From Pathology to Biotech: Unlocking Impact Beyond Patient Care

Shownotes

Michelle's journey from medical school and pathology into biotech Why leaving the traditional physician path initially felt like failure Finding new ways to create an impact on patients Building a company to help physicians explore alternative careers Moving from entrepreneurship and consulting into biotech Why successful biotech requires both good science and a viable business strategy What the work of a Medical Director can look like Translating complex scientific and clinical data into meaningful decisions The importance of communication across regulatory, medical, statistical, and clinical teams Balancing objective clinical endpoints with patient-reported outcomes and quality of life Designing clinical development strategies for different patient populations and global markets Population representation and the applicability of clinical trial results Bridging trials, PK data, and alternative approaches to generating evidence The opportunities and uncertainties surrounding real-world data and real-world evidence Why registries can play an important role in clinical development Leadership, mentorship, and learning through conversations with others Why personal growth often requires deliberately becoming comfortable with being uncomfortable Dealing with rejection, uncertainty, and failure when changing careers Why believing that change is possible is often the first step toward actually creating it

Michelle closes the conversation with an optimistic idea: progress starts when people are willing to look at the way things are today and openly discuss how they could be different tomorrow.

Transkript anzeigen

00:00:00: It was really healing for me to have conversations like this with people who were considering something different.

00:00:30: but also for our audience.

00:00:32: And yeah, I would love to jump in connecting to that point specifically.

00:00:37: so if you could briefly describe to us first of all what do you do now and then afterwards we'll talk about how are you got there?

00:00:47: Great thank you!

00:00:49: That was a great introduction.

00:00:51: So let me give you little bit context on what i'm doing right now And I've worked for multiple small biotechs and medium-sized biotech over the years.

00:01:07: Prior to joining the smaller biotecs, i did a lot of consulting work in medium and large bioteches so entities.

00:01:22: And I think it gives a really interesting perspective when thinking about clinical trials and clinical research, how we can best serve patients through this work.

00:01:34: Excellent but you of course didn't start out in biotech?

00:01:38: It was the whole transition then!

00:01:40: This is a great start for our conversation here.

00:01:43: so... How did you first get interested?

00:01:47: And what was your starting point into the world of sort like following that path of yours, that passion of yours?

00:01:56: Oh wow.

00:01:57: What a fun thing to think about.

00:02:00: going back to that point!

00:02:02: So I had always wanted to be a doctor since i was in fourth grade in US and I told my father that i wanted to be a doctor and of course his response was very positive.

00:02:18: so, that helped too promote me working hard.

00:02:23: And school comes easy to me...I like school!

00:02:27: So..that also helped.

00:02:29: Um....i went straight from regular primary school to university then medical school.

00:02:38: What my goal was at the time, Was to choose a specialty where I would have The most impact on patients.

00:02:46: But i didn't really know what that meant At the time?

00:02:57: In medical school, I had a great experience.

00:03:08: So I feel very grateful for that, but i built these friendships and as we were continuing through school.

00:03:32: We got to the point of clinical rotations where each person gets to experience And while I liked them all, I couldn't figure out which one was going to be the one that i would concentrate on for the rest of my life.

00:03:56: Because this is a big commitment!

00:03:58: This is like getting married and this is what you're gonna be doing for your life...and so While I went into medical school thinking I would be a trauma surgeon..I ended up choosing pathology....and why pathology?

00:04:14: Well pathology touches every aspect of the different specialties, and so I knew i would have a chance to still have my hands literally in an anatomy um...in the different body systems.

00:04:32: And the disease states were always so fascinating to me!

00:04:36: So pathologists are called The Doctor's

00:04:38: Dr.,

00:04:41: But everyone thought that I was a little bit crazy for choosing pathology, because... ...I get along with people and-and I like people.

00:04:50: And generally pathologists work in the lab and they don't talk to anyone?

00:04:53: No no!

00:04:53: That's not always the case.

00:04:55: but um.. In general thats' the stereotype uhmm....but i chose it nonetheless and thought would write off into this sunset be a pathologist umm... ..and that is actually how things ended up going.

00:05:08: Okay so When you first described sort of like, I'm going to be a doctor for life.

00:05:13: It's...I think what for me immediately resonated as well is this very intense relationship that can have with your patients sometimes for long periods where they are really invested in becoming better and their wellbeing which i think outside us it was easy to associate.

00:05:36: doctor can or will do.

00:05:38: And it's very interesting that you may have said, okay no despite my maybe a good initial interest in interacting with humans I chose something that was much more scientific.

00:05:55: and what like?

00:05:58: the key point where this is or was it just a gut feeling?

00:06:02: Was, uh...was it a person in pathology that sort of like inspired you to take that path.

00:06:07: Or how as we said It's really difficult decision-to make.

00:06:09: How did you Make your decision To work on the more scientific piece even though You could feel for yourself but engaging with other humans?

00:06:18: what something That you liked and then enjoy doing?

00:06:22: I think that such A great question because it was Really hard And i was a really Hard time For me Because i was young.

00:06:30: when you're choosing your path for your career, typically.

00:06:34: You're in your early twenties and...you don't know that much about life and-and you don't have that much experience with life then the consequences of what things are going to lead too.

00:06:46: And so sometimes I look back and think..I just made a really crazy decision on Wim But it was not exactly like that.

00:07:00: It was more of a turbulent time where I went back and forth between what do i do, how to manage this interest in science disease state and medicine, helping people to get better.

00:07:17: Having those long-term relationships not only with patients but also your colleagues because the intellectual aspect of being a doctor is so interesting as you have such an interesting and smart colleague.

00:07:30: how do I resolve this?

00:07:33: And pick something that i can enjoy for and also have some work-life balance because I knew that i would want a family, and I ran marathons at that point.

00:07:52: So just interest in life and not let my career suck me completely dry but still get to experience joy of getting to be a doctor and doing something big picture, an important for patients.

00:08:19: Did it feel like you need to overcome also?

00:08:22: Like mental hurdle in that transitioning because I'm sure as you envisioned yourself on fourth grade being a Doctor Pathology was not on your mind right is something that informed You so long over Your career path of.

00:08:34: this Is what i think A doctor does.

00:08:36: And then Like, did that already feel like a transformation and something where you needed to early on say well I held onto this idea of what would be when i've grown up for so long.

00:08:47: Let me reshape it now even at the young stage.

00:08:51: Did It Feel Like That To You?

00:08:52: Absolutely!

00:08:53: You described it perfectly And was really hard For A Twenty-Something Year Old Who Didn't Have A Lot Of Experience Very Sheltered In Life I Hadn't Traveled very much lived in one place, had a great family.

00:09:08: Didn't have a whole lot of obstacles.

00:09:10: this was my first really big challenge that I had to figure out and it wasn't mental hurdle.

00:09:16: sometimes i forget how hard is at the time but I was different from colleagues in medical school.

00:09:24: no one could quite understand why didn't want choose on other specialties Had more of a hands-on approach to patients and a long term relationship with them because typically pathologists either work with other doctors or after the patient has died.

00:09:46: So that's what everyone thinks about when they think about it pathologist.

00:09:49: It is not quite that way, but it is a little bit.

00:09:54: When I transitioned over from science into working at a contract research organization, think it took for me around half-a year or so where still struggled with the idea of whether that was sort of like this shift because to me It also felt more radical.

00:10:09: I worked in the lab all the time and then you know basically hung up my pipette And like the Eppentorf tubes and everything and i went over to work on the laptop.

00:10:20: So this fear felt quite a change for me.

00:10:23: And I can't really describe if there was like, a certain point in which that transition.

00:10:27: but i loved what... What I was getting to do.

00:10:29: so much That eventually it's just the point where look back and said no this is the right thing!

00:10:35: ...and.. ..I know that I'm on the right path.

00:10:38: Is There A Certain Point Where You Can Connect To For Your Own Transition?

00:10:42: Where you sort of let some doubt Which I am sure still lingered after your transition behind and got to fully embrace It.

00:10:49: It took a long time for me, probably longer than it took you.

00:11:19: being a doctor, but it's just in different way.

00:11:23: But this was time before lot of social media and so is hard to know if I did the right thing or not because i didn't done things differently.

00:11:37: Maybe gone to a professional school like you, gotten a science degree and then chosen a path that was maybe considered the dark side because I also had comments your sign that says, this is where Dr.

00:12:04: Mudge Reilly practices and I would try to explain what i did and how.

00:12:11: That work was bigger than just seeing patients day after day And I got to work with doctors that were doing that Still but I was Doing things.

00:12:23: my work Was slightly different But it's still very hard To explain to others.

00:12:27: so thats part of why like these conversations because a lot of times people in professional programs are considering their own career path and thinking, I really like what i'm doing here in school.I' m good at it but don't see myself doing the traditional path that has been set before

00:12:47: me."

00:12:49: And you made your mission then also?

00:12:52: You venture out career transition, how did that come about?

00:12:57: Like what was the starting point for you to say hey this was rough on me but I think of matured enough so i can also lead other people through that process.

00:13:07: Well I definitely wasn't mature enough...I just started talking about it because It-it was really healing for me too have conversations like this with people who were considering something different and maybe they had already started down a career path in their career, but they knew that it wasn't making them happy.

00:13:31: And so there was an interest on their part in understanding themselves better and I would write articles for magazines just for free or do talks at universities as you do.

00:13:47: some of the stuff to get asked more did open up doors for people and I would have, People come in talk to me afterwards.

00:13:58: And say thank you so much.

00:13:59: You might just changed my life For Me.

00:14:04: that was wonderful To hear because it Was So hard for me doing That.

00:14:08: choosing that path originally i sort of felt like a failure when i had first started Going down that alternate Path Because who goes to medical school?

00:14:19: doesn't take care of patients, but I am taking care of patient just in a bigger way and when i was able to better understand that and communicate it.

00:14:29: That helped me with my mindset and helps other people also understand hey maybe I can do something a little different too?

00:14:36: And we need people doing different things in the world!

00:14:40: We absolutely do yeah...and so how did that grow for you?

00:14:45: because here and there, publish an article or give a presentation.

00:14:51: It's manageable but I'm sure that as your presence in the outreach grows so do some requests and opportunities more people probably innately you feel like want to help because their journey resonates with much of what they can do.

00:15:12: how did it grow?

00:15:14: Yeah, so I had a full-time job in an nonclinical area for small company and as through more of the conversations happened.

00:15:30: do that.

00:15:34: I formed an LLC and became founder, CEO of a company where i would help other physicians to better understand what their career paths might be whether they were already halfway down or fully.

00:15:53: it was applicable to young physicians, to medical school.

00:15:58: To people doing well in school...to people not doing well on school because they weren't reaching their full potential but also too full-fledged professionals who may have been double boarded in trauma surgery and pediatrics just throwing out into specialties really satisfied with how their career was going and thinking about what are alternative ways to use these skills, an experience.

00:16:26: And eventually it morphed into working medium and large biotech companies because there was so much need for physicians in those companies to speak to their experience, and bring that experience into the company as drugs were being developed.

00:16:46: That's where I first started getting a sense of

00:16:52: even more about the dark side!

00:16:55: Is this something the people that you talk to sometimes struggle with a little bit, because I feel like for academia?

00:17:03: it's sort of non-academic fields which are not basic science.

00:17:07: The industry is more money driven and that's negatively associated.

00:17:15: Health and caring for health is such high regard that a company who could make profit out of it immediately associated with something negative.

00:17:25: Is this also what happens in the heads of people you're talking to?

00:17:29: It's wide range, but do you first need to reframe their head?

00:17:37: Reframing is great way to put that absolutely.

00:17:41: as scientists we are taught Science is pure, and it's done for the good of science.

00:17:49: And then go to people that are to come in.

00:17:52: a good of the recipients have that science and money adds A layer that is also seen as negative In a lot of situations.

00:18:05: so I did go to a university and got a business degree, because I did not understand the money aspect in the economics.

00:18:15: The accounting side of helping to run a business and then running my own business.

00:18:23: so that helped me better understand how those things might factor into science.

00:18:30: but ultimately what i learned is company cannot be successful with their science if there is not some sort of business plan involved.

00:18:42: And a business plan can be like a protocol in a lot of ways, it's just a Plan about what to do and how to execute that?

00:18:51: With the goal in mind whether its endpoints or Goal.

00:18:55: It still focuses A group of people Or one person and it allows for the proper allocation of resources, which means you're not overspending or underspending either.

00:19:16: Which is really important for advancing science because it's... I also believe that science is pure and should be done a way to execute that.

00:19:41: It's hard to put into words in, but I think people who are listening and have been involved with some sort of industry or anything outside pure science can understand even physicians now understand medicine is business situations and if the business is not making money, then people can't do what it's they want to.

00:20:10: I think in general having worked on let us say fundamental science one of things that drove me also be a bit more applied And thats where you get into industry aspect.

00:20:24: It simply doesnt matter what type of research unless someone is willing to take a risk, and that also means investing funds into advancing this to the point where it can have an impact on society or people.

00:20:43: On patients... It just remains that idea in your head which has never been actualized I think quite a bit worse here than you are in the US because there having sort of like a spin-off from at university, for some research that is being done in the lab.

00:21:07: It's quite normal it feels and here this really extraordinary to get to the point where what you're researching moved with intention of applying it And always has component on commercialization some level of understanding what it takes because no development is worth spending the time and effort, money energy in it.

00:21:35: If at the end you cannot reach market readiness unfortunately unless its purely funded by government who do not really have that business side.

00:21:48: but thats also why probably a lot of what is funded doesn't actualize into something that impacts us, it has to have a business drive in it.

00:21:56: To get into the market and then also requires as you said putting in the focus and attention to the details that require that focus.

00:22:04: otherwise your too broad.

00:22:06: so everything is interesting understanding that product at end of today needs first minimum be able to move over to the market this really important thing.

00:22:16: And You don't learn that in science.

00:22:18: Right, exactly.

00:22:20: You learn how to do a SWAT analysis for example in business.

00:22:23: so strengths weaknesses opportunities and threats.

00:22:26: And just considering any situation from that standpoint can also help to focus one like you said actualization of the impact on what science may bring.

00:22:43: From that realization, I think you're already at a point had acquired entrepreneurial spirit then.

00:22:47: You formed your own company.

00:22:49: That also requires an attention to business as such and so i think here And with your MBA you sort of transition quite smoothly over into a sphere that is more focused on Plans Execution narrow models and let's say clear drive To market which the biotech sphere?

00:23:12: in initial scientific idea, an opportunity for treatment of patients out there.

00:23:17: And whichever indication they have and whatever modality the treatment may come... ...and let's say mapping out a path what does it take to get this to actually treat patient later on?

00:23:29: So how did that transition then when you moved away from your own business as primary source-of work or pathology before biotechs, you're working within the gears of making science happen and impacting patients.

00:23:48: How did that transition feel for you?

00:23:50: Yeah yeah so that's really exciting because I love my job now!

00:23:55: And i would not have known ten years ago That I would be where I am now.

00:24:01: So two thousand twenty changed everything.

00:24:04: a lot of people with COVID.

00:24:06: And what it did for me was help me to reevaluate my own career path again, because I was very happy in what I was doing.

00:24:15: and um...it was working for me.

00:24:18: but just thinking about hmmm..and that awareness of oneself which i think is so important no matter what anyone ends up going to do thinking, is this really where I want to be in ten years?

00:24:30: And we're... Where do i wanna be in Ten Years.

00:24:33: What does that look like?

00:24:34: getting specific and That led me to thinking hmmm..I think I would like To join a small biotech and have A team and See how being part of that internal team and taking all the experience that I had gained to that point in medicine, business, entrepreneurship.

00:24:58: And shaping a small biotech what it looked like.

00:25:00: And so then I was part of a larger biotech again, and since I have joined another small bioteche.

00:25:19: So all the things about Biotech are interesting to me most especially at the clinical development side because that is where you really have to marry science in business.

00:25:35: but considering the pipeline of a company and how many assets, or how many drugs they have where they want to go with those drugs whether it's in one disease state or multiple disease states.

00:25:49: And then executing that successfully with the resources they have is... It's difficult!

00:25:55: You see companies fail every day and it isn't because of the science always sometimes portion of it.

00:26:04: So making sure that there's good science, but also the business is focused and really important.

00:26:12: And thats what I do now.

00:26:15: Can you run us through like a normal day?

00:26:17: Maybe not normally because your days are all over the place as well But maybe in a week or so What are key recurring themes where you say In your position as medical director have an impact on the inner-goings of a biotech company.

00:26:36: What are the focal points that you can drive and how does that connect, let's say to your experience in specific?

00:26:45: It is all about working with other people and being able to communicate science in way everyone can understand further than science.

00:26:54: so I will work with regulatory teams for example How does this science and this protocol, the study plan make sense from an approval standpoint in multiple places throughout the world?

00:27:12: Because things are different.

00:27:13: In the

00:27:14: U.S.,

00:27:14: Europe, Asia... That's one example.

00:27:18: Speaking with other physicians is another aspect of what I do when helping them to better understand the science our company but also their clinical practice because Physicians who are practicing clinically, they're so important.

00:27:34: That wasn't something that I wanted to do for the rest of my life but... ...I find it so inspiring.

00:27:41: there's physicians out here that spend all their time taking care of patients and It is very important when developing a drug or thinking about where you can take your drugs whether to launch them what their experience is like in the clinical room with a patient, it's all about.

00:28:05: ultimately because the approval of these drugs isn't about money.

00:28:09: It's not doing more and more...it's helping patients at end-of-the day.

00:28:16: so those are two examples.

00:28:21: I travel alot that great but can also get to be arduous for some people.

00:28:28: I work with data, worked a lot of data.

00:28:32: Worked with statisticians to understand how the data is processed and how that data is interpreted And how this data's communicated too because you can get whole list from scientists if no one knows about it doesn't matter.

00:28:50: helping with that translation is really, really important.

00:28:54: Also working with strategy.

00:28:56: so what is important?

00:28:58: Is it more important to consider the preclinical aspect of a molecule or is it more working with some of our medical team to do that.

00:29:14: And what are the prioritizations and why?

00:29:18: What areas of medicine need to be concentrated on more than

00:29:23: others?".

00:29:24: So these all aspects, there's probably twenty different aspect.

00:29:29: so sometimes I get overwhelmed by how much i have every day but...I love my job!

00:29:35: I'm

00:29:38: very happy to hear that.

00:29:41: You describe it quite well.

00:29:42: how basically you span everything from the, let's say individual patient interaction and what that means based on the perceived impact.

00:29:54: one thousand patients and five hundred patients across different programs, across the entirety of the treated population.

00:30:07: And you know markets to come.

00:30:08: so it's really from this small individual that feels very close up to the macro lens.

00:30:16: look at everything is off course between all of that spans quite a lot work.

00:30:21: Now you also said, and of course as a former statistician myself that quite resonates with me.

00:30:28: The look at the data.

00:30:30: how in development do different facets see your molecule?

00:30:38: You have a scientific idea about what it's supposed to be doing.

00:30:43: then you get to look into data approach that clinical development aspect of clinical research, because as you said there are many different indications we can go into if you have a monocule.

00:30:59: So first need to find the appropriate one.

00:31:01: then even within an indication your choose specific patient group You define them more narrowly at beginning and wider when moving towards later developments stages But also get to choose different endpoints.

00:31:16: Do you, from your perspective approach that development considering you have the individual patient lens versus the macro lens?

00:31:23: Like where on that scope do you see their development and what is sort of like there.

00:31:27: The inspiration they use for decision making?

00:31:30: Yeah

00:31:31: so it all comes down to clinical translation.

00:31:36: What happens with a drug in certain disease state?

00:31:40: So looking at serious adverse events, for example treatment-related adverse events.

00:31:46: That's an important component of it better understanding how what those side effects might be for a patient and how critical Those are from a laboratory objective standpoint but also from how the patient feels And there are various instruments that can measure that quality.

00:32:05: So that's really important too.

00:32:08: Um, so really looking at the clinical consequences is where I have a lot of expertise as a doctor and then as someone who sees things from a big picture standpoint because i can take all those aspects and think about it From The Patient's Standpoint And Then That Is Ultimately What We All Care About why I could resolve in my mind that being a doctor, in the traditional sense was okay to not be because i'm still ultimately helping patients.

00:32:43: You mentioned sort of like the patient perspective and you know the FDA has been very pushy on that side have tried to put focus also more on patient reported outcomes let's say in the last decade, how do you from a clinical perspective weigh that way?

00:33:08: Let's see.

00:33:08: The more subjective How does the treatment impact the patient and sort of like an equals one assessment That you morsel get with the patient reported outcome versus their traditional clinical quote unquote objective endpoints if we're talking hematology, for example overall survivor response rates and so on.

00:33:32: From both your perspective as a medical director but also as scientists how do you weigh those two?

00:33:39: Now, patient-reported outcomes instruments are very important to that.

00:33:44: And I think those instruments being developed more and more systematically and positively.

00:33:50: Europe has actually done a better job than the US in leading that effort.

00:33:55: so approvals for drugs have often really heavily relied on the patient perspective as an end point And I think the FDA in the US is really starting to catch on, too.

00:34:11: The importance of that with good reason because why would a patient want to live longer if they didn't feel better?

00:34:19: That's

00:34:22: very powerful message and this is sometimes where you get into a field of tension here.

00:34:34: your survival is innately tied to getting the product of the market and being able to help patients.

00:34:40: And, of course you need to make decisions that increase the likelihood.

00:34:43: if you're getting regulatory approvers If we say there are differences also across the world in terms how likely you are or bring a positive example of you potentially proving a drug because it benefits the patient's quality-of life whereas in

00:34:57: U.S.,

00:34:58: more objective end point measures required.

00:35:00: How do you balance this?

00:35:02: And because at the end of day, I'm sure US is very attractive for all biotechs.

00:35:05: That's sort like a go-to you need to get to that market.

00:35:10: if there was a lot of pressure on finding endpoints that might not directly correlate with let say patient quality of life how do you balance that especially in your role on the medical scientific side?

00:35:24: Yeah, I think that's a challenge and it will continue to be a challenge.

00:35:56: instrument or multiple instruments that can then satisfy not only the subjective side of it, but more that objective side

00:36:24: taking a more like, big picture approach to global clinical trial conduct.

00:36:30: You have seen it now from different perspectives because you said small and mid-sized or larger biotech... ...you've supported the clinical development pipelines which means that we're involved in various projects probably spanning the entire globe.

00:36:42: so its logistic challenge of course.

00:36:46: how do What's the one thing that all, small to medium and large-sized biotechs a piece of clinical research everyone struggles with?

00:36:59: And is there one which particularly smaller biotech companies struggle with?

00:37:04: Applicability for populations.

00:37:08: For example when looking at approvals in various countries if trial hasn't had certain subset patients say Japanese patients, for example.

00:37:21: If there are no Japanese patients in a trial then Japan is going to ask a lot of questions about the applicability Of the data to that population.

00:37:30: and it makes sense.

00:37:31: if you look at the seer data The NHANES data You look at some of these other Population-based data?

00:37:38: You see that There are differences In populations in African Americans in Caucasians in various South African and South Asian descent, even European descent.

00:37:51: So there are commonalities between trials absolutely.

00:37:55: And if one looks at treatment sequencing for example across countries US Germany France Spain you can see maybe how things can apply to the different populations.

00:38:11: but But at the end of the day having A representative out of the various populations is important for trials.

00:38:21: And I think all of the regulatory agencies are coming to that understanding and asking questions about applicability of data.

00:38:32: So as a direct consequence, what you just said it means at the end.

00:38:38: because clinical trials You cannot simply say well okay but we want a person representative or like people statistically significantly enough in so that needs to be a certain volume of population represented across all the different regions, which means immediately as consequence what you just said.

00:38:55: There has to be some like commercialization focus for your drug because it's impossible to develop a drug thats gonna reach and provide evidence from markets.

00:39:06: see me really choose a market.

00:39:09: And then new therefore have to say okay it means additional costs will have to be invested, to breach into other markets after.

00:39:16: So there can be some ways to bridge that?

00:39:19: There have been bridging trials that've been done.

00:39:23: so thats one way.

00:39:24: even smaller phase three trials are large and expensive And running Phase Three Trials isn't always the answer a company is looking for.

00:39:36: But there can be smaller phase two trials that could run with fifteen, twenty patients and while still a bit arduous it does allow data to obtain faster.

00:39:51: the safety of the PK even efficacy.

00:39:58: Not quite apples to oranges.

00:39:59: It's not quite apples-to-apples, but it does allow for that comparison.

00:40:04: So so that's one way I've seen it done well

00:40:07: Which let's say in an ADU case still means maybe four or five years difference between regions.

00:40:16: A phase two trial could be run in, I would say even two years.

00:40:21: Then you do the analysis and then you need to approach market authorization...

00:40:26: You can do a lot of these things in parallel though yes yeah which we could debate about.

00:40:32: but

00:40:34: if your small biotech might have issues everything are parallel anyway.

00:40:38: well or you might be more nimble.

00:40:41: so

00:40:44: I think it shines a very good light on how complex and how multifaceted the decision-making process is at the end.

00:40:53: Because even if you have enough support of evidence, You might not even think about bridging trial because population level studies have been done before... ...you can skip all that way to simply argue why your results should be transferable.

00:41:09: But of course, we don't always have that luxury and especially if you're looking at oncological indications there's also much more work on terms like a genomic level.

00:41:18: even then different mutations frequencies might occur in different relations.

00:41:23: so... At this point I think we've reached the frontiers where science is now which will make it hard for us to simply explore the globe with an easy manner.

00:41:36: We come back to what do we manage first?

00:41:38: Where did you make a decision, this is where science meets business.

00:41:42: Exactly!

00:41:43: Real-world evidence can be another area that could also be pursued for some of the data but it's also expensive and time consuming.

00:41:55: I think still a bit of work has been required as well in order.

00:42:02: regulatory demands won and we are.

00:42:05: I think, We both know that regulators sometimes don't move as fast.

00:42:08: As we would want to ourselves.

00:42:10: or even the prospect of risk like knowing Or not knowing whether or not you read what evidence will be accepted makes a big difference in The business decision.

00:42:21: And i Think In That Subject You Still Have.

00:42:26: We still have A lot Of Uncertainty And uncertainty means we default back to paths where maybe they are slower, but at least We have a clearer idea of the outcome

00:42:39: Definitely.

00:42:40: Yeah yeah.

00:42:41: again another area Where Europe I feel like is A little bit more advanced than The US in some senses with registries that Have been part Of europe's culture scientific culture for very long time and I think registries haven't always been as prevalent in the US and aren't many disease states.

00:43:00: So that's another aspect, yeah?

00:43:03: And then it is just about managing let us say... The level of access we have to data.

00:43:11: so European health space is developing which is very positive for regulators who want use this also general population perception again.

00:43:25: Okay, but should this data be given to people that sort of monetize it for health developments?

00:43:31: And I think this is the black and white view where as long money's made out why should publicly available data on subjects in European Union or

00:43:41: U.S.,

00:43:42: be made available with these companies from that?

00:43:53: even if yes, there's an industry behind and Yes.

00:43:56: That industry also needs money to survive to grow to develop further.

00:44:01: Yeah absolutely

00:44:04: All right.

00:44:04: so maybe in Moving too let's say the last segment of questions.

00:44:14: I would want a once more touch.

00:44:15: sort on your reflection for where you are now.

00:44:18: Also on leadership because you've had various different leadership positions.

00:44:22: I think sometimes, so at the beginning for other people that are transitioning over or redefining let's say what their career as a doctor can look like in your position also for biotech companies.

00:44:37: but something that you also of course have to do is lead yourself through your own path and made your own experiences.

00:44:49: Now in giving advice to others, I always feel you have too very much be grounded In yourself and your own decision-making for you.

00:44:58: It wasn't you mentioned earlier an exploration?

00:45:02: You weren't fully sure of Your own direction as he already started.

00:45:08: Yeah just being outspoken first sharing your uncertainty but of course i'm assuming that over time That has transitioned much more into a certainty in yourself, and for that reason also being able to give concrete evidence others.

00:45:22: How did you approach on like how do you guide your self through the process?

00:45:26: Was it primarily speaking about it then taking in resonance from outside or what were the resources used to guide you though your own?

00:45:35: let's say transition transformation.

00:45:37: Yeah.

00:45:38: so I think there are two things really useful over time looking back thinking transition and also continue to transition, then bring that to other people.

00:45:54: And one of them is just through relationships and conversations.

00:45:57: so anytime I had a question—and this even goes back when i was in university days considering being a doctor–I wrote a mail an actual physical male to fifty different doctors.

00:46:11: To ask them if they were happy with their decision.

00:46:14: and what I should consider is, i was going to be a

00:46:18: doctor.".

00:46:19: And about half of them wrote me back but that started a conversation and it allowed me then think things I might not have considered.

00:46:31: So through my entire career, I've really tried to find mentors.

00:46:36: To reach out and also mentor people myself because i learn not only from mentoring them but Also From Them.

00:46:46: When I Mentor Them And it gets you outside of your head Gets You Outside Of Yourself.

00:46:54: That's Always A Good Thing.

00:46:58: The Other Thing Is Just doing the things that are hard.

00:47:02: I think as humans, we try to be comfortable We try to get back to that equilibrium space of feeling comfortable and when you're can be Comfortable in being uncomfortable which is not fun.

00:47:18: but consciously and Consistently trying to put myself into situations That are hard for me helps me grow and I see that with other people too, so i would recommend that whether it's a small thing like...I have terrible spatial awareness.

00:47:35: And-and..i get lost everywhere i go but still try to walk around.

00:47:41: um take public transport do things that im probably gonna wrong the first time But will help me learn.

00:47:48: Um So those are th-the two tings that really helped me.

00:47:53: I love tha-that two things here and this is important And resonate also with what other podcasts of mine have said.

00:48:04: One, if you put yourself out there I think your expectation on the resonance around people is going to be much worse than anything that they will throw back at you and second piece as you do it learn so many genuinely happy to help.

00:48:27: if you're just asking them that it's sometimes, It feels surreal.

00:48:33: how easy is this?

00:48:35: simply reach out or someone.

00:48:36: If we generally just reached our to some one not only two-one person because they can always be hit and miss but if he put yourself up there an you take the risk of reaching a couple people their certainly gonna be.

00:48:47: people are happy to simply share Yeah, that is such a positive message.

00:48:53: I really like... That's sort of what really pushed you and something that you can also confirm from your perspective in your path?

00:49:07: And anyone could do it!

00:49:10: So if you're feeling stagnant right now or even listening to this then put yourself into an uncomfortable situation making some realizations about your own life.

00:49:24: So, I think that is very easy way to try and grow yourself.

00:49:37: From my wife who's a psychotherapist one of the things she mostly reflects with me... ...is her patients have an issue with self-actualization or their belief in self actualization are actually at the helm of your own life, that you can take a step forward.

00:49:53: And I think if people realize that... ...that you can in fact change your life and know it's not necessarily easy.

00:50:02: no one is saying that but you have to believe first that you could do that.. ..and then the rest.

00:50:08: what he takes really just handling rejection.

00:50:11: also moving through there will be surprised by

00:50:17: how

00:50:18: much less rejection you get than your anticipated, but also by how easy it is to handle rejection as you put yourself out there more and continue doing that.

00:50:28: As I said... You need to get comfortable handling a level of uncertainty.

00:50:35: Yeah,

00:50:36: yeah!

00:50:36: I agree nobody likes rejection.

00:50:38: ...I still don't like rejection.

00:50:40: It's not fun to do things wrong, it is not fun fail or have people laugh at you.

00:50:47: But...it does get somewhat easier and makes for a good story!

00:50:52: So sometimes that what I think about this will be a good Story later!

00:50:58: It would indeed This really inspiring conversation.

00:51:03: Thank You For That.

00:51:04: Now..I've heard alot take as an answer for what I'm gonna ask, but still i want to hear from you.

00:51:11: What is something that gives you hope?

00:51:13: As a person

00:51:16: Conversations like this where there's an openness To thinking of things being different.

00:51:24: I think it's easy to complain about things on a daily basis because The world does not perfect and There's a lot that we all wish We could change.

00:51:33: there's direction That we see that we don't like But the fact that we're all willing to look at what is now and think about how things could be different or better.

00:51:46: And talk about it, isn't?

00:51:47: What will bring that change about?

00:51:51: Love it!

00:51:52: Michel anything you still want to say That We didn't touch upon today in our discussion... ...that do You Think Is Important for The Audience?

00:52:01: No I think this has been Really fun discussion.

00:52:04: Thank you so much for having me and thank

00:52:07: you for stopping by.

00:52:08: it was me just reaching out on a win expecting your rejection.

00:52:12: Oh, well You know I actually got your email And iIwasso excited about It!

00:52:16: I told A couple of my friends this person wants to do a podcast with Me.

00:52:20: This is So unusual and so great?

00:52:22: I thought it Was the greatest request ever so keep that in mind That people People may think it Is Just a really interesting an awesome Awesome idea like I did.

00:52:33: Thank you very much for stopping by and inspiring.

Neuer Kommentar

Dein Name oder Pseudonym (wird öffentlich angezeigt)
Mindestens 10 Zeichen
Durch das Abschicken des Formulars stimmst du zu, dass der Wert unter "Name oder Pseudonym" gespeichert wird und öffentlich angezeigt werden kann. Wir speichern keine IP-Adressen oder andere personenbezogene Daten. Die Nutzung deines echten Namens ist freiwillig.