Real-time algorithmic exchange and processing of pharmaceutical quality data and information.

Herein, a modern method is proposed for exchanging and processing real-time medicinal product information using Health Level 7 International's (HL7) Fast Healthcare Interoperability Resources (FHIR®) standard, Application Programming Interfaces (API), digitization and artificial intelligence. FHIR is presently in use largely to facilitate interactions between patient-facing healthcare institutions, such as hospitals, doctor's offices, and laboratories, for electronic health record management and exchange. There are several ongoing efforts to adapt the FHIR standard for regulatory use cases to support the needs of the global biopharmaceutical industry, including the exchange of Electronic Product Information (ePI); chemistry, manufacturing, and controls (CMC) data; and adverse event reporting.

Structured content and data management-enhancing acceleration in drug development through efficiency in data exchange.

Innovation in pharmaceutical therapeutics is critical for the treatment of serious diseases with unmet medical need. To accelerate the approval of these innovative treatments, regulatory agencies throughout the world are increasingly adopting the use of expedited pathways and collaborative regulatory reviews. These pathways are primarily driven by promising clinical results but become challenging for Chemistry, Manufacturing, and Controls (CMC) information in regulatory submissions.

The Future of CMC Regulatory Submissions: Streamlining Activities Using Structured Content and Data Management.

Recent advancements in data engineering, data science, and secure cloud storage can transform the current state of global Chemistry, Manufacturing, and Controls (CMC) regulatory activities to automated online digital processes. Modernizing regulatory activities will facilitate simultaneous global submissions and concurrent collaborative reviews, significantly reducing global licensing timelines and variability in globally registered product details. This article describes advancements made within the pharmaceutical industry from theoretical concepts to utilization of structured content and data in CMC submissions.

Re-Envisioning Pharmaceutical Manufacturing: Increasing Agility for Global Patient Access.

The traditional paradigm for pharmaceutical manufacturing is focused primarily upon centralized facilities that enable mass production and distribution. While this system reliably maintains high product quality and reproducibility, its rigidity imposes limitations upon new manufacturing innovations that could improve efficiency and support supply chain resiliency. Agile manufacturing methodologies, which leverage flexibility through portability and decentralization, allow manufacturers to respond to patient needs on demand and present a potential solution to enable timely access to critical medicines.

The Confluence of Innovation in Therapeutics and Regulation: Recent CMC Considerations.

The field of human therapeutics has expanded tremendously from small molecules to complex biological modalities, and this trend has accelerated in the last two decades with a greater diversity in the types and applications of novel modalities, accompanied by increasing sophistication in drug delivery technology. These innovations have led to a corresponding increase in the number of therapies seeking regulatory approval, and as the industry continues to evolve regulations will need to adapt to the ever-changing landscape. The growth in this field thus represents a challenge for regulatory authorities as well as for sponsors.

Transitioning Chemistry, Manufacturing, and Controls Content With a Structured Data Management Solution: Streamlining Regulatory Submissions.

The process of assembling regulatory documents for submission to multiple global health agencies can present a repetitive cycle of authoring, editing, and data verification, which increases in complexity as changes are made for approved products, particularly from a chemistry, manufacturing, and controls (CMC) perspective. Currently, pharmaceutical companies rely on a workflow that involves manual CMC change management across documents. Similarly, when regulators review submissions, they provide feedback and insight into regulatory decision making in a narrative format.

Innovation in Chemistry, Manufacturing, and Controls-A Regulatory Perspective From Industry.

This review describes the landscape of novel modalities such as cell and gene therapies, viruses, other novel biologics, oligomers, and emerging technologies, including modern analytics. We summarize the regulatory history and recent landmark developments in some major markets and examine specific chemistry, manufacturing, and controls (CMC) challenges, including suggestions for exploration of potential science-based approaches in support of regulatory strategy development from an industry perspective. In addition, we evaluate the economic factors contributing to patient access to innovation and discuss the impact of regulation.

A View on the Importance of "Multi-Attribute Method" for Measuring Purity of Biopharmaceuticals and Improving Overall Control Strategy.

Today, we are experiencing unprecedented growth and innovation within the pharmaceutical industry. Established protein therapeutic modalities, such as recombinant human proteins, monoclonal antibodies (mAbs), and fusion proteins, are being used to treat previously unmet medical needs. Novel therapies such as bispecific T cell engagers (BiTEs), chimeric antigen T cell receptors (CARTs), siRNA, and gene therapies are paving the path towards increasingly personalized medicine.

Ketamine for prehospital use: new look at an old drug.

Introduction: Ketamine has been used extensively for analgesia and anesthesia in many situations, including disaster surgery where extra personnel and advanced monitoring are not available. There are many features of ketamine that seem to make it an ideal drug for prehospital use. The reported use of ketamine in the prehospital environment is limited, however.