After years of development and billions in R&D spend, the vast majority of drugs never make it to market. Failure is a near certainty, and there’s no shortage of dangerous pitfalls along the way.
Here are three costly missteps that can derail the process of bridging a new drug to the market.
Drug development misstep 1: Blind spots in strategic planning
By some estimates, 10% of drug development failures result from poor strategic planning. This can include a wide range of problems such as sub-par clinical studies, changes in therapeutic focus or company mergers that make prior research untenable. Given that it generally takes an average of 14 years to bring a drug to market, it’s crucial that companies invest enough time in strategically planning the drug development process, from target identification through to (hopefully) approval.
Is the projected ROI realistic?
Investors care about the return on the investment, and they need to see facts and figures to back it up. This is especially true in a tight funding environment. But it is a major mistake to over promise in order to secure investment. That leads to overly ambitious timelines, and underestimated budgets.
Setting manageable expectations from the outset is key to maintaining healthy investor relationships and suitable budget guardrails.
Has product market fit been thoroughly assessed?
Before proceeding to the first step in drug discovery, fundamental questions about the project’s viability need to be answered. Companies should only pursue products that are likely to match a medical need in the market.
Physicians and patients are the people to consider at this stage, before investors even enter the picture. Ideally, the product should be something that will have a significant impact on patient outcomes, with minimal adverse effects. It’s also worth considering whether the proposed product is a “me-too” drug – a drug that closely resembles an existing product – as these often have lower return on investment.
How likely is the product to qualify for reimbursement after approval?
Reimbursement rates are important for long term profitability. If federal or private insurers are unlikely to reimburse for the product, it may not be worth pursuing. Insurance coverage is often overlooked in the early stages of the drug development process, which is a strategic oversight. To increase the likelihood that they will be reimbursed, companies should build a value proposition that demonstrates the clinical and economic benefits of the drug, before they embark on the discovery process.
Drug development misstep 2: Not having a clear compliance and approval strategy
Once a drug has made it through clinical research, it needs to clear an FDA review (or comparable authority outside the US). To pass, drug developers must submit extensive documentation on safety and efficacy. FDA approval takes a wide range of factors into account, including:
- Treatments already available for the target condition:
Reviewers weigh the risks and benefits of the drug to determine whether it is needed in the market. Risk tolerance varies according to the severity of the disease that the drug treats, and the severity of adverse effects. - Clinical findings:
The agency expects a minimum of 2 adequately designed trials, and may demand more. To reach a decision, reviewers scrutinize all of these results and weight the benefits and risks for target populations. - Risk mitigation measures:
The agency assesses the risks for consumers, and may make recommendations such as an FDA-approved label. It may also require companies to implement a Risk Management and Mitigation Strategy (REMS).
The complexity of this process calls for specialized teams, which adds another layer of cost, which small to mid-sized pharma companies may struggle to absorb.
In cases like these, partnerships and alliances can do a great deal to speed up the process and lower the cost. Strategic partnerships can help to expedite approval, by filling gaps in a company’s compliance expertise. Partners with experience navigating the drug approvals process can help with long-term submission planning, and handling questions that health authorities may ask.
Drug development misstep 3: Failure to keep an eye on the landscape
Even with solid product market fit and an experienced team guiding the process, it’s vital to keep up with developments in the market. To support their own market positioning, drug developers need to stay in the know about what other companies are doing, both rivals and potential partners.
For example, news of a failed clinical trial can help R&D teams to steer the project in a safer direction. On the other hand, a successful trial conducted by another company may eliminate the need to design and run your own.
All of this information is missed when companies fail to track their competitive landscape before and during the drug development process. This can easily lead to a lack of distinction in the market, hindering market access and reducing the quality of returns. By staying abreast of competitor information in real-time, companies can better identify viable white spaces, and allocate budget and resources accordingly.
Avoiding costly pitfalls through AI-based insights
With these and even more challenges around every corner, the need for comprehensive and accurate data is more acute than ever. In the world of drug development, what you don’t know can kill you – and there’s simply too much data out there for humans to track and manage without the help of AI.
Similari augments research and business development teams, enabling them to make faster, more accurate decisions through intelligent insights. From identifying innovation white spaces to spotting promising partnership opportunities, Similari helps companies to maximize the value of their drug development process, and steer clear of potentially mission-ending pitfalls.
Discover the future of drug development today, through a live demo of Similari’s next-generation capabilities.