00:01hi everyone welcome to the a 6nz podcast
00:04I am sonal so today we have another one
00:06of our special episodes with more
00:07special guests that was recorded during
00:09the recent JPM healthcare conference in
00:12San Francisco the topic is all about
00:14diagnosing and treating cancer in pets
00:16to humans but we also go into other
00:18topics relevant to all kinds of
00:20healthcare and tech startup founders
00:22from data network effects to real-world
00:24evidence and science to clinical trials
00:26to how to think about product and
00:28roadmap when building a bio company so
00:30first our special guest is Amy Abernethy
00:32who has been named the new principal
00:35deputy commissioner of the FDA the US
00:37Food and Drug Administration pending
00:39ethics clearance she is currently the
00:41chief medical and chief scientific
00:42officer at Flatiron Health and we also
00:45have christina lopez CEO and co-founder
00:47of one health which provides dogs access
00:50to the latest cancer treatments and in
00:52doing so contributes data to developing
00:54better future therapies for humans she's
00:57the first voice you'll hear and finally
00:59we have a six in c general partner Jorge
01:01Conde of the bio Fund who will be
01:03moderating this episode which ends with
01:06the question of what does it take to
01:07build bio companies but begins with the
01:09question about why cancer in dogs and
01:12the link to humans you know dogs come
01:15from wolves they co-evolved with us
01:17right and similar to other animals they
01:21are predisposed to cancer as we are very
01:24similar the idea there is certain
01:27litters I got bred sadly got bred with
01:30their beauty and you know all sorts of
01:32great things and sadly cancer also which
01:36is a disease of genetic origin a
01:39mutation moreover the epigenetic factors
01:42the dogs as they shifted from safe farm
01:45animals to your home they're also
01:48sharing often they eat the same food you
01:50do or eat the scraps of what you eat
01:52obviously they don't smoke but they're
01:55exposed to second-hand smoking they
01:58don't drink alcohol so that one we can
01:59take off the table but there's a lot of
02:01the environmental factors and then if
02:04you factor in things like they're lower
02:05to the ground there near golf courses
02:07right there's a plethora and that's a
02:09more complicated I would have never
02:11thought of that yeah yeah that's that
02:13there's actually studies about that
02:15certain breeds near golf courses have
02:17had actually bladder cancer transitional
02:20cell carcinoma is its action area of
02:22study so it's it's actually a very
02:24compact way to look at you know a
02:27snapshot of disease and health hopefully
02:30also with those who give us their best
02:32right has the dog genome been sequenced
02:36so the the genome of the dog was
02:39sequenced but very recently I believe it
02:41was you know 2010 2005 it's very recent
02:46veterinary medicine has not had the
02:48resources and even from the NIH level
02:51what the mouse has been very well
02:53characterized and studied the dog really
02:55hasn't so for me as a founder I see a
02:57massive disconnect between the
02:59importance of the dog the growing
03:01importance of the dog in our lives as a
03:04source of love and then the lack of
03:06funding yet the families as you rightly
03:09put our spending in its cash and its out
03:12of pocket and it's expensive so let's
03:14talk about that six million cases a year
03:17diagnosed cancer in the United States in
03:20dogs how do they get diagnosed and how
03:23do they get treated today so the
03:25diagnosis is a hysto path so that's
03:28basically it stops there they say that
03:30to reduce histopathology that means
03:33you've gone to your vet and you yes
03:36suspect that your dog has cancer bumps
03:38the dogs will start lethargy doesn't
03:40want to eat is a big thing this I hear a
03:43lot is my dog has come to the door every
03:45day and over the last week not once that
03:49that's a that's you know radical change
03:52of the behavior and from the data side
03:54what we're very interested in also is
03:56capturing the data from the families who
03:59this their studies also who will neglect
04:02themselves you know if you ask them to
04:04take diabetes medicine they don't take
04:06it they don't give you any feedback but
04:07will be copiously observing the dog and
04:11will give you huge like annotated
04:13reports of like you know fluffy didn't
04:16eat you know she loves this type of food
04:19she usually you know runs to me at the
04:23all the little activities are not
04:25happening so that that's a big that
04:27change of behavior is a big one and and
04:30actually what we can capture there as
04:32disease progresses in real-world
04:34evidence is really fabulous so Amy
04:36you've been a longtime adviser to one
04:38health what is the link between dog
04:41cancer and human cancer well you know
04:43it's really interesting so first of all
04:45I'm not a melanoma doctor by background
04:48so I was a human oncologist definitely
04:50not a veterinary oncologist dogs get
04:52melanoma dogs get melanoma
04:54they certainly do and to be honest
04:57before about five years ago I didn't
04:58know that at all my interest in dogs and
05:01sort of veterinary oncology came as I
05:03started to understand the link between
05:05veterinary oncology and human oncology
05:07and how understanding better and being
05:10better able to take care of pets could
05:12also help us understand and be better
05:14taken care of humans and vice versa so
05:16what is that link what is the link
05:18between dog and human oncology so when
05:22you know Christine was talking about all
05:24of the different aspects that are
05:27contributors to a dog developing cancer
05:30and some of those are genetic and
05:31genomic aspects the fact that there's a
05:34lot of inbreeding some of them are
05:36exposure issues so the fact that there's
05:37secondary smoke inhalation of the dog or
05:39exposure to pesticides so as we think
05:42about the biologic pathways that
05:46ultimately lead to the development of a
05:48cancer which is essentially cell
05:50division gone awry those pathways are
05:53very similar between the dog and the
05:56human and further not only are some of
05:58those pathways similar actually at the
06:01biologic level within the context of the
06:03cell there's a pathways are very similar
06:05is that more similar say dog in human
06:08versus mouse and human or or primate in
06:12humans is there is there a reason why
06:13dog is it is a good model so so there's
06:16much more conserved biology between dog
06:18and human and then mouse and human and
06:20as a matter of fact this now becomes a
06:22better model to think about for example
06:25exposure to a anti-cancer drug and how
06:30that tumor is going to now melt in
06:33response to that drug or not and so
06:35ultimately if we think about
06:37human oncology informing veterinary
06:39oncology or vice versa it is a better
06:42model system to look at the
06:45interrelationship between drugs and
06:46whether or not the tumor is going to go
06:50so this is I mean this is for me this is
06:52not common knowledge that there's such a
06:54tight link what was the aha moment for
06:56you that made you connect those dots I
06:58sit on a component of the National
07:02Academy medicine sometimes called the
07:03Institute of Medicine there's something
07:05called the National cancer Policy Forum
07:06and a couple of years ago we had a
07:09meeting on the conserve biology between
07:14animals and humans and specifically dogs
07:17and humans and for me personally the aha
07:21moment was I was sitting in this
07:23conference which frankly I was against
07:25having in the beginning because it
07:27seemed like it was extraneous and I'm
07:29sitting there and the fact that if we
07:33could better understand how drugs
07:34perform and their impact on the tumor in
07:38dogs we could accelerate our
07:40understanding in humans was a huge aha
07:43moment for me do we test human drugs in
07:45dogs as part of the approval process not
07:48standard also it's not necessarily
07:50standard of care their message that
07:53really I walked away from that
07:55conference with was that if we now
07:58embedded into the drug development
08:00process for human drug development a
08:03better understanding of how those drugs
08:06performed in dogs we could save many
08:09tens of millions of dollars in the
08:11development of each drug just by having
08:13better gonogo decisions because we know
08:15how those drugs are working and
08:16importantly this is not just about
08:19testing in dogs where dogs are
08:21essentially you know test models but we
08:24don't care but this is because we
08:26actually can also understand do these
08:28drugs help take care of pets and can we
08:31ultimately treat veterinarian cancers in
08:34the same way we can better treat human
08:35cancers yeah so full circle so something
08:38to that's really come up for us is both
08:40from the genomic side but also
08:41immunological II dogs that have natural
08:44disease spontaneous disease have an
08:46immune system also that's working and
08:49that's a radical difference
08:51mice models that are much more
08:54engineered and sometimes don't have an
08:56immune system to have the cancer and
08:58then the ones that they really try to
08:59figure out to you know have immune
09:01system and cancer last 20 days so it's a
09:04incredible challenge in in your
09:06neurology so the mouse model is an
09:08engineered model to actually create to
09:10force the the essentially the the
09:13appearance of the disease yep and dogs
09:15dogs very natural spontaneous exactly
09:19our analysis the human version exactly
09:21well of course it's a different species
09:23than human it is indeed much closer to
09:26the human than the mouse is and you know
09:28in the case of primates that first of
09:30all I think the regulatory framework is
09:32you know not super becoming on that
09:34department but also they're used more
09:37from a toxicology angle so you really
09:39don't have in certain circumstances
09:41especially as the science gets very
09:43sophisticated a real kind of model but
09:47there is a huge proportion of dogs who
09:51get naturally-occurring cancer that
09:54natural activity or that natural biology
09:56sets up a living laboratory at scale now
09:59how do these two dogs get connected I
10:01had been at that conference and now I'm
10:03sitting in a meeting in Boston and I
10:07literally am talking to the guy sitting
10:09next to me and lunch which happens to be
10:10Ben Kristina's co-founder and he's
10:12telling me about this idea that they're
10:15gonna start to develop a company to work
10:17on dog cancer and one of the things that
10:20struck me sure there's many things but
10:22first we were talking about the role of
10:25technology and that there would be
10:28potential to develop a linked data
10:31system across dogs in the country we
10:34talked about the fact there could be dog
10:36clinical trials and that dog clinical
10:37trials could have parallels to human
10:39clinical trials and then we talked about
10:41it the fact that pet owners actually
10:43wanted this and there was endorsement
10:45from the national organizations around
10:48pets is that we almost a month later met
10:50at a roundtable about clinical trials
10:53and one of our assignments for the
10:55intimate discussion was you know like
10:57instead of just complaining about the
10:59development we was very oncology focused
11:01of drug development what is like a real
11:04solution that we could do right now and
11:07that was the assignment that was how we
11:08were gonna get dessert and I raised my
11:10hand it's probably in your house and I
11:17started discussing the row of the pet
11:19dog and the impact of cancer and luckily
11:21I had Len Lichtenfeld who's from the
11:24American Cancer Society and he was like
11:27oh my god yes I'm super devoted and you
11:32know the story of rebooting a lymphoma
11:34drug that you know the dog and the human
11:36and actually the evidence from the dog
11:38helped not just this company be alive
11:41but the drug be alive and he said how
11:43his dog had lymphoma and a friend had
11:45lymphoma and he was able to somehow
11:47interconnect and I mean he was almost in
11:49tears you know and I was like some crow
11:51I'm in the right place so Amy you
11:53obviously are at Flatiron data is very
11:56valuable I would have never thought of
11:58sort of a national or global network of
12:02dogs being driven the data they
12:04generated has been an important source
12:05of data so let me ask you I guess two
12:08questions related that to that first of
12:09all from a mechanic's standpoint how
12:11does that data get housed do dog Lia
12:14Mars exist is there such a thing as dog
12:17HIPAA is how do you actually generate
12:20and aggregate all of that data so when I
12:24was sitting there talking to Ben that
12:25day two of the other a ha moments or
12:28that he was telling me about dog
12:30electronic health records they do exist
12:32they totally exist and there's also
12:34Centers for excellence and the you know
12:37key opinion leaders in veterinary
12:38oncology they all know each other so
12:40very similar to the human oncology
12:42system and the system of managing human
12:45health electronic health records and
12:46humans and how we move science forward
12:48with key opinion leaders that all is
12:50replicated within the veterinary system
12:53except for I don't think we put it to
12:55use as well so that was the first thing
12:57that was obvious to me the second thing
12:58was that oh my goodness there's no doggy
13:00HIPAA now we have to do the right thing
13:04by pets and pet owners and we need to
13:07basically only think about using that
13:11information in a way that's that's good
13:13for society for pets and pets of owners
13:17any of the impediments as we think about
13:19data aggregation and data use that we
13:22run into in human health we don't run
13:23into in dog health the spirit of HIPAA
13:26is to protect patient privacy it's among
13:29other personal health information for
13:31people and there's any dog owner knows
13:33dogs don't worry too much about their
13:34privacy right people are so effusive
13:38about their dog stories and and their
13:40pets are you know hugely a part of the
13:43family but also something that you talk
13:45about freely in many different ways
13:46we're much more closed about our
13:49personal health information than we are
13:50about our pet health information and so
13:53you know if I now fast forward to that
13:57vision of how this might all come
14:00together it was the realization that at
14:02scale dogs were developing cancer and
14:04that scale their information was being
14:06collected in common frameworks and that
14:10if we put that together at scale then we
14:12could overlay the process of drug
14:13development and the process of learning
14:15how to take care of pets better I work
14:19at Flatiron where what we've got is a
14:21combination of electronic health record
14:23as well as the ability to curate and
14:26clean up data in order to now put that
14:28into action to learn what works for whom
14:32and when in human oncology space so I
14:35can see how that would actually come
14:37together I also sit on the board of
14:39directors of Athena health or I could
14:41see that you know not only do you apply
14:44this approach within the context of one
14:47disease but you actually now can
14:48aggregate data across electronic health
14:50record across health and start to get a
14:52almost ringside seat across healthcare
14:54and so those two pieces and that day at
14:57the meeting in Boston were in the back
15:00of my mind as I was thinking about how
15:03this might create an a national or
15:05international system to try and
15:06accelerate drug development both for
15:08dogs and humans so just touching on what
15:10Amy's talking about in terms of you know
15:13no doggy HIPAA I want to just layer on
15:15that there's you know the accelerated
15:17timeframe of disease of life of the dog
15:20right so you'll hear commonly spoken
15:23about the seven years to one and if you
15:25correlate cancer with aging the dogs
15:28after the age of even five the
15:30probability of cancer goes way up so we
15:33can see a lot in a very tight timeframe
15:37which from a data angle is very
15:38interesting we really want to transform
15:41the story from the dog getting a cancer
15:43diagnosis of a death sentence which used
15:46to be for pediatric cancer how can we
15:48get into the lymphoma journey of dogs
15:50much earlier and intervene this is a
15:54really interesting question so early
15:55diagnosis of lymphoma and dogs as
15:59possible so two things one is that
16:03having dog owners and veterinarians
16:06think of the role of one health earlier
16:09in the lymphoma journey as well as any
16:11cancer journey is not only potentially
16:14good for the management of that dog's
16:17cancer but also will ultimately
16:19contribute more meaningfully to the
16:21overall system of how we're going to
16:22figure out it better take care of dogs
16:23in the future that's the first part the
16:25second part is similar to what we know
16:27from human cancers the better we can get
16:30at early diagnosis early understanding
16:33of exactly the details and features of
16:35this particular disease both at the
16:36genetic and his histologic level but
16:38also in terms of factors that were
16:41driving it and how this person is going
16:43to perform there's similar parallels in
16:46dog cancer and as the science evolves
16:48and I mean from the human side bringing
16:51what stopped in human back to the dog at
16:54an affordable price when a dog is
16:56diagnosed with cancer are they treated
16:59is there is there chemotherapy for dogs
17:01yes there are the toolbox is probably 13
17:04therapies in total that we were talking
17:06about with Cheryl London one of our kos
17:08that's really popping canine oncology
17:11total and the chemos are quite Oh a lot
17:16of them some are not so bad but then
17:19there's an issue and I want to talk
17:20about that because it's really dear to
17:21my heart of access not everyone can get
17:25to a vet oncologist which there's only
17:28about three four hundred in the United
17:29States for you know and think about six
17:32million dogs three four hundred like old
17:33country there's only three or four
17:34hundred they don't call yes it's a
17:36specialty veterinarians are there in the
17:38couple of twenty three thousand I'm
17:39gonna say so it's a very big difference
17:41so there's a really limited scope of
17:44access to two top treatment so we want
17:47to help democratize that and as we
17:50democratize we come in earlier and are
17:52very passionate about access I've been
17:54you know on the advisory board of
17:56international Planned Parenthood for
17:58many years the whole Western Hemisphere
17:59and all I cared about was like providing
18:02access to you know precancerous vaccines
18:05HPV cervical cancer in Bolivia I always
18:08used to say I want to care for those
18:10that are voiceless and on the margin and
18:12kind of be a fighter for that with all
18:14the technology so on that note we're
18:16talking about catching disease earlier
18:18so we can have you know more successful
18:21intervention humans have cancer
18:24predisposition genes
18:25Braca probably being the most famous
18:28there's the equivalent thing exist in
18:30dogs as far as we know is there bracha
18:32for dogs um so it's a much limited right
18:35like we are working and developing this
18:37this data set one that is well let's say
18:40well known or characterized is a b-raf
18:43in TC seen transitional cell carcinoma
18:46and bladder cancer however we don't know
18:49if it's a driver mutation or not but at
18:51least we know the correlation and it's
18:5485% of dogs with transitional cell
18:57carcinoma or b-raf positive and it's
19:00v600e b-raf very particular but there
19:04are a lot of discussions and a lot to
19:05learn so help me close the loop here and
19:07you know where this conversation starts
19:08is a connection between dog health and
19:11human health Cristina you're focused on
19:13one health here to really change the way
19:16we think about managing and treating
19:18diseases and dogs one of the it struck
19:21me that you said Amy was that the dog
19:24could benefit a lot from the human but
19:27it sounds like the human can also
19:29benefit a lot from the dog so help me
19:31close that loop the two sides of the
19:32leash the two sides of the leash we've
19:34been trying to be very intentional about
19:37being able to collect information at
19:39scale that has detailed information
19:42about the dog about the dog tumor
19:45including histology and some of the
19:47genomic information and hopefully soon
19:49more immunologic information treatments
19:51and outcome and by being very
19:54intentional about the product
19:57as for example to fight a cure product
19:59which is a combination of a diagnostic
20:02and treatment starts to now become more
20:05widely available the more use of that
20:07product the more that we get wide-scale
20:09and information that's got those details
20:11about disease and outcome the reason
20:13that that's important is that the more
20:16that we can understand that interplay
20:17and dog genetics and histology of
20:20disease treatment and outcome we've got
20:22the same set of expectations and
20:24opportunities to understand that on the
20:25human side so that we can do a number of
20:29things first of all we can have very
20:31accelerated understanding of treatment
20:33and outcome that we can now start to
20:35think about on the human side whether
20:37that's in the development of new human
20:40drugs we can accelerate the treatment of
20:43dog drugs using essentially real-world
20:45evidence type mechanisms and we can
20:48start to start to think about how do we
20:50understand more genomic information and
20:53the interrelationship with treatment and
20:54and start to push that conversation
20:57forward so we have both diagnostic and
21:00therapies they're all precision
21:02therapies we're taking everything from
21:04the best that we could get our hands on
21:06from the human we have the first
21:08next-gen sequencing panel for dogs so
21:11we've been working in the genomics and
21:13this with our dog's tumor yes absolutely
21:16we've done many that we've done whole
21:17genome we've done gene expression I mean
21:20we've done every enchilada that you can
21:21think of an R panel it's the first of
21:23its kind so I'll a foundation Madison
21:26call it - foundation medicine for dogs
21:27yep and then we make up reports okay all
21:30right we're doing our real-world
21:31evidence research that's our you know
21:34scientific or indie hat really but we
21:36really want to treat and serve the
21:38community so to that end we look at
21:40actionable mutations and then what
21:43therapies are out there that we can then
21:46bring to the dog to you know target what
21:49we believe might be a driver mutation of
21:52that dog's cancer so this is precision
21:56tailor-made tailor-made based on the
21:58genetics of their camp exactly and we're
22:00also looking by like tumor type also you
22:04know where can we draw some correlations
22:06it's not as well-known as in the human
22:07but what data there is
22:10so that we can also work with perhaps
22:12even faster quicker tests and
22:15interventions that accelerate the
22:17intervention so those two you mentioned
22:20that there's the potential as we learn
22:21more about drivers of disease if we
22:24learn more about what's effective are
22:26there any limitations on how you can
22:29think about combination therapies for
22:31dogs we're seeing an explosion across
22:33oncology of the development of
22:35combinations including combinations in
22:38the Emilia Oncology space and so think
22:41about setting up this network now
22:43imagine that the dog has two potential
22:46targetable mutations and perhaps we've
22:49got early qualitative or quantitative
22:52information from veterinary oncology key
22:54opinion leaders that suggest these two
22:56drugs can come together and now we can
22:59recommend within the context of the
23:00report you may want to consider these
23:02two drugs together but here's what you
23:04want to think about in terms of dosing
23:06and watching for tox and then what that
23:09allows us to do is give the information
23:12back to the veterinarian who may not be
23:15a veterinary oncologist who can then
23:16recommend these particular treatment for
23:20this dog and this pet parent so you
23:22provide the therapy we provide the
23:24access and then we can follow what
23:25happens over time and that will then
23:27create a reinforcing data set to go
23:29along with what we know from the key
23:30opinion leader to now understand better
23:32the combination not just the individual
23:34drugs so you know we spend a lot of time
23:37thinking about data network effects and
23:39so what you're describing here is sort
23:41of a canonical data network effect that
23:44the more dogs you treat in more
23:45combinations results in better
23:47information to treat more dogs with
23:49better combinations and so on and so
23:51forth so the product gets in
23:52continuously better is there an
23:53ancillary data network effect that
23:55actually accretes back to the human side
23:57is there anything we can learn about
23:59combination therapy that might be
24:01translatable back to how we think about
24:02treating human cancer I think about it
24:04in a couple of different ways but the
24:06first is that as all of those sites are
24:10networked together essentially the
24:11datasets are networked together the
24:13first thing we can do is start to
24:14understand how combinations potentially
24:18are synergistic or those combinations
24:21may actually be harmful in combination
24:24understand not better within the context
24:26of dogs the second is that Network
24:28doesn't just have to now be referential
24:30to drugs that are already currently
24:33available and are sort of passively
24:35given within the network we can start to
24:37get intentional and start to look more
24:38like clinical trials because we've set
24:40that Network up to now be ready for more
24:42clinical trials like model yeah what
24:44spiritual clinic it's a virtual clinical
24:46trial of really consent in place and
24:48that sets us up to be able to study the
24:51combinations that we'd like to be ready
24:53to do in humans but we're not ready to
24:55do it quite yet because we don't have
24:56enough data historically we'd only do it
24:59in mouse models but now we can pressure
25:01test that in a dog based model with
25:04appropriate permissions in place from
25:06from the pet parents and then be able to
25:08translate that very quickly to the human
25:10space is this a flatiron for dogs this
25:12is flattering for dogs we've already
25:15begun to do that both in the traditional
25:17more R&D setting with clinical trial
25:20sites but then also now you know
25:23thinking from a flatiron of real-world
25:25evidence and the longitudinal data with
25:27the outcomes but can I make a comment
25:29about product development as it relates
25:30to this you know when I first started
25:32talking that day my mind was already on
25:35the clinical trial side and if you go
25:36back and you sort of think about this
25:38sequentially in terms of a startup and
25:41sequential product development and being
25:44able to think through what are the
25:45things we have to have in place first
25:47right so being able to have a product
25:51that veterinarians today can understand
25:53and see is valuable and so can pet
25:55parents seem like that's a pretty
25:57critical step one being able to think
25:59about what are the unique data points
26:02that we're going to need to have
26:04routinely embedded in the system to be
26:06able to now make that clinical trials
26:08model move faster is step to being able
26:11to be you know confident about what
26:13drugs to give and how to give advice to
26:15veterinarians across the country it is a
26:17critical step in this I think that's
26:18probably something Emery or maybe step
26:21one point be and then another thing that
26:24we have to get right somewhere in this
26:25process as endpoints so we have to be
26:28able to be confident that this is how we
26:30know that the cancer is getting better
26:31whether or not the dogs passed away
26:33because of the cancer toxicity etc so as
26:37we've been trying to set up the clinical
26:38how's model we've actually gone back to
26:40the building of the network and building
26:42in the data model to ready all of those
26:44things because of that stuff's in place
26:46then the clinical trials model just
26:48flows really easily that's extraordinary
26:50right because that you have there are
26:51really two products here that are of
26:53course interlinked but product one is
26:55the benefit to the dog the treatment of
26:58the dog and product two is the data that
27:00gets generated with the experiment over
27:02over time with the experience that all
27:04of the animals that go through the
27:06network and that's very similar to what
27:08we saw flatter so we saw flutters you've
27:09got to make sure that you take care of
27:12oncologists and patients first and have
27:14a mechanism to bring the data in and
27:16then you can get the data ready to have
27:18secondary purposes but if you have that
27:20out of order you're actually you're
27:24never gonna get things yeah well you
27:26know in marketplaces there's the the
27:27same that the folks use which is come
27:29for the tools and stay for the network
27:31it's such an element of that that um so
27:34let's talk a little bit about the
27:35company building so you know you're
27:38going you're going through what is going
27:40to be an incredibly ambitious you know
27:43product development roadmap a very
27:45important one given the the sort of the
27:47problem as you've laid it out and the
27:48challenges we've laid them out how do
27:50you build a company in that context
27:52number one you have to be you know kind
27:54of courageous and wanna take risk
27:56because it's not you're building the the
28:00train and the tracks almost at once for
28:03us we've surrounded ourselves with folks
28:05who can help us right because the idea
28:07is you you're gonna make mistakes but
28:09you wanna lessen the mistakes you make
28:11and that zero to one is a very very
28:14particular world mm-hmm
28:16I don't know if there's a resume for
28:18that so what is leadership is really
28:20jumping in that fire and that challenge
28:22but being Prudential you have to a bit
28:24work on your vision not just like a
28:27stair you know where there's not
28:28established set of rules so you're going
28:31along and you have to be very in it
28:33paying attention to the details and
28:35almost at the same time with like a big
28:38canvas view so what advice would you
28:41give the founders in terms of you know
28:43sort of pitfalls to avoid or mistakes to
28:45make so you know some of it is what
28:48Christina brought out in terms of you
28:50need to be able to telescope out
28:52but also then get back into the weeds I
28:54think there are a couple of critical
28:56pitfalls that that I've seen over and
28:58over again the first is create some
29:02short-term goals and be really really
29:04intentional what you're gonna do at
29:06three months and maybe three to six
29:08months six months plus is where I'd like
29:10to get to but don't spend too much of
29:13your time and hear the details of
29:15exactly what I'm going to do in six
29:16months two plus until you've got early
29:18data coming back when I say data I mean
29:20feedback from the market and you know
29:22what your investors are telling you and
29:24you know what your mother tells you
29:25about what she thinks about what it is
29:26you're doing right because that that
29:28feedback is very critical to chart your
29:30course meanwhile when you're doing
29:33something like one health is doing you
29:34need the input of key opinion leaders
29:37and especially scientific experts I'm a
29:40clinical trial is my background I've
29:41been reading outcomes resources like
29:43I've been doing large scale science for
29:46and we have to think five and eight
29:48years out so in that hat I'm gonna come
29:52at the problem and provide you my advice
29:54with an eight to ten years out hat and
29:56so as the founder trying to work within
29:59this space you have to think about how
30:01do I translate that into my three and
30:04six months you know product roadmap
30:06vision and conversation without
30:09dismissing it as unimportant right
30:11because that is really critical
30:13information but they're not those
30:15advisors who are bringing that
30:17scientific advice to you either in your
30:19company or as external advisors are not
30:21going to understand why you're not doing
30:24all the things that you have to do for
30:25that seven-year time frame because
30:27really what you've got to do is focus
30:28right now and so I think that the
30:30biggest you know pitfall that I have
30:32seen over and over again is the
30:34inability to walk that line and you
30:37either dismiss and somewhat disrespect
30:40one group or the other somewhere along
30:43the way so that's that's super helpful
30:45perspective to have given that you guys
30:47are on the ground as founders I think
30:49one of the things that I've always found
30:50in building a bio company and this is a
30:53unique one because you're outside of
30:55human health you're in dog health you're
30:57there's going to be a consumer aspect to
30:58this but one of the biggest challenges
31:00is figuring out how to narrow product
31:03scope given the massive mandate
31:06that you have to try to cure disease and
31:08I you know um it's inspiring to hear you
31:11go through the product roadmap in terms
31:12of what you were looking to do and I
31:13think you're absolutely doing you're
31:14doing it absolutely in the right order
31:16to say product first to the benefit of
31:18the dog and the pet parent and then you
31:21know generate the data and the data you
31:22know obviously will benefit the network
31:24over time but to me I think it's one of
31:26the biggest questions is you know you
31:28could always do more with the product
31:30you could always do better but
31:31remembering that right now what exists
31:33is so basic that had over-engineering
31:36the product I think it's one of the
31:37biggest challenges that exists in the
31:38space and finding that right balance
31:40between making something that's
31:42beneficial in this case to the pet and
31:45the pet parent recognized and that it
31:47can always be better and it always will
31:48get better and they'll always be more
31:50data you can incorporate there's always
31:51be more sophistication that you can have
31:53but not trying to sort of nail that in
31:55version 1.0 because I at a gory creation
31:57is a very difficulty so I'm very much on
31:59this boat internally folks they're like
32:02wait it's not perfect we it needs to be
32:04perfect what do you mean you know it's
32:06gonna mess up the whole data set if like
32:07that is not perfect or external more
32:10advisors or I have to see biologic
32:13activity and you have to prove it to me
32:14now you know so it's it's it's really
32:17it's it's a tough balance in to
32:19harmonize having the patients but also
32:22validating what's important over the
32:23roadmap but then what you have to do now
32:26right there is a first step to that
32:28sequence so this is music to my ears but
32:31but hard in a bio company because you're
32:34also hiring folks that are coming out of
32:36school right and they're very ambitious
32:38but very um you know maybe you know we
32:41have multidisciplinary teams so they
32:43don't all come from understanding even
32:45you know the challenge of cancer itself
32:47well actually on that one piece of
32:49advice I would give you a new hire
32:50multidisciplinary people some coming
32:52from Texas I'm coming from the
32:53veterinary world others coming from the
32:55entrepreneurial world is you know one of
32:58the big challenges you always have is
32:59that each group doesn't know what they
33:03don't know about the other group so for
33:05example Amy Abernethy is an oncologist
33:08or some credible amount that she knows
33:10about cancer someone that comes out of
33:12the tech world probably doesn't even
33:16to ask her and so one of the things that
33:18makes cross-functional teams in the bio
33:20space especially important is finding a
33:22way to develop shared languages and
33:24shared frameworks for thinking about
33:27disease especially in biology which is
33:29messy because otherwise you run the risk
33:31that people are actually talking past
33:33each other without realizing that
33:34they're talking past each other so Amy
33:36you've been named to a senior role at
33:38the US Food and Drug Administration can
33:41you tell me a little bit about the role
33:43as you see it and what do you hope to
33:45accomplish and I'd also be very
33:46interested in hearing a little bit about
33:48the journey that led you there to the
33:50FDA so this is an incredible honor as I
33:53step back and I think about the things
33:55that have motivated me for the last 20
33:58years I've been really focused on how do
34:01we get treatments to patients who need
34:05them faster and how do we have
34:07confidence and how those treatments work
34:08and also how do we make sure that the
34:11treatments are specifically effective
34:13for that person and as specific as
34:16possible I worked on this when I was in
34:18academia I then kind of hit the
34:21boundaries of what I could do from the
34:23academic side so I thought okay I'm
34:25gonna try and go and do this from the
34:28private and commercial side and so I
34:29went to Flatiron and I was on the board
34:31of Athena health and did other things
34:33including one health and have hit the
34:36boundaries of what I can do from the
34:39commercial side but I think what it also
34:42did was give me a visibility into what
34:45potentially could be done from the
34:47government and regulatory side and so
34:49for me going to the FDA was this
34:51incredible honor to be asked to do it
34:54that also lined up with this natural
34:57progression of trying to move that
34:58forward when I'm at FDA I will have a
35:02trans FDA remit so I will need to spend
35:05my time and energy working on the things
35:07that the FDA needs me to do and I'm
35:09looking forward to learning more and
35:10more about that every day but I know
35:12that I'll least spend some of my
35:14personal extra energy on three core
35:17areas one being accelerating evidence
35:19generation I can't work with one health
35:21anymore but you can sort of hopefully
35:23see how I've been thinking about
35:24evidence generation for a long time the
35:26second is as it relates to personalized
35:29has been a core focus for me for a long
35:31time as an oncologist in this just as a
35:33person and then the third is patient
35:35informed drug design extraordinary and
35:38as a citizen the United States I'm
35:40grateful that you will be in that role
35:42thank you for me - I thank you Christina
35:45thank you Amy before joining me today on
35:48the a 16z podcast thank you both thank
35:50you thank you so much
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