Eugene.
And that vision is the vision of the Knight
Campus.
And it's why I came to Oregon.
So with that I'll finish with this quote from
Leonardo da Vinci that I really like which
is, "There is an urgency in doing.
That knowing and being willing is not enough."
We have to translate.
We have to do in order to move the technologies
from the labs into people and impact lives.
And so with that I'll end my talk.
I thank you for being here tonight.
I hope it was interesting.
And on behalf of my wife Tina and I I'd like
to say just thank you to all of you for making
us feel so welcome in our new community.
Thanks so much Bob.
So bear with us for about 15 seconds.
We have a crack team that's going to flip
the stage here and then we'll we'll convert
over to a more conversational setting here.
All right let's get go in with the evening.
So Bob thank you so much for a brilliant talk
and very exciting.
It's unbelievable.
I think where we are in this field and I'll
just say personally it's great to have you
here.
And you know when we hired Bob we were hoping
for the best.
And it's more than the best, and part of the reason
why you know we're we're not as expert in
Bob's field is obviously he is and I've now
given talks around the country and every, literally
every single place I go they say "Oh you hired
Bob Goldberg good work." So he's terrific.
So I'm going to be looking at some of these
messages.
But just to get us kicked off you know was
a bit of a leap of faith to come here to Eugene
and Eugene Springfield area I should say.
The mayor of Springfield is here.
So thank you for coming.
And so how's Oregon?
We love it actually.
You know we grew up in Michigan.
So Atlanta at 20,
We were 22 years in Atlanta.
But it was always a little bit hot.
And so we would escape to the mountains of
North Carolina which actually it turns out
are a lot like Oregon.
So we're loving it.
I think the biggest probably hardship has
been not being able to watch our son play
baseball but fortunately now we can get all
these games on TV and go back.
So we're loving it.
We love the community we love the lack of
traffic and I don't even mind the rain.
That's great, so
One of the the first question that I hit was
actually interested in the economic impacts.
And you talked a little bit about that at
the end as you know we're making this big
investment.
There's a lot of faith by the community but
also the whole state we're a state institution
what do you think about how this is gonna
be a catchment for some of that work?
And how does it make sense?
You haven't been here that long but Eugene and
business sometimes have differences of opinion
on what that means.
And so what's your perspective on how the
university can be more engaged in those activities.
Yeah.
I mean I tried to touch on that a little bit
at the end.
I don't envision or at least I hope Eugene
doesn't turn into Atlanta with all the traffic
and the industrial complex that has become
but there's tremendous opportunity I think
for having an incubator space for startup
companies and you know personally if I was
doing a startup and I want to be on the west
coast this would be the place to be.
I mean like the cost of living the weather
the quality of life here in Eugene is
is so much better than elsewhere.
So I think that's a great opportunity that's
a little bit of an unrealized opportunity
we will have actually incubator space in the
Knight Campus building.
And so people will be able to start their
companies right there engage the students
to do this.
The way I've done my last two startup companies
actually is to have students that have been
trained early on in entrepreneurship and business
and working with Andrew Nelson from the Business
School where we're starting to build that
into the plans for the Knight Campus students
and then the idea is to have them go off and
do the companies because it turns out professors
actually make terrible business people so
why not let the students do it.
So I wonder if you could talk a little bit
about the one of the major themes you touched
on is that you were able to really accelerate
the movement cycle and we have a couple of
questions that you know how do you get around
the FDA in that?
Is it that that part is not totally clear.
How are you able to move things so quickly?
Yeah.
So I mean I guess the first comment on that
is you learn as you do this that the FDA is
not the enemy.
They actually serve an incredibly important
function.
And I would say our FDA is probably one of
the more innovative aspects of our government
in fact where they're really interested in
working with the companies to make this work.
And so the first thing you do is you talk
very early on with the FDA.
They do have a challenge with these new technologies.
I remember regenerative medicine when it started
the first company,
This is a little bit an interesting story
so I'll take a minute to tell it,
One of the first companies was called Advanced
Tissue Sciences out of La Hoya and they were
developing a tissue engineered skin so a living
skin basically.
And this skin was actually made from an unusual
cell source that was a discarded medical waste.
It was made from a human foreskin.
And you could take the skin cells from a human
foreskin and make a football field of living
skin from that.
And that living skin actually was used for
treating diabetic ulcers very successfully.
It was used for treating burn victims and
remove the pain much more effectively than
the current technology.
So it was a successful technology.
Advanced Tissue Sciences went out of business
though because the FDA didn't know how to
regulate them they had they'd never had a product like that.
It was they they did drugs and they did devices
they didn't do a combination of material and
living cells.
And so at the time the company unfortunately
went out of business.
Fast forward today now the FDA has much more
knowledge about this.
There's a combination product office and they
help to move things through.
3D printing is exactly at the same stage
right now.
They don't really know how to deal with this
because the FDA is used to dealing with having
to design you fix that design as I said and
then you take it through.
And so the way that, to answer the question
directly, the way that we've been working with
this is that in the one case you saw with
the baby that was a humanitarian exemption.
And so the FDA gave clearance because it was
an extreme situation for the patient.
There's also an exemption called a customization
exemption which is sort of like a physician
writing a prescription for a particular need.
And so the device as you saw that were customized
devices that we're making for adults are through
this customization exemption.
If we ever want to scale this up and do a
large number of 3D printed devices then we
will still have to get full approval through
the FDA. Great thanks, so
One of the questions is about the relationship
between kind of these rapid innovations especially
in some respects your you know you can extrapolate
this in the future redefining what it is to
be a human with these sorts of things.
How do we couple this with our ethical considerations
and within the university context.
Thinking about ethics training how how are
you thinking about that in relationship to
the Knight Campus.
Well it's extremely important and so we're
already partnering on bringing in speakers
and ethics and so forth.
There actually is a very strong ethics procedures
that all faculty have to follow but I think
it's very important that our students get
this training early on and in a broader context
I think it's important that our students are
getting not just technology training but they're
also understanding ethics and how to communicate
well and what is the history of these different
technologies and even business aspects and
regulatory issues.
So we're trying to build in a lot of these
sort of if you will non-technical parts of
the education early on in the process so that
as they learn the technologies they have that
foundation.
So one of the great aspects of Eugene is that
we have a local medical community.
Do you see potential for partnering with local
groups and in terms of testing or even development
of these kinds of technologies.
Yeah absolutely so,
and there's several in the audience tonight
that I've had meetings with already because
I've always come from a place that had a connection
to the medical community University of Michigan
had that at Georgia Tech we didn't have a
medical school but we partnered with Emory
University and formed a joint department in
biomedical engineering and we're working on
something very similar here where I anticipate
our biomedical engineering program will be
a joint program with OHSU and also likely
with Oregon State.
They've been very excited about partnering
with us on that as well.
But proximity makes a big difference because
it turns out that.
Clinicians are very busy people and professors
are very, and scientists are very busy people and
so having them very close to each other and
having mechanisms to make it easy to work
together is really important.
So we're definitely gonna be working on that.
We'd like to have some programs where we can
provide some funding for the local conditions
and scientists to work together and that's
so important, it's particularly important for
the students for them to understand what the
needs are and not be working on their science
in a vacuum.
So one thing you didn't have a chance to touch
on are student impacts and it's still early
days for the Knight Campus.
But we have a couple of questions that are
wondering what's the connection with existing
departments and opportunities for students
as well.
What's the vision moving forward.
Well you know it is early days I guess I'll
speak to one that's getting off the ground
now that I'm excited about the honors college
and the Knight Campus have been meeting
about ways that we can partner together.
And so a couple of ways that we're doing that
is we've launched a program called The Knight
Campus Undergraduate Scholars Program in which
undergraduates get a full year experience
in a laboratory that's actually paid.
So instead of just having a summer experience
this is a real research experience and gives
them an idea of where their research is what
they want to do for a career or not.
And so the Honors College is actually providing
funding for a couple of those students.
And then we're also talking about it.
We have a master's program in the in the Knight
Campus that started actually over 20 years
ago at U of O its internship program where
the students take classes with it intense
training then go off and do an internship
and then typically have a job at the end of it.
And so what we're talking about doing is a
an accelerated program with the honors college
where the students could come in and get basically
a combined Bachelor's and Master's in an accelerated
fashion by working through the honors college
and then coming into the Knight Campus internship
program.
So I think those are the types of innovative
programs will be trying to put together.
So we're obviously at the cutting edge here
and so we have a couple of questions that
are wondering about how far we can push this.
So we've touched on this in previous talks
about genome editing and you mentioned that
with the Chinese example.
So where's the intersection between regenerative
medicine and in sort of genomic technologies.
We seem to be at a potential intersection
here.
Yeah well you know on the one hand understanding
patient specificity the genomic technologies
that are going to really help with that and
whether we want that information or not I
think it was going to have to be a personal
decision.
But certainly in terms of guiding therapeutic
approaches genomic technologies are going
to be very useful for that.
In terms of gene editing it's extremely powerful
and in some ways extremely scary technology
that can be used in many many good ways actually
the cancer immunotherapies there's a subset
of the cancer immunotherapies that are now
relying on a portion of gene editing that
will make that much more effective approach.
But when you get into the realm of gene edited
babies obviously that's a much scarier situation.
I actually saw a talk several years ago on
this that I thought was very interesting which
was if you think about a person late in life
that has a disease that could be corrected
by gene editing and they give approval
to have that treatment.
Well that's that's probably not not bad.
That's probably ok right.
And then you start thinking going backwards
or what if you had a child that had that disease
and you knew it was safe but they really weren't
old enough to be able to give permission to
do it.
That's a that's a different gray area of ethical
consideration.
And then you start to get into you know babies
and if a newborn has a disease obviously
they can't give approval for being
treated.
And then you start to get him into worse areas
like well what if parents want a baby with
blue eyes or something like that.
Or someone wants to make a super soldier.
You can think about the whole range of things
in this case supposedly they were trying to
make the baby more resistant to HIV is what the supposed purpose was.
But I think the scary thing is in this case
also they don't really know what that gene
editing did.
They knew one thing about that gene and its
purpose in HIV but that gene could have had
so many other different functions.
And that's part of what makes gene editing
scary. So I want to read this question verbatim,
speaking as one of the many audience members
over 50 when or how can I benefit from some
of those dang stem cells
back to the time therapies? Help!
Can you read that again.
When can I get this in my body basically?
How can I turn back time?
Yeah.
Now I mean if you want to now you can.
I think -- when is it a good idea to get a sense
out there.
That's a different question.
Yeah.
So it's again this has been an area that has
been not entirely regulated.
So if it turns out that if you're using tissues
or cells in what's called a.
Homologous.
I don't wanna use that word.
If you're use if you're using them were you.
You take them from one person and put them
into another.
It used to be that that was not regulated
by the FDA.
Think about bone banking right there's banks
of bones where you can get a bone graft.
And so that was not regulated by the FDA.
And so it turned out that stem cells kind
of fell into that same category.
And what that has led to is a number of clinics
popping up with unproven approaches where
they're willing to if you want to pay them
ten thousand dollars to inject stem cells
and just about everything.
And so I would not advise anybody to do that
but there's a lot of great science going on
and a lot of clinical trials going on and
the FDA is now cracking down on this.
So I think we're we're moving into a more
mature state where the cell therapies that
are going to come through the clinical trials
will be ones that you want to take advantage
of.
But I would wait for the science.
Yeah.
And do we have to tell people that came from
a football field full of foreskin since it was
it was -- if you can you take home tonight,
I hope that's the evidence that you have.
It is a more serious topic because you talked
about the relationship with the honors college
but what's the responsibility of the role
of the night campus and kind of building equity
in society and academic and educational access.
What are you thinking about that?
How are you preparing for that?
Yeah I mean that's a great question and a
big challenge.
I think you know in biomedical engineering
we're a little bit fortunate.
It's the one branch of engineering where there's
a high proportion of women for example in
the field and I'm not sure exactly why that
is it may be because it's a little more focused
on helping people but it's still,
It remains a huge challenge.
And so we're already even though we're very
early stage we're already implementing some
what we call active recruiting measures where
we've announced that if anybody has
a diversity candidate that they would like
to bring in what we might consider it for
a faculty position we'll bring them in to
do a seminar on campus.
We're also going to be developing a postdoc
program where we provide funding for underrepresented
minorities to do postdocs.
And then I'm excited about implementing a
leadership training program which will provide
funding.
This is something that I benefit from a lot
when I was a young faculty member to get some
leadership training.
And there's you know even if we are doing
okay in.
Hiring professors you see a real decline in
women in leadership positions.
And so why is that and how can we address
that.
And so I think you know doing programs like
this hopefully will help so we heard some
amazing research you got companies you got
your lab you're getting things set up your
got the night campus started.
So what had been the biggest challenges that
you've seen just over the last year and how
are you possibly doing this.
Well I'm not coaching baseball anymore so
that helps.
Biggest challenges I, you know it's all good.
I really learned and the reason I came to
do that is I had I had built something similar
to this at Georgia Tech but I hadn't started
it.
In fact I took over sort of midstream and
I tripled in size.
But I didn't have the chance to build it from
scratch.
And so.
This is an opportunity to do that and that's
what I'm so excited about.
What are the challenges?
I think you know the challenge is, probably
the biggest challenge is getting the word
out and attracting really great students.
I would say that's probably the thing that
I think about the most.
I have no doubt that we're going to be able
to recruit fantastic faculty and we're already
doing that.
But getting the students to recognize that
this is a amazing opportunity and come to
Eugene.
You know it is a bigger challenge it takes
a longer time.
And so I want to accelerate that.
I don't want to wait a decade for that to
happen.
And of course you have some help also.
Yes I have some help also.
And I prompted him with this question and
then I totally forgot it.
Thank you.
So yeah we you know when I came into this
I was really very fortunate and I'm going
to take an opportunity to thank him because
he was the, he was the founding acting director
of the night campus and did an incredible
job getting things off the ground including
the design work for the initial building.
And so that's been just fantastic.
But I was also blessed with having an incredible
staff in place and they're the ones
that really make things happen they're the
ones that organized tonight's event.
So if we could just take a moment and thank
them for putting this all together tonight
So that's a great note.
We've come to the end of our evening I really
apologize.
There's about 100 questions on here and I
obviously couldn't get to them all so.
I beg your patience with that.
But there's great opportunity to thank Bob
one more time for a great talk and.
