Tuesday, November 21, 2006

LCCC Closed Chemistry Interview

LCCC Closed Chemistry Interview

Original Post

Beth Ritter-Guth: The person we're speaking to is Kim Ashman. She's the Director of Quality and Compliance at Sanofi-Aventis. She'll pronounce it for us so we'll all know how to pronounce it. I'm going to ask her the first few questions. I'm just going to ask her to tell us what she does, what her job duties are. Once I'm done asking that question and she, when she, once I'm done asking that general question, you guys can ask anything you want. Remember that you want to gather information that will be useful for you on your paper.

Beth: I am recording everything but I don't know how well it's going to pick it up. I will do my best to get her voice to come through, but you should take manual notes as well. Try to get as much information as you can. This is somebody who does this for a living, so she knows more than I do about the process.

Student 1: Now this is the corporate process, correct?

Beth: Right this is the corporate process, good question.

Student 2: Do you know if her name is Dr. Ashman?

Beth: No I don't think so, but I don't know.

Beth: How do I put it on speakerphone now? Can I hang it up or do I?

Student 3: Yeah.

[phone ringing]

Kim Ashman: Hello?

Beth: Hi may I please speak to Kim?

Kim: This is Kim.

Beth: Hi Kim, this is Beth Ritter-Guth from calling from LeHigh Carbon Community College.

Kim: Hi.

Beth: How are you?

Kim: I'm good.

Beth: Can you hear me OK?

Kim: I can. And can you hear me? Because I have you on speaker.

Beth: Yes. I have you on speaker as well. I'm going to make sure all of my students can hear you. Can everybody hear?

[students make noise]

Beth: What would you like us to call you? Dr. Ashman?

Kim: No, I'm not a doctor.

Beth: OK.

Kim: Just Kim.

Beth: Kim, OK Kim. I'm going to ask you one or two questions to start off, and then the students are going to have an opportunity to ask you questions after that. They're writing a paper that is detailing the process of drug development from the chemistry lab at an academic institution, in our case Drexel.

Kim: OK.

Beth: And tracing that development through open source sharing of data, in-process data, and open access publishing though to the community. The community we're working with is in Kabala, Sierra Leone.

Kim: OK.

Beth: So we've been looking at the academic side, but we're interested in knowing how the corporate model works because there are good reasons why some chemistry is not made open to everybody through open source methods.

Kim: OK.

Beth: OK? So our first question is what do you do at, first of all I need a tutorial on how to say it. How do you say, Sanofi-Aventis?

Kim: That's pretty good, because people say it many different ways. I say Sanofi-Aventis, I've heard people say "Sanoffi" Aventis. But Sanofi-Aventis it is. For today.

Beth: I say it ten different ways a day. Can you tell us what it is you do at Sanofi-Aventis and what your job duties are and how you interact with the process of making drugs?

Kim: OK, well let me tell you first of all I am in the U.S. Quality and Compliance Department. My title is Director of U.S. Quality and Compliance and Management Representative for the Dermatology Medical Devices. I have responsibilities, lucky you, for drugs and devices.

Kim: So I was going to use the model today, medical device. But let me tell you that medical devices come in extremely such a broad range of types and we go through phase one to phase three and four for medical devices, anything from a Band-Aid to implantables to MRIs and pacemakers. But we do make a medical device that is somewhat formulated like a drug, but it's considered a medical device. It's implanted, but there are no active ingredients so it fell under the classification of medical device.

Kim: So my primary responsibilities, although I support all the quality and compliance activities for dermatology, I cover and have the authority for the dermatological medical devices globally for the company. Basically my responsibilities there include the management oversight of the quality systems, both from the design and development aspects to the commercial production side and from that perspective and the design control.

Kim: So that covers additionally auditing of sites that do manufacturing, auditing sites that supply us with raw materials, hosting inspections by FDA and notified bodies around the world. Fixing problems, I facilitate investigations when there is a deviation or an incident or if we have customer complaints and adverse reactions.

Kim: I facilitate the research and exploring for the root causes and mitigation planning. So it's always exciting in quality and compliance. But that's pretty much it in a nutshell.

Beth: Great, thank you so much. I'm going to let the students ask you some questions.

Kim: Sure.

Beth: OK, who wants to start? OK come on up here so that you're by the phone. Tell her your name.

Candace: Hi my name is Candace. We've done some research on the video that you have on your website as well as looking at some documents and transcripts of the video as well. So I was just wondering basically in your words what the basic steps are of developing a drug in the lab and taking that to people who need the drug.

Kim: OK, I'm going to use the model that I use and it's say for the medical device. The terminology may be different, but it's the same process for drugs. And that is in a sense, a five-step process. We have planning and feasibility, is the initial stage where we identify primarily with, starting with marketing, what are our customers' needs and their requirements. And we list those in a listing, a table in a sense, of questions.

An example of one could be you want a product that will eliminate this product and is long lasting, is biodegradable, OK? So in our phase two, then what we do is we design the functional requirements which would be selection of the materials that will meet our customer requirements, testing those materials to criteria that would prove their biodegradability and their stability, if one of the requirements is that it is long lasting. OK?

You would continue that research and, again the selection of the materials and development of the methods and the stuff, the methods to test those materials. Then what we call phase three, or design, development, verification stage. Then we move into our phase four area, and we'll call that our design validation. People are most familiar with that being our clinical studies.

So later obviously after we've researched on the bench, we go into humans. We need to verify that, again going back to the functional and the customer requirements, we can achieve those specifications. Lastly, is our commercialization stage, which is then transferring the product to, or from, our research facilities at small scale, scaling up into the commercial facilities which requires validation of methods, validation of processes and equipment and facilities, developing up your final labeling. Then you wait for the appropriate regulatory agencies globally to approve your submission. I know that's a quick overview.

As far as marketing, I'm still involved with a lot of the activities for the Durham products in that once you have proven in your clinical studies that your product is safe and effective and put a freeze on the produce design then we have what is finally called change control. Change control is something that I facilitate. It involves marketing, our research folks, regulatory affairs, and medical affairs people to accept every change after we've proven in the clinic. Every change has to be reassessed to determine, as an example, if we would want to add a new indication. Obviously, that would require new clinical, so we would have to go backwards into design phase four, to recreate protocols and execute that protocol in the clinical environment. So I hope that answers your question.

Beth: Thank you. She's coming back. She has another one.

Candace: I was also wondering when you test the drug on people, how do you choose which people to test the drug one, both healthy people and unhealthy people?

Kim: I'm not in the clinical medical affairs group and I've never written a clinical protocol so it's hard for me to answer that question. From a parity perspective, when quality gets involved, it's usually once the protocol is approved by the medical team, we ensure that the doctors are complying with that protocol and that they have valid data to support the carrying out of that protocol. So, my view is from a different perspective. Again, it depends on the indication. Typically, I would imagine that they want to use as broad a population as possible because that will go into the labeling at the end during the commercialization phase. Depending on what the drug is, you want to make sure that it's effective on the indication that you're filing for. You would go for that sick or ill population and different age groups depending on the disease that you're focusing on. But, that is by the medical and clinical team.

Beth: Anybody else have any other questions? Have you ever heard of open source science?

Kim: Open source science? No.

Beth: Or open source data? Meaning within the research process, the sharing of data using web technology with these blogs and chem informatics?

Kim: Oh gosh no. I'm too old.

Beth: That's OK. Basically, what we're looking at is called "open source science" which we also call "open notebook science." It's also called "open data." It's the sharing of data and findings before the end of the experiment in the chemistry lab.

Kim: In the lab for your verifications?

Beth: Right. We're doing that in the lab, and researching the molecules and doing the different tests on the molecules. That is very controversial, because when you share your data, you lose the right to patent. In the international community you lose the right to all patenting rights and then you have one year to patent in the United States but you can only get the United States patent, you can't get the international patents. So obviously it's not something that not many public or private companies do but it's something that academic institutions are looking at. You've not heard of it, so I'm imagining that people don't really talk about it at the corporate level.

Kim: Well, we have on our corporate teams, always someone from legal, for patent issues. As part of our phase one activities, patent search and patent development is part of that early stage.

Jen: I'm Jen. The five steps that you have - about how much does it cost for all five of the steps and about how long does it take for each step?

Kim: Oh boy. Cost? I don't worry about the cost. I worry about the quality. I can't answer that question. I really work on the commercial side, not the research side. Someone from our research team would have to answer that question. With respect to the phases, the phase one is developing your product's overall strategy, what indications you're planning to ultimately file - you develop for those indications your customer requirements - depending on the drug that could be somewhat simple or could be more complex depending on the number of indications you're filing for. With phase two, the development of the functional requirements is typically a little bit quicker because you can narrow down, based on the cures you've already used, so some of that is already one for you based on other research you have already done previously. Your verification in your stage three section, in your bench testing - again, you may have some earlier work or previously executed data that you can reuse. This generally includes some stablity so typically many products have a shelf life of up to two years so you'd have to do your development and stability which would then take two years to pick out all that data for verification. Your clinical studies, sometimes there's a phase one and a phase two. Your phase one is just the initial information and then you have follow up.

For the particular study that I'm working on now, for the device we have a five-year risk history study that we're doing for the FDA. So that can take a lot of time, your clinicals. To transfer the product, it depends on the complexity of the process. It could be a sterile injectable, which takes a lot of time because there's multiple sterilization phases. To get a validation, you have to repeat the entire process three consecutive successful times, so this may take you up to a year. You may want to choose one injection site, you may want to have a backup site. A lot of companies do that. So then you have to do all of your transferring validations in parallel. So that can definitely take you up to two years as well. In parallel, you're developing your labeling and you're filing with the FDA or other agencies around the world. A lot of the time you spend early on, and primarily with the clinical studies.

Jess: My name is Jess. Since you're on the commercial end of it, I was.

Wondering if you know that after all of this time and money is spent, do you know the percentages of drugs that companies put out that goes to other countries such as Africa?

Kim: Oh boy, I don't. That would put... you know our supply chain team would have to answer that. I'm not sure if you're interviewing other people, but our supply chain representatives in the business end would know that. You know, for my medical device that is right now currently marketed in Europe, Brazil, Australia, U.S. and Canada, exclusively. Some of the other products, I don't know the stretch of the market.

Kim: OK.

Adrian: My name is Adrian. You were talking about doctor follow up. How would you make sure that a doctor was using your product properly?

Kim: That's interesting. Now, from my perspective, from a quality perspective, what I do is I get complaints from the manufacturing sites for those products that I have responsibilities for. I do a quarterly trend analysis for on the categories of complaints. So if I see that there is a trend, upward or down, I open an investigation, and I work with the medical, and medical is usually the contact with the doctors, the practitioners. And we would ask these questions, if we think... and it's funny...this question you ask, because we have, I'll give you an example, we have a product that we had clogging. And it's a very difficult product to reconstitute, it's a lyathializate that is reconstituted, you have to let it sit for several hours before you use it, it's a injectable device, and if it's not to the exact instruction you can have problems, so you can have clogging. So we have followed up, through medical affairs, with doctors to understand their practices. Number one, are they doing the reconstitution, or are they having a nurse do the reconstitution? Because in many cases we have trained the doctors, but then they are using maybe a nurse to do the reconstitution piece. So it's just important for us to have contact with first the visual complaints that are coming in, and we'll be able to read and determine whether it's something related to the product or if it's something that's maybe related to practitioner use. OK?

Adrian: OK, thank you. I have one more question. How do you get a product from a doctor initiated, or say, get a prescription to an over the counter type of drug.

Kim: How do we do that... OK, I think that would first start from the marketing team. Because if we already have something on the market an RX, that would have to first be part of their strategy, number one, to change. Because we have to number one go back to the agencies, like FDA, and file submissions to get approvals to make that change. I haven't been involved in any products that we've done that, so that's somewhat difficult for me to answer. But I would say it would start with marketing wanting to take that position, and then we would work with our regulatory affairs team to make sure we didn't need to do any additional testing, that we would be able to back a design and research group, come up with the data required for a new submission to FDA.

Adrian: Thank you.

Beth: Which is more profitable, is it more profitable for over the counter drugs or are prescription drugs more profitable, from a company standpoint?

Kim: I would say that prescription drugs are more profitable. The only thing... I don't know from... my thinking is, I'm not a marketing person, but if I was thinking of moving my product from RX prescription to over the counter, it would probably be because of competitors. So we're trying to be competitive and move into OTC.

Beth: Who are your major competitors? Is it Johnson and Johnson?

Kim: We have, and it depends, Bristol-Myers-Squib, we have some products that we co-manufacturer and co-market with them. For my...for dermatology, it's a totally different group of companies, not the big companies that you might be thinking of. Some of the more popular drugs, like the oncology drugs, Bristol-Meyers-Squib would be one of them, from the oncology perspective.

Beth: OK, a follow up questions that Sarge is going to ask you...

Kim: OK.

Sarge: I was just wondering, how does the competition in this business work? It seems like if you are all producing drugs, that it would just basically come down to advertising.

Kim: You know, you hope that you are developing innovative products, not "me too" drugs. As an example, our dermatology medical device is a unique and new innovation in... all say the medication we have approved in the U.S. right now is for the lipoatrophy... if you're familiar with face depression for AIDS patients. It's actually a filler when people have advanced HIV and have lipoatrophy, they have a lack of facial fat...the product is injected as a filler, that does some amazing things. That again, is a very unique, there is no other product out there like it. And that last as long as this particular product does. So I think it depends on... is it a "me too?" and when you talk about new cancer and new heart medications, one of the other benefits is... it helps this but there is another product with less products, having to market it differently. It may be for the same indication, but there is less side effects, that would be how they would market the benefits.

Sarge: One more question. There's got to be some kind of reason behind why you research some kinds of diseases and the cures for them? Do you guys go to some sort of repository and look up what needs to be done, or do you do market research for what kind of disease is most...

Kim: You know, I can't answer that question. Again, I'm pulled on to projects once they... Now that I'm on the commercial side I used to work in research, still in quality. But I would drop into a team once the planning and feasibility had already been established. So, it was already on the table, we were beginning our formulation work and lab work that then quality would have contribute to and review and audit. So, that I cannot answer.

Beth: Has anyone ever stolen any formulas or anything?

Kim: What's that?

Beth: One of the things that we see when we look at open source science on the academic side, is that there is a big fear of intellectual property which we assume is protected in corporate science, because it is a closed system. Do you know of any examples, and you don't have to give us specific examples at Avantis or any other place where you have heard of stealing within the industry and passing trade secrets to a competitive company? You know, like somebody going and leaking information to Bristol Meyers Squib or anything?

Kim: Well you hear... I don't have a specific example but you hear of [throat clearing noise] individuals that are maybe with a company that have done research and they know the patent and.. they leave and go to another company and there's loopholes in all patents, that they would be able to then pursue a slight variation of what they did at the other company based on the holes in the patent.

Beth: Hmm.

Kim: That happens.

Beth: Wow. That's interesting.

Kim: Any other questions?

Beth: Oh... Matt has one.

Kim: One down.

Matt: Is the return profit a big factor in how you go about taking on your project?

Kim: It totally is...

Matt: Yeah.

Kim: You know, you would think yes, but I think it is also important that the company has a broad portfolio of products, so that their doctors and all their customers can go to one company for all their needs. So there may be some products that aren't as profitable, but because it broadens and it strengthens the entire portfolio, it would be a part of the overall strategy to do that.

[papers rustling, whispering]

Rich: Uhm, In your opinion...

Beth: Oh, you have to tell her who you are.

Rich: Oh. Hi, my name is Rich and my question for you is: In your opinion, do you think that any of the research, or marketing, or any of the things that your company develops would be able to help third world countries, like, at all?

Kim: Absolutely. We have one product I use... I just used last week. It's the flu vaccine. We have a plant in the Poconos in Pennsylvania, but it develops all of that, all of our vaccine products. So, absolutely.

Rich: But, is it in your opinion reasonable to conclude that it's available?

Kim: Available?

Rich: Right.

Kim: You know, I don't have vision of what products the company maybe has from a charity perspective contributed to different parts of the world. I don't know. I should probably find that out for myself because it is an interesting and an excellent question. I would hope they do that, but I'm... I'm not positive, I don't know.

Beth: Do you think it is a corporation's ethical responsibility to address...

Kim: Absolutely. Absolutely.

Beth: You do. OK. That's interesting. OK. Anybody else? Jennifer? Jenny, I know you want to ask a question. I see you bubbling back there. Come on down. Don't think I don't see the rest of you hiding back there.

Jenny: I guess it would be along the same lines as, like... My name is Jenny. Do you think it is more profitable to create drugs or medical devices generated towards the United States or is it more profitable to generate them towards other countries?


Kim: Well... I hate to say, but I would say for the US... My company is actually the largest pharmaceutical company I know in Europe and I forget what... you know... what number in line we are in the US, but it seems that across the industry, it is more profitable to... to sell drugs and devices in the US.

Jenny: And does that affect your decision on what drugs to make?

Kim: Oh No. No. We supply globally. All of our products.

Beth: What's interesting is that in the United States we seem to have a little bit more knowledge because medical knowledge has been made popular by magazines like Time and People, where the rhetoric of science, or that communication about science is more made accessible to everyday people. Do you find that it's true that in the United States people are just more proactive about their health care and more preventative measures and that that situation doesn't maybe exist in parts of India or parts of China where people are going to their doctor and saying "I want to try this particular medicine for my depression" or "for my problem." Do you think that the people in the United States are more proactive than other people?

Kim: Well, I have not visited those other countries and I don't know exactly the exact situation, however, I would say that in the US, we have availability of so much information from so many different avenues. You know, you mentioned magazines, but through the Internet, and everyone has access to the Internet in the United States. You know, be it your own personal computer, or a library, it's just exceptional that we have the ability to get that knowledge. So, I would say, because we are given that power, that we tend to... then obviously are more educated and more educated, at least to ask more questions, and... I think, even... Most of the younger generations are better using these avenues such as the Internet to get information and absolutely more proactively, the younger generation, but I think it's just that in essence being an American we have so many sources of information.

Beth: So, it isn't necessarily an issue of us having more money as a country, it is probably that we are more affluent in terms of knowledge and what we know and what we can find out through resources?

Kim: I believe that. Yes.

Beth: OK Great. Somebody else has a question for you.

Jess: Uhm, it's Jess again. I was just going to say, Do you think that it is really because of the United States having more power, or is it because the media markets fear towards us and we should have this, and we should have that, and we should have to worry about getting sick?

Kim: I think it's because of the media. I do. We're fortunate, I think. That's my feeling. There is just in some cases, I think, too much in the news and on the television. As an example, pushing the question of ask your doctor about this, ask your doctor about if you have this symptom. It almost makes people think that they need a drug, but in some ways that can be negative because it is in a sense putting thoughts into people's minds that are, in a sense, negative thoughts. Because many people will think, "I have a twitch here, I have this problem." So marketing is has the power over their audience and not everyone is obviously an optimistic thinker. You have people who may think they have a problem when they don't actually have a problem but, I think for the most part, the information that is out there is to give people the knowledge and the information that that they can make choices and ask questions and give them more power than a doctor over them. You know?

Beth: Any other questions?

Kim: Anyone, cause I have [laughter] to think first. Yeah, I know I am in the pharmaceutical industry but I try to think first. You know, eat right, exercise, do all the good things first.

Beth: Right. Right.

Jess: yeah.

Beth: OK. [clears throat] Sarge?

Sarge: Yeah just one more. Do you think that maybe the media scare had kind of boosted drug use, maybe?

Kim: Scare, what do you mean scare?

Sarge: Oh, kind of following off the last question you know how the media almost persuades us that we need drugs for almost every occasion. Do you think maybe that the people who can't think as well...

Kim: Oh no, I think part of that is because there are so many me too drugs.

Beth: Right.

Kim: You know, every company has a drug for this and that, some of your main health care issues. So I think that is really their focus, to get their name out there too because there are so many others just like them. But this one is better because, as I mentioned earlier, our products at Sonofi-Aventis are excellent but in addition have less of a side effect. And I think that's because of all the "me too" drugs that is what they have to focus on that there are less side effects with this particular product over this one.

Beth: When a chemist does a patent, does that patent belong to the company or does that patent belong to the chemist?

Kim: The company.

Beth: The company. So when they create the patent, and I've heard this from other chemists, they intentionally put loopholes in it so that if they do move on they can use it elsewhere.

Kim: Right. I mean this is the point I was making earlier.

Beth: Right. So that it is not that the loophole was an accident, they put it there on purpose when they designed it.

Beth: Does the company change?

Kim: I mean where they're working with someone that develops the patent and they know enough about it that there are ways around it. Yep.

Beth: That's interesting. Any other questions before we wrap up?

Rich: Yeah. It's Rich again. I was going to ask, are there any current affiliations with charitable groups that your company has connections with at all? Like the Red Cross or something?

Kim: I don't know. I'd have to go to our Internet site.

Rich: OK.

Kim: But offhand I don't know.

Woman 3: So we could access that information on your website?

Kim: You should be able to. But if not you should be able to ask questions through the site.

Kim: You know a question like that I think they could answer.

Beth: What do you see? How long have you been at? You must have been at Aventis before?

Kim: Well I was...my history is I was actually with another company.

Beth: OK.

Kim: But in research back in college in Pennsylvania and then I left, they closed down that facility and they moved to a different state. So I left and I went to Wyeth for a couple of years and then I came back to Sonofi-Aventis about a year and a half ago now. But overall, in service, I've had ten years with the company.

Beth: In that time have you seen a lot of changes? And based on the changes you may or may not have seen, what do you predict for the industry, you know just for our predictions and nobody's holding these to you. What do you predict that you think might happen in the future based on past indicators?

Kim: Well, there have been huge changes in my career with the company, and actually my mentor when I started with the company, he just retired and he was with the original company, the American company, and has gone through I don't know how many mergers. Maybe fifteen. It's just crazy. But he stayed within the company for his whole career. You know I worked for an American company and then they merged and they were a German and French company and then they merged again and they were even more global but French and French company now. But I see extremely different perspectives on different things. The biggest difference is obviously you're going through multiple mergers and before the dust settles and you truly integrate you have another merger. So it's quite difficult and when you're talking about global companies merging in different countries really that were in power I'll say or in control of the company and that changes hands it's very difficult to understand the culture.

Beth: That's interesting.

Kim: Because it's huge.

Beth: The intellectual property rites must get really confusing with all of those swaps.

Kim: Well, you know you lose, in the mergers too you lose people and sometimes you lose people very quickly and it can be a nightmare; you're left with new management, new philosophies and people that have the historical knowledge maybe aren't even in your group any more. It's very difficult. And I see for the future this happening more and more.

Beth: Hmm.

Kim: More mergers and my problem with, and again I'm on the compliance side, so my issue with mergers is we never really finish reintegration before another one, it just happens more frequently it seems and it is difficult to insure that your systems are completely understood and absorbed, in a sense, by all the new affiliates you're working with. So it is very complicated. So what becomes difficult is you may be missing someone on your team that you didn't even know you were supposed to involve on your team, as an example. It's becoming more complex and as companies become larger and more globalized it becomes more difficult because many times it's just cultural differences but additionally because in some cases you have systems that are compliant from the merged groups but then people aren't willing to change. If theirs was working well, and they've passed all their inspections, why should they have to utilize now a new process. So that I think is the challenge for the future is that we'll see more and more mergers and what gets in the way of research and development is just basic integration and some of the politics that come with it.

Beth: Well, our class has ended. I don't want anyone packing up yet it gets all garbled. What I've done is I have made a recording of our interview so that students can use it for their notes. If you are uncomfortable with that being made public on their blog, I can password protect it. So I will leave that up to you whether you want it accessible to anybody.

Kim: That's fine...

Beth: Is that OK? You were very careful not to mention any names of any products so I think you're.

Kim: Yeah, I didn't do that.

Beth: So you didn't do that at all. I was watching for it.

Kim: Names of drugs I hope.

Beth: Yeah you were very good about it. I'm always very careful about that when we interview people because I can put it under a password that only the students then could access so I will send you a link to that and if at any. We've interviewed people in the past who've asked us to remove different parts. I can edit any part of the interview and remove parts if you like.

Kim: Right.

Beth: If you think something's at risk. But thank you so very much.

Kim: No problem.


Beth: And we'll thank Candace's Dad for hooking us up with you. She got a big gold star.

Kim: Good luck to everyone and you're all going into pharmaceutical research I assume?

Beth: No actually we only have one student in here studying chemistry.

Kim: Oh, OK.

Beth: We are all students in an English 105 Honors class and we're learning the research process. Our theme this semester is looking at the way science addresses world problems. Chemistry specifically, how does chemistry address world problems.

Kim: OK.

Beth: So thank you so very much.

Kim: You're welcome.

Beth: Take care.

Kim: Bye guys.

[various goodbyes]

Beth: Thank you very much Candace, that was wonderful.

Kim: That was interesting, you guys ask great questions.

Beth: They're a brilliant group.

Transcription by CastingWords


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