Life Sciences Review: News

An unexplained death investigation often starts with very little to go on. There may be no clear medical cause, limited information from the scene, no reliable witness account and no obvious physical explanation. That can leave the coroner or pathologist with a difficult question: did a substance play a role, or can toxicology help rule it out? Choosing a laboratory service therefore involves more than selecting a testing panel. The service needs to work effectively when important details are missing, without allowing that uncertainty to result in delays or inconclusive interpretation. Drug-related deaths are also becoming more difficult to investigate. Routine screening remains important, but post-mortem testing increasingly has to deal with unfamiliar compounds, very low concentrations, prescription histories and combinations that fall outside established testing assumptions. Novel psychoactive substances make this particularly challenging because some can be highly potent at concentrations that are difficult to detect. Laboratories need broad screening capability and sufficiently sensitive detection methods, along with the expertise to recognize unusual chemistry and identify when targeted testing is necessary. Without that combination, a report may be technically accurate but still fail to answer the main question behind the investigation. “Toxicology UK brings post-mortem toxicology testing and interpretation together within the same service model.” Turnaround time has consequences well beyond laboratory administration. Delays can postpone an inquest, extend uncertainty for families, complicate police decisions and slow the identification of emerging public health patterns that might otherwise be preventable. Speed alone, however, is not enough. Reporting that a substance is present without explaining what the finding means can leave the pathologist with another question to resolve. When assessing a provider, buyers should look at testing capacity alongside the scientific expertise available to interpret the results. A toxicology report is most useful when it arrives in time to narrow the possible explanations for a death. Accreditation provides an essential foundation, but it does not tell the whole story. ISO credentials and established quality systems matter because toxicology evidence may face scrutiny long after the original analysis. What matters in practice is how those standards are applied through internal controls, external quality schemes, method validation and corrective action processes. Reporting requires the same care. The final report needs enough scientific reasoning to withstand expert review while explaining the findings in terms that coroners can use and understand outside the laboratory. Interpretation is often the more difficult part of the work. Detecting and measuring a substance does not, by itself, establish its significance. The concentration has to be considered alongside the case history, possible tolerance, pathology findings and any other substances present. Post-mortem redistribution and gaps in the available background information can make that judgment more complicated. Adding more detail to a report does not necessarily make the answer clearer. What decision-makers need is a provider that can explain the significance of each finding without losing the uncertainty and context surrounding it, rather than leaving them to draw conclusions from concentration values alone. “Accredited analytical work is provided through NMS Labs, while UK-based toxicologists support case strategy, reporting, interpretation and HM Coroner inquests.” Toxicology UK brings post-mortem toxicology testing and interpretation together within the same service model. Accredited analytical work is provided through NMS Labs, while UK-based toxicologists support case strategy, reporting, interpretation and HM Coroner inquests. This approach is suited to investigations where broad screening may need to be followed by targeted testing before the findings can be clearly explained. Its Toxicological Significance Score gives coroners a structured way to assess the likely relevance of each drug finding. The result is a service designed to provide more than an analytical result, giving coroners information they can use to understand what the toxicology findings mean within the context of the case. ...Read more

Cell therapy product development is becoming more manufacturing-led as companies recognize that clinical promise can weaken if process design is not addressed early. Developers are moving beyond a research-first mindset and placing greater attention on scalability, product consistency, release testing and manufacturing evidence before late-stage trials. The market context supports this shift. The global cell therapy manufacturing market is estimated at USD 6.51 billion in 2026 and is projected to reach USD 17.65 billion by 2033, according to Coherent Market Insights. Growth is being shaped by demand across autologous and allogeneic therapies, along with development activity in oncology, musculoskeletal conditions, cardiovascular disease, neurological conditions and other areas. For developers, the manufacturing process looks very different depending on the type of therapy being produced. Autologous therapies require each patient's cells to be collected, processed and returned through a carefully coordinated, individualized workflow. Allogeneic therapies, by contrast, are designed for larger-scale production but bring their own challenges around batch manufacturing and immune compatibility. In both cases, success depends on building manufacturing processes that are reliable enough to support clinical development while remaining practical to scale as therapies move toward commercialization. The problem often appears when early research methods are carried too far into development. Manual steps may work in a small study, but become difficult to reproduce later. A release assay may be acceptable for early-stage work but insufficient for a broader program. Raw material variation can also affect performance if it is not understood early. Regulators are placing more attention on chemistry, manufacturing and controls. The FDA issued final guidance in May 2026 on CMC flexibilities for human cellular and gene therapy products being developed for biologics license applications. The guidance describes how the agency applies flexibility to CMC requirements under BLA development. Developers still need to show that the product can be made consistently and that critical quality attributes are understood. Process changes during development must be justified and documented. Sponsors that wait too long to define their manufacturing strategy may face comparability questions that slow progress. Technology is also changing the development environment. At BIO 2026, cell and gene therapy companies discussed using AI and data systems to improve manufacturing work, pointing to a sector where digital tools are becoming more relevant to production learning. The business implication is clear. Cell therapy product development is no longer only about biology and clinical response. It is also about whether a company can build a repeatable product pathway. The next phase will favor developers who treat manufacturing as part of product identity from the start. In cell therapy, a strong clinical idea must be supported by a process that can survive scale, scrutiny and real patient delivery. ...Read more

One of the common concerns within biopharma is not a matter of generating evidence per se. What makes it even harder is the possibility of sustaining a consistent stream of information through several studies or regulations over prolonged periods of time. As such, the issue of data continuity gains more importance as evidence generation software solutions are currently evaluated by potential buyers. Evidentiary initiatives are never limited to the sole scope of their objectives. Information retrieved once can become relevant several times over the life cycle of a particular product. Researchers may need to re-examine certain findings, compare results of treatment between different periods of time or study data acquired within separate research processes. It becomes especially complicated if there are no consistent information sources within an organization. Such considerations begin to impact the choice of evidence generation software. While the tools themselves are hardly ever used to produce any scientific insights directly, their contribution lies in facilitating further evidence processing and management. The problem becomes apparent as evidentiary research programs move past their initial objectives. It is rare for evidence generation initiatives to have a definite deadline or goal. Several years may pass between the start of the research process and its end, which means that there can be many staff changes, reconsiderations of previous assumptions or emergence of new questions. When information proves hard to find or analyze, the whole process can be slowed down significantly. The amount of effort spent tracking documents, verifying the integrity of information and understanding research history may prove to be considerable. At the same time, these aspects might not become a major focus of technology evaluation. Procurement conversations about evidence generation software solutions are shifting in this direction. Buyers' attention moves from operational effectiveness to information sustainability as evidence programs grow more extensive and complex. They are starting to see evidence generation software platforms as tools for sustaining knowledge over time rather than project management resources. This brings a change to the list of priorities for software developers. Features aimed at optimizing research processes are essential but buyers become concerned with data preservation as well. As such, information continuity becomes part of a solution's institutional memory function rather than just another aspect of project management. While data continuity may not be as prominent as some new trends in evidence analytics, it addresses a pressing problem faced by many biopharma teams. Evidence generation projects tend to outlast their budgets, original objectives or even the members of a team conducting research. For biopharma companies investing in such tools, the problem is shifting from acquiring new information to keeping existing data context-sensitive. ...Read more