CMO
Data Management Will Become Strategic
There are several major initiatives within the industry that will be disruptive in terms of business strategy and execution. One is the next step in the Drug Quality Security Act- H.R. 3204, legislation that requires all manufacturers to have serialization in place by November 2017. Serialization equipment and control procedures are not inexpensive and can easily cost $500,000 in hardware and software solutions per packaging line. The control and reporting elements will require the creation of infrastructure that must manage a practical framework across legacy and new customers. Beyond the normal system integration challenges when engaging a CMO focused on quality and the supply chain, the need for transparency as part of the serialization process will impact the IT architectures of both the CSP and the customer. Currently there is no formal mechanism in either the Supply Agreement or Quality Agreement structure for handling this shared responsibility.
One innovation that is already having a huge impact on not only the industry but society in the broadest sense is the integration of smart technology. The “Internet of Things” (IoT) deployed in the industrial sector and making inroads in the consumer sector is providing unprecedented access to behavioral and decision making data. Lifestyle technologies measure everything from diet and exercise to how much sleep you get. The Industrial Internet of Things (IIoT) is a network of sensors that collects data in real time and transmits the data to other machines or people using the cloud or other systems. This data can build upon existing data acquisition systems such as Supervisory Control and Acquisition Systems (SCADA) or Distributed Control Systems (DCS) although they typically can measure other types of data. The IIoT has the potential for real time data access and analysis and there are myriad hardware and software solutions from major manufacturers to build this capability within our industry. These systems are being used in many innovative ways on the factory floor, including modular intelligent facilities and equipment designed to measure and report their operations on a continuous basis. This information is being used by the industry to generate predictive analytics that can be used to inform operational and clinical design. One area of significant concern is the security of data generated by IIoT devices. These systems typically communicate via Bluetooth or Ethernet with IIoT devices typically connected an IP network to the global Internet. Although these architectures are by design, simple they can be vulnerable to Man in the Middle (MIM) cyberattacks where an attacker secretly relays and possibly alters the communication between two parties who believe they are directly communicating with each other.
Clinical trial management has seen significant transformation over the last five years thanks to the ubiquity of smartphones and the maturity of mobile patient interfaces. New software applications are designed
to meet GCP requirements as well as CDISC/CDASH elements of good clinical data management and have dramatically reduced the cost of data input. Any patient data being captured and transmitted must meet HIPAA privacy requirements for data security. Today these security and privacy requirements are relegated to the project level however, the consequences of non-compliance will be greatly elevated because of regulations associated with the Good Data Protection Regulation slated to go into law in Europe in 2018. This new regulation will expand the definition of privacy and comes with potential punitive damages up to 2 percent of an organization’s global revenue! These issues, compounded by Clinical Data Transparency requirements which have been required by law across all EU member states since 2013 will move data management to the forefront of any business strategy for drug developers.
Issues surrounding data privacy and cyber security are intimately linked. Cyber security breaches consistently make the headlines as the instances of ransomware increases and the depth and extent of data breaches continue to escalate. Complicating any countermeasures are the varying levels of cybersecurity requirements across the global supply chain. Some governments that do not embrace the same privacy requirements complicate both the architecture and reporting solutions for data security and privacy.
What's Next
Historically the pharmaceutical industry has lagged behind other markets in terms of its integration of technology, often citing the limitations created by regulation as a main justification for not innovating. However, this is changing. Technology as a framework to provide new and better tools for drugs development will dominate the regulated life sciences, and will have to meet the impending demands of data regulation. Just as 2016 has been a year of extensive activity, the responsibility for commercial product development scale-up and regulatory and compliance guidance fell to CSPs, spurred by the growth of combination products and drug delivery projects and the rise of virtual biotech. The evolution of each of these areas will escalate the role information security and privacy play in an organization's business strategy and are likely to be the basis for long term and lasting change in our industry.
Mr. Chatterjee, President and Chief Scientific Officer for Pharmatech Associates, has been in the bio-pharmaceutical, pharmaceutical, medical device and diagnostics industry for over 30 years. He has guided the successful approval of over a dozen products across U.S. and Europe and is a frequent speaker at industry and regulatory events.
Pharmaceutical Outsourcing | 22 | November/December 2016
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