A new medicinal drug typically takes up to 12 years from its initial discovery to market release. In new areas of life sciences like gene therapy, this process can take up to 30 years. Drug development in the life sciences domain typically comprises 4 stages namely:

  1. Drug discovery
  2. Pre-clinical research
  3. Clinical development
  4. Market approval

Depending on the importance of the drug (or product), each stage in the product lifecycle – including clinical trials and regulatory approvals – can last for months or even years. With product lifecycle management (PLM), life sciences companies can address the complexities of new drug development by:

  • Tracking product data across multiple teams involved in drug development.
  • Providing complete data related to the drug’s chemical compounds, formulations, and analytical tests.

That said, “traditional” PLM models are prone to providing fragmented product data and depend on manual processes. Here are 5 potential roadblocks (or challenges) with legacy PLM tools:

 

  • Functional silos

48% of decision-makers in drug development believe the presence of data silos impacts cross-functional collaboration in their company. Effective collaboration between life sciences functions is the “backbone” of drug development initiatives.

However, traditional PLM systems provide limited cross-functional visibility, thus indirectly creating functional or data silos. For example, the regulatory team doesn’t share the same perspective about the new drug as the drug research team.

Functional silos can potentially create severe roadblocks to faster drug development and quality issues.

 

  • Manual operations

With traditional PLM solutions, life sciences companies continue to rely on manual spreadsheets, emails, and physical documents to share product-related information. For example, 80% of clinical trials are delayed due to challenges in recruiting participants manually. Similarly, life sciences companies continue to rely on manual spreadsheets to change drug specifications and development methods. This can lead to the continued existence of outdated product information in the legacy PLM solution.

Manual operations can increase the risk of costly human errors, while also creating data integrity and version control issues. 

 

  • Poor data quality

Life sciences companies work with multiple disparate systems, each of which generates data in their own formats. This can lead to poor data quality, which can hinder the decision-making abilities of business executives in the life sciences domain.

Here are some of the other data-related issues that can pose challenges in the life sciences industry:

  • Lack of data integration due to the presence of fragmented data sources.
  • Non-standardized data systems in each life sciences department or function.
  • Limited access to sensitive data including patient records and clinical trial results.
  • Lack of compliance with data-related regulations like HIPAA and GDPR.

 

  • Data fragmentation

Besides integration-related issues, fragmented data (from disparate sources) create a “dysfunctional” environment in life sciences companies. Drug development teams spend a lot of idle time and resources simply accessing approved product data. Without comprehensive data traceability and auditing measures, companies can also face regulatory scrutiny due to data fragmentation.

Without unified data, clinical trials in life sciences can face challenges related to patient safety and shortage in drug supplies. Even after drug approval, fragmented data in PLM systems can impact later activities like market research and regulatory approvals.

 

  • Finding the right PLM tool

Based on their product lifecycle requirements, life sciences companies also face the challenge of choosing the right PLM tool from the market. Selecting the “best fit” PLM depends on the company’s specific business goals, maturity levels, and priority areas. 

Here are some factors that can influence the choice of the right PLM tool:

  • Level of scalability and flexibility
  • Integration with existing third-party systems
  • Brand reputation and partner support
  • Overall cost

 

How modern PLM solutions can deliver value in life sciences

With modern, digital PLM solutions, life sciences companies can strive to improve the development of drugs and other medical products. Powered by digital platforms, PLM solutions can help companies and teams collaborate using updated product-related information and automated workflows.

For example, the Wrike PLM solution acts as a collaboration platform for streamlining the product lifecycle. By hosting product-related operations on a single central platform, Wrike facilitates real-time communication between different teams, including external stakeholders. With its product management functionalities, Wrike enables product development teams to monitor their product’s health – from inception to phase-out phase.

Designed for the healthcare and life sciences industry, Siemens PLM solution enables orthopedic product manufacturers to save time and improve their time-to-market. With this PLM solution, business functions like product manufacturing, engineering, quality testing, and marketing work in a parallel and coordinated manner.

Here are some of the benefits of the Siemens PLM solution:

  • Increased growth in profitability
  • Extended product lifecycle and higher returns
  • Reuse of best practices and business models
  • Lower product development costs

 

Wrapping up

To tackle their challenges and complexities, life sciences companies need a modern digital PLM solution that can eliminate functional silos and deliver high-quality data. That said, companies need the services of an experienced technology partner specialized in the healthcare & life sciences domain.

As a life sciences technology implementor and consulting partner, Trinus can help you implement customized PLM solutions designed to your business needs. Our team of life sciences experts can deliver services ranging from consultation, and execution, to customer support.

Looking to work with an experienced industry partner? Get in touch with our team at lifesciences@trinus.com.