Transcript

[00:00:00] Jeff Cranmer: Welcome to BioCentury this Week, I'm Jeff Cranmer, Executive Editor of BioCentury and I'm joined by

[00:00:06] Simone Fishburn: Simone Fishburn, Editor in Chief 

[00:00:08] Steve Usdin: Steve Usdin, Washington Editor 

[00:00:10] And Josh Berlin, Head of Business Development

[00:00:12] Jeff Cranmer: Today we'll talk about what the next FDA Commissioner needs to do to restore confidence in the agency's independence. We'll also preview this week's COVID-19 vaccines advisory committee meeting, as well as our upcoming China Healthcare Summit. Steve, you wrote a commentary for us on Friday about the next FDA Commissioner you say it's guaranteed one way or the other whoever wins we will have a new FDA commissioner. And then you have quite a laundry list of what this person needs to do to get the agency back on track. Is anyone going to want this job after reading your article? 

[00:00:50] Steve Usdin: Yeah, I think so I don't think you'll have any problem finding... I don't say guaranteed by the way, I think it's most likely. Where I start from is saying look regardless of the election outcome, I think there's going to be a new FDA Commissioner next year. Obviously if Biden wins he's going to name his own person to that position. I think Hahn is goning to be forced out if Trump is reelected, probably as part of a larger turnover that's going include HHS Secretary Alex Azar, CMS Head Seema Verma, and others.

[00:01:15] Look, I think the most important job for the new commissioner is going to be regaining the trust of the public that it's acting in their interest, untainted by political considerations. The situation at FDA is not as bad as at CDC, but Trump, Azar, and Hahn have really driven FDA's reputation into a ditch. The COVID experience has demonstrated that trust is a fundamental prerequisite for a public health agency to be effective, so that's gotta be job one for the next commissioner. The other thing of course is that the next FDA Commissioner is not going to have the leisure of only dealing with the trust issue. They're going to have to steer FDA, and the country through the pandemic. Then when the pandemic's finally in the rear view mirror, they're going to have to figure out how to move the agency forward. 

[00:01:54] To do all that effectively I think they're going to have to get a number of things that the Trump administration has put in place reversed. Things that were put in place that advanced a deregulatory agenda, and that add a layer of political control to FDA and prevent it from acting quickly to advance its missions in medicine and science.

[00:02:11] Simone Fishburn: So obviously the chance of doing that is much harder for the next FDA Commissioner if it's a Trump administration than a Biden one. You've been talking to FDA insiders and obviously no names here, but what is morale like, and you talked really about the idea that they need to gain the public trust, but what does the next FDA Commissioner task in terms of it's own staff? 

[00:02:35] Steve Usdin: Oh absolutely, and I did include that in the commentary, it's absolutely essential the next FDA Commissioner regain the trust of the FDA staff. The FDA staff on the one hand they're working 7 days a week, 24 hours a day, and they're exhausted. They also feel like they're embattled. And especially the ones who are not working directly on COVID issues their morale is under threat, because there are a lot of things that are happening at FDA under Hahn that the outside world doesn't see. One of them is a clamp down on FDA staff talking to the media, and also presenting at scientific conferences, and generally interacting with the world. One of the attractions of being at FDA is the opportunity for staff to become thought leaders, really should be one of the goals is to have FDA officials become thought leaders in their areas of expertise. Under Hahn they're being prevented from communicating with the outside world, which is by definition what thought leaders need to do.

[00:03:31] Simone Fishburn: Yeah, just to be clear probably all FDA staffers start out as I did with a scientist, with the scientific path. And those people while they're not necessarily desperate to speak to the media, their form of communication is scientific conferences and it's really important for FDA to stay ahead on that. One of the other things you talked about and I hear this as well moving away from COVID the day job of FDA for all of the diseases outside of this one, the adcoms people have talked about that being a mess. A new FDA Commissioner can certainly build public trust but there's also a lot of things that drug developers want fixed, maybe just highlight a couple of those.

[00:04:09] Steve Usdin: Well yeah, and those are going to play into another thing which is on the top of the next FDA Commissioner's agenda, which is steering FDA through reauthorization of user fees for new drugs, generic drugs, biosimilars, medical devices. I think that one of the things that's on the top of the agenda for medical product developers and it always has been is increasing the consistency of FDA policy. There's a sense that there's an arbitrariness to some of the decisions that are made. That one part of FDA will make a decision about something, and then another part of FDA will be faced with exactly the same circumstances or very similar circumstances and will make a different decision, that's tremendously frustrating for companies.

[00:04:49] I think that the whole area of getting outside expertise from patients, from scientists, from the medical community at FDA needs to be overhauled. Right now FDA largely relies on the advisory committee process which is broken. And even if it were to function correctly, it comes too late in the process, it's supposed to inform the decisions that FDA make about approvals. They need to find ways to access outside expertise earlier in the process, as products are being developed.

[00:05:18] Jeff Cranmer: Talking about the arbitrariness of some decisions that CEOs are complaining about, I think it was the Sarepta's first approval in DMD, the most recent one that really created a firestorm...

[00:05:31] Steve Usdin: Actually the second, they're second approval in DMD was probably more contentious than the first one, but yeah.

[00:05:37] Jeff Cranmer: Yes that too. What specifically can FDA do to improve this process? 

[00:05:43] Steve Usdin: Look, I don't know. I do know that it's far easier to be on the outside like we are criticizing FDA in pointing out what it's problems are. I'm really hesitant, and I think it's a fool's errand for somebody who isn't in the agency and really immersed in it to understand culturally, and organizationally what they should do. I'm not gonna say, "Oh they need to move the boxes and organizational chart around this way or that way, or fire this person, or hire that person." I don't know enough about it to say, and I think I know more about it than most people who aren't there, but it's got to be one of their priorities.

[00:06:14] Jeff Cranmer: Speaking of the broken advisory committee system, what should we expect out of this week's COVID vaccines committee meeting? 

[00:06:22] Steve Usdin: We shouldn't expect a decision about Emergency Use Authorization of a specific vaccine because they don't have one to discuss, and that's not what they're going to be discussing. They're going to be providing advice, and I think even more importantly they're going to be providing a public airing, and a public forum about the criteria FDA should use for reviewing, and potentially approving COVID-19 vaccines -- approving or authorizing under Emergency Use Authorization. So it's all going to be about what should be the standards that FDA uses to judge whether there's enough data to determine that a vaccine is safe and effective enough to expose it to the American public, or two portions of the American public which is more likely what's going to happen.

[00:06:59] One of the areas I think that's going to be of particular interest, and there's been views expressed about it before the meeting is the amount of safety data, the duration of safety data that FDA should require before it makes an Emergency Use Authorization. FDA is going into this saying that their intention is to require a median of two months of data, that means half of the experience could be less than two months and half would be more and that would qualify. There's a letter that was signed by a large number of public health experts who say that they think that FDA should require two months data for all of the patients who have been in the trial prior to authorization of a vaccine, I'm sure that's gonna be one of the things that's going to be discussed at the meeting. 

[00:07:39] Jeff Cranmer: Will they be discussing access to vaccines as well?

[00:07:42] Steve Usdin: I don't think so, that's not really FDA's job. FDA may limit Emergency Use Authorization to certain populations I think that would make sense, and It'll probably happen based on the data that they're presented. For example, does a vaccine work well in the elderly, is there any data about its safety and efficacy in children, or adolescents... 

[00:08:04] Simone Fishburn: Steve, I have a question about... I have a question about this sort of thinking about it on the one hand there's a ton of data. Theres pandemic going on so there's no sadly lack of cases, on the other hand this diseases is what 10 months old or something. I'm trying to get my head around how this compares with any historical precedents for this kind of a meeting. Normally, you've got years of information and understanding about the biology of a disease. What happened in the AIDS era, was there anything similar to this then?

[00:08:34] Steve Usdin: I don't think so because the development of drugs for AIDS unfortunately did not move it anything like this kind of speed. There were meetings you could say that were comparable. There were meetings where they discussed whether surrogate endpoints could and should be used as the approval basis for AIDS drugs. But it wasn't happening with anything like this kind of speed the level of public attention and urgency to it. This is all really unchartered ground. And I'm quite confident there's never been an advisory committee meeting to talk about Emergency Use Authorization. Advisory committee meetings usually discuss approval, accelerated approval, or regular approval. 

[00:09:11] Simone Fishburn: Well, yet another first for you there.

[00:09:13] Jeff Cranmer: Last week we saw news, I think Steve you were one of the first to report this if not the first. Chris Christie, the former New Jersey governor, and sometime adviser to President Trump was treated for COVID-19. He went to a hospital where a clinical trial is being run for the antibody product from Raegeneron. Christie apparently declined to join the trial and then went on to receive a similar therapy from Eli Lilly. To me this raises massive questions about the fairness of decisions to grant access to investigational therapies...

[00:09:51] Simone Fishburn: Let's just to be clear Jeff, the therapy that Christie received from Eli Lilly is not one that is available to other patients...

[00:10:00] Jeff Cranmer: Exactly, neither has been approved. I should say especially as a New Jerseyian myself, that we're very happy to say that he's recovered. And he's now out there saying that he was wrong all along about wearing a mask, and urging people to wear a mask. But this question of fairness in gaining access to drugs that are not available to anyone who walks into, or is rolled into an ICU. Steve, what's your take here?

[00:10:26] Steve Usdin: Well, I think there's a lot of things done pack there. I think part of it is he sent an awful message to the world by declining to participate in a clinical trial. Can you imagine what the publicity would have been what the public would have taken away from it if he'd gone out there and said look, I participated in a clinical trial, I don't know whether I received the a investigational agent or a placebo but in doing this I'm advancing science and I'm helping the whole world learn about what works and what doesn't work for COVID-19. That would have been a tremendous message. Secondarily, the fact that he received the Lilly monoclonal antibiotic product that's a cocktail. Lilly has said that they're only going to have 50,000 doses of that ready between now and the end of the year. Very few people, if any,, are receiving it on a compassionate use basis before approval, and even after approval, it's going to have to be strictly rationed. This really raises questions of fairness. If any of us, if any of our loved ones, if anyone we knew was in a similar situation to Chris Christie they wouldn't be able to get it, so why should he get it. We had a similar discussion a few weeks back about President Trump, and perhaps you could say he's the President whatever you believe about him politically, he's a President United States the Presidents get treated differently. Chris Christie is in that position, he's not even a governor he is a former governor. So I think...

[00:11:39] Simone Fishburn: I want to raise the point, because what one person has said to me is that, just that happens all the time. Anybody who has a loved one who's sick or gets sick will pull whatever levers they can in order to get access to the best treatment. I personally don't espouse that view, I think that there's also a difference between having a child with a terminal disease and using any contact you possibly can and being in the middle of a pandemic. I feel like Steve, he's not a public official, he actually doesn't hold any public office. So it's really his fame. You call him a politician, but actually it's not even at the moment. I do think that it's a very problematic area given that we know how much demand there's going to be for this, and, how little access people have to even some of the most basic care at the moment...

[00:12:27] Steve Usdin: I think it's also, it's on Eli Lilly and other companies to explain what their policy is. They've said that they're making decisions based on a case by case basis, I don't think that's good enough. I think that the public deserves to know what are their criteria for making decisions. Personally, I think the companies shouldn't be making these kinds of decisions. I think there should be independent experts, advisory committees for example like Johnson & Johnson uses, or other criteria that should be used. Or there should be clear, and transparent criteria for deciding who gets access to something that hasn't been approved. Then after it's been approved, when it's in short supply, the same question is going to be raised what are going to be the criteria for deciding who gets it. Just saying that a company makes decisions on a case by case basis isn't good enough. It isn't fair, and people aren't going to believe that it is fair. Maybe the situation with Trump, and with Christie hasn't created a level of public outrage. But it will, when people realize that these drugs potentially are life saving, if that's in fact what we learn. And that there are arbitrary decisions being made about who gets them, and who doesn't get them. There has to be something that is fair and seem to be fair put in place. I think it has to be done very quickly otherwise the situation is going to turn very ugly, and it's going to turn ugly for the companies that are making these products. Instead of being heroes, they're going to turn them into villains.

[00:13:45] Simone Fishburn: I have to make one more point it's my job to do that. I agree with Steve on a lot of this, I actually personally draw a line between the office of the president of the United States, and somebody who isn't that. But I should emphasize that some of the opinions that we've just expressed are ours and not necessarily BioCentury's opinions.

[00:14:03] Steve Usdin: But they should be. 

[00:14:04] Simone Fishburn: And we may make them that be the case.

[00:14:07] Jeff Cranmer: Steve, last word on this Steve? 

[00:14:09] Steve Usdin: No, I think that this is something that we're going to be hearing about more in the coming weeks. It's likely that at least one of the monoclonal antibodies is going to receive Emergency Use Authorization sometime relatively soon. That the supplies of it will be far below demand, and there's going to have to be a rational, defensible system for determining who gets access, and who doesn't. People are going to have to know in advance whether they would qualify. And why they or someone that they care about isn't getting access to it when others are. 

[00:14:40] Jeff Cranmer: All right, I fully agree with you there. Of course this is all of our own opinions and not the BioCentury position. 

[00:14:47] Registration is now open for our 7th BioCentury-BayHelix China Healthcare Summit. Normally we'd be getting ready to buy our plane tickets to head over to Shanghai. Get togther with some of our friends, and colleagues from everywhere, from the UK to the far reaches of Asia. But it is not the case, our colleague Josh who joins us today, he's cooking up a digital event that's going to run from November 9th to 13th. That will include strategic panels, one-on-one virtual meetings, company presentations, and two conference reports from our partner McKinsey. Josh, what are you cooking up for us?

[00:15:25] Josh Berlin: Yeah, thank you and thank you for having me on the podcast for the first time. I'm really pleased to be here. I think you hit a couple of key points there for our Western audience, here's a great chance to participate in the China Summit this year without having to get on a plane, without having to worry about jet lag. We're going to have record attendance this year from China biotechs, and China investors. Here's a chance to learn about the latest intel as to what's happening for the China market for biotech companies. Also a chance to meet one to one via virtual meeting system. We're really expecting a great series of panels this year. I should also say you are correct that registrations open, it does start November 9th for the main part of the program. We also this year for the first time have a pre-event program tied to our digital sessions. So we have already running several webinars that you would get access to right away if you register for the event. We also have a data presentations that the BioCentury team has put together that we call scene setters, looking at China deal-making and China financing for instance. The one to one virtual meeting system is open now, and you can start scheduling your meetings right away. We have all of this on our website you can check out the agenda, as well as the schedule which is BioenturyChinaSummit.com. 

[00:16:38] Jeff Cranmer: Thanks Josh, I'm curious are there any panels in particular that you're really excited about?

[00:16:43] Simone Fishburn: Mine, all of mine, right?

[00:16:45] Josh Berlin: I should mention that Simone will be moderating a few sessions. Jeff, you yourself will be moderating a session. Steve, is going to be joining the program this year, moderating a session. All of those of course I highly endorse. I had to pull a couple that I really wanted to highlight, one is we do have a late breaking session that we've just added on China IP reform, there is a major new China patent amendment about to be passed. That'll add quite a few new rules, and regulations for China biotechs, as well as western innovators doing business in China, patent linkage for instance. So this year we're putting together a panel that'll include a senior judge, a former judge from the IP division of the Beijing High People's Court, really rare for him to speak like this to a global and Western audience, that is a session I definitely plan on tuning into. 

[00:17:32] We also do have a round table that will include looking at regulatory reform,the round table will include the head of RDPAC, which is the big pharma trade association, and the head of PhIRDA which is the local pharma trade association. Again, pretty rare to have these two on a panel together talking about reform, and what it's going to mean for innovators, that's another one I'm really looking forward to.

[00:17:56] We also will have a China GM panel. The heads of China for companies like AstraZeneca, GSK, and Sanofi onstage. Then we have an annual Heads of Research round table, that's moderated by Steve Yang, Dr. Steve Yang who's the Co-CEO of Wuxi apptec. And we have several really hot companies on that session including Everest Medicines, and Genor both of which just recently IPO'd in Hong Kong this past month.

[00:18:21] Jeff Cranmer: And we'll have company presentation tracks as well. I know there's the Korea track again this year, what are the other tracks? 

[00:18:28] Josh Berlin: Yeah thanks Jeff, so we will have Korea Delegation, and Korea Roadshow track. We'll have eight Korea biotechs presenting this year. We'll also have two China Biotech Road Show tracks, one for private companies, and one for public companies, a who's who of companies that have recently listed in Hong Kong or on the STAR board. Then we also will have a global biotech track where we have western companies from Europe, and the U.S. as well looking to find potential partners, or investors in China, so we do have Western companies presenting as well. This year for the first time we'll also have a med-tech track. We've added med-tech discussion this year based on requests we've had from others in the healthcare ecosystem who wanted us to do what we've been doing on the biopharma side to also extend that to the Med-tech side. 

[00:19:12] We're really looking forward great program. If you do have any questions please contact our team, check out the website BiocenturyChinaSummit.com, and we hope to see you there virtually. 

[00:19:22] Jeff Cranmer: And of course the the price of admission includes those two conference reports from McKinsey which no doubt are worth the price of admission alone...

[00:19:31] Josh Berlin: Yeah McKinsey really does a great job with those a lot of data, and a lot of insight that they get from interviews with KOLs in the China market. Those will definitely be two highlights of the event. 

[00:19:41] Jeff Cranmer: Excellent, that's all we have time for this week. 

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