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White Paper
Improving Clinical Development in EBP Settings
​How model based drug development leads to smarter, more predictable trials
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  • Improving Clinical Development in EBP Settings
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This insight brief explores the benefits of Model-based Drug Development (MBDD) for emerging biopharma companies. MBDD is the process of leveraging modeling and simulation throughout the project life cycle to predict trial results and inform planning and design decisions. MBDD is a proven and often effective method for reducing the costly delays and changes that plague typical development efforts by enabling project teams to select the right dose, estimate patient recruitment, and optimize protocol, study and program design.

Emerging biopharma organizations have become a key component of the drug development industry, playing a crucial role in bringing new therapies to patients across a range of therapeutic areas. Many of the programs and compounds from these companies act as the “fuel” for larger organizations’ pipelines, in large part because due to the speed with which they can pursue new development paths.

However, their streamlined organizational structure can present unique challenges. Longer and more expensive development projects can present resourcing and utilization challenges, while some younger companies might have limited in-house experience on the operational side of drug development. In some cases these challenges cause companies to skip or simply overlook vital planning and development steps, which can add preventable cost and risk to their process.

One way of overcoming these issues is by investing in more thorough up-front planning and design, and implementing model based drug development (MBDD) strategies to streamline their processes and steer clear of many of the risks that add extra time and cost to the development life cycle.

Innovation is a necessity

When it comes to innovation, emerging biopharma companies benefit from the fact that they are small. Their efficient hierarchy and lean infrastructure give them the ability to more rapidly make development decisions, and to implement and adapt projects plans with greater agility than their larger peers. This often gives them an advantage in developing innovative drugs which has had a far-reaching and lasting impact. Consider the facts:

  • From 2003 to 2012, more than 40 percent of approved products were in-licensed or acquired from emerging companies.
  • Biotech products in Big Pharma clinical pipelines have grown dramatically, and large molecules represent the dominant share of Big Pharma sales.

    •  

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