Improve data integrity and quality, ensure IP protection, increase efficiency, and collaboration and enable faster and better decision making.
Forty-two years ago, Arthur C. Clarke envisioned the HAL 9000, a sentient computer capable of directing a space mission to Jupiter. At the Symyx Symposium in Barcelona(2010), Stephan Taylor, director of project and process optimization systems in process R&D at Bristol-Myers Squibb, envisioned another version of HAL: the Highly Automated Lab, managed by a sentient electronic lab notebook (ELN).
The reality is that paper is more of a habit than a requirement. AstraZeneca discovered this when they aimed to introduce ELNs to improve the efficiency of their validated workflows for GMP API (active pharmaceutical ingredient) manufacture. Paper and its associated workflows were standard only because they were familiar and had been defined over time to meet the needs of scientists, process engineers and quality control and assurance staffs.
When dealing with data at the level of diversity familiar to MedImmune, a requirement of any effective informatics solution is that it be tailored to the specific scientific processes involved. Scientists, along with the project team and supporting stakeholders, were involved in every step of the solution’s procurement and deployment including research, development, legal, clinical manufacturing, and quality. According to the team, the continuous feedback ensured that everyone felt like they were participating in the process, rather than being handed a platform that some unknown entity was pushing onto them. This tight collaboration drove a focus on simplicity creating time for the scientists to focus on science, enhanced with a new ability to find information from any stage of the R&D pipeline.
Change control is collaborative, iterative and labor-intensive. For any specific change event, multiple users are required to follow a prescribed set of tasks and processes, which need to be carried out in a defined sequence and are subject to multiple stages of review and approval. It’s very easy to lose track of where you are in the process, what actions need to be completed next, who owns them, and when they are due. Yet the consequences of such lapses can be very costly. This paper examines why it is absolutely vital for organizations to take a comprehensive, closed-loop approach to automating change management, spanning all areas of the organization and extending throughout the product lifecycle.
In 2008 Hollister did a thorough evaluation of available solutions to automate some key internal business processes including the tracking of product registrations and the management of CAPAs. Since Hollister has to track registrations for its products in many different countries, the Regulatory Affairs department needed an automated solution to track when a registration was coming due so they could submit a new packet to renew a registration. Additionally Hollister needed to upgrade its existing Corrective Actions and Preventative Actions (CAPA) management system that was built on a Lotus Notes platform that was going to be retired.
“Digital born data” is found everywhere in regulated Good Practice environments for laboratory (GLP), clinical (GCP), and manufacturing (GMP) purposes, e.g., (GXP). Paper documents are also scanned into digital format (PDF) for storage and retention. This document explains the fallacy of thinking that system backup tapes suffice for electronic archive purposes. It then describes the characteristics of electronic archives and discusses the history and concepts supporting today’s practical experience with digital preservation for long term retention compliance in organizations subject to US FDA, EU EMEA, and other global authorities.
One tool holds a unique position among R&D informatics systems. Unlike other systems, electronic laboratory notebooks (ELNs) both produce data and consume information. An ELN’s ability to capture data, observations, experiences, and context is particularly powerful when combined with other data pipelining tools. The ability to link key pieces of data and mine experiments captured in the ELN for insights fuels true scientific knowledge management. This use case describes the broad organizational benefits that BIOVIA Workbook made possible for a global pharmaceutical company, highlighting how the system is supporting efforts to gain predictive control over key processes in Research and Development.
Takeda Pharmaceutical Company Limited and Ovid Therapeutics Inc., a privately-held biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, recently announced the formation of a global collaboration focused on the clinical development and commercialization of Takeda’s investigational new drug TAK-935, a novel, potent and highly selective CH24H inhibitor, in rare pediatric epilepsies