Drug Discovery Featured Articles & Applications

  1. Automation, Modularity Allow mAb Biotech To Cut Scale-Up Time

    AlphaMab deploys Finesse G3 Series Controllers with TruBio® DV (DeltaV) software as a common control platform across its R&D lab systems and cGMP manufacturing. This ensures consistency and stable control for scale-up and scale-down.

  2. How Image Analysis Can Improve The Results Of Drug Development And Clinical Trials

    In recent years there have been several potentially life-saving medications approved for cancer treatment, including targeted molecular entities and biologics such as Opdivo (nivolumab) and Keytruda (pembrolizumab). Oncology drugs remain a pharmaceutical priority and investments into cancer account for 30% of all pre-clinical and phase 1 clinical development expenditures. There is an impressive list of close to 800 drugs and vaccines currently in the industry-wide development pipeline, many with promising results in early-stage clinical trials. However by historical measures only 10% or fewer of these drugs will ever make it through FDA approval and become part of routine patient care.

  3. Five Major Benefits of Tissue Phenomics

    Seeing is believing – this is an important aspect of Tissue Phenomics, where cellular structures in tissue slides taken from patients are investigated in real space. Observing directly what type of structures form and what kind of interactions take place is in general of much higher value than concluding indirectly from other type of data. I experienced this factor very clearly thirty years ago when people speculated about the atomic structure on the surfaces of matter from indirect measurement.

  4. 3 Ways Tissue Image Analysis Will Shape The Future Of Cancer Treatment With Immunotherapies

    As healthcare continues its transition towards precision medicine, physicians are eager to maximize both the quantity and quality of data obtained from their patients’ tissue samples.  In the current “one drug, one test” paradigm, physicians struggle to balance the number of tests required to make a treatment decision with the limited amount of tissue that is available. 

  5. Implementing Next-Generation Laboratory Informatics

    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).

  6. How AstraZeneca Improved Validated Workflows In GMP API Manufacturing

    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.

  7. MedImmune’s Data Solution From Early Stage Discovery Through Clinical Manufacturing

    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.

  8. Streamlining Change Control In Today’s Complex Life Sciences Organizations

    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.

  9. How Hollister Selected An Automated Solution For Tracking Product Registration And CAPA Management

    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.

  10. For Regulatory Retention Compliance In Life Science Industries And Clinical Trial Research

    “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.