Our guest today is Dr. Moshe Rosenwein. He has a B.S.E from Princeton University and a Ph.D. in Decision Sciences from the University of Pennsylvania. He has worked in industry throughout his professional career, applying management science modeling and methodologies to business problems in supply chain optimization, network design, customer relationship management, and scheduling. He has served as an adjunct professor at Columbia University on multiple occasions over the past 20 years and developed a project management course for the School of Engineering that has been taught since 2009. He has also taught at Seton Hall University and Rutgers University. Dr. Rosenwein has published over 20 refereed papers and has delivered numerous talks at universities and conferences. In 2001, he led an industry team that was awarded a semi-finalist in the Franz Edelman competition for the practice of project management. Well, welcome Moshe. Thank you, Avy. And I'd like to ask you a few questions regarding your current position as head of management science in a pharmaceutical company. Sure. Can we start? Please. Okay. So, this is part of a course on innovation in project management and new product development project management. And the first question is, when does the pharmaceutical companies start to prepare a marketing plan for a new drug? The marketing plan for a new drug probably starts 12-24 months before it's actually approved by the FDA to be marketed. There's a lot of market research that takes place. And research takes place with both physicians, as well as patients, and in some cases, caregivers. And in addition, the marketing materials have to be prepared. And the marketing materials go through a lot of scrutiny. There's a lot of regulation in the pharmaceutical industry here in the United States. And any single piece of marketing literature has to be both approved internally and then submitted actually to the FDA. There's a branch of the FDA that actually reviews marketing material and gives its approval. So anywhere from 12-24 months, you're going to see the marketing brand team being formed and you're also going to see the sales team, if not the sales people themselves being hired, but certainly the sales leadership, beginning to plan the structure of the sales force, what the messages are going to be, what the customer segments are going to be, and so forth. Who is involved in the preparation of the marketing plan for a new drug in each phase of the project? So, I would say that thinking about the marketing plan, it's really two branches. You have the marketing brand team, which you might think of as really the planners. These are the people, if you will, with the conception, the vision. These are the folks that define the customer segments, the different messages that they want to put out. These are the folks that are going to do the market research, integrate the market research, synthesize it, and they're basically the visionaries, if you will, for the brand. Then you have the sales team, which is, if you will, the execution. The guys in the trenches. These are going to be the people on the ground, so to speak, that are going to be going into doctors offices and trying to give information and promoting the products. Now of course, we have also the rise of digital tactics. And I think the pharmaceutical industry in general is probably a little bit behind the Amazons of the world. In part, the margins in the pharmaceutical industry are such that for many years really, there wasn't a great deal of pressure on the pharmaceutical companies to use digital marketing strategies. But of course, as everything becomes a little bit more scarce and as other products go generic and so forth, even the pharmaceutical companies are beginning to explore digital marketing techniques as well. I've been involved somewhat in using things like YouTube, and Facebook and so forth, page search, as digital channels for marketing. How detailed is the plan by the time the drug is approved by the FDA? So, it is very good questions because unlike other products where you can say, for example, Coca-Cola, there's a new Coke coming in three months, stay tuned. We can't do that in the pharmaceutical industry. We have to be very, very careful and regulatory is a big deal. In every company that I've worked with in the pharmaceutical industry, regulatory is almost a constraint on the marketing and sales team in terms of what they can say, what they can do, and so forth. And so, there's a big difference between pre-FDA approval and post-FDA approval. So, one of the things that I've seen done pre-FDA approval is, because you can't actually promote your particular product since it hasn't been approved, what we do is what we call disease awareness. So, for example, particularly for some of the rarer diseases, and we see more and more products now coming out for rarer diseases or orphan diseases as we call them. A lot of the more general disease states, blood pressure, cholesterol, and so forth, and a lot of generic products at this point. And so the pharmaceutical companies are going to, if you will, where there's unmet need, whether it's oncology or whether it's just rare diseases. And so, you can do what we call disease awareness. So you can go into a doctor's office, and you can begin to talk to him and her about whatever disease state it is that you will ultimately be promoting in. And we do have a sales force that will go in and do these kinds of calls. But then once the product is approved, at that point, there's really a rush to go to market, right? Because we have a patent expiration and that's a big deal in the pharmaceutical company. There is a joke, I guess, as Shakespeare said, our truth is said in jest. But, there was a joke that if you're going to start a pharmaceutical company, do you want a chief medical scientist or do you want a lawyer? And the answer is you want the lawyer to protect all your patents and so forth. So, the patent is a really big deal. And every day that you're not out there promoting your product, you never get that back, because you ultimately will lose the patent, and at that point all the competition is allowed to copy your invention and sell the same product at a much lower price. And so, we talk very much in project management about the rush to get to market and how it's costly if even a few months elapse and you're delayed in getting to market, it's very true in the pharmaceutical industry. And so really, you want all your materials to be teed up and ready to go once the drug is officially approved. Okay. And who is actually managing the execution of the marketing plans and how it is monitored and controlled? The plan is really monitored by the brand director. And so the brand director is nominally a marketing person, but very much the brand director is actually a project manager. Because he or she is not actually creating the marketing material, he or she is not actually going into customers offices and selling, he or she is really if you will monitoring the project plan and the new product innovation plan. And so, the marketing director is looking at weekly reports around sales, typically the brand team will have one person responsible for professional promotion, which would be the doctors, and then another person would be responsible for the consumer promotions, which would be things like the digital or television. And then of course there's the sales team, that the brand team has to work very closely with because they're typically in different organizations so the brand director doesn't have direct control over the sales team, but on a project basis is really the project manager for the salespeople. And so, it requires working very closely if you will with the functional manager of the sales organization, which is typically a vice president, and really getting the co-operation of the sales vice president to buy into the marketing plan so to speak. To hit these customers with these messages, and so forth, and to go to these doctors with certain frequency and so forth. And frankly, we see if you will as we talk about in project management, we frankly see sometimes the struggle, between the brand's director, and the sales vice president, where the brand director is saying, "We need more calls to specialists." And the brand director might say, "Well, you know we try to get into the offices, but in the States it's very difficult for our sales representatives to meet with the doctors because there are a lot of restrictions.", and so forth. So, there is a certain tension between the marketing and sales teams very often, and the marketing director has to manage that. Again, we are very fortunate, I think to have data across the industry. By that, I mean we not only see sales for our own products, but we also see sales for the competitors. And we can actually look at the physician level, on a weekly basis and see which doctors are writing our products and which are writing the competition, and that allows the brand director again working with the salespeople to maybe tailor things a little bit. Quite frankly, working on the analytics area, part of my job is to sort of if you will calm everybody down, so that they don't get too excited with weekly oscillations in the data because, why did it go from three prescriptions to four prescriptions? And you and I would say, "Well, it went from three to four because it didn't go from three to two." I mean, there's really no great reason. But the point is that there is weekly data that can be examined, and every quarter actually the sales force has certain incentive goals and those goals are evaluated as well and updated every quarter. So, that would be another point in time that evaluation and monitoring takes place. Thank you Doctor Rosenwein for willing to share your knowledge with our students. Sure. This a course on a new product development project and if you have any important issues you like to tell our students about, please do. Well, the pharmaceutical industry really is high risk high reward. So, here in the United States, it's interesting they did a survey of industries, and it seems like the pharmaceutical industry is about as popular as the tobacco industry, which is a little bit ironic because I think that at least on the surface, two industries are sort of at different poles of the axis so to speak. But I think, and again not to sound sort of so pro-industry or anything like that, but there are many times that a product almost gets to market and then fails. And actually, I tell my students an example because we talk about project management and some of your questions are very relevant to what I want to say, which is at what point do you proceed with a certain task? And so for example I worked for a company, and we were working actually on a blockbuster for diabetes, and we were in a competition with another company, and two chemical compounds were very similar, or so we thought, and the other company got approval, and we thought, oh for sure, it's imminent that we're going to get approval. And in the interim, we actually hired 500 people to form a sales force for this new diabetes product. We thought it was going to be a blockbuster. And in fact, for the other company it's turned into a billion dollar product, so it's turned out to be a very big commercial success for sure. As it turned out, we did not get FDA approval. Now, interestingly enough they got the approval in Europe, I was working for a European country at the time, so I you know, these are government agencies and things happen. So, apparently, it's safe for Europeans but perhaps not for Americans. And now, we're stuck with 500 person sales force. On the one hand, we wanted to have everything ready, because we thought the probability of approval was 98-99%. I mean I still have a tote bag with this drug that never got approved. You know it's a logo. And so, we talk about in project management a predecessor constraints and so forth, and we didn't really wait for the FDA approval to happen. We jumped the gun a little bit, and we had 500 people that we didn't know what to do with, which is not such a good thing. I mean, eventually, in a big company, you can sort these things out. But seriously, there are risks in the pharmaceutical industry, and I think in general as project managers, I think sort of always remembering that when we talk about probabilities, there are tails. And sometimes, the unexpected really does happen, and we can't always guard against risks and mitigation plans and so forth. But still as project managers, we always have to leave open the possibility, what happens if the FDA doesn't approve the drug? We all think that it's the best thing, but things happen in life. And I think that would be something for project managers just to keep in mind, that the probabilities of certain events or be it small sometimes do happen. Thank you so much for the insight, and for everything you've told our students. Thank you. And I really appreciate your help. Thank you so much. You're very welcome. Thank you for inviting me to be with you today.
