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Overview
These solutions can range from drug development, molecular simulation for compounding, clinical trials management, and laboratory data management to generative design tools and 3D printing for human joint replacements.
Today’s life sciences industry faces many challenges, including those related to product development. Increasing operational costs coupled with often high drug development failure rates can limit the number of viable candidates entering clinical trials. This increases the pressure to deliver better results, faster.
At the same time, drug manufacturers and other life sciences companies generate increasingly large volumes of research and development data; but have not implemented a corresponding increase in the tools and solutions needed to analyze and interpret these data. These include solutions that would enable employees to access and collaborate with data, support a common knowledge base, and provide virtual design tools to drive the development and delivery of therapeutics, vaccines, and health care that are so critical to the health and welfare of society at large. PLM technology and science providers are leading the charge to meet this important human need.
The complexity of today’s pharmaceutical market requires more efficient drug development and production. Clearly, the current COVID-19 pandemic has made this even more critical. PLM solutions help make pharmaceutical production more effective and reduce risk – even in this vastly complex environment. Digitalization for the biotech and pharmaceuticals industry is happening at a rapid pace. PLM solutions support this drive toward digitalization with an all-important digital thread that provides a data continuum across all product lifecycle stages.
Pharma and Drug Development: Applying Proven PLM Tools Along with Emerging Technologies
Drug development has always involved chemistry, manufacturing, and controls (CMC). Each area involves its own unique set of science, research, technologies, and processes. The data and information generated by each of these disciplines must be managed efficiently and accurately to ensure accessibility and collaboration across the entire development process and for all scientists and technicians involved. This has presented a consistent challenge for pharma and biotech companies that must deal with the complex and time-consuming development process of drug discovery.
This begins with investigating and researching potential chemicals for compounding and narrowing down candidates for efficacy, followed by lab and animal testing and multiple phases of pre-clinical and clinical trials before moving on to validation, final FDA reviews, and large-scale manufacturing. It is not unusual for the drug 
discovery-to-market process to take years and consume many millions of dollars. The pharmaceutical industry has been striving to shrink the time and cost of drug development. Achieving this goal is critical to both the financial health of the company and the physical health of its consumers.
Due to the many commonalties between product development processes and drug development processes, many pharma companies have adopted the product lifecycle development approach offered by PLM solutions and found these tools, solutions, and processes to be extremely useful to speed and reduce the cost of drug development. Designing, engineering, and manufacturing a new product is not that different, in the context of the lifecycle development process, than designing, testing, validating, and manufacturing a new drug. PLM tools and platforms used for product development were adopted by pharma companies to increase the efficiency of data and information accessibility across the drug development lifecycle.
New Approaches and Tools for a Challenging Landscape
Pharmaceutical companies must deal with a specific set of disciplines and processes across the drug development lifecycle. These include CMC, supply chain management (SCM), quality management, clinical trials, regulatory mandates, safety, and commercial and marketing strategies. Product research and process data define a new compound. As this compound moves from discovery through development, and (ideally), to the market, information is typically stored in electronic lab notebooks and other data repositories. These are separated among the various functions, research disciplines, and organizations across the drug development lifecycle. It is not unusual for a large pharma company to have dozens of separate databases and/or systems to collect, categorize, and store very large amounts of data. Moreover, it is not uncommon for the development process to encounter time delays and bottlenecks when collating the information required to file with regulatory agencies, respond to clinical trial inquiries, or revisit technical or management decisions.
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Keywords: Life Sciences, PLM, Drug Discovery, Product Development, Virtual Simulation, Data Science, AI/ML, Clinical Trials, Compounding, CMC, Digital Twin, ARC Advisory Group.