1 Episode results for "Myeloid Malignancies"
Episode 148: Akshay Sharma on gene therapy's setback, biotech's brashest VCs, & the FDA's future
"Welcome to this week's of the read out loud a weekly biotech podcast from stat. I'm meg terrell. I'm adam feuerstein and damian garden. it's thursday february eighteenth. And here's what we're gonna talk about this week. I will break down a significant setback for bluebird violence gene therapy program with some help from dr akshay sharma of saint jude children's research hospital then stat colleague. Kate sheridan joins us to discuss her. Deep dive into flagship pioneering the superlatively successful venture firm behind madonna. Just don't call it a venture firm finally once in store for the fda after a year that many say dented the goldstar regulators credibility. We discussed the prospects for the next commissioner. But first a word from our sponsor hi i'm angus mccauley from stat. I'm here with chris. Banco the ceo of connector a software company that power patient centric research. The newest version of the apple watch includes real advances in terms of collecting health. Data using fit for purpose sensors. Chris do you think it will help. Advance the overall use of wearables in clinical research. The apple watch will definitely impact clinical research. Perhaps most of all by helping participants feel comfortable taking the trial home with them. The days of awkward clunky looking sensors are over for research to truly benefit. It's critical for patients to feel comfortable incorporating these technologies into their everyday life. Today's tools blend right into their routines and they're not just willing but often excited to wear them for more information on connects visit connects a health dot com. That's k. o. N. e. s. a. health dot com earlier this week bluebird bio was forced to suspend clinical trials involving it's gene therapy for sickle cell disease after receiving reports that to patients treated with the one time medicine were diagnosed with cancer. These new cases follow an earlier cancer diagnosis in december. Two thousand eighteen and a refocusing attention on whether there's a causal link with bluebirds gene therapy while bluebird investigates there's rising concern that these cancer cases could have a broader impact across the gene therapy field. We're going to discuss some of the implications of that and one under appreciated aspect of gene therapy with an expert later on in the show but before we do adam. Can you tell us what we know. So far about any link between bluebirds gene therapy and these cases of cancer. Yeah you know. We don't have much definitive information right now. Because bluebird has only learned about the two new cancer cases and is still investigating them. But here's what we do know. So one person who received bluebirds gene therapy five years ago and again. This person received that gene therapy because he had sickle cell disease up but that patient was recently diagnosed with a form of leukemia. Now the second case involved a person who received bluebird therapy more recently but then rather quickly was diagnosed with mild as plastic syndrome or md s. And that's a cancer like disease. That could also progress to leukemia now. According to bloomberg there is no definitive evidence collected yet which points to its gene therapy as the cause of these cancers but at the same time the company can't disprove that link So now it's clinical. Trials have been suspended so maybe just step back for a moment and explain at least theoretically how gene therapy might cause cancer so let's step back even further and kind of go over what gene therapy is right. Gene therapy is a procedure in which a damaged disease causing gene is replaced with a healthy gene. That functioned normally now to do that. They use viruses. These viruses are engineered to be harmless. And they're used to deliver the healthy genetic material inpatients because viruses are very adept at infiltrating cells. Now however if that virus shuttles that genetic material into the wrong place. On a patient's chromosomes it could for instance switch on cancer causing gene or it could disable a gene that prevents cells from turning into cancer so the cancer risk associated with gene. Therapy is really small but still it's enough that companies put in place safety checks to make sure that these viruses don't miss the liver that genetic payload and still the these safeguards how are like. They're just not foolproof. So figuring out the root cause of these cancer cases we talked about is obviously deeply important. For bluebird in the short term but as mentioned earlier there are potential repercussions for the entire gene. Therapy field right. Yeah that's damian. So this bluebird gene therapy uses a particular type of viruses called a lengthy virus to deliver those healthy genes into patients. Now lentiviruses are particularly adept at integrating into the genome of target cells. Which makes them effective delivery vehicles for gene therapies that target cells that divide or turnover rapidly. So that's true with sickle cell disease for instance which involves red blood cells Now if these lundy viruses are found to carry an unacceptably high cancer risk you know. That's obviously a big problem. For bluebird but also for a host of the other companies that are developing gene. Therapies that utilize lenny viruses as delivery vehicles. So we should note that. It's entirely possible that these cases of cancer have nothing to do with the lenghty virus component of bluebirds gene therapy. And a rather stu random chance however it's also possible that the culprit is a decades old. Chemotherapy called butyl fan. That is used to prepare patients. For gene therapy. This is one of the more underappreciated in less discuss aspects of gene therapy so to help us understand what's going on with the situation. We're joined by dr shave. Sharma a bone marrow transplant expert at saint jude children's research hospital. Welcome to the podcast. Thank you so much damian and thank you for the opportunity to speak to all of you today. we'll maybe let's start with your thoughts on kind of the situation overall. When you saw the news what do you think might be going on. Here honestly was a shock to many in the community both providers what taking care of patients as well as the patients Off spectacle cell disease. Something that we all need to be aware of and should be obviously looking out for is that there may be multiple mechanisms which are involved are multiple risk factors which may be involved. I am aware that many in the field and lay public are definitely concerned that this could be related to lend viral vectors as we just talked about that is obviously a factor that is under investigation and a point of concern but lengthy viral vectors. Not unique to sickle cell gene therapy lengthy viral vectors off. Some kind have been used in over ma many hundred patients so far for multiple diseases. So that's one aspect that needs to be investigated but many people don't know that sickle cell disease by itself is a myeloid leukemia. predisposition syndrome. There was a study published a couple of years ago from california where they found that the risk of myeloid malignancies in patients with sickle cell disease was very high in fact it was almost four times higher than the general population and patients of had severe sickle cell disease. And then of course. There is the question of exposure to milo toxic agents such as butyl fan which was discovered to be the case in the previous patient that was described almost two years ago so i wanted to zoom in on the fan aspect in particular. I think people might be surprised to learn that. Chemotherapy is a necessary step in the gene therapy treatment process. These patients are seeking treatment for an inherited disease like sickle cell disease. They don't have cancer. So why are they. Getting chemotherapy damian. That's a very good question in fact that's something that i'm asked all the time. When i i meet with patients who are want to undergo either transplant gene therapy. You know people normally assume that. Chemotherapy is only used to treat cancer. But that's not absolutely true. We do use milo toxic. Our agents are drugs which are which stem cells in order to create space in the bone marrow so that then we can put new stem cells. Either from somebody else as happens in the case of aboard marrow transplant or genetically modified stem cells from the patients themselves. Back into their bone marrow. So right now. Chemotherapy is an essential part of just gene therapy. But all types of transplants that we are doing for inherited disorders of the hemorrhoids system. Not just tickled disease. But palestinia certain bone marrow failure syndromes immunodeficiencies et cetera. Is there an established link between the use of fan and an increase risk with so-called secondary cancers even even years later so we know from you know giving chemotherapy to patients Over the last several years that data is a data connection of some milo toxic agents and development of second cancers down the line what i mean by second cancer as most of the times. Obviously these chemotherapy agents have been used in patients who have had some type of cancer previously so these minor toxic agents not just beautiful fan but other milo toxic agents such as taiyo tampa mel philan- etc class of that we call alka liters. They are known to be associated with occurrence of cancer in these patients. Many years down the line and as far as the hamada boyd cancers are concerned myeloid neoplasms such as am l. and md are the most common occurrence. So when you sit down with your patients with sickle cell disease to discuss potentially curative. Jennifer therapy was the reaction to the need for yourself and bone marrow conditioning. To be honest with you. It is a challenge for many patients to grasp that because first of all. They're not prepared to are. They don't even know that they are going to receive chemotherapy in order to undergo gene therapy or transplant. There is very little information out there and quite frankly a lot of misinformation out there about transplant. Angie therapy man. How these treatments work and so i always tried to make sure that all my patients understand completely. What the risks are i. Try not to give them percentages. Because you know to say something like there's a twenty percent risk of x. y. and z. is is not appropriate in my opinion because when it happens to that patient for that patient twenty percent risk doesn't mean anything for them. It's one hundred percent or zero percent right. And so i tried to tell them what's common what's going to happen. What might happen. And what's unlikely to happen. And at the same time. I try to help them understand these rats and balanced them with the risks associated with their underlined sickle cell disease. Many patients who are choosing to undergo either transplant gene therapy. Currently they obviously have severe sickle cell disease to begin with so sickle cell. Disease is a pretty bad disease which reduces the life expectancy by almost half. But when i'm talking to a patient who is in their teenagers are early twenty s. It's very difficult for them to grasp that. And that's what i envision. And i tried to do in in multiple meetings when i'm discussing either. Gene therapy transplant for them. So that the on me look at the acute toxicity and the effects of chemotherapy. But also the long term picture of what might happen. If the choose not undergo transplantation especially if they already have a very severe sickle cell disease. So you've been following the efforts to develop safer drugs than than beautiful fan for bone marrow conditioning. How far along are these research programmes. And is there anything to your mind. The teams particularly promising. There are at least three agents which i believe are quite far advanced and their clinical or preclinical development. So one agent. That i have seen which seems to be quite promising. Are cd forty five. Antibodies which are labeled with the radioactive antigen There is a trial which has ongoing currently called the sierra trial which enrolls patients were aml an md s. It's restricted to adult patients right now. Who are unable to tolerate. Chemotherapy prior to transplant and in that trial the cd forty five labeled to radio. Iodine has bruin to be a much safer alternative and much effective alternative honestly compared to chemotherapy drugs which certain older patients are. Frankly unable to tolerate another agent which we have recently learned about as a secret antibody which has been used in patients with severe combined immunodeficiency. It's a naked antibody. Secret as an antigen which is present on hemorrhoids stem cells. It's been used in patients with in a clinical trial with patients with severe combined immunodeficiency out of stanford and the results honestly in those patients have been quite promising and those are pediatric patients. I must point. Magenta therapeutics has another drug that they are currently developing a which has the same secret antibody combined to a cytotoxic. There was data presented by dr john dimsdale at believe last year's ash conference where he showed in to monkeys. They use this antibody and it was able to completely deplete their Stem cells and then they were able to rescue that by giving them autologous. John modified stem cells. So you mentioned earlier that you know when you when you talk about these bone marrow conditioning processes you know both shelves and the side effects there you have to balance that with the fact that these patients have severe sickle cell disease and there's obviously risks associated with that. But i wonder if you look ahead to a point where maybe gene therapy for sickle. Cell disease is approved And does require bom conditioning with fan at least initially like how widespread of acceptance do you think you'll see this gene therapy in the sickle cell patient community. Yeah adam that's a very difficult question to answer. But i think we have to assume that exposure to fan. You know whether it is related as it pertains to developing second cancers or as it pertains to all these other side effects including infertility which is a major concern for patients undergoing curative therapies for sickle cell. Disease i think it does make a huge impact and it does in some way reduced acceptance of these knowledge curative therapies to only a few patients who are obviously seeing an impending mortality risk to them. Obviously every therapy has its on side effects but if it can sure that the side effects associated gene therapy and the conditioning that requires are obviously less than the side effects associated with the disease itself in the long term in the next twenty to forty years. I think that's what's it finally going to lead to a widespread acceptance of these gene therapies at least in the developed countries sharma. Thanks for joining us. Thank you so much and thank you for having me turn. Venture capitalists are some of our societies beth self mythology if you spend time run vs biotech or otherwise. You're likely to hear about how they live at the absolute bleeding edge of new ideas and about how they're exceptionally good at turning those ideas into large sums of money. There's perhaps no better example of this than flagship pioneering the cambridge massachusetts-based venture fund. That has made a comment. On its seat investment madonna. The firm is produced dazzling returns in recent years and by its own account. That's the result of simply thinking better and harder than other. Vc's one press release described. The company as unique disruptive unforeseen an unprecedented all in the same paragraph. But a clear explanation of flagship. Success can be found in the firm's culture which former employees say is hardly for the faint of heart stats kate. Sheridan reported out an excellent story. About how flagship actually works and she joins us today to talk about it kate. Welcome back to the podcast. Yeah thanks guys. So flagships claim basically is that it's unique among venture firms that invest in biotech. What did you learn in your reporting. Do they actually go about this business differently. The answer to that question is a little complicated. Yes and no. I think flagship is possibly unique. Among venture firms for filing patents. That is pretty unusual for a venture capital firm even biotech and their mindset. I think truly is actually a little bit different than than other. Venture capitalists a lot of folks. I spoke to at flagship. Certainly believe that as you say but also the the things. They learned the things that they find most valuable and important. It's not necessarily a therapeutic from the get go it's it's the idea itself Which i think is really interesting however some of the things. They do are very much similar to two other venture capital firms the way they spin out companies the way they fund their companies Is like what any venture capital firm would do their series as bc rounds. They also like many other kind of venture creation style firm support their companies by offering administrative functions. That are kind of housed within the firm itself so while flying should definitely has its unique points. It's not necessarily wholly unique. I suppose so much of the firm's culture and trademark bravado seems to start with new bar fan flagships. Ceo what's he like. And what role does he play in the organization like every firm of course flagship has a set of partners. And i don't want to minimize their contributions certainly not not in the slightest But based on my reporting New orleans the firms north star. You know he sets the tone. He guides and shapes the philosophy. Many people contribute to the culture. But it really does seem that. He plays a really fundamental role in in defining. What flagship is and does one of the things that that struck me reading. This is so much of the the flagship magic is not. Just you know the ideas as you mentioned and also the financial success. But it's very much one of branding and marketing. And you touch this in your story but this seems to come from a fan and be shared along the way or down the line i should say. Flagship is very invested in like the semantics and the descriptions of its work like. What did you learn in importing out when a source of mine told me that The quote that's that's included in the article about semantics and word choices being very very important to flagship and specifically are that just clicked immediately for me right. I think we've all seen the press releases for companies that described the work. They're doing in terms and this. This approach is very intentional. As flagship is told me repeatedly they take crazy ideas. that's what they do. That's their whole shtick. But i think it was really interesting to kind of see from people who who had a lot of experience with the firm that that's work from that it has come from From the top. So kate tell us a little bit about the process. That flagship uses to kind of find these modern as in the making a and and why there are so many whiteboards for sure so about the whiteboards. That's kind of what someone told me. They spend a lot of their time Doing and what they do with. Whiteboards is basically just kind of thank Think out loud on the whiteboards. There don't think necessarily about what kind of drug They might like to make but rather what kinds of concepts might fit together to make something that could be interesting and potentially useful lacob scientific experts and what flagship likes to hear from us. Experts is not. This idea is a great one but rather this idea is is crazy. It'll never work. It's a little bit out there. That's that's what they go for. And if all that sounds sounds good and if they can file broad patents They will consider building a company around it. They express these ideas in the form of what if statements eventually not. What if we could make a better jack inhibitor. But what if cells could talk to each other and then eventually if the if the partners like the idea They'll they'll put the money into it and they'll find some lab space for it and they'll start testing some of the basic ideas and run some of the basic experiments to support the idea. In that way at this point we start getting a little bit closer to adventure creation. Model that that folks industry will will know But that's that's the early stages anyway. The process sounds wacky and like it couldn't possibly work I guess in one sense you have to say. isn't it. good that people are thinking like this and people who have the resources to try. These things are thinking so differently rather than like what. If we could make a better jack inhibitor. I mean we do need better jack. Inhibitors presumably also. Those could serve a role. But it's kind of a different a different approach and we mentioned before that flagships been incredibly successful making money for its investors. So how much better is the firm doing than its peers. It's doing very very very well for itself. I wanna caveat everything. I'm about to say by saying that. My numbers are a little out of date. I'm planning on updating than later this year And also that these numbers will include The value liquid holdings in stocks for example and in companies. That aren't even public yet. So all that said Flagships performance has been really exceptional. The the data that i've been able to collect indicate that for one fund They've been able to create a nine x return. So one dollar into flagship in our two thousand and ten fund would create nine dollars as of the end of two thousand nineteen which is massive. It's really massive. Their forms overall. I found in in one of my reports is less consistent perhaps than some other firms who have been just machines and turning out Pretty good returns but not nynex returns But ever since flagship decided to go all in on venture creation their performance has been really really good that nine x is before the pandemic. that's before the pandemic i mean. Wow so sitting here in two thousand and twenty one flagship has made all of this money. And it's become something of a household name at least in our corner of the world but you know that's all taken place during a prolonged boom biotech in general. So how does flagship keep up this pace and you know. Do they have a plan to adapt if the broader market sours biotech. Yeah i mean. The rubber really meets the road for biotech venture capital firms. When peos happen and so far. It's been a very good time to be a biotech company. By showing people have been able to to put companies out in the market that don't have clinical data or even really the promise of clinical data. We saw that a little bit with somma. They haven't started clinical trials yet and both for for quite some time ultimately that that kind of data is going to be what makes flagship and its investors money so if people are demanding more evidence from companies that are that are going. Public than flagship is going to be stuck funding companies much later into the development process while still trying to maintain the kind of massive ownership stake that they typically have. But let's add. Flagship is a firm. That i think really prides itself on being able to evolve They are doing some new new things. some of which. I don't think i fully understand yet. But i'm looking forward to seeing how they play out. I'm thinking right now about Pioneering medicines which again is a new initiative. That i'm still trying to fully understand But potentially is is one way for them to to move away from being completely dependent on the performance of untested companies in the public markets. Okay thanks for joining us. Thank you this. Podcast focus on biotech and no federal agency is more important to this industry than the food and drug administration. Actually one could argue and we did on wednesday night in an impromptu conversation on the audio social networking app clubhouse and the national institutes of health is also up there. Given how much basic research it funds but francis collins is sticking around as an i h director so today we're going to focus on who president joe biden will pick to lead the fda so the race according to multiple meteo ports including from our own stack colleague. Nick clark comes down to fda veteran. Dr jenny woodcock versus johns hopkins. University's dr joshua scharfstein who is seen as less drug industry friendly and the lobbying is strong for both candidates Earlier this month eighty five. National groups ran a full page ad in the los angeles times. Supporting woodcock calling her a passionate advocate for patients and consumers an ally to patient advocacy groups and a fearless leader at the fda where she has served since nineteen eighty-four. She's currently the acting fda commissioner meanwhile a group of doctors and public health experts published an open letter in support of scharfstein saying he would strengthen the fda's gold standard as a regulator have gone on the attack in favor of scharfstein and against woodcock most notably perhaps his yale epidemiologists aids activists. Gregg gonsalves says who accused woodcock on twitter of being a little too close to the drug industry that regulates. But does it really down to just these two. And how important is biden's pick for who leads. Fda in the midst of this pandemic and after the agency's reputation took a beating capitulating to president. Donald trump on hydroxychloroquine and convalescent plasma. So guys. I wonder your thoughts adam. Is this pick more important than usual for the fda. Will i think for the reasons that you stated mega. It is really important. I think that we all have seen the credibility of the agency from a science perspective. Take a hit of the last four years where politics intruded into decision making processes the policy initiatives that the fda you know we we've had podcast episodes and segments about this so from that perspective bringing in somebody who can help restore the the image of the fda the credibility of the fda within the scientific community within the general public. I think is is really important. I wonder also damian. I mean what do you think the job of this new commissioner is going to be and how is it similar or different to what we heard from helen branch while last week for rachelle valenki the new. Cdc director and needing to potentially boost morale at the agency or is the sort of external public. Trust even more important for fda. I think that's interesting. I think both of those things are probably top of mind for the people looking to pick someone which is to say that you know. Is that a mention. The fda has been bruised This past year in the public eye but that is also undoubtedly had an effect on the internal politics of the agency. And then you know maybe most importantly their ability to retain talent which we know is just a longtime struggle at fda which employs people who quite often can make more money at the company's regulated by the fda but then you have also the public perception aspect which which has not gone. Well i think by all accounts in twenty twenty related to near the relations with trump. but also you know a few other things. I mean even even dating back to the opioid crisis and some of the Issues around vaping that predate fda commissioner. So i guess you know the next person. Whoever it ends up being will have to kind of fight that battle on both fronts to reassure the people within the agencies such that they stay around and stay committed to the mission but also to reassure the united states at large that as you mentioned this sort of gold star regulator is how it's longman perceived is still an education and important institution so meghan. We're one month. Roughly one month into the biden administration in. We're having this discussion about who the next. Fda commissioner will be. Do we feel like you know. Do we wonder why the decision or why naming that person is taking this long or you know. Is this kind of standard practice. Actually looking back at the history. I have to credit damien with actually doing this research. And telling us about it you previous. Fda commissioners often were not named until april or may or nominated. It is a position that needs to go through. Senate confirmation. So it's more complicated than naming the cdc director. But as we've been talking about we're in a pandemic where the fda so important we're about to see the next Review of covid covid nineteen vaccine next week. Jj vaccine has its advisory committee meeting on friday. The twenty sixth so the fda is playing this integral role in it just for vaccines It's for tests. it's for You know drugs. I mean it's a lot of things for the pandemic and then of course everything else that it does And so yeah would think you would have heard a little bit more of a concrete discussion around who it might be. And and of course we've been hearing about these two different candidates but there's a lot of suggestions that might actually not be down to these Only two candidates yeah. i think. What's maybe more unusual is that we just haven't heard other names floated out there. We've heard these two names right woodcock scharfstein and it's pretty consistent and you would think that maybe that other names could floated out there. You get into the press. And i'm not like totally plugged into the whole. Dc thing but even like the really most plugged in dc reporters haven't been writing. Stories speculating on other potential. Fda commissioner nominees. And i think that's sort of unusual. I mentioned two names. That i have heard. Not as from a from a well-placed source in terms of saying they are actually under consideration. But from somebody who has advocated on behalf of cancer patients Sending why not. Rick pastor who of course has been leading the cancer unit add fda forever and why not amy abernethy who is a more newcomer to leadership at the fda. You know who we know for her work at flat iron and who has done a lot with real world evidence and a big data And who could bring a different kind of perspective as commissioner in that way. I think it's interesting. Thinking about rick. Pastor amy abernathy and some by extension janet woodcock versus joshua scharfstein in that the differences between them are not partisan than like i. I'm not sure that there's a discrete democrat or republican way to run the fda but they're definitely ideological and so when you hear things about like good advocate for patients Or flexible regulator or open minded or at cetera. That's often put in contrast to someone like scharfstein which is maybe a little bit unfair to him. I don't think he's close-minded minded per se but like the traditional idea of the regulator who who keeps industry in line in in the idea of protecting the safety of the american public and i wonder sometimes that push and pull gets a little bit can be a little bit reductive. We frame the fda so often in the context of new medicines. I think there's probably a large contingent of people within the fda within the health community in general who look at scharf. See not as a hardliner on the drug industry but as a person with an admirable record in public health and that includes tobacco and regulating food and all the other things that the fda does. So it'll be interesting to see how those constituencies kind of line up as this conversation goes on because it's it's an agency that does much more than just review drugs. And i guess maybe. I'll put potentially last question to you since you've been covering this industry the longest Janet woodcock has been an fda since nineteen eighty-four and in your real leadership roles at least since one thousand nine hundred four You kind of can't be at an agency like that for that long. Without some bad things happening And a lot of those are kind of late at her feet You know they're the letter supporting scharfstein mentions For the fda bad decisions it's around opioids hydroxychloroquine obviously during this pandemic viaducts and attempt larssen. Of course the drug for duchenne muscular dystrophy. We've talked a lot about on this podcast. Which just seems like a clear shot to against woodcock given. She was so into role in that decision. I wonder your thoughts on having covered this industry so long. How much of that can sort of be said is is tied to janet woodcock decisions. And how much is you know the agency as a whole and she was there that it strikes me about gentlemen because i think that she is very much a person who has Tried to advance the fda. And i think she's she thinks about the fda the legacy of the fda what the fda can do when she's making some of these controversial decisions. And i think like the templars indecision for instance was probably one in which you know. She was thinking they're about you. Know what impact. That decision would have on the fda. Let's say for instance if they had rejected templeton And it was later found out to be ineffective drug because essentially what you have done is denying a medicine for for dying children and that that can cause a lot of blowback on the fda so for her. It was a better decision to approve the drug. Even if the evidence supporting that drug was i you know the let's call it iffy or controversial You know on the same side you know. She's also somebody who has probably more than anyone else tried to bring the patient perspective into the fda and make sure that sort of realized that they're not reviewing drugs making the decisions in a vacuum. That patients are very much at the center of everything that the fda does on the drug side so with all of that said we should note that for all we know. It may not even come down to these two potential candidates and furthermore there may not be that much of a sense of immediacy within the white house. Because you mentioned earlier. Janet woodcock is currently acting commissioner and is obviously qualified for that role. She's qualified to be the actual commissioner. So we may have just spent a lot of time dancing around at issue that pederson super pertinent so before we go the first two episodes of stats new podcast. First opinion launched this week. Host pat skirt sits down with emergency room. Physician j barrack and health equity specialist. Lauren powell listen to first opinion on apple podcasts. Deter where ever. You get your podcast. Thank you to theresa. Gaffney for producing. This week's episode of our senior producers highland benito analysts ambrose and our executive producer is rick burke and is always. We'd love to hear from you. Tell us what you like about this week's episode. What you didn't like and who you think should lead the fda you can do all of that by sending us an email at read out loud at stat news dot com and if you like what we do leave a review or a rating on apple podcasts. Or whichever platform. He used to get your podcasts. See next week