Revolutionizing Research and Early Development in Biopharma: Accelerating Drug Development and Cutting Costs

The journey from drug discovery to market launch is one of the most time-consuming and expensive processes in the biopharma industry. Bringing a new drug to market typically takes around a decade from candidate nomination to launch, and the costs of investigational new drugs (INDs) have risen significantly in recent years. As a result, biopharma companies are exploring innovative ways to streamline research and early development. 

Accelerating Drug Development: How Biopharma Companies Are Cutting Costs and Time 

Despite advancements in technology, the complexity of research and early development remains a significant barrier. Researchers must analyze vast amounts of data generated from diverse experiments across therapeutic areas, balancing the need for robust clinical evidence with the pressure to get medicines to market more quickly. To tackle these challenges, top biopharma companies are leveraging automation and digitization to create leaner processes that have already led to up to a 40% reduction in cycle time from concept to first-in-human (FIH) trials. 

In this article, we explore 12 actions taken by leading pharmaceutical companies to streamline their research and early-development processes, focusing on how these efforts drive improvements in three critical areas: speed, cost, and output. 

Speed: How Biopharma Companies Are Reducing Timelines by 40% 

One of the primary goals in modern drug development is speed. Through process improvements, many pharmaceutical companies have cut the time from candidate nomination to clinical trials by 40% or more. The integration of AI and automation into broader closed-loop systems can yield even greater gains by utilizing data to continually optimize each step of the preclinical development process. 

Here are some key strategies to speed up the drug development process: 

• Front-loading Investments and Parallel Processes: Early drafting of IND application sections using audited draft reports like GLP toxicology studies can prevent delays and accelerate the completion of required modules. 

• Simplifying Experiment Designs: Research teams are simplifying experiments by focusing on essential data and reducing the number of experimental variables. Some unnecessary studies may even be skipped with health authority guidance, significantly saving time. 

• Adopting Next-Generation Technologies: Technologies such as in silico methods combined with machine learning can quadruple the speed of lead optimization, while advanced cloning technologies can reduce timelines by months. 

• Improving Organizational Governance and Decision-Making: Streamlining decision-making processes and digitalizing record-keeping with tools like laboratory information management systems (LIMS) can improve speed and accuracy while empowering teams to make quicker decisions. 

Cost Efficiency: Strategic Approaches to Managing R&D Expenses 

As the landscape for drug research and early development continues to evolve, managing costs becomes increasingly difficult. With the rising complexity of new technologies and modalities, companies are looking for ways to optimize their research investments. Several strategies are being adopted by leading biopharma companies to manage costs effectively: 

• Adopting Minimum-Viable FIH Strategies: Streamlining processes to ensure compliance with regulatory requirements and engaging with regulatory bodies early can reduce unnecessary experiments, ultimately saving costs. 

• Anchoring Planning in Clinical Development: Involving clinical development teams early in the research phase helps ensure that critical outputs, like dose projections and drug product volumes, are optimized for efficiency. 

• Replacing In Vivo Experiments with In Vitro or In Silico Methods: New in vitro and in silico techniques are being used to replace traditional animal studies, reducing costs while accelerating the development process. 

• Utilizing Lab Resources Efficiently: Integrating digital management systems and connected equipment enhances the tracking and management of lab resources, optimizing operations. 

Increasing Output and Capacity: How to Maximize Research Productivity 

Biopharma companies are also focused on increasing output and optimizing capacity in research and early development. Despite the growing complexity of research portfolios, companies are finding efficiencies through new experimental tools, designs, and processes. 

Some key strategies include: 

• Miniaturization and High-Throughput Screening: Advanced technologies like acoustic liquid handling and droplet microfluidics can increase throughput by up to 100 times and reduce material usage by up to 90%. 

• Applying Lab Automation: Continuous automation of screening processes can triple throughput and, when combined with automated data analysis, enable AI-driven lead discovery. 

• Using In Silico Experimentation: Computational models allow for rapid screening of thousands of compounds, improving candidate prioritization for physical testing. 

• Strategic External Resourcing: Collaborating with specialized CROs allows companies to access advanced capabilities and scale testing efforts without significant upfront investment. 

How to Capture Value and Drive Innovation in Biopharma R&D 

Achieving operational excellence in research and early development requires a systematic approach that drives progress across multiple functions. Companies should focus on the following: 

• Setting Clear Ambitions: A clear and realistic ambition serves as a guiding principle for prioritizing efforts and making informed decisions across the portfolio. 

• Leveraging Digitalization, Automation, and AI: Companies should integrate AI, machine learning, and automation into their processes to enhance target identification, lead optimization, and biologics development. 

• Fostering a Culture of Innovation: Encourage innovative thinking within preclinical teams and across functions to address challenges and ensure efficient decision-making. 

• Designing a Future-Ready Research Model: To handle increasing complexity, biopharma organizations need to evolve their research models, ensuring they remain agile and responsive to new challenges. 

• Selecting the Optimal Delivery Model: Whether in-house or through external partnerships, companies must determine the best approach to ensure speed, efficiency, and access to cutting-edge resources. 

How BioBoston Consulting Can Help Your Company Transform Its R&D Process 

BioBoston Consulting is here to help your organization streamline its research and early-development processes. By optimizing your R&D tech stack, integrating advanced technologies, and implementing best practices for speed, cost, and output, we can help you accelerate drug development and bring therapies to market faster. 

Contact BioBoston Consulting Today to learn more about how we can help you enhance operational efficiency, reduce costs, and drive innovation in your research and early development efforts. Let us be your trusted partner in creating a more agile, efficient, and successful R&D strategy.