MAINTAINING A LONG-TERM VIEW

BioPharm: How can a start-up company best digest this type of long-term view?

Mottram: Building strategic capability is a key, not just for small companies but also for the larger companies. We tend to be reactive by nature, especially in this industry. So if you are a start-up company, first understand where you fall within the industry and what problems your product can solve that others cannot. Think about the product's life cycle. It can take several years and lots of investment to move forward. How will you create value? This thought process demands a longer-term view—even for just one product. Companies need to think about what the world will be like by the time their product reaches the marketplace.

Winning companies are distinctly different from average companies. They don't just invest in traditional market research. They invest in building top scientific leadership, capable of deep thought around what the future will hold; they bring customer and clinical insights together to address unmet needs. But, they don't jump into responding to an unmet need. Instead, they think thoroughly about what is needed and where their strength lies. This is an important element of success because when we talk about sustainable value over time, ultimately, the value is measured by the healthcare outcomes generated for the healthcare system.

For the business, the value also lies in what the business can produce in a successful way, so that it can stay in business. It therefore becomes important to marry the science and the business inside the company for a longer-term view and to become much more targeted in thought process and strategic thinking.

At this stage, the company should no longer be focusing on launching the next product, but rather, about what the impact of that product will be. This approach forces a portfolio view—even within a therapeutic area.

ADDING THE BUSINESS ANGLE

BioPharm: Introducing a business element to the R&D side can be complex. How can a company marry these two things together, as you mentioned, and demonstrate that both remain efficient?

Mottram: At the front end of the product development or innovation cycle, the focus is on finding the right product candidate to meet certain unmet needs in the market. Those needs should be driven by a clinical-need and market perspective because there are a million companies potentially trying to go after the same need. How do you make that area yours? What's the opportunity? What outcomes are possible? In the end, science rules.

By that, I mean it's not just about science. But if a company doesn't get it right, doesn't get that scientific foundation right upfront, then it won't find a way to differentiate itself in a truly affective way. Different factors come in to play, including understanding what clear success criteria looks like, evaluating risk tolerance, accelerating the proof of concept, and more. That's how the foundation is set. It needs to be scientifically sound.

Business comes into that discussion because, obviously, the company needs to validate the proposed need and commercial value. But I would suggest that it's not until a company gets through that early process, that the focus starts shifting. The science doesn't go away, but at some point, the company starts to think about making major investments. The closer one gets to clinical trials, those investments get bigger and bigger.

Here, the business plays a much larger part in driving the right value along with the right medical outcomes. The other way to think about this stage is that that there is an increased focus in efficiency as a company goes through development; this phase introduces a new business element into the review and governance process.

Finally, if the company reaches commercialization, it needs to shift its attention to optimizing the impact of its product in the marketplace. It's important to understand these different stages, and to understand that they're integrated.

Start with the end in mind and what your company is trying to achieve in the marketplace. Be clear about the scientific opportunity. Based on that information, define the best development and commercialization path. That's what marrying business and science is all about.

This article is Part 1 of 2. Part 2 will appear in the May 2012 issue. You can listen to the full interview with Mottram as a podcast online at: http://www.biopharminternational.com/ and click on Drug Development Basic Training.