Expensive Failures: 3 Drug Development Missteps, and How to Avoid Them

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.

The Anatomy of a Search Query: How AI Knows What You’re Thinking

The word “Google” became a verb in 2006, when it found its way into the Merriam-Webster dictionary. But like all shifts in language, it had caught on long before official recognition caught up to everyday usage.

That happened because search engines like Google had caused a seismic shift in the way humans access information. The algorithms read linking behavior between pages to enable information retrieval on an unprecedented scale. And it was all wrapped up in a streamlined, easy-to-use interface that gave users (even non-technical ones) what they wanted, fast: lists of websites semantically linked to their search query. 

Bad news for public libraries, but amazing for almost everything else. It’s become so ubiquitous that most of us struggle to imagine the “before time”.  

Why you might not be Googling for much longer (or at least not in the same way)

None of this is news to anyone, so why am I talking about it? Simple: we’re now at another inflection point, heralded by the arrival of powerful new technology. Generating lists of websites ranked according to relevance is useful, but it’s just the starting point. The user still needs to sift, evaluate, analyze and synthesize that information.

And as Google itself has acknowledged, there is now a pressing need to go further. Lists of websites are not enough: users want “deeper insights and understanding.” In this post, we’re taking a look at how generative AI is changing how we search, paving the way to richer insights and better decision making. 

But first, a brief diversion on semantic analysis. 

Semantics: building search queries, word by word

Every word has what is known as a semantic domain, a range of other words that connect to a shared substrate. For example, the word “vehicle” is part of a semantic domain that includes words like car, plane, ship, and many more. “Vehicle” can also signify a means of achieving something, particularly in medical and scientific applications. 

Search engines operate by identifying pages that contain keywords in the user’s search query. But one of the conventional limitations of keyword-based search is that it lacks the human intuition to situate the right part of the semantic domain. So, “vehicle”, taken out of context, can recall the entire semantic domain of “things that travel”, and the entirely different domain of “biological component that delivers drugs”. That’s too broad to be useful.

But there are many ways to refine a search query to get narrower and more relevant results:

  • Quotation marks around a phrase to fetch exact matches of that phrase: “the costs of drug discovery” will fetch only results that contain those words and in that order.
  • Hyphens to exclude certain results: if you want to get results about unicorn companies, but don’t want to deal with pages that talk about magical creatures, you can use: unicorn -creature 
  • If you need information in a specific format, you can ask Google to only return results in that format, as in: tech talent shortage filetype: pdf

From keyword search to generative AI: bridging the human/machine gap

Behaviors like this simulate the context-driven decision-making that we take for granted when we communicate with other humans using a natural language. And they are behaviors that generative AI can now automate. 

Generative AI reads search queries using NLP algorithms that interpret language in the way that we do as humans – but on a much larger scale. This allows it to understand the intent behind a user’s query, and create content that matches it. In other words, generative AI makes that crucial step that search engines couldn’t make – interpreting the information on web pages for the human user. And, much like search engines did in the early 21st century, generative AI like ChatGPT combines this new power with a user-friendly interface that people love to engage with.

Why it isn’t quite over yet for search engines

As others have noted, search engines still have the edge over chatbots when it comes to crawling the web to find up-to-date information. Chatbots are trained on large but static data sets. For researchers in particular, this is a major limitation. 

And much like search engines, the output of generative AI is only as good as the input it receives. In other words, it takes knowledge and skill to create an effective prompt for the AI to use. We can all expect to hear a lot more about prompt engineering as an in-demand competency as the AI revolution continues to unfold. 

What’s needed is a way to leverage the real-time information gathering of a search engine, with the intuition and nuance of generative AI and NLP.

Similari: AI-based insights for the future

By leveraging the latest advances in AI, ML and NLP, Similari equips researchers and business development professionals with continually up-to-date insights on their industry and their competitors – all without the need for complex human-led prompt engineering.

Because it learns the habits and preferences of human users over time, Similari can refine searches by identifying the most relevant terms from a semantic domain, and tailoring results to specific business needs. 

Get in touch to learn how Similari combines the intelligence and power of an AI chatbot, with the flexibility and 360-degree line of sight of a search engine. 

Planning Your 2023 Conference Schedule: So Many Events, So Little Time

In-person conferences are back in full swing, and the event schedule for pharma and related industries is already jam-packed. But with so many events to choose from, businesses need to think strategically. Which events are really worth traveling to and attending in person, and which ones can you afford to piece together through publications and press releases?

Here is our quick guide to the conference scene, and how to refine the list.

Why attending in-person conferences is good business sense

Firstly, conferences provide an opportunity to learn new strategies and gain knowledge from industry experts in real-time. They also offer a unique chance to network with like-minded people: founders, researchers, healthcare executives, and leaders. While we’ve all become accustomed to doing this virtually, being in the room physically has definite advantages when it comes to relationship building.

For startups, conferences are a great way to get up to speed with the latest trends and regulatory requirements in their industry. Startups can also showcase their products at turnkey exhibits, generating exposure to potential customers and investors. Some conferences even offer pre-scheduled one-to-one meetings with investors or strategic buyers.

How to whittle down the list

With dozens of events spread over the entire globe, business leaders need to be selective. It’s simply not possible to be physically present at any more than a handful of in-person events.

Begin by identifying your goals. Are you primarily interested in networking or gaining specific information? If it’s networking, are you hoping to rub shoulders with potential partners, or investors? Each conference will have a different audience, so research this in advance to determine if it matches your goals.

Next, consider the agenda and speaker lineup. Conferences usually advertise a core organizing theme to distinguish themselves from others. It’s important to evaluate this theme in light of your own business needs. For early-stage startups, it makes sense to attend an event that emphasizes strategic partnerships. A telemedicine company may benefit from hearing industry leaders talk about digital transformation and compliance. 

To help you make the most effective choices, we’ve compiled a list of 5 upcoming events that are attracting industry leaders and innovators, each with a distinct focus.

Pharma USA: March 28 – 29, Philadelphia

This event will feature talks from over 100 industry leaders, with over a thousand change makers and innovators in attendance. Major themes for this year’s conference include the value of partnerships, and the primacy of data and insights for innovation and business strategy. 

Global Pharma & Drug Delivery Summit 2023: April 24 – 26, Frankfurt

Just like it says on the label, this event promises to examine the most vital pharma trends and key issues in the drug development process. Its stated aim is to bring together masterminds, including researchers, practitioners and technologists to forge collaborations and learn from the industry leaders in the room. 

BIOMED Israel: 16-18 May, Tel Aviv

The BIOMED Israel Conference and Exhibition is the largest convention in Israel for life sciences, bringing together industry experts, manufacturing sectors, and leading companies throughout the supply chain. The conference program will explore trends and innovations that are shaping the future of the life sciences industry. 

Similari will be attending, and we are especially excited to see conference sessions devoted to discussing AI in biopharma.

BIO International Convention: June 5-8, 2023, Boston

The BIO International Convention is one of the largest global events in the biotechnology industry. Hosted by the Biotechnology Innovation Organization (BIO) that brings together leaders and stakeholders in the biotech industry to exchange knowledge and ideas. It includes keynote presentations, panel discussions, networking events, and an exhibit hall showcasing the latest technologies, products, and services in biotechnology. The convention attracts thousands of attendees from around the world and provides a platform for connecting with potential partners and exploring new business opportunities in the industry.

Similari will be attending, and we are especially excited to see conference sessions devoted to discussing Innovation intelligence biopharma.

CPhI Worldwide: October 24-26, Barcelona

CPHI is a pharmaceutical event that brings together more than 100,000 pharmaceutical professionals annually through exhibitions, conferences, and online communities to network and identify business opportunities. CPHI Worldwide is the world’s leading pharmaceutical exhibition, hosted at a different location every year. The event covers all aspects of the industry and provides a platform for the global pharma community to gather and discuss the latest trends and innovations in the industry.

Similari will be attending, and we are especially excited to see conference sessions devoted to trend detention usign AI in pharma.

Being virtually everywhere at once, with Similari

The reality is that missing out on any large industry event comes with a cost. The value of creating in-person connections and learning directly from expert presenters is hard to quantify. But there is a way to stay in the know, without missing a beat. With Similari, you can access the most relevant insights from top conferences you weren’t able to attend in person – and even the ones you weren’t aware of. 

Similari’s insights mechanism surveys thousands of data points in press releases, M&A announcements, clinical trials and articles, and extracts critical insights for human decision makers to interpret and act upon.

Our next-generation AI empowers you to be (virtually) everywhere you need to be. Get in touch with our team to learn more.