How Vaccines and Other Drugs get to Market with Susan Goebel

Intro: Hey, everybody. Welcome to episode 127 of How I Built It, the last episode of season six. I am so excited to talk to Susan Goebel today. Now, she is very different from the people I’ve talked to so far. She is a BioScience coach and expert. She has information on marketing intelligence, and she works with prescription drug companies to bring their new drugs to market. She has experience in the full stack from doing the lab work all the way up to lobbying governments and everything in between. I thought this was such an interesting conversation. While it doesn’t directly relate to small businesses, there is a lot of stuff to take away from this conversation. I could have kept talking to Susan for hours, I find this super interesting, and I hope you will too. So as we wrap up Season 6 and go into a short break, I hope you like this episode with Susan Goebel, which we’ll get to in a minute after a word from our sponsors.

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Joe Casabona: Hey, everybody. Welcome to another episode of How I Built It, the podcast that asks, “How did you build that?” Today my guest is Susan Goebel, a 20-year veteran bringing products to markets around the world and an expert in BioScience business development. Now she’s a consultant and coach in the BioScience field, and I’m excited to talk to her today about what it’s like to bring products at that scale to millions of people. Susan, how are you today?

Susan Goebel: I am good, Joe. I’m excited to be here as well. A lot of people don’t understand the process of what it takes to bring that product to market, and I got to say, when you’re sitting there at the dinner table, and you’re watching the news and people are going “Look at this great thing that this scientist made,” in my head I’m thinking “That’s a good 10 years away.” So, let’s learn about this.

Joe: That’s fantastic. I’m excited to talk about that because I’ve gotten a little bit of insight. My father in law is in the R&D field for a large pharmaceutical company, so he’s told me what the process is like. But why don’t we start with a little bit about who you are, and what you do?

Susan: Great. OK, so 20 years and I have had the pleasure and the privilege, I would say, of spanning a whole bunch of different areas within my career. I started out as a scientist bench top level, and then I moved from there to project management, and from there running divisions, co-founded a company– It’s been everything from lobbying to full commercialization successes, as well as failures. You’ve got to remember and celebrate those just about as much as the wins, and doing it across multiple regions around the world.

Joe: Wow. You have basically run the gamut. You started off on the front lines on the ground level as a scientist, and then you went up to lobbying. I am excited to hear about a lot of that stuff. Today you are leveraging your background and your experience to help other people bring new medical solutions to market, is that right?

Susan: That is right. There are a lot of people, whether they be doctors or veterinarians, who have the experience in clinic to go “I’m seeing a lot of whatever the problem is, and I think I have the best solution possible to help the health of my patient and give them the best quality of life. But I’m an MD or I’m a DVM, I don’t know what it takes to take my product and make it a success.” That’s where I come in.

Joe: Nice. That’s fantastic. I think that’s an important aspect. You’ve got the implementer or the person who is creating this product, but as a developer myself, I always find that there’s a disconnect between me creating the product and then me being able to bring it to the right audience, which can be difficult, especially when you’re so close to the product.

Susan: Joe, you are absolutely right. We get so emotionally invested. I’ve had a couple of my clients, and they call it their babies. It’s not the four-legged furry kind, they’re not the two-legged kind, but these ideas because they really– They come from the heart. A great example of this is that I had a colleague who is developing a unique product. Smart guy out at the University of British Columbia, and he and his wife– The wife is a pediatrician, and she was encountering a number of kids whose kidneys were shutting down because of a bacterial infection. She was lamenting one day about the life these poor kids have, and how in some cases it’s a very painful death, and “What can we do about this?” The husband went out the next day, and he goes for a run, and on the run, he has this “A-ha” moment. The bacteria that that’s causing all this doesn’t even come in humans. It comes from cattle. So, “Why don’t we create a product to treat it in the cow? Then we don’t ever have to get to the human side of things, and those kids can be safe.”

Joe: Wow, that’s incredible. As close as I can be to the web applications that I create, I imagine that the people who are coming up with life-saving technology or breakthroughs are a lot closer. Why don’t we talk a little bit about your process? You’ve had the experience of working in the lab and of talking to the people and the government organizations that you need to talk to get this to market, and now you’re consulting with people through this process. What does that process look like? If I came to you with an idea today, to say, “I’ve got this great idea that’s going to be huge in the medical field.”

Susan: Great question, Joe. That’s awesome, because if you came in and you said “I’ve got a problem that I think I have a solution to,” the first question I’m going to have to ask is “Have you protected your idea? Have you patented it? Is it any copyright, patent, industrial design? There’s a whole bunch of things that we need to do.” Or in the case of say Coca-Cola, which everybody’s usually familiar with, “Do we just keep it a trade secret because patenting can be expensive?” So there’s some thought process that needs to go into that and plan around that, and once you’ve gone past that stage, you’ve usually got an idea of the competitive market and where your product fits. Once you know that then we can go on to go, “OK. If I have a solution to a specific problem and this problem I know I can solve, I know that there might be one or two competitors out there, but I believe that I have a better mousetrap. Then let’s see if I can develop it.” Now, that can be a whole lengthy process in and of itself. Then “Let’s see if I can develop it, can I manufacture it at a larger scale? What are the regulatory compliance issues I’m going to have, and what country am I going to go into?” Because that’s different depending on the country that you want. As an example, Australia is an island, and so it’s very protective about what it brings into its country. You not only have to go through the regular regulatory approval processes, like in the US it would be FDA for example, or in Australia, you’d have to do the equivalent of the FDA plus an import security process as well.

Joe: Gotcha. Wow.

Susan: All of that to say that sometimes, in the case of the doctor that I told you about and the pediatrician, ten years had passed by the time it got approved, and the marketplace had shifted, and all of a sudden you no longer have a place to put your product.

Joe: Wow. My father gave me a little bit of insight to this, but we talk about how expensive medical stuff can be. Stuff is, of course, the scientific term here. But ten years getting patents which are expensive, developing it, which is expensive, manufacturing and going through the government approval processes is expensive, and then by the time, it gets to market there’s not even– There’s nothing to do with it. So, what happens in that case? Once it’s to market you can’t do anything with it, what do you do? Do you still have your patent, or is it just back to the drawing board?

Susan: That’s a great question. Unfortunately then the patent, by that point in time which has, depending on how you calculate it a 17 year or 21-year lifespan, is already half gone. In some cases, you can try when you have patents and experience to license it to somebody else, but you don’t have a lot of patent life left. If the market doesn’t want it, unfortunately, it’s not going to be a product that is going to be viable commercially. So, you have to go back to the drawing board. You have to work with whatever the evolution has become. I would say that for anybody listening to this, if they’re spending the time to put that thought process in up front, that you also have to make sure you’re keeping in touch with the market and how the shifts and the changes are going so you know whether or not you need to make a shift or change yourself in the strategy. Don’t get too married to the strategy.

Joe: Yeah. That makes a lot of sense. This audience traditionally is people who work on the web, or smaller scale physical products. We always talk about, “Make sure to put out as fast as possible that the minimum viable product.” It’s just simply not feasible in this case. So, is there things that you can do in your research process to maybe soften that blow or make sure what you are bringing to market will be accepted by the general population, or we’ll have a fit somewhere?

Susan: There are things that you can do, and I would say the fun part is that in real estate, they talk about “Location, location, location.” So in planning and in pharma, I would say it’s “Planning, planning, planning.” You need to put that thought process in upfront first, because if you’re going to go down a pathway where in 100 drugs, for instance, that may come to market, one will make it all the way through, and it’s not a minimum viable product. You have to have full formulas and expectations, whatever you’re doing in the trials with people, you’re doing exactly that when the product is fully approved. There is no minimum viable product when it comes to pharma. It’s an entirely different beast for that. If you don’t know what the various steps are and the processes are from a regulatory perspective, and you haven’t dotted your I’s and crossed your T’s or even know what those are. That’s a problem. So step one, plan. Because you may find that there’s something in that pathway that is a hurdle you can’t overcome.

Joe: Yeah, wow. Let’s back up a little bit, because again, what you’re saying– I’ve heard a little bit about from my father in law. But if we’re talking specifically about pharmaceuticals, there’s a whole long process. There’s the patent and the idea, and then there’s the trials, and the double-blind study, and the– What’s the path for a drug to make it to market?

Susan: Let’s take the example of the evening news. You see the evening news, the evening news goes into a University usually in a setting and says, “Here’s this researcher that’s come up with this great idea.” OK. In order to get to that great idea, there’s probably been years of research alone, maybe five years of research. OK, so now we say that the scientist has the actual plan in place and they’ve got, say, a small molecule that they want to bring to market that’s going to target a very specific disease. OK, so now they’re going to need deep pockets because the total process from a dollar perspective to bring a new drug to market, it can be upwards of– I mean a “B” when I say this, a billion dollars.

Joe: Wow.

Susan: Now, there are ways to make that not a billion dollars, but it’s still going to be several hundred million dollars in order to bring that new product to market. That’s a lot of money. So next phase, go get some investing. You’re going to need people to come in and help you because it’s a long process. Let’s assume that you’ve gone in next and you’ve done a trial, proof of concept. Small animal molecule in beakers, labs, whatever that needs to be depending on the planning stages that you’ve done. OK, so that’s probably taken you another year. Now you’ve got proof of concept, and if you’ve made it past that stage, I want you to give yourself a really big pat on the back because at this point half the products have failed out of those 100.

Joe: Yeah.

Susan: Now, you’ve done that, assuming you still have funds available you can go into the second phase. But now you need– Any product that goes in really has to be your final formulation. Now you also have to be able to test all of the raw materials, and you have to be able to test the final product, even something as simple– This was a big eye-opener for me when I went into the manufacturing side, the water that gets used. You can’t go out and use the tap water, and you have to have water that meets very special requirements. Rooms that air is extremely clean. It’s all about protecting the product so you can protect the person or the animal, wherever that’s going. OK, so let’s say you make it through phase two. You’ve got all your I’s dotted, and all your T’s have been crossed, now you have to go into phase three. Phase three usually is your final licensing, and depending on what your indication is, now you’re looking at another two to three years to finish the trial because you’ve got to recruit the patients and you’ve got to recruit the physicians, the clinicians, the veterinarians, whatever it winds up being. Probably at this point, you’re down to about 20% that have actually made it through, so those 100 that you saw on the evening news, 20 have now made it this far. Now you’re getting another three years, now you have to go another year before the data comes in, and let’s say that’s all you needed before you submit to the regulatory agencies. Depending on the agency itself, once you submit the document, the clock starts ticking. Different agencies, different timeframes. In some cases it could be six months, once upon a time in some countries, it was three years before you’ll get an approval. If they ask a question, then the clock starts over once you submit your answer. All of this time, so you’ve got a window there where you’re not even doing anything. That’s where you want to start your marketing. You want to start your commercialization processes, your lobbying. You get your payments plans, your insurance companies, all these stakeholders onside and make sure it works. Then the day comes where you get your final “Yes” or “No” from the regulatory agency, and that’s where it’s usually one or two out of the 100 that make it that far.

Joe: Wow.

Susan: I’m exhausted already, and now I’ve got to go out, and I’ve got to sell it.

Joe: So we’re talking about ten years, maybe 10-12 years from research to market depending on how long it takes for the regulatory agency to come back, assuming they have no additional questions.

Susan: I’ve never seen that happen, by the way.

Joe: I’d imagine they probably come back with several questions. I had questions on my first trademark, and that’s like generally benign. So I imagine that they are probably a lot more stringent. You said maybe one to two of those initial 100 drugs or products come to market, so the evening news here, they hear a story and they want to report it. This is a little bit tangential, but what we’re seeing on the news, they’re making it seem like it’s so close, but it’s a decade away.

Susan: In a lot of cases, that’s true. Now you will see things on the news that talk about pharma products where they’ve finished the phase three trial, and that’s when they’re talking about it. It depends when the news report comes out, are they talking about the basic research at the University? Or are they talking about the final product and the clinical trial results and all the great news pieces that have already taken place? When you hear it on the news, you need to put some thought into “Where is it in the process? Is it right at the beginning, or is it close to the end?” I would add, having spanned both the human health world and the animal health world, that they are different again. Because recruitment in human trials takes a lot more time, whereas if you wanted to develop a product for a herd of cattle or dairy cows or something to treat some disease there, recruitment of the herd is usually more up to one or two stakeholders as opposed to each individual cow having an opinion.

Joe: Right. That makes sense. What does that look like, when you’re about ready to enter a trial? Is it you talk to doctors, and then they look for patients that fit and ask their patients?

Susan: Yes. Now, that’s a very general process. There’s ethics boards, and approvals, and regulators that all have stakeholders and involvement to make sure that anything that goes into people is as safe as it possibly can be, and has had as much smart minds around the table to ensure that the thought process has gone into it. There’s no more accidental thalidomide or anything like that coming out.

Joe: Gotcha. That makes sense. Are things–? Maybe this is too specific of a question, but I’m just generally interested. Is the general mental health of the patient, like if they are too emotional, like “I’ll do anything to help cure this disease,” is that taken into consideration? Or does the doctor usually vet that before he presents an option to the patient?

Susan: That’s a great question, Joe. Not a lot of people ask that, so kudos to you.

Joe: Thanks.

Susan: It’s up to the physician who they enroll, but they are given a list of criteria. “Here’s the specifications, if the patient is this or has this, go ahead and talk to them about it. If they have this or that, then you need to exclude them.”

Joe: Gotcha. Again, that makes a lot of sense. We got a pretty high-level overview, and maybe we got into some pretty good specifics here of the process of bringing a product to market. I haven’t asked the title question yet, which is, “How did you build it?” But I feel like we’re talking in this nebulous space where we’re talking in the abstract, and I do want to ask you about the lobbying side of things because this is– I’m in America, and we hear all sorts of things, mostly negative, about lobbyists. It’s a very interesting process to me. So, could you unpack that a little bit? Like, what does that look like?

Susan: Sure. I’ll take a step back, Joe, if I could. Just to the manufacturing side, just for a moment.

Joe: Yeah.

Susan: Whether you’re doing a drug or a biologic or a device, and those are very much three key terms in the industry, because they have three different processes that are involved in them. It takes specialized experts in order to do each of those. If you’re doing a drug or you’re doing a sterile device, or you’re doing something that needs fermentation capacity, each one of these is done very differently, and that’s only a handful of a myriad of different ways to bring products to market. So it’s a little tougher to say it’s one or the other, I had worked on a project once where it was plastics manufacturing, and then you’re embedding the drug directly into the plastic. That’s an entirely different process again, because now you’ve got molds and dyes and casts, and you’re doing an embedding and extruding and all of these sorts of processes. It has nothing to do with the fermentation or growing anything that makes it secrete, or whatever. Or collections and harvesting, which is very much a biologics process.

Joe: Right.

Susan: I know we didn’t get very much into that little nitty-gritty detail, but there’s certainly lots that can be done and talked about from that perspective. I had to go to your lobbying question, a very similar thought process, and I’m sure that you and I are not alone. “Lobbyists. I don’t know, are they good, or are they bad? Politicians, are they good, or are they bad? I don’t know.” But it was an eye-opening experience going in and being a registered lobbyist for a while. To the amount of effort that these individuals who are the politicians do take, and the care, and how hard they work. I could not imagine doing their job at all. I would not want it. We were up, and we would go to the Hill for days at a time, so you’re literally going to 15-minute power meetings, and you’ve got at least 10 of them booked in a day because we didn’t live in the same town as the Hill was. So you’ve literally got these 15 minute– Assuming that nothing chaotic had gone on. Overnight one night when we went up to lobby there was the opposition party, and the opposition party had decided that it wanted to throw something as a matter of parliamentary procedure in place. All of a sudden, your meetings are all gone because now the politicians are very much involved in the bureaucracy, and the in-fight, and the “What’s this little piece mean? How does our party feel about it?” And you’re like, “But I really would like to save some kids.” They’re like, “We know. So we’re going to do our best to try and walk with us.” There’s this building over here, and that building over there, so you get these little 15 minute snippets as you’re going from this place to that place, and you’ve got to get your elevator pitch down properly and be able to address the questions and develop the key messages. Even though you’re talking directly into the politician, it’s not likely the politician that you’re going to be continuing to develop the relationship with, and it’s usually their chief of staff or someone else. So at the end of the day we had a product that after five long years of lobbying, we were lobbying on one side and we had another party that was lobbying on the other side, and that association had a much stronger lobby than ours did, so they won and we didn’t get the funding.

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Joe: This is a very tumultuous process that could basically fail at any moment. You said it, 98% if we’re looking at 100 of these products, 98% are not going to make it to the market because of something. So, let’s then talk about something that has made it to the market. It’s gone through the research, the trials, the investments, the lobbying. It’s now on the market. What are the steps once a medical product is approved, and you can bring it to market?

Susan: If you’re in the veterinary field, that’s pretty much it. Now you need to go out, and you need to sell it. You need to sell it to the associations, and you need to understand the distribution channel. You need to get your message out there, and usually you’re using your– I’ve heard the different terms “Alpha marketers,” or “Key opinion leaders,” “Early adopters,” these sorts of people in order to make that a success. On the human side of things, it can be a little more complicated because now you have insurance companies involved. Are they going to go through another approval process? Is the government going to pay, is the insurance going to pay? How do you determine if you’re selling the drug–? This is always a fun one if you’re selling the drug in more than one jurisdiction you need to make sure that you’re following all the rules and you’re not giving favoritism to one jurisdiction over the other, because there are certain rules against doing that. Which is part of where the third world countries, they have so much trouble in paying for the cost of the drugs, because there are these strange barriers and rules that companies don’t want to work around. They want to comply, but they also want to be able to save lives.

Joe: So for example, you can’t sell a drug in the United States for a $1,000 but in third world countries it’s $100 dollars or something like that. Because it’s more cost affordable, or–?

Susan: Not unless there’s some special arrangement, that would be government lobbying, that would get that done. Special funding, so if you had assistance with the Bill and Melinda Gates Foundation as an example, they do a lot of stuff in third world countries with access to drugs and whatnot. Lobbyists are not all bad. Depending on the skill set, you’ve got to try your hardest in order to make a positive impact in the world. I was talking to a group of people one day, and they were heading over to the United Nations to talk about anti-microbial resistance because there were certain things that some countries were doing that other countries were not, and they wanted it all to be as harmonized as possible. Which is a very long process, trying to get countries to agree, let alone getting politicians within one country to agree. It’s a fascinating process in and of itself, and it’s certainly not straightforward. It’s not like– I’m launching a digital product called the BioScience Boardroom, and in this product, it’s a mastermind group. I don’t have to go through a lot of regulatory processes, it’s about bringing this knowledge and expertise to people who want to understand the process have an idea of something they’ve discovered that fits their clinical application and solves a problem, but “What do they do with it?”

Joe: Yeah, absolutely. Let’s talk about that a little bit because we are mostly digital builders here in the How I Built It community. Do you know the platform that you’re using for your digital product? Do you know any of the– Are you using WordPress or Wix, or are you using teachable or anything like that? This was not prepared, by the way. This is off the cuff. So if you do not know the answer to this, I wouldn’t expect you to.

Susan: In preparing some of this I honestly think I’d rather go back to splicing DNA, it’d be a heck of a lot simpler than what you guys do, honestly. ClickFunnels is what I’m using. I do have a website that’s powered by Wix because I started out with the free version and thought “That’s easy enough to do,” and I had tried WordPress in the past and I was not very good at it. It took me a day where it probably would have taken somebody who understood the terminology like five minutes to do something simple. So it’s been a longer process than what I wanted, but I’ve got these clients that have this problem and when I talk to the business development experts and the people who are the angel investors for them they go, “We get these people, and they come in, and they want to pitch us their product, but they’re not ready. They haven’t put the thought into it.” OK, so now we have a blue ocean. I have a skill set that I can fit to allow that understanding of this process if I can provide a digital product, a place for them to go and get this information, then I can do my part as a business expert in this field and in this area to move it along. Now you’re doing the interviews, and the building of the site, and drafting the text, and doing the beta testing, and oh my goodness I really would rather bring a drug to market.

Joe: I am a little bit glad to hear that as a web developer myself because clearly, you are much smarter than I am, but I’m glad that I have a skill set that that is valuable. That sounds super interesting, so I’ll be sure to link that in the show notes, and we’ll get to where people can find you in a bit. But I do want to ask you, wrapping up as we’ve covered a lot of ground in about 25 minutes. But then we talked a little bit about what you do and how you did it, what are your plans for the future? Are you going all in on the BioScience Boardroom or are you going to continue to be boots on the ground for people bringing medical products to market?

Susan: That’s a great question, Joe. I would love– My goal frankly with the BioScience Boardroom, if I could, I would love to help 10,000 BioScience wannabes or entrepreneurs and inventors to be able to have that understanding of “This is what it takes to get from concept to commercialization.” That would be my ideal golden scenario, and I’m going to work hard to do that this year. Out of that though, just like the 100 only became one, probably only 1,000 of those would ever go on to do anything, and I’d respect that. Even out of that 1,000, if I could help 100 of them to work a little more closely with me like I do with my current products, my current clients, to help their products get to market. Or be and out-license or joint venture or whatever it is that needs, to be able to positively contribute to animal and human health, I would love to do that. So, I’m going to do both. I’m going to do the BioScience Boardroom which is a lot of bringing experts and the inventors together, as well as continuing with my current clients and bringing their products to market to make sure that we can positively get people back to health as much as we can, as well as animals.

Joe: Yeah. That’s fantastic. I like the sound of that. So, I’m going to ask you my favorite question now, which is, do you have any trade secrets for us?

Susan: Hmm, trade secrets. Oh, my goodness. Don’t tell anyone, are you ready?

Joe: I’m ready.

Susan: OK. There is a lot of really good free stuff out there on the web. Use that first to do the planning.

Joe: Awesome. That is a great piece of advice. There’s a lot of really good free stuff on the web.

Susan: Hey, Joe.

Joe: Yeah?

Susan: Shall we tell your listeners that that’s true for any product they want to bring to market?

Joe: I think we should. That’s true for anything. Look for the free stuff, and then you know what you need to pay for.

Susan: Exactly, and do the planning. Do the planning and know your competitive marketplace. Know where you fit and know where your niche is, know who your customers and your avatars are going to be.

Joe: “Know who your customers and your avatars are going to be.” I think that’s also a great piece of advice because a lot of– I don’t want to generalize the folks in my field, so I’ll speak specifically about myself. I know other people feel the same way, is I always took a very Field of Dreams approach to marketing, “I’m going to build something good, and then people will come.” But that’s just simply not the case anymore, you need to understand who you’re talking to and you need to talk to those people because those people want to know that you understand them.

Susan: Exactly. Great advice. Did you hear that everyone? Great advice.

Joe: Thank you. You said, “Hmm, trade secrets.” I think I’m going to start adding a ding when people say that in post-production because that’s like my favorite part of the show. Where people go “Trade secret.” I want to make a compilation of that. So thank you, I didn’t tell you to do that, but I’m sure glad you did. Susan Goebel, thanks so much for joining me today. Where can people find you?

Susan: Joe, thank you. It has been a pleasure. You are just a lot of fun to be around. You guys can come over to the website, and we’ll put the link for it into the show notes if that’s OK.

Joe: Absolutely. For our listeners, I think I want to make sure it’s SusanGoebel.ca/HowIBuiltIt is the URL I have? Of course, it will be in our show notes over at HowIBuilt.it as well. Susan, thanks so much for joining me today. I appreciate you taking the time.

Susan: Thank you so much, Joe. I appreciate that.

Outro: I want to thank Susan again for joining me on this last episode of Season 6. Again I super-duper, I don’t know if you could tell during the interview, but I enjoyed it. I love hearing about the process. We talked a bit about how she built her marketing website, and some of the tools she’s using there. Then her trade secret is something really important for everybody, that I think that everybody can take away from that, which is knowing your customers and your avatars. Create a customer avatar. In development, we call them “User stories.” “Who is the perfect person, the one person you’re talking to?” I think that’s important. So my question of the week for you is, “What is one customer avatar that you want to create?” Let me know by e-mailing me Joe@HowIBuilt.it or on Twitter @jcasabona. I want to thank my sponsors for this week, and those sponsors are Soshace, Plesk, and Pantheon. In particular, I want to thank Plesk and Pantheon because they sponsored the entire season, and so all of my sponsors make this show possible. But the backing that Plesk and Pantheon gave me helped me take this show to the next level by hiring a new editor and a new transcriber and do things well. So, I hope to continue to grow this show for next season, season 7. We’re going to take a few weeks off, a little bit of a break. I might release one or two bonus episodes in that time, but you can look for season seven to launch at the beginning of July. If you liked this episode, feel free to share it with a friend or family member, and until next season get out there and build something.