4 Minute Read

For many life science companies, the FDA approval process is a long, arduous journey that spans years and requires tens of millions of dollars. The stakes are high, with groundbreaking science, fierce competition, and tight regulatory oversight rendering this a highly competitive industry.

-- Article Continues Below --

Ultimate Guide to Competitive Intelligence in Life Sciences

Competitive Intelligence (CI) plays a critical role in the FDA approval process. It might take a new drug as long as twelve years to be approved for commercial distribution. Often, intensive, large-scale trials are required to determine the safety and efficacy of a new technology. 

Throughout this period, companies that leverage CI can build a comprehensive knowledge of their competitor’s strategies and take steps to build internal competitive advantages that will enable them to sustain and grow their business in the long-term. 

The role of CI differs at each stage of the product development process, and it’s critical practitioners understand what to be aware of as new technologies proceed through the approval process. For the majority of pharmaceutical and biotechnology companies, the process consists of five key phases:

  1. Preclinical
  2. Phase 1 Trials
  3. Phase 2 Trials
  4. Phase 3 Trials
  5. Approval & Launch

Let’s take a look at the role of CI at each stage in this process:

CI at the Preclinical Stage

At the preclinical stage of drug development, all eyes are on the academic community, research institutes, and government funded labs. The vast majority of research never makes it past this stage, with high failure rates being commonplace. 

The applications of CI in this stage are relatively speculative, but life science companies should focus on being aware of promising new developments in their field as early as possible. CI practitioners should track leading medical journals like Nature Biotech, and should take note of what the most esteemed academics are currently researching by monitoring conference speeches and publications. 

While it’s unlikely that insights at this stage will drive major strategic shifts, monitoring preclinical discoveries is an effective way to gain knowledge about new technologies and market opportunities at their conception. Done right, this acts as a technology pipeline for life science companies, helping discover innovative new opportunities they could bring to market. 

CI and Phase 1 Trials

Promising drug therapies that emerge from preclinical research are often licensed by pharmaceutical companies for further development.  The major landmark in this stage is the submission of an Investigational New Drug (IND) filing to the FDA. The filing is usually submitted once the researchers determine that 1) the new drug is relatively safe for trial in humans, and 2) there is sufficient evidence to suggest that the drug could become a commercially viable treatment.

Once an IND has been filed, human clinical trials start, with the primary goal of proving the safety and efficacy of the new drug, albeit on a very small scale. Even at this stage, many promising concepts falter, and only 10% of drugs that enter Phase 1 trials make it to market. 

CI teams should note these failures, and ensure their own company avoids similar missteps. Because drug development is so capital intensive, there is a focus on failing fast. If a new technology doesn’t make it past Phase 1 trials, it’s over. On the other hand, if Phase 1 trials are successful, firms will begin the process of identifying where these promising new treatments might fit into their existing drug portfolio as they progress to Phase 2 trials. 

New call-to-action

CI and Phase 2 Trials

Phase 2 trials tend to be much larger, involving several hundred participants. The goal of these trials is to quantify the effect of the drug on patient health, and identify how to effectively dose and deliver the drug.

CI starts to play a much more significant role from Phase 2 onwards, with the focus on building a complete picture of the market for a new drug. CI teams will be assigned to assess issues including market segmentation, reimbursement strategies, and the role of lobbying. By proactively anticipating competitive and market responses to a new drug, companies can begin to prepare the launch of the drug for commercial success. 

It’s also important to track potential indicators that competitors are developing innovative new drugs of their own. Of particular note are competitor activities like a surge in hiring, the creation of a new department, or the purchase of new web domains, all of which could indicate the upcoming launch of a new technology. 

Phase 3 Trials

By the time a new drug technology reaches Phase 3 trials, the race to bring the technology to market is truly on. Phase 3 trials are significantly larger than the preceding phases, and life sciences companies can utilize CI to monitor their competitor’s trials. 

Clinical trial data–available from sources like TrialTrove and Cortellis–requires sophisticated technology to be effectively used in competitive intelligence. Software platforms like Knowledge360Ⓡ are highly valuable for this, employing sophisticated technologies to collect and categorize data, freeing CI professionals to spend more time on valuable analysis. 

Phase 3 trials are the last stage before a product launches. It’s critical that CI teams build an understanding of competitors’ go-to-market strategies. Of particular importance here are attempts to secure breakthrough designation from the FDA.

Breakthrough designations are given to drugs that solve an urgent, unmet clinical need. By demonstrating that their drugs fit these criteria, companies can advance through the FDA approval process significantly faster, and be the first to market with an important, life-saving innovation. One recent example is the rapid development and approval of COVID-19 vaccines from leading life science companies like Pfizer, Moderna, and Johnson & Johnson

Approval & Launch

The final date in the FDA approval process is the PDUFA date: the date that the FDA must review a new drug by. Most life science companies announce their PDUFA date in advance in an attempt to satisfy shareholders. These announcements typically contain details relating to the launch strategy and timelines. As such, these announcements represent important information for CI professionals. 

By the time a company is approaching their launch, many decisions will already have been made, but there will be a lot that’s still up in the air. From international market strategies to aligning on key marketing messages, many decisions still have to be made. It’s the role of the CI function to provide as much actionable intelligence as possible to leaders responsible for making these decisions.

Using Technology for CI in the Life Sciences Industry

CI analysts need the support of sophisticated technology to effectively conduct CI throughout the FDA approval process. 

Many life sciences companies rely on Knowledge360, the world’s first intelligence hub. Knowledge360 is an all-in-one platform that sources, categorizes, and presents competitive and marketing intelligence. It has several features built-in for life science companies, like data integrations with the FDA and clinicaltrials.gov  

To learn more about Knowledge360 for life science companies, schedule a demo

Knowledge360 Demo