The Five V's of Smart Data Use and Management

So far, the pharmaceutical industry has been conservative about embracing innovative technology, and particularly Big Data. However, business developments will demand that it change its practices, in order to be able to use data intelligently. The following changes are among the business forces driving the need for better approaches to data, says Bikash Chatterjee, president and chief science officer, Pharmatech Associates, whose views appear in the CPhI Annual Industry Report 2016:

• Outsourced drug development and manufacturing, and the rise of a distributed supply chain

• Supply segmentation, in which one single chain is made up of multiple virtual supply chains

• The rise of virtual startups and their move deeper into clinical drug development. “For many biotech products, the ability to utilize a prefilled syringe or autoinjector dramatically broadens the potential patient market. However, the complexity of establishing and controlling the drug, device, and system supply chain is significant for many virtual organizations,” Chatterjee writes.

Chatterjee expects the following to have the greatest impact on the industry’s approach to data and drug development:

• E-clinical mobile platforms, which allow clinicians to customize data gathering and interpretation, potentially facilitating compliance with good clinical practice (GCP) requirements. Some challenges, he notes, stem from regional difference in mobile platform preference and use, e.g., the fact that the US market prefers the Apple IOS operating system, where the rest of the world prefers Google’s android, or that US phone users change phones every two years, while the rest of the world may do this every four to five years.

• Cloud-Based Electronic Data Capture systems, which offer rapid search and query functions, editing and the ability to establish rules to separate good data from anomalies, even for clinical trials in remote locations.

• The Internet of Things, which would transfer data without the need for human-to-human or human-to-computer interactions, allowing objects to be controlled remotely across the network infrastructure. One challenge in this area is the lack of universal standards, but this should change within the next few years, Chatterjee predicts.

Big Data is there for the pharmaceutical industry to mine, and projects are already underway in discovery, research, and development.  However, Chatterjee writes, there is a need to balance and control each of the following: volume, variety, velocity, veracity, and value. When even one of these attributes is not controlled, problems will result.

Finally, he says, the industry will need to ensure data integrity and transparency and information security, especially as pharmaceutical companies move from yesterday’s vertical discovery to a collaborative model, in which companies that may compete in some areas, work together to innovate in others. The need to protect confidential patient records and clinical data integrity will also drive improvements in security.

Despite the challenges involved, Chatterjee writes, “the next decade of therapeutic drug development will be based upon new and more effective means of data mining and analytics.”

Source:  “Intelligent Application and Management of Data Will Define Pharma for the Next Decade,” p. 64, CPhI Annual Industry Report 2016.