Latest / The BioHub - by Avetix / Episode 248- Marshall Fordyce - Founder & CEO of Vera Therapeutics

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Episode 248- Marshall Fordyce - Founder & CEO of Vera Therapeutics · The BioHub - by Avetix

• 0:06
  So welcome to another episode of the Bio Hub and Avetics podcast.
• 0:11
  Today, I'm joined by Doctor Marshall Fordice, founder and
• 0:15
  CEO of Vera Therapeutics. Marshall began his career as a
• 0:18
  physician before moving into drug development at Gilead,
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  where he contributed to multiple FDA approvals and later founded
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  Vera with the ambition of transforming treatment for
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  serious autoimmune diseases. Today, he's leading the company
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  for a major transition as Vera grows rapidly and prepares to
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  commercialize its own medicines. In this conversation, we discuss
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  his journey from medicine to biotech, building a genuinely
• 0:42
  patient centric culture, the values that guide Vera, and what
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  it takes to scale a biotech from its next phase.
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  Marshall, it's a pleasure to have you.
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  How are you? Doing great.
• 0:53
  Thanks Max. I'm looking forward to the
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  conversation with you. Absolutely, absolutely.
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  I I want to start right at the beginning of your career as a
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  physician before moving into drug development at Gilead and
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  then eventually founding Vera. What inspired that journey and
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  when did you realize you wanted to build a company yourself?
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  Well, it all begins with medicine for me.
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  I think it's a fantastic profession.
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  You get to swear the Hippocratic Oath and commit your working
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  life to taking care of patients. And that's a profound calling
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  for anyone in medicine. And that's really what I did
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  before I applied to medical school as an undergraduate.
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  And yeah, that's the root of everything.
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  And, and now, now that we have a new medicine for autoimmune
• 1:46
  disease that patients are taking and benefiting from, it's, it's
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  an incredible journey, but it all goes back to that, to that
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  route, starting with, you know, committing to patients.
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  I'm, I'm 52 and, and so the world's was a little different
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  when I was making those decisions.
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  And from a, from a, a physician's point of view, the,
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  the interest in doing something about diseases, not just in the
• 2:16
  United States, but globally with was at a peak.
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  And many of us were inspired and for me as an undergraduate,
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  inspired to do something about major global infectious diseases
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  that includes malaria, tuberculosis, and importantly,
• 2:33
  HIV. And so I'm one of those
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  physicians inspired to do something about that.
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  And, you know, HIV taught the world a lot about itself and
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  science and medicine and society, and I was interested in
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  all of that. So that kind of defined my
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  career mostly. And why I'm here today is that
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  one of the biggest things that changed the the lives of
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  patients infected with HIV, what were new medicines, medicines
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  that worked, that prevented death and disability death from
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  AIDS, which I saw many times over in my career as a
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  physician. And then it and how how
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  medicines improved from the beginning.
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  So I really as a physician was defined by how a product, a new
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  medicine could change outcomes for patients.
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  So that's kind of the way to think about my journey from,
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  from a physician to being an entrepreneur and now building a
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  company around a new approach to treating autoimmune disease.
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  So it's one way to say that is the power of a product.
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  And in, in HIV, when I moved from my medical life, I went to
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  medical school at Harvard and then trained in internal
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  medicine and infectious disease in New York City at NYU and
• 4:00
  Columbia, respectively. Was then in the laboratory as a
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  translational scholar at Rockefeller working on acute and
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  early HIV and started to work on, on a, on a drug development
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  program. And I thought this is
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  fascinating. I, I, I want to go work for a
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  company out in California that makes 1 pill once a day for HIV.
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  So it was really that power of a product and, and here we are
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  Vera, and you can hold the product in your hand now.
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  It, it's incredible. I, I, I have so much gratitude
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  and respect for the team that I was able to pull together to, to
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  make this product that was initially A tachycept and now
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  marketed since July 7th of this year as Trutacna.
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  It's an auto injector. Patients can take it at home
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  and, and eight seconds a week. They now get the potential
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  benefit and, and, and from it from a transformative medicine.
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  So that's a bit the the journey there many elements of that Max,
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  many things that inspired me along the way, but that's that's
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  the short of it. I love that you when you talk,
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  you can, you can hear the passion in what you do as well.
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  You know what, where you've come from and what you've got to a
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  big part of that passion. Obviously become, like you said,
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  is, is the patient centric side. But but then obviously passing
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  that on as ACEO to the rest of the team is where the challenge
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  comes, right? Like this is what we're doing it
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  for. This is what matters and and
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  also people say they're patient centric and talk the talk, but
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  don't necessarily walk the walk for you guys.
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  What what is it? What does it mean actually
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  genuinely being patriot centric in practice compared to, you
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  know, just saying it out loud? Yeah.
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  Well, first leaving academic medicine and working at a a
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  larger company, in my case Gilead, I missed teaching.
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  I miss teaching Med students and residents.
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  And the way to replace that is to be a good resource for the
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  the non MD's, the non clinical colleagues that you've got in
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  regulatory project management, all, all across the board and
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  sharing the meaning of the work. So I was passionate about that
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  before starting Vera and being the CEO.
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  I just think it's we all want meaning in our work.
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  So that's kind of been a core drive and, and kind of stitching
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  that into the company over the last 10 years.
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  We've done that in so many ways. And I agree it's, it's, it's
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  important at at least companies say they do it.
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  That's good. But then how do you do it?
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  Is, is, is also pretty important, I'd say in a few
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  ways. One is, is choosing the, the
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  disease, the mechanism, the, the therapeutic approach.
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  You really have to think about the patient if you want to end
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  up where, where we are today, which is we think Trutacna is a
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  huge step forward for patients because we understand their,
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  their situation. So the big idea Vera was that
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  autoimmune diseases are, are a massive problem, like oncology,
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  like like cancer, like like infectious disease, autoimmune
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  disease as a category is huge and the standard of care for
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  patients with autoimmune disease is inadequate.
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  And, and that's a patient centric view.
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  You have to listen to patients if you want to hear that
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  steroids, their side effects immediately and their side
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  effects long term or acute and chronic side effects of steroids
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  are actually a really big issue. And, and, and we need better
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  treatment and we should look to our understanding of immunology
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  to, to come up with better solution.
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  So that in itself is a patient, patient centric, a pursuit.
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  The clinician in me knows for real the side effects of
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  steroids because I've seen it many, many times in my patients
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  and the entrepreneur in me says, I'm sure we can do better.
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  So that, that's kind of the the root of it.
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  More recently we've we've stitched it in even even before
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  we worked on IGA nephropathy, the autoimmune kidney disease
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  where we're first indicated for, for Trutacna.
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  I'd have patients come and speak to the company.
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  We worked on sickle cell disease in the early days and and I had
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  a sickle cell patient or the, the parents of a sickle cell
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  patient come speak with our lab group in the early days of the
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  company. So I think, you know, providing
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  that perspective and that meaning is, is motivating and
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  and clarifying for for the work, whether you're preclinical in a
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  dish and an animals or you're already in clinical trials.
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  More recently, I I've been visiting the we have close
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  relationship with patient advocacy in the IGA nephropathy
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  space. The Igan Foundation holds an
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  annual summer meeting and I go every year.
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  I think I'm the only biotech CEO to show up and and listen to
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  patients and spend time sort of like, you know, is that worth
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  the CE OS time? We believe that's true.
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  Like sitting down and having an, you know, a sometimes seemingly
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  awkward conversation. Oh, like you're a patient.
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  Great. Who are you?
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  I'm I'm the CEO of a company making new medicine.
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  Oh, how does that help? What, how do I get access?
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  These are these are like uncomfortable sometimes type of
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  confrontation, but I think we should have the courage to to
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  put ourselves right in front of the patient and hold ourselves
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  accountable as as a business another way.
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  And I know I'm going on and on, Max, but I'm passionate about
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  this. Well, we'll meet first.
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  So this was like the one thing you wanted to talk about in the
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  podcast, right? So.
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  So go ahead, let's do it. Dive into it.
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  You know, and this is a little technical, but we're, we're, we
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  are running a large phase three trial.
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  We have 428 patients. They're patient volunteers and
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  they're randomized 1 to one between trutacna and placebo.
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  Placebo also means they're getting standard of care.
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  But turns out standard of care isn't great.
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  And we know from our trial that those patients are losing 5 to
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  10% of their kidney function every year.
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  So a 40 year old over the period of two years could lose 10 to
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  20% of their kidney function. That's a big deal, especially
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  when they start with only half their kidney function.
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  They, that's a, that's a lot of loss.
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  And so we've been really attentive and one thing we did
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  this year is we really advocated to FDA to take an early look and
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  not wait for all the patients on placebo to have a lot of decline
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  in their kidney function. And we got agreement and we just
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  did the analysis and we showed that Trutacna really helps these
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  patients. And we we've switched every one
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  of our patient volunteers from placebo to to true TACNA.
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  So we got the data we wanted. It's it's a fantastic effect
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  size. And we looked after patients by
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  giving them access to something that already the evidence is,
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  is, is pretty strong that this looks like it's going to help.
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  So you know, this is important from a put make yourself
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  accountable to the patients from front of you, inspire your team
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  and also, you know, look after your patient volunteers in
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  trial. So those are are pretty patient
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  centric things that we do. I think you said a really
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  important part in the middle of that answer as well in the fact
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  that you said the entrepreneur in you wanted to make those
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  medicines better for that patient.
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  I think sometimes people think there's a conflict between this
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  entrepreneurial ship and being patient centric when you worded
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  it perfectly like that, that there's not.
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  But then also like during your career, you've seen a bunch of
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  successful drug approvals. You now built Vera from the
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  ground up. Generally, what mentality do you
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  think biotech leaders need to succeed in the space?
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  That's a good broad question. I guess I would just say, you
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  know, you do need to be, need to have the, the, the mission in
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  mind and the right objectives and, and keep your values close.
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  And those are, you know, maybe, maybe really basic, but I, I
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  really believe that excellence comes from doing the, the
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  fundamental things very well. And I think that's how we've
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  gotten here. It hasn't been without its
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  twists and turns. There's certainly been no
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  straight line ups and downs. And but I, I, I do like to break
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  down our industry into pretty simple terms.
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  The problem we're trying to solve is a medical problem.
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  Dissatisfaction with how we treat autoimmune disease,
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  dissatisfaction with patients dying of HIV.
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  Why don't we have a better treatment armamentarium for
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  neurodegenerative diseases like Huntington's, Alzheimer's, ALS.
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  You know, these are that dissatisfaction is incredibly
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  important and frankly, it takes an enormous ecosystem, an
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  international one to invest in basic research, clinical
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  research and and then getting it to patients who who need, I
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  think having that broad mentality of our role within
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  biotech. I think there's some interesting
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  comments to make. One is that, you know, so the
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  medical, the medical part is the problem.
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  The solution is science and you really need to believe and and
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  not you know, you need to use the power of science and it and
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  it's evidence to direct to direct that solution.
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  So you need a disease with a really well characterized
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  understanding. How does this disease happen?
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  We're lucky in IGA nephropathy because we have a good sense of
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  the path of Physiology. There's a four hit hypothesis.
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  We relied on it and we targeted the source of that, of that
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  cascade and everything downstream resolved.
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  And we haven't been so lucky in another challenging diseases.
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  So relying on the science, the basic understanding of what
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  drives the disease, but that's just the beginning.
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  There's so much to science. What does the molecule look
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  like? What is the, what is the PK look
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  like? And how do you get the right
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  therapeutic window? Are you going to run a phase two
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  trial that that tries to determine that that, that
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  therapeutic window? All of those things are, are
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  driven by science. And I think in, in this
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  industry, sometimes we get really excited about cool
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  cartoons of, of molecules and, and then we add money and hope
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  it all works. And I think that's sometimes an
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  important thing to, to pause and look at and say, well, actually,
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  you know, science is applied across the spectrum from what is
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  what, what disease are you are, are you targeting?
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  What's our understanding? What mechanism do you think you
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  can hit? You know, what is, what does
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  that data look like? What does it look like in a dish
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  versus in animals versus healthy volunteers versus patients with
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  the disease? It there actually some pretty
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  big differences across that spectrum.
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  What do you trust? And then, and then all the
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  science that goes into making a product and, and the clinical
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  science, all of those things have been important.
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  So problem medical solution scientific.
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  And then and and then really how do you do that as business?
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  And, and I, and I think, look, I'm a, I'm, I'm a founder and
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  CEO. We've, you know, had some
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  success over 10 years. I don't have an MBA, thank
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  goodness. I've got good business trained
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  people around me who, who've been enabling that.
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  But I will say that, you know, business is about people first,
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  and it's also about money. And you have to understand both
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  of those things, organizing resources, people and money and
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  time and space to enable the translation of of science to
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  serve medicine. I mean, that's how I would
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  formulate this. And you have to take all of that
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  seriously. You, you can't be a biotech CEO
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  and, and not recognize that no cash, no company, you know, like
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  without cash, you don't operate. And they're, they're only a few
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  ways to bring cash in. And the major one for biotech is
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  your stock price. If you're a public company or,
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  you know, major one is equity, whether you're private or
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  public. So, you know, thinking through
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  that is, is really important as well.
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  And, and, and you got to be disciplined on on that journey.
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  Yeah, it's like no other industry, right?
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  You know, I tried to explain it to to people who aren't in it
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  and it's like, how do I explain it?
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  It's like, OK, at the top side of cutting edge science, like
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  being super innovative, but this is entrepreneurial side to it as
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  well. And it's like you meet both
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  those things and it's one of the most fascinating industries in
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  the market. But also, it's just like being
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  sat on a roller coaster the whole time, right?
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  You know? I got to tell you it's the best
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  industry in the world and, and it is because our mission is so
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  important. They're easier ways to make
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  money. If that's what you want to do,
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  do it another way. So, so 2 great things.
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  The mission is amazing to improve medicine is amazing.
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  People used to die of HIV, they used to die of, you know, liver
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  failure and Hep C. These kids used to die of, you
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  know, leukemias. Children like those things don't
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  happen anymore because of what we do.
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  Not just industry, but, but invest in, in biomedical
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  research mostly through federal funding.
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  And I really think you, you can't lose sight of that.
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  And that's true even with my hardest core investors, They
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  would, they would share that every once in a while people
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  belly ache and say, oh man, it's such a tough industry, But you
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  know, mission's important. The second is science.
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  You know, the benefit of science and, and you can use that to
• 18:45
  varying degrees. And I think relying on science
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  and thank goodness, you know, other industries that don't rely
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  on science are much more vulnerable to the vagaries of
• 18:56
  people playing with the truth. Now people play with the truth
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  and every everywhere, it turns out.
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  But but I think, you know, having science as a tool
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  internally, externally, driving business decisions, getting, you
• 19:10
  know, navigating through little knotholes, threading the needle.
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  We've done that over and over and over again.
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  And thank God for science. I really don't think we should
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  take a step back on that. And then the tough part my, my
• 19:23
  way of describing this Max to, to other people is imagine
• 19:27
  you're, you're, you're starting a business selling brownies, but
• 19:31
  you know, you got to buy all the ingredients and make your
• 19:34
  brownie. But, but in biotech, before you
• 19:39
  sell your first brownie, you have to, you know, it's going to
• 19:43
  take 10 years and $2 billion. Yeah, yeah, right.
• 19:47
  Like before you sell your first brownie.
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  So that's a, that's a tough one to, to help help people wrap
• 19:54
  their minds around. So it's, yeah, it's high risk.
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  It's definitely high risk, but there are a lot of ways that you
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  can minimize it. And look, you know, there there
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  been. What 4050 drugs approved this
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  year? Some of them are incremental,
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  some of them are a huge step forward for patients and
• 20:11
  patients lives are improved and you got to love that to to get
• 20:15
  into the business. Yeah, I think it's an amazing
• 20:18
  industry. There's also the part where, you
• 20:20
  know, you in other industries, you talk about competitors and
• 20:23
  yes, you sort of have competitors, but if they have
• 20:26
  good data, that's ultimately good news for you and like
• 20:29
  ultimately good news for patients.
• 20:31
  And like you're all working as one team as an industry, right?
• 20:37
  Yeah, I mean, it's amazing in so many ways.
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  I, I could talk about this mindset and, and your mentality
• 20:43
  all day, but I also want to give you the chance to talk about
• 20:45
  fairer, like what's going on with you guys, what's exciting,
• 20:51
  all of that. Yeah, so there is in San
• 20:57
  Francisco we're about 400 employees, but half of us are
• 21:03
  distributed across the United States.
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  We got our first product True Tacna approved in July.
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  So we're, we're just about 1/4 in about 3 months into our
• 21:16
  commercial launch in the United States.
• 21:19
  We have an awesome commercial team that's been out there.
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  So what's happening here is we're going through a, you know,
• 21:25
  important transition from a mostly development focused
• 21:29
  biotech company to one that's commercializing in the US and
• 21:34
  that's where the majority of the value is.
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  We've been able to retain that value for for Vera for all of
• 21:40
  its stakeholders and shareholders and that's been
• 21:45
  that's been exciting. So preparing for that moment of
• 21:48
  feeling ready in July of being ready, seeing early success,
• 21:54
  that's what's happening here. And and then expanding that
• 21:59
  opportunity, what what happens next?
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  Where is, you know, how does the pipeline, how's the opportunity
• 22:06
  expand? That's where we're focused.
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  But already, you know, having a drug approved minimizes a lot of
• 22:15
  of the risk that occurs in this business.
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  We're we're now launching Trutacna and and offering that
• 22:24
  to patients with IG nephropathy. And we've got final data is
• 22:30
  something that doesn't happen often, but we got approved on a
• 22:32
  surrogate endpoint of protein area reduction at nine months.
• 22:36
  But the team as I mentioned already agreed with FDA to to
• 22:40
  look at the final data. We're going to be able to show
• 22:43
  that data at the major kidney meeting of the year, which comes
• 22:47
  later this month in Denver, Co called ASN American Side
• 22:51
  Nephrology. And we hope to share that data
• 22:54
  both in presentation and hopefully publication form at
• 22:57
  the same time. That's a big kind of, that's
• 22:59
  sort of the Super Bowl for us as we get into the annual cycle of,
• 23:03
  of our of the physicians we hope to, to serve and give them a new
• 23:07
  tool. I think we talked about
• 23:09
  patients, but especially as a doc myself, I think giving
• 23:13
  physicians a tool that really can help their patients is one
• 23:17
  of the great satisfactions that we're all feeling in the company
• 23:20
  right now. And so that's a big deal.
• 23:22
  That's where we're focused and show them, you know that, you
• 23:26
  know, at the end of this study, we've now shown that there is
• 23:31
  not just a reduction proteinuria, but we can stop
• 23:35
  kidney function decline. And there's even some evidence
• 23:38
  that that patients might avoid dialysis on trutacna versus
• 23:43
  standard of care. And that's, that's a big, big
• 23:46
  idea that the data seem to support, will present that to
• 23:50
  FDA and will be aiming to get that into the label the middle
• 23:57
  of next year. And, and really continue to
• 23:59
  build the evidence of the benefits and, and continue to
• 24:03
  update the potential risks in, in, in how we're presenting this
• 24:08
  product to the market. So pretty amazing, amazing
• 24:12
  moment for us. A lot to, to look back on and be
• 24:15
  proud of and, and be grateful for.
• 24:17
  But also, you know the, the mantra within the within the
• 24:21
  company now is get Trutacna to the patients who who could
• 24:25
  benefit. That's, that's the rallying
• 24:28
  call. And that's true for the
• 24:30
  Salesforce, it's true for our medical science liaisons, true
• 24:34
  for all of us to communicate. When you have an opportunity to
• 24:38
  create a category of medicine, a new category that's truly
• 24:41
  differentiated from standard of care, we all feel responsibility
• 24:46
  to do that well. So that's what commercialization
• 24:51
  means to us. It's a continuation of the
• 24:53
  mission. We do that in close conjunction
• 24:57
  with regulators. We think that's really important
• 24:59
  to get right and in a compliant way.
• 25:03
  But you know there's and as you, as you mentioned by not being
• 25:08
  alone, by having others who are creating this category with us,
• 25:12
  we have a much better shot at changing standard of care.
• 25:15
  So we're excited about all of that right now.
• 25:18
  Yeah, I'm super excited for you guys.
• 25:20
  Like you said earlier as well, sort of 10 years in the making
• 25:24
  to get to this point, So love that.
• 25:27
  And still standing on the shoulders of giants, you know,
• 25:30
  like, and I do, I'd love to come back to this concept that we
• 25:34
  have the benefit of, of having a good understanding of how IGA
• 25:39
  nephropathy works, the pathophysiology.
• 25:41
  And we can't take that for granted, particularly in today's
• 25:45
  environment where, you know, biomedical research as, as
• 25:50
  supported by the US, the federal government is, you know, looking
• 25:54
  shakier than it used to. It has to be stronger so that we
• 25:58
  can make this kind of progress in other disease areas.
• 26:02
  Yeah, yeah, definitely. And look, that brings me to my
• 26:07
  final question, Marshall, which I ask every one of my guests.
• 26:11
  If you could have dinner with any scientist or innovator, past
• 26:14
  or present, who would it be and why?
• 26:16
  I love that question. Yeah, it sounds like a common
• 26:22
  question, but you got to do some thinking about it For, for, for
• 26:26
  me, especially the way you ask it.
• 26:29
  Scientist, innovator, dinner. It's got to be a good time.
• 26:33
  So it's Ben Franklin for sure. So, you know, Benjamin Franklin,
• 26:37
  what an amazing mind. What an innovator, a scientific
• 26:41
  mind, but also someone you actually want to have dinner
• 26:44
  with. Yeah, he's a funny guy.
• 26:48
  So I think that that would be fun.
• 26:51
  You know, I might have one. You know more than one glass of
• 26:53
  wine at that dinner and have a laugh.
• 26:56
  Yeah, I like it when people take that question really literally.
• 27:00
  It's like, well, I'm having dinner with them, right?
• 27:02
  I wanna have a good time. Yeah.
• 27:05
  Thank you so much for coming on, Marshall.
• 27:07
  It's been an absolute pleasure. Awesome.
• 27:10
  Thanks so much for your interest, Max, and thanks for,
• 27:12
  you know, elevating the voice of of the industry and we're doing
• 27:16
  something really important here and I appreciate your work.
• 27:18
  No, absolutely. Thank you so much and please
• 27:21
  everyone like and subscribe to the Bio Hub and and thank you so
• 27:24
  much again, Marshall. Thanks Max.