Discusses KRAS G12C and the importance of biomarker testing in non-small cell lung cancer (NSCLC).

Classical, randomized placebo-controlled efficacy studies of vaccines for seasonal illnesses, such as influenza and respiratory syncytial virus (RSV), must conform to the calendar and run like clockwork. Typically, they are very large studies – with tens of thousands of subjects – and operate within a compressed timeframe dictated by the respiratory season. Thus, they cannot be undertaken as “business-as-usual,” but rather require accelerated processes, rapid decision-making, and a different approach to risk. Here, we outline the challenges in these studies and share our recommendations for study planning, enrollment, surveillance and study closeout. With the right planning and support, these challenging studies can be completed successfully within the narrow seasonal window.

Drug development costs are increasing annually, with clinical trials identified as one of the most expensive and time-consuming stages of the development process. One factor contributing to this cost inflation is more complex study protocols, which can lengthen trial times while increasing the burden on sites and patients.

The deadline is fast approaching for biological products approved as New Drug Applications (NDAs) in the US to transition to Biologics License Application (BLA) approvals under the Biologics Price Competition and Innovations Act of 2009 (BPCIA). As of 23 March 2020, NDAs for insulins, human growth hormones, and other proteins authorized under Section 505 of the Federal Food, Drug and Cosmetics Act (FFDCA) will be ‘deemed to be biologics licenses’, and regulated as such, by the US Food and Drug Administration (FDA) under the Public Health Services Act (PHSA).

The continuing interest in cell and gene therapies is reflected by the 800+ active investigational new drug (IND) applications within the field that are on file with the US Food and Drug Administration (FDA).1 This trend is only set to increase, with the FDA foreseeing the approval of 10–20 cell and gene therapy (CGT) products per year by 2025.2

The pace of innovation in oncology, with aggressive drug development, new approaches such as immunotherapies, increasing patient segmentation and multiple drug targets even within a single cancer type demands equally creative responses from regulators. The US Food and Drug Administration (FDA) has expedited cancer-drug development through mechanisms and incentives such as the accelerated approval program, the breakthrough therapy designation and the Orphan Drug Act. Associated initiatives such as adaptive study endpoints, reliance on earlier evidence supplemented by real-world data and less complex trial designs have helped to ease the pathway for cutting-edge cancer therapies.

The German tech company LabTwin is launching its voice-activated (VA) lab assistant at BIO in Philadelphia in June. The technology is a game-changer for scientists working in labs and is a major advance in the digitization of the laboratory.

The critical time for many drug development companies frequently comes after successful clinical trials, during the regulatory approval process, and beyond. Moreover, the 2018 survey Formulation in the Drug Product Development Process found that formulation issues had led to project failure and significant delays during drug product development.

To position themselves for success, life sciences companies must accelerate their agendas on two fronts: the creation of focused business models and the acquisition of disruptive, digital capabilities.