As noted, it can take many years for new drugs to pass through the product development process, but CI can play an important role no matter how many years a product is from market. It’s important that CI practitioners understand the various stages of product development, and consider the role of CI at each stage.
The preclinical stage of drug development is centered in the academic community, National Institutes of Health (NIH) funded research labs and, increasingly, research institutes associated with regional health systems. At this stage, little thought is given to the commercial applications of new drug technologies, and research is focused on driving novel scientific discoveries. The failure rates are high, and the vast majority of research projects don’t make it past this stage.
The findings of successful early stage research are published in leading medical journals, like Nature Biotech, Cell, and the New England Journal of Medicine. The wider industry pays particular attention to the work of the top researchers in their field – the likes of Joe Dudley at Stanford, or Chris Mason at Weill Cornell.
At this stage, the applications of CI are somewhat speculative, but that’s not to say it’s not worthwhile. By practicing CI, it would be possible to spot potential opportunities at the very earliest stage of their inception – when they first become proven at a basic scientific level. In some ways, this could serve as the top of the funnel for life sciences companies, and could serve to inform business development strategy.
Phase 1 Trials
Once a new discovery has been peer-reviewed and published in a credible journal, commercial conversations begin between companies in the life sciences industry and the business development teams at academic research institutions. When a new drug therapy shows real promise, it is licensed by one of the major pharmaceutical companies.
In this stage, the major landmark is the Investigational New Drug (IND) filing. This filing is submitted to the FDA after a researcher determines that a new drug is reasonably safe for trial in humans, and that there is sufficient evidence that it could be a commercially viable treatment.
Following the IND filing, initial human trials will start, albeit in a very limited scope. The majority of Phase 1 trials are funded by pharmaceutical companies, but are primarily administered by contract research organizations, or CROs. The primary goal of this trial is establishing the safety and efficacy of the new technology.
In Phase 1, the role of CI is still relatively limited. There are many different innovations, most of which don’t even have names yet, and are just referred to by their molecular names. The failure rate remains high, and only around 10% of drugs that go through Phase 1 trials ever make it to market. Because drug development is so expensive, many biotech and pharma companies operate on a ‘fail fast’ principle, and are quick to cut their losses if new technologies fail to show promise at this stage. It’s certainly worth watching what your competitors are failing at so that you can avoid making a similar mistake.
At this stage, pharmaceutical companies will also begin the process of stratifying treatments into therapeutic areas and franchises, and identifying where new technologies would fit best with their existing portfolio.
Phase 2 Trials
Phase 2 trials are larger, and tend to focus on the dosing requirements of the new drug. Typically, all kinds of variations are trialled: different dosage sizes, delivery systems, the effect on different types of patients, and much more. The aim of researchers is to determine the effects of the drug on patients, and to quantify the improvements in patient condition that result from the drug.
Towards the end of Phase 2 trials, commercial functions like marketing and sales are deployed in a more meaningful way. Resources will be allocated to explore market analytics, total market segmentation, reimbursement, and more.
CI teams will consider a vast array of data to build a clearer picture of the market for a new drug. Meanwhile, lobbyists will kick off conversations with insurance companies and the federal government.
At this stage, CI starts to play a pivotal role, quickly becoming top of mind for executives as they move closer and closer to market. Strategic planning comes to the forefront, and companies employ a range of CI strategies to anticipate competitor and market responses.
These include scenario planning, indicator warnings, and early warning programs. Many companies overlook critical information at this stage, so it’s important CI teams know to look for key indicators like domain purchases or changes in hiring practices.
Phase 3 Trials
By the trial stage, it’s pretty much a race to bring the new drug to market and CI becomes front and center. Clinical trials are conducted on larger numbers of participants, and may take place in multiple countries, meaning there’s ever more information for CI teams to process.
Biotech and pharmaceutical companies employ CI strategies to monitor competitor’s trials, understand what’s happening in different markets across the world, and to gauge the conversations that competitors are having with regulators and payers. The vast quantity of data in this phase from sources like Informa’s research tool TrialTrove or Clarivate’s solution Cortellis demands that CI teams use appropriate technology to effectively parse and analyse data. Recent developments in Artificial Intelligence (AI) are helping to streamline this process.
Of particular note for CI practitioners are attempts to secure breakthrough designation. This particularly applies in the biotech space, where companies are innovating new treatments to treat rare diseases. At first glance, it might not make sense, as there may only be a few thousand patients with the condition the drug promises to treat, but by demonstrating that their therapies address an unmet medical need, companies can advance through the FDA approval process significantly faster, and be the first to market with an important innovation.
Recently, we saw exactly this happen with the COVID-19 vaccines that are now approved for use in the U.S. and other countries. By securing breakthrough designation, companies were able to bring their treatments to market significantly faster and start addressing an urgent medical need.
As soon as a company gets approval to launch, all of the pieces start to come together in a meaningful way. A key date to note in this final phase is the PDUFA date: the date that the FDA must review a new product by. Most drugs are subject to a ten month waiting period for review, but drugs that fulfill an urgent clinical need are reviewed in six months. This underscores the importance of achieving breakthrough designation.
Many times, life science companies will announce their own PDUFA dates in an attempt to boost their stock price. In this announcement, companies outline their launch plans and timeline for the drug. Clearly, it’s important that CI functions closely follow these announcements for competitive players.
By the time a company gets to the launch phase, there are all kinds of data points that need to be reviewed, and CI plays an important role in coordinating this. From go-to-market strategies to how to best serve patients without insurance, there are many important decisions for companies to make. The role of CI is to provide the best information possible to the leaders who make these decisions.
Post Launch - Lifecycle Management
After a new therapy has been approved and launched into the market, a corporate portfolio strategy team sits over the therapeutic area. They determine the ongoing role of the product and how to allocate resources against it. These teams run very advanced statistical models to assess where to allocate capital, and tend to occupy a very prominent position in the organization, often reporting directly to the CFO.
In the pharmaceutical industry, the majority of this work is conducted with throughput analysis, or a similar capital budgeting model. The more valuable data these groups have to input to their models, the more accurate and definitive the models will be.
For example, considerations of how comparable products are performing in international markets, or information on a new product that a competitor might be preparing to bring to market, would both be invaluable data sources for these analyses. The role of CI is to gather, organize and synthesize as much of this data as possible.
The more complete the picture, the better the corporate strategy team can advise how the company allocates its financial resources against different areas of their portfolio. By continuously employing CI, life sciences companies are able to better react to market changes.