HealthApril 04, 2024

Turning the tide on drug development costs: How life sciences leaders can leverage clinical insights

Life sciences companies should prioritize effective use of real-world data, smart drug pricing analysis, and deeper understanding of clinician decision journeys

Life sciences companies face challenges in drug development

Bringing new drugs to market has grown increasingly difficult and less profitable in recent years.  Today, it costs an average of over $2 billion per therapy to develop a new drug, from discovery through clinical trials and to market, and the industry saw an increase of 15% in 2022. At the same time, return on investment has plummeted, dropping 62% to 1.2%, a number Deloitte reports as the lowest since it began annual reports on biopharma research and development (R&D).

But life sciences companies can counter these trends.

Success relies on taking advantage of advancements in clinical insights, but sourcing appropriate data and resources to support these insights can be time-consuming and budget-intensive.

Barriers to building clinical insights in life sciences

Clinical insights don’t come easily. In their efforts to integrate clinical insights into R&D and market strategies to improve efficiency in the drug development process, most life sciences companies will likely struggle in a few key areas:

  1. Understanding the clinician journey.
  2. Discerning market needs.
  3. Tapping into real-world data.

Understanding the clinician decision journey

When applying pharmaceutical solutions in patient care, clinicians go through a complex process that balances both science and personal insight. They generally walk through four steps, including:

  • Determining probabilities based on symptoms and patient history.
  • Gathering data through patient evaluation, including vital signs and physical exam.
  • Updating probabilities based on information gathered from sources, including diagnostic tests.
  • Considering an intervention to determine whether it crosses a treatment threshold.

Since the outcome of this process often includes consideration of pharmaceuticals, life sciences companies benefit from understanding of physician awareness, opinion, and knowledge of how pharmaceutical options play into clinician decision-making.

Discerning market and customer needs

Life sciences companies need deep understanding of their market to achieve success. This includes insights into the patient journey, developing roadmaps to optimize the value of drug products, and leveraging data to determine contracting and pricing strategies that properly address access, risk, and revenue potential.

Tapping into real-world data

Real-world data (RWD) and its role in creating real-world evidence (RWE) is an area of significant opportunity for life sciences companies. They have the potential to accelerate drug discovery, advance patient-centricity goals, and enhance the value that drugs offer all stakeholders. McKinsey estimates that in the three to five years after 2023, top pharmaceutical companies could “unlock” more than $300 million every year by applying RWE to the value chain.

Applying clinical insights to drug development

Once clinical insights are accessible, life sciences companies have a wealth of options in translating them to results.

Influencing product adaptation and compliance

Clinical trial data and RWE are foundational to understanding how drug products should be adapted across different markets. Researchers can use case studies with clinical trials to build insights into local applications of drug products. Clinical trial evidence is sometimes also required for regulatory approval. Clinical insights and drug data solutions can be used to inform trials, including evaluating eligibility criteria and improving target selection.

Informing drug development and launch strategy

Clinical insights should be a core component of life science market research, in turn informing research and development. They are also crucial in supporting a successful launch as they paint a clearer picture of the true needs of a market beyond qualitative information. This is especially true when building entry strategies for a global market where there is significant variation in patient demographics and population health factors.

Supporting medical communication and education

The communication between patient and provider in drug therapy decision-making is complex and benefits from drug development that incorporates this fact. In hemophilia gene therapy, for example, the value of discussions between providers and patients with hemophilia is influenced by the language adopted, a factor that depends on health literacy. This increases the value of content that is accessible and tailored to patient needs.

Use cases in real-world evidence across the product lifecycle

Life sciences companies have expanded their use of RWD and RWE across the product lifecycle. It now stands as a true, end-to-end resource, with 90% of executives in a survey from Deloitte Center for Health Solutions stating their organization was working to leverage RWE for decision-making across the product lifecycle in 2022. Areas of use included:

  • Satisfying post-market requirements.
  • Regulatory submissions.
  • Understanding the efficacy of COVID-19 diagnostic test.

Medical affairs and regulatory decision making

RWE was pivotal in post-marketing surveillance and understanding the impact of the 21st Century Cures Act. The Department of Health and Human Services (HHS) and Federal Drug Administration (FDA) evaluated the use of RWE for approving new drug indications and help in post approval study requirements. The FDA regularly approves drugs based on regulatory submissions that included RWE.

Commercial and market access

Informed market access strategies require deep insights into regional and local clinical evidence. This includes identifying and vetting investment opportunities based on unmet needs based on standards of care and developing market and competitive mapping.

How can a comprehensive platform serve different departments in a life sciences company?

To maintain and improve profitability in an increasingly challenging drug development market, life sciences companies should take advantage of every opportunity to leverage RWD and RWE in clinical decision-making. Watch this video to learn more about UpToDate® for Life Sciences, a solution that combines clinical insights from industry-leading UpToDate decision support with drug pricing data and analysis from Medi-Span® Price Rx®.

To learn more, watch the video on UpToDate® for Life Sciences.
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