Welcome to The Emerging Biotech Leader,
where we help biotech leaders
maximize the value of their therapeutics
from clinical development to product launch.
We’re your hosts,
I'm Kim Kushner.
And I'm Ramin Farhood.
We are here to help
you navigate the pitfalls of the biotech industry
and illuminate the path forward.
For those in the gene therapy space,
you've probably heard of him.
Dr. Suku Nagendran is quite the household name.
Starting his career practicing internal medicine in Arizona,
he joined the industry in big names,
like Pfizer, DSI, Quest Diagnostics,
before the leap into biotech.
He was the chief medical officer of AveXis gene therapies.
He's now the president of R and D at Jaguar Gene Therapies
and he's serving on boards across the industry.
Suku, welcome to the podcast.
To get us started, we wanna hear more about AveXis.
It's the darling of the industry
and you've had a great experience there.
Can you tell us more about it?
Thank you, Kim, for this invitation
to talk to you all about my experience
in the world of biotech and gene therapy.
Before I get into AveXis, what I'd like to start by saying
is that I wake up every day and pinch myself
for now being considered an expert in gene therapy,
given that my background is internal medicine
and I always considered myself a country doc.
So as you highlighted, I've spent almost 24 years now
in the pharma biotech diagnostic sector.
And during that course of my career
is when I ran into Sean Nolan, who was at Reata with me,
which is also pretty well-known biotech.
And it's that connection that actually took me to AveXis.
So in 2015, when I was at Quest Diagnostics
heading the medical organization
and actually being quite happy and satisfied
with what I was doing, Sean calls me up
and says, Hey, you know, I just became CEO
of this company called AveXis,
and you have to go talk to Jerry Mendell
and Brian Kaspar at Nationwide Children's Hospital,
because he thought that they had something
that could be transformative.
So I went out to Nationwide Children's Hospital
in Columbus, Ohio, looked at the data,
looked at their early animal data,
as well as the data that they had from the clinic
in a horrible disease
called spinal muscular atrophy type 1,
and I was blown away.
The one-to-one translation
of the preclinical work into the clinic,
and the fact that this was a devastating disease,
and the fact that I had never seen this kind
of data translation from the animal into the human
gave me this gut feeling
that this could eventually become a cure.
So on my way out, when I left the Nationwide,
I called Sean Nolan, and I said, “I'm in.”
"I'm more than happy to join you as chief medical officer
because I think we can do something magical
and transformative for patients."
Incredible.
So was it the data that really made you decide
to take the leap?
It sounds like a lot of people told you not to go
to AveXis at the early days,
a lot of your mentors and people you trusted.
What made you decide to move over?
It wasn't just the data.
It is the translation of the data.
So what I'm talking about is that the Delta 7 mouse model
had significant death rates at 14 days.
And the fact that these mice lived quite long,
and on top of that, the fact that in the human beings
that they had actually dosed the first six children
were doing things that were not expected.
This gave me significant hope.
And yes, many people, including folks
at the company I was working for, said, "Hey,
you're gonna take a very big risk in going to a startup
that is still not that well-funded."
But something told me based on my prior experiences
in drug development,
this gene therapy program could really transform life.
So I had the confidence not only in what I had seen
from Jerry Mendell's work,
but also I had confidence in Sean.
Because Sean Nolan historically
had done some very interesting work
in other disease states in biotech.
And I felt that the team, if it came together,
could really make a difference for patients.
So it was not just the translation of the data.
It was also the leadership team that you were joining
and the confidence and the people
that you were doing it with that you really thought
that something was special at AveXis.
Absolutely.
So that is something I would always highlight
to anyone who wants to get into biotech
and play a leadership role,
which includes being a chief medical officer.
That is that not only do you have to have confidence
in yourself, you have to have self-awareness of your gaps,
but you also have to have the right people around you.
And I want to throw this quote in,
which I always remind many of my team members
and also even my superiors around me,
that I consider myself a nobody who is now a somebody
because of everybody around me.
It is my team and the people around me
who have helped me and others be successful.
So on that note, Suku, tell us a little bit
what it was like to be the CMO at AveXis,
a small biotech company.
I believe you were in the first maybe 30, 40 employees
that the company has hired.
And you were coming from big pharma.
You were coming from diagnostic.
All of a sudden, you were put
into this fast-paced biotech gene therapy.
Tell us a little bit more about that
and how was it like to be a CMO,
some of the challenges you had to face.
So Ramin, that's a very good and important question
because it does give many people insights
into what it is like to start in an early-stage company.
So I'll give you my first day.
I get to Chicago, I walk into this tiny office,
and Sean points me to a corner desk with a chair
and says, "That's your office."
So that was my first day.
And I still remember thinking to myself
at the end of the day, what did I sign up for, okay?
Because I was actually I think in the first 15 employees,
and I didn't really have much of a team.
I had a couple of junior team members
and there was a ton of work to do
because the program was already
in the early stages of the clinic
and we were trying to execute on this program
with Nationwide Children's Hospital, and at the same time,
we were also planning to put together a regulatory package
to try to move this program forward,
given how the data was accumulating.
And we were also talking
about actually putting this company together
and growing it rapidly but also taking it public.
So what I would highlight is a chief medical officer
and his or her role at a early-stage biotech
can be multifold, okay?
So you will have external facing roles
and internal facing roles.
External facing roles,
especially if you're good at communicating data
and talking to different types of audiences,
you and the CEO will be out there quite a lot,
which takes up all day.
Then at two in the morning,
you're running the internal operations,
which usually include anything from preclinical
to clinical development to clinical operations
to planning commercialization,
which includes medical affairs.
So it is a lot of work, a lot of stress.
And frankly, you have to be quite self-aware
to manage through all of this.
Otherwise, it becomes incredibly challenging
to be successful in that kind of environment.
And you have multiple different stakeholders
that it also becomes very challenging
for each one have a different need,
each one have a different agenda, different focus area.
How did you manage the board at that time when you joined?
I believe you were tasked to pull together quickly
a clinical development plan in a very short period of time
and there was a lot of pressure on that.
I remember those times.
And how did you end up managing that?
So that is another important question, Ramin.
So before I went to AveXis,
a good clinical development plan usually took up to a year
in most companies,
because obviously, I worked for bigger companies.
My first day, Sean brings me into his office
and says, "Look, I need a clinical development plan ASAP
to present to the board, such that we can get funding
and move this program forward rapidly."
So essentially, I had 10 days or less.
So guess who I called? I called you guys, SSI.
I talked to Doug, I talked to Madhav,
and we all got together
at the local Parsippany New Jersey office
with a crack team of neurologists
and others who were really experienced in drug development,
including biostatisticians.
And frankly, I still cannot believe we pulled this off.
We put together
a full clinical development plan for a gene therapy program
in a neurologic space, spinal muscular atrophy,
within seven to 10 days.
And then we took it back to Sean,
the executive team and the board, and we presented it.
And then most of it got executed when I was at AveXis.
Now, the point I will make here again
is, remember, I was not a neurologist,
I was not an expert in gene therapy,
and I was not an expert in spinal muscular atrophy.
So what I did wasn't what I did.
It was what the team did with me.
That includes the SSI team.
And then the rest became history
because, as many of you know, this company flourished
over a course of 2 1/2 years when we were there
where the data that we generated
in the clinic was incredible.
This became a life-saving product.
And we took this company public in February '16.
And as all of you know, in April of '18,
Novartis purchased us for $8.7 billion.
So this is a experience that I consider one
in many lifetimes.
And it's what one would consider a unicorn biotech.
So to kind of wrap this up, though,
again, that plan could not have been put together
if not for the team that worked with me from SSI and others.
So a lot of compliments to everyone
who worked on this program.
Suku, tell us a little bit about the leadership team
at AveXis, and the dynamic of the leadership team,
and your interactions with the group there,
and your takeaways.
And how were you able to kinda overcome some
of the challenges that you initially had?
So I had a very diverse leadership team,
people with very different experiences
from clinical development to clinical operations
to medical affairs to health economics, et cetera.
And one cardinal rule that I had with all of you,
which as, Ramin, you are part of my leadership team there,
was that I would remind everybody,
"Yes, I'm the chief medical officer,
but there's a lot that I don't know.
The reason I have all of you with me
and I hired all of you is to make sure we do far better
than myself leading this team and making decisions."
I wanted all of you to be very candid with me,
which I encouraged, and also challenge me appropriately
where when I made certain decisions,
if you all thought that was not the right decision,
let's talk this through
and then come up with the right solutions
to move the program forward for patients.
And I found that open, honest, transparent conversations
with my leadership team paid dividends
because it not only enabled us
to be even better than what we were,
but it also enabled us to execute on a program
that was moving through at warp speed.
So as all of you know, we delivered results every quarter
for AveXis that I've never seen any other company do
in my experience.
And that was partially because of us working together
in an open, honest, transparent manner,
focusing on the patient.
And I would also add that I encouraged,
and Sean Nolan was very good at this, too,
in bringing together diverse personalities
where we could have disagreements in the room, right,
to move a program or a decision forward,
but then we left the room, we held hands together
as a cross-functional team, and represented the company
and the patients in the best manner possible.
So disagreements in an appropriate venue
was always encouraged.
And this open, honest conversations are what led
to the strength of the team, such that diverse expertise
and experiences could come together
and work together to advance a gene therapy program
that was transformative for patients.
And the open, honest conversation
is not always an easy one to have
because you never know how the other parties
are going to react or if they agree with you or not.
And it's not as easy as...
You would think that it's an open and honest conversation,
but the other parties may not quite see it that way.
They may get defensive or they may have other thoughts.
And how do you overcome at that point when people come back
and say, "Oh, absolutely not, I fully disagree with you"?
How do you manage that, especially at the executive level?
So another important question, Ramin, right?
So one thing, if you remember, is when we got together
as a cross-functional leadership team within medical,
we had disagreements, right?
And eventually, sometimes I would tell all of you,
"I've heard all of you," right?
"And I have an opinion,
and I am going to adjust some of my decisions,
but now I am in the position
where I have to make a decision."
So actually, I would say this was one of my strengths.
I, sadly, for the good of the company,
never had a problem making a decision, okay?
So I would make a decision and run with it
because there were times we didn't have time
to sit and pontificate.
So what I'm getting at is, as a chief medical officer,
you have to mature to a point
where you're willing to encourage your leadership team
to share their thoughts, share their disagreements,
then you have to take all that information,
process it and digest it,
and then make decisions sometimes very quickly,
especially when you're running clinical trials
and you're dealing with patient safety.
As you know, in gene therapy programs,
there have been issues around patient safety.
And we were a pioneer when it comes to AveXis.
And there were a lot of things I saw
from a safety standpoint
that had to be appropriately managed.
You had to get in front of them.
Whether it was managing with appropriate therapeutics,
wrap around with the principal investigator working
on the program, using more prednisolone
or immunomodulatory agents to manage the patients,
these were all difficult decisions that were instinctive
based on collective leadership feedback,
where eventually my experience drove some of those decisions
with the PI as to do what was right for the patient.
So again, there is no cookbook answer
to your question, Ramin,
but I think there are many principles based
on what I just said.
'Cause again, you have to be confident
and comfortable in yourself as a chief medical officer
in having those open conversations
with your leadership team,
and then having the ability to make the right decisions
that sometimes only retrospectively you know
you made the right decision.
And that teaches you for the future, okay?
Great point about decision-making.
And I think your earlier points
kind of culminating some of this are around the need
to have a really productive culture
where you can have healthy pushback across the teams.
And it sounds like there was also a deep sense of trust
in your collaborative cross-functional partners
and what their expertise was
and how you could work together.
And I definitely see that as a critical point
in the clients that we're working with.
But Suku, it sounds like that was part
of the secret sauce that at AveXis in particular.
No, absolutely, Kim.
And I would also highlight that when you work
with multiple biotech companies and customers,
something many of these companies have to do is,
and at a leadership level, is actually be self-aware
and look within, and be open and honest
when it comes to some of the gaps they may have
and where they actually need help.
Because many a time, I see companies fail
because they don't do so
and they're not honest with themselves.
And this is why many a time I have reached out to SSI
to bring you all in to be kind of the person on my other,
as I say, the person on my shoulder who points out,
"Hey, you have a problem here.
You better pay attention to that.
Hey, you have a problem here."
'Cause sometimes, internally,
they won't point that out to you.
But people from SSI have been very courageous
when it comes to working with me in pointing out those gaps
and helping me sometimes address those gaps
for the greater advancement of the company
and our programs for patients.
Right, absolutely.
And I think one of the other secret sauce
that you've brought up a few times,
they were really the patients at AveXis.
We were so laser-focused on these babies, right?
At the time that we were coming to the market,
there was just only one other product in the market.
And these babies were basically dying
before they were two years old.
So I think the whole company,
especially being such a small company,
we were so much in touch and laser-focused on these babies,
their parents, and what they go through,
and our partnership with the advocacy group,
that it translated to our everyday being
and decision-making,
which I think was also very, very unique at AveXis.
Maybe one other question.
During that time, what would you think was one
of your best decision or the leadership best decision?
And what would you consider to be not,
maybe not such a smart decision looking back?
What do you think those would be?
So from a decision-making standpoint,
it was the team that I built.
Because I knew what I was good at.
Thankfully, I had been in the industry long enough
and I had taken a lot of punches, okay?
So I had been involved
with some mega drug development challenges.
Some of them which were big pharma companies
where it really makes you self-aware
of what to look out for very early.
So I was able to hire people in clinical development,
clinical operations, and also, medical affairs,
given how quickly this product was moving
through the developmental life cycle to fill my gaps
and to actually assist me in doing the work.
'Cause I spent a lot of time during the day with Sean Nolan
and others talking to investors, going to Wall Street,
preparing for quarterly meetings, okay?
Some of the mistakes I made during that period,
which I still regret, is not taking time out for myself.
That 2 1/2 years that I spent, I worked so hard
where I never got any sleep,
I had no time sometimes for my home, my family.
Now, I was lucky that this was only a 2 1/2-year period,
but frankly, it felt like I was doing this for 10 years
by the time I exited the company after Novartis acquired us.
So that's one thing I would remind anyone
in a leadership role, including as a chief medical officer,
eventually, when you go on and move on to another world,
people are not going to put on my tombstone,
"Hey, this guy worked for AveXis," right?
It's really how your family remembers you
and your close friends remember you.
So this is part of reality.
So I always remind people around me, career is great,
but always remember there is much more to your life
than just your career, okay?
I think it's a really important point.
And one of the other questions that Ramin
and I have really wanted to dig into a little bit, actually,
we weren't gonna ask this question
with regard to your family,
but would love to hear the perspective from your family
as well as professionally.
You've gotten a bit of a reputation for being a cowboy
and taking some calculated risks
and being really comfortable with that
where many other people wouldn't be.
How has that influenced the path that you've been on,
the decisions you made,
whether it was at AveXis or elsewhere?
How has that influenced your family life
and some of those connections?
Most of what I've done in my career I could not have done
without the support of my family and my wife, Ann.
If she hadn't encouraged me to take this chance with AveXis,
I probably would not have.
'Cause as I said-
So she's like a cowgirl, too, huh?
Well, she has good instincts, right?
I mean, you have to have a partner
who keeps you grounded, right?
So at Quest Diagnostics, as I said, I was very happy.
I was making a good living and my career was set.
And actually, even the CEO there
was absolutely shocked when I left.
But sometimes, as people say, you have instinct
and you have to take a calculated risk.
And you have a family,
people around you have to support you.
And I would say my wife, Ann, was very supportive.
And frankly, it paid off, right?
It paid off for patients. It paid off for the family.
It paid off for my children, the three boys,
who also have been very supportive.
They have watched my career with absolute fascination
and they still chuckle about the AveXis days,
because obviously, that kind of experience, right,
from a career standpoint, from a personal standpoint,
and also what it allows you to do for the future for others,
I think is remarkable, but it is a retrospective look.
Now obviously, this may have not worked out.
If the AveXis program and the company hadn't succeeded,
people would have looked back at me and said,
"Well, we told you so," right?
But thankfully, that's not how it worked out.
It actually enabled me to open my world to obviously go
and work on multiple other gene therapy programs
as an investor, as a board member.
But frankly, financially, it also enabled me
to be very philanthropic.
Because one of the things I've been absolutely interested in
is helping other people in other parts of the world
where people are challenged economically.
So there's a lot of good you can do once you succeed
in your career, both from an emotional
and a career standpoint, but also financially.
So my collective conclusion here
is there's a lot you can do,
but you cannot do it by yourself.
If you have a family or a partner and children,
they all, hopefully, are with you to support you
and be there for you.
And then in terms of the calculated risk-taking,
tell us a little bit about that in terms of,
it's clearly paid off that you've had the ability
to walk into conversations with your board,
the rest of your executive team,
maybe say things that people didn't wanna hear,
but things that they had to hear
or that were really strong convictions for you.
Tell us about how you've gone about that
and maybe advice for others
in terms of when it's appropriate
or how to appropriately do it.
And now, you just mentioned you're a board member
for a number of organizations,
so I'm sure people are having those conversations with you.
How do you want those conversations to go
if they're going to?
Well, so, I mean, I have evolved over the years
where I've always decided, even as a young physician,
to follow my true north,
and that is really doing what you believe in.
So when I'm in situations from the time I remember
as a physician in my career, as it has evolved,
I've always made up my mind to do the right thing.
So whether it comes to making decisions
on organizational structure, clinical development plans,
patient safety, those are critical features to me,
and I will not allow anything to get in the way
of things that I believe.
And I have always decided that if I'm part of a team
that I feel I don't believe in their edict
and I don't believe in what they're doing,
I will have a open conversation.
And if it's not for me, I will walk away
'cause then I do not wanna be a part of that.
And that has always worked in my favor
because many people who may find that challenging
when somebody's very honest and open,
eventually appreciate that openness.
Because most of the time, it works in favor of the program
or whatever you're trying to achieve for patients.
'Cause remember, what all of us are doing in the world
of biotech and pharma or diagnostics
is we are trying to help patients, right?
So if we don't keep that in mind and we forget that,
eventually, not only do we hurt patients,
but we hurt ourselves and we hurt our company.
So this is something I kind of tell all my people around me,
always remember your true north, do the right thing.
It's much easier that way in the bigger scheme of things
and towards the end of life.
Right.
Definitely, it comes back to your early point
about the need for self-awareness not just in the skills
and the things that you're really good at,
but also in terms of what your true north is
and how you really think about your role
and things that you can and can't do in the industry.
So it's really important point here.
That's amazing.
And I think the courage is the part
that makes it really challenging to do that.
A lot of us know what the right thing it is
and we know exactly what we need to do.
But that extra step to have the courage to speak your mind
and telling to your leadership, to the board, to the CEO,
it takes a unique personality to be able to do that.
And thanks for sharing that, too.
That takes a lot to be able to do that.
To do some of what I just said,
you also have to take the risk that you may get fired.
Not every board nor every boss of yours
is going to want to address some
of these things you may put on the table.
And obviously, there has to be a certain way
to communicate these things
that are politically appropriate as well.
But then there are situations
where you may want to thump the table with your fist
because sometimes you need to get people's attention.
And I've done that more than a few times in my career, okay?
And I do that, especially when I feel people
are not hearing me and I feel that it is critical
for patients and patients' lives that I step up
and stick my neck out.
So I will always remind people
who want to be chief medical officers,
you have to do the right thing by your patients.
It doesn't matter what the share price is
or what you're trying to do for the board.
It's the patient first, okay?
As long as you remember that, you will be successful.
Tell us a little bit about talking
about the patients and your career.
And obviously, you have been incredibly successful
and have launched a lot of products, have also mentored
and hired many people in our industry.
And I believe recently you have established an award
for translational science.
Tell us a little bit about that.
What is that award? Why was this so important to you?
And what's your goal there?
Yeah, thanks for asking about that award, Ramin.
So this was an award my wife, Ann, and I established
at the American Society of Gene & Cell Therapy.
It's called the Jerry Mendell Clinical Translational Award.
So you know Dr. Jerry Mendell,
Nationwide Children's Hospital.
I am a huge fan of his, he doesn't know this, because he
and I used to have some very interesting conversations
when I was at AveXis as CMO.
But I took my hat off to him when he was the physician
who dosed the first child
in the spinal muscular atrophy type 1 trial
without prednisolone prep,
where he gave this child a trillion viral particles.
And that is what led to the history of AveXis
and the success of ZOLGENSMA.
And to me, Dr. Mendell has been at this field
for 40 years-plus.
So when I left AveXis,
and I was in a financial position to do so,
I felt I had to honor him in some way.
So this was one way for me to emphasize to the community
of gene and cell therapy
that you need brave translational physicians
who will take the animal data
and then be willing to work with patients,
whether they're children or adults, to make that difference
when it comes to the clinic.
And actually, ironically, the first recipient
of that award was Dr. Jerry Mendell himself
because the committee felt very strongly.
By the way, I had nothing to do
with the award being given to him, okay?
So I'm completely unbiased.
They felt this gentleman was incredible
in what he has done in his career.
And then the second winner was Dr. Kathy High,
who is also a pioneer. And I have a lot of respect for her.
And as y'all may know, she was president of R and D
and the chief medical officer of Spark Therapeutics.
So if you think about it, AveXis had ZOLGENSMA approved
for SMA type 1 in SMA,
and then you have Spark Therapeutics
that had the other gene therapy approved
for retinal dystrophy, right?
Another rare, difficult-to-treat disease.
So I felt incredibly honored that this simple award
that my wife and I put together for ASGCT
was able to actually recognize two of the pioneers
in gene and cell therapy.
That is incredible.
I think he's well aware of your affections now.
You can't really hide it anymore.
So Suku, many of the people that are gonna be listening
to this podcast probably are not at the stage
in their career that you are,
probably earlier in their career as CMOs or aspiring CMOs.
If you were to give them some advice
at this stage, what would it be?
What I would tell somebody
who wants to be a chief medical officer,
who just became a chief medical officer,
is number one, remember to be yourself.
Never forget who you are. Always be humble, okay?
That's the first thing.
Second is work on self-awareness.
Be very sure, eventually, of what you're good at,
what you like to do, what you're interested in,
and what your actual gaps are,
and how quickly those have to be filled.
Because many a time, I find young physicians,
or physicians who've just become,
or other experts in the field
who have become chief medical officers,
tend to get wrapped up in themselves
and suddenly get overwhelmed with what they have to achieve
and forget to build the network and the team around them.
If you look at my career, for example,
most of what I have done, I didn't do by myself.
I did it because of everybody around me.
And I sincerely mean it. Ramin, you are part of my team.
There were people at SSI.
There were many others,
Doug Feltner, Doug Sproule, Courtney Wells,
who were all part of my team.
I mean, if not for that incredible team around me at AveXis,
we would not have delivered
on everything we had to deliver on.
And obviously, I didn't refer to the C-suite,
Sean Nolan and others who were part
of the C-suite at AveXis,
and obviously, other companies that I'm involved with.
If not for this incredible team around me,
none of this could have been delivered as a CMO.
And this is what I would always remind a young,
up-and-coming CMO or somebody who wants
to be a chief medical officer,
is remember who you are, remember where your weaknesses are,
don't be shy to admit that you don't know,
and make sure you have the right network
and people around you.
Oh, and one more important thing.
Don't feel shy to ask for help.
I have never had a problem asking for help.
Actually, sometimes I think that's my strength.
And actually, sometimes even people think
maybe I'm a little crazy about that,
but I will put my hands up and say, "Guys, I need help
because I don't know what the hell I'm doing here."
And there's nothing wrong with that.
Absolutely. That's great advice, Suku.
We have come to at the end of our podcast.
And I know we can probably do another couple of hours
and questions.
We had so many different questions that we wanted to ask,
but we focus on these few for this first podcast
that we had with you.
So perhaps maybe in the future, you can join us.
I do wanna thank you for taking some time of your day
and be with us today.
And also, really appreciate sharing your knowledge,
your insight, your experience with us in such a candid way,
in such a authentic way and pragmatic way
that actually our listeners can take it to their day-to-day.
So Ramin and Kim, I wanna thank you for talking to me.
But can I leave both of you with one more thought?
Of course. - And this is for all of you,
including up-and-coming chief medical officers.
Remember that everybody around you matters,
which includes the person who opens your door,
the guy who takes you to the airport, right,
the guy who comes and does your work at the house.
Because all of these people can make a difference
in your lives.
And maybe someday, if you ever do another podcast,
I have stories of where a taxi cab driver changed my life,
where a doorman in New York City had significant influence
on what I did in biotech, et cetera.
And I'm telling you, people around you,
always be nice to them
because you never know when you need them, okay?
That's an incredible point.
So on that note, thank you again, folks, okay?
And have a good day, all right?
Thank you so much, Suku.
Great to see you, Suku.
Have a great day. Bye-bye.
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The Emerging Biotech Leader
an SSI Strategy Podcast.
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