Hi, and welcome to business concepts for life sciences strategy course. I am Deb Dauber, I have a PhD from UCSF and I'm currently a competitive analysis consultant. And I'll be taking you through part one of this course. Here are the course objectives. By the end of class today, you should be able to one, define strategy and how scientific enterprises use strategy. Two, identify the value proposition of a scientific enterprise. Three, determine key stakeholders for a scientific enterprise. And four, discuss how organizational context impacts budget and resource allocation. Let's start by defining what a scientific enterprise is. For the purposes of this course, we'll be using some scientific enterprise to describe both research labs in academia, as well as companies in a business setting, as an umbrella term. Because we know that you're interested in both settings. What is strategy? Strategy is a term that's often used and rarely defined. Either in the business setting or in academia. Strategy is how a scientific enterprise plans to conduct activities in order to achieve a set of overarching goals. Or put more simply, strategy is where the enterprise would like to be in the long-term and how they plan to get there. The purpose of the strategy is to help guide decisions, and establish boundaries on the scope of work. Or in other words, to make sure that the day to day activities are taking that enterprise in the right direction long-term. Now strategy may be formulated differently depending on the context. So for example, in biotechnology, the strategy will describe how the company plans to achieve their clinical goals, as well as their financial goals. Whereas in academia, the strategy may determine what research questions the lab wants to pursue and what grants they decide to apply for. There are two foundational concepts to understand when thinking about strategy. The first is value proposition. The value proposition describes the technology of that enterprise and the value that it has within the market of that enterprise. Second, organizational context describes the enterprise itself, what are its capabilities, its structure, its funding, et cetera. What are the limitations of that enterprise within the context of what they'd like to get done. Together, these two pieces of information drive the context in which a company or enterprise can form a strategy. I'm going to start by talking about value proposition in this part of the presentation, and then Sandy Ruggles will come in and talk about both organizational context and strategy in part two. So let's talk more about value proposition. There are three core questions that drive the creation of value proposition. The first question here is why? Why is the work important? What is unique about the technology or product being made? And finally, who has a stake in the outcomes? And importantly, what do those people value most? Let's start with the why. Why is the work important? Well, ideally, a scientific enterprise is looking to meet a market need. That's a gap, that something is missing from the marketplace. In the world of health, this could be a drug, a disease that has absolutely no drug to treat it. In the world of science, this may be an unanswered scientific question. There are a couple different forms of market need. One option on meeting market need would be to meet an unmet need. This would be an example, as I mentioned earlier, a disease with absolutely no treatment available today. Alternatively, the goal may be to build a better mousetrap. Perhaps there are treatments for that disease today, but they're not very safe. They cause toxicity and a company may set out to create very similar drugs but with less toxicity for the patients. Similarly in the generic market, a company may set out to make exactly the same product that's available already, but they can make it for cheaper, they will sell it for cheaper, voila! You have generic drugs. Here's an example of a company that was founded based on the why. Why is this important? Akashi Therapeutics is a very small biopharmaceutical company that was founded with the mission to develop treatments for Duchenne muscular dystrophy and other rare pediatric diseases. Let me tell you about Duchenne muscular dystrophy, it's a particularly debilitating form of this disease, it's hereditary, and hits boys only. It puts them in a wheelchair by their teenage years and they end up dying very early. Currently the only treatment for Duchenne muscular dystrophy is steroids, which are not fun to take and also slow the disease only minorly at best. Akashi recognizes that this is a need and their long-term goal is to be able to provide better treatments, or even a cure, for Duchenne muscular dystrophy. They're a why company. Our second question is what. What is unique about the technology? Now the first question I'm going to ask about the technology is, what is its efficacy? Does it work? This is a critical question and this is a pay to play question. Because if the technology doesn't work, the enterprise either needs to find a new technology or shutter their doors, because there's no progress forward with the technology that doesn't work. Clearly. But there are a couple other questions we can ask about the technology that help you understand if this is a good long-term strategy or not. First of all, what's the potential for portfolio growth? Is this technology a single drug to treat a single disease that's never going to grow to be anything more. That's a very small portfolio. But the technology may be a platform that can be used to develop many different drugs. Or it may be one drug that once it shows proof of concept can actually be used to treat many diseases. Those are both great strategies to build a larger portfolio in the long run. The second question is what is the competition today? What other enterprises have similar technology that may be used in similar ways? And how do the technologies compare to each other. Does the enterprise you're interested in have a technology that's an advantage in some way shape or form, relative to its competition? The third question is about barriers to entry for future competition. Does the enterprise have a patent or a world expert or a trade secret that makes it difficult for a future competitor to come in with similar technology and work towards the same goals. Or, is there going to be competition in the future? Let's take an example of a what company. And here I'm going to look at Catalyst Biosciences. Now you'll hear a little bit more about Catalyst later on, because Sandy Ruggles worked there early in her career. I'm just going to talk about when they were founded. Catalyst was founded as a what company with a technology platform of protease engineering. Catalyst scientists believed they had a great new technology that they could use to engineer or select proteases to hit novel disease targets. They were founded as a technology company because they were looking at a wide sort of diseases with one kind of technology. So we've talked about two different ways to start building a strategy. One is a need based strategy, or why. And the other is a technology based strategy, or what. Whichever way an enterprise starts, they need to ask both questions. So a why company needs to get to the what at some point early on. And a what company needs to get to the why at some point early on. And both Akashi and Catalyst should've done this. So Akashi founded to find treatments for Duchenne muscular dystrophy went out and identified the rights to compounds they felt would be promising treatments for Duchenne muscular dystrophy and are now working on developing those compounds. Catalyst started with an interesting platform to engineer novel proteases, reviewed a wide set of disease states, identified those disease states they felt would make the best targets for their proteases, and are now selecting and developing products in their market. So we've been talking about the why and the what, but those two together are meaningless if you don't also think about the stakeholders. Who has a vested interest in the outcomes of the scientific enterprise. And specifically, what do they value? What's important to them? As a little thought exercise, I want you to take a few moments to think about whether it be in a lab setting or a biotech setting some stakeholders that have a vested interest in the outcome of an enterprise. If you've been thinking about an academic lab, here's some example of stakeholders you may have been thinking about. They range from students in the lab to peer researchers outside of the lab, all the way to granting agencies that fund the work being done in the lab. And as you can see in this slide, I've started to group the stakeholders into sets of common interests. For instance, students, postdocs, and lab managers, can all be grouped together as employees of the lab because they all have a vested interest in the overall body of work being done in the lab, whether or not they're doing every last little bit of the research. I can even take a step bigger and group these stakeholders into internal versus external stakeholders, based on where they are relative to the lab. Now the grouping is really helpful because as enterprise creates its strategy, it may not want to develop a strategy for every single group of stakeholders. By grouping, it can set strategies for groups of stakeholders, instead. Making the work a little bit simpler. This complexity gets even more critical when you think about pharma industry stakeholders. As you can see on the lab, it gets very complex. Now we still have employees as a group on this lab. And we still have funders, although on this slide, we're now calling them investors. There's still the people funding the work being done in the lab. Now we have new levels of complexity, and I want to really zoom in on the customers group of stakeholders. Customers for the pharma industry could include providers, patients, or payers. And each of those groups have very different interests, with respect to the company and the drugs it's selling. And even within each of those subcategories, I can divide it down further. For instance, a provider could be a doctor or a nurse, or it could be a pharmacist. Or a provider could be a hospital or even a hospital system. So you can see this group of customer stakeholders is a very, very complex set of people and as you might imagine, pharma companies spend a lot of time thinking about their strategy with respect to each of those customer stakeholder groups. Why do we care about stakeholders? We care because it's their perception of the enterprise and the work being done that creates value. And each of these stakeholder groups value things differently. Let me start with patients, a drug company, with the drug company as the enterprise, the patient cares very much about the drug that they're buying. They care about the efficacy and safety of that drug. They care about the convenience of that drug. And of course they care about the cost and how much they have to pay for the drug. Think about investors, an investor cares about all those things, but they care about it on the portfolio level. They care about how robust is the portfolio, how much revenue is the portfolio bringing in today, and what's the stability and growth of that portfolio long-term? Employees on the other hand, care in some ways about all of those things, but they also really care about the mission of the company and what is being done. Because they spend a lot of time there, so they want to be excited and proud of the work that they do. They care about the culture because they spend a lot of time at that company every day. And of course, they care about the long-term sustainability of the company, as well. Because this is their livelihood and they want to make sure they're going to be able to pay their bills and take care of their family in the years to come. It's really critical to understand each of the stakeholders, think about what they value and think about how to communicate with them, when to communicate with them, and what to communicate to them, as part of an overall company strategy. So, let me recap all the different topics we've covered as part of the value proposition. We've talked about why is the work important. We've talked about what is unique about the technology or work product. And finally, who has a stake in the outcomes of the work and what do they value. Now some of you are interested in pursuing careers in business, so I'd like to give you some advanced topics, in case you'd like to do some more research on your own after this course. Much work is done in support of the development of a value proposition, including competitive analysis, market research, and stakeholder or customer mapping. In addition, companies often use tools such as the SWOT analysis to consider their value proposition and its strengths and weaknesses both with respect to their competition, as well as the market in which they're operating. In addition, the value proposition itself drives articulation of mission and vision, product or brand positioning, and messaging. All of which are really critical components of that company's strategy. Now I want to think, if you're moving into an academic lab, there are a lot of parallels to academia. So we're going to do a little thought exercise, think about your academic lab right now, and I'm going to pose you a few questions. First, would you consider your lab to be primarily need based or technology based? Is it a why lab or a what lab? Second, how do you think about the why's and the what's of your lab's research program? And third, who are the stakeholders that you think about the most? And can you think about ways in which you might address different stakeholders in different ways in different times? This concludes part one of our course today. Thank you very much for listening.