Clinical

The United States Food and Drug Administration (FDA) is dramatically transforming the biopharmaceutical landscape by formalizing a modernized approach to the statutory standard for therapeutic approval. Moving away from the historical reliance on dual clinical investigations, the Agency now explicitly recognizes that data from a single adequate and well-controlled clinical trial, when paired with robust confirmatory evidence, can satisfy the mandates of Section 505(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This article evaluates the statistical and operational requirements of this new regulatory framework, exploring its effects on clinical trial design, Contract Research Organizations (CROs), Good Manufacturing Practice (GMP), and specialized clinical procurement, while substantiating these findings with recent case studies.

Lab technicians in animal research are clinical first responders whose intuitive attachment to animals serves as a diagnostic tool for identifying welfare issues and ensuring research quality. Scientist.com's VERIF.i framework empowers techs to act on their clinical judgment, recognizing that emotional connection and gut instinct, not detached professionalism, are essential for both animal welfare and sound science.

CROs, CDMOs, and CMOs serve distinct roles across the drug development lifecycle, from preclinical research and clinical trials to formulation development and large-scale manufacturing. Scientist.com streamlines the process of identifying, evaluating, and engaging the right outsourcing partner by providing access to vetted suppliers, compliance verification, and AI-powered procurement tools.

Biological material licensing grants researchers the right to use proprietary biological materials containing intellectual property, such as cell lines and organoids, while ensuring legal compliance and protecting IP holder rights. Licensing mitigates risks of cross-contamination and misidentification while maintaining the reproducibility and reliability critical to preclinical research outcomes.

This blog post was written by Cureline, a global translational and precision medicine CRO providing HBS biobanking and laboratory services for...

Systematic literature reviews (SLRs) play a crucial role in shaping inclusive and diverse clinical trials by offering insights into the demographics and health factors of various patient populations. Aligned with the FDA's DEI initiatives, SLRs help clinical trial sponsors understand the diversity of treatment populations, ensuring trials are representative and addressing potential biases in healthcare research. By drawing on comprehensive data, SLRs support the FDA's goals for more equitable and generalizable clinical trials.

Market access and health economics must be integrated into drug development strategy from the earliest stages, not treated as a post-approval concern, to prevent costly mistakes and ensure commercial viability. Early MA planning enables biotech companies to align clinical development with payer expectations, de-risk projects, and improve valuations while ensuring innovative therapies reach patients efficiently.

The 2024 T Cell Talks Summit, sponsored by STEMCELL Technologies, was a 7-episode webinar series exploring the latest advances in T cell and CAR T cell therapy research and manufacturing. Speakers including Dr. Julian J. Lum of BC Cancer's Deeley Research Centre, Vimal Keerthi of Stanford University, and Dr. Dominika Nackiewicz of STEMCELL Technologies covered topics ranging from serum-free T cell expansion and non-viral CRISPR knock-in CAR T engineering to point-of-care manufacturing and regulatory considerations for clinical translation. Collectively, the series highlighted the technical, manufacturing, and regulatory innovations driving CAR T cell therapy from bench to bedside.

The 2023 Academy of Surgical Research Series, in partnership with the Academy of Surgical Research, was a 4-episode webinar series covering certification exam preparation and advances in chronic vascular access techniques for rabbits, minipigs, and other research animals. Collectively, the series highlighted practical refinements in surgical models, from vascular access buttons to indwelling ports, that improve animal welfare while supporting reliable pharmacokinetic and toxicokinetic study design.

This episode of tHEORetically Speaking features real-world evidence experts Alexandrina Balanean, Parisa Asgarisabet, and Danielle Gentile from Cardinal Health discussing the problems caused by lack of diverse representation in clinical trials.

What can biological age tell us about our health? Is it a fixed number, or can it be reduced? A recent study from Poganik et al. investigates the fluctuations in biological age in response to physiological stress.

This installment of Tech Snapshot highlights Invicro's bioluminescence platform, which is focused on providing sponsors with image datasets...

Scientist.com has expanded its Japan-based supplier network to 56 companies since establishing a Japanese subsidiary in 2018, offering researchers access to integrated drug discovery, kinase research, preclinical testing, and bioinformatics services. The platform enables global researchers to outsource work to specialized Japanese suppliers across multiple research domains and therapeutic areas.

This installment of Supplier Spotlight® highlights Invicro, an industry leading imaging CRO supporting the discovery and development of...

This installment of Supplier Spotlight® highlights Crown Bioscience, a global contract research organization (CRO) providing discovery, preclinical...

Recently published in Brain, Gonzalez-Ortiz et al. report the design and development of a novel blood-based biomarker specific to brain-derived tau. In this blog post, we dive into the advantages of their novel immunoassay over those that are commercially available, as well as its future implications for Alzheimer’s disease diagnosis.

This episode of Share Science features Chris Rand, MSc, sales and marketing manager at Aurora Scientific. In this interview, Chris shares Aurora Scientific's history, their journey within the preclinical research world, and their advance into the neuroscience space.

Dopamine's role in fear conditioning extends beyond its "pleasure hormone" reputation, with a recent study showing that endogenous dopamine release in the amygdala directly strengthens aversive learning and fear memory formation through long-term potentiation. This evolutionarily conserved mechanism highlights dopamine's multifaceted roles in learning and emotional processing beyond traditional neurotransmitter functions.

SMC Laboratories developed the STAM™ model, a proprietary mouse model that replicates human NASH progression from steatohepatitis to fibrosis to hepatocellular carcinoma with superior clinical relevancy compared to other preclinical models. With over 35% of compounds tested in the STAM™ model showing clinical correlation upon progression to human trials, the model helps bridge the translational gap and reduce drug candidate failure rates due to lack of efficacy.

Meaghan Loy's participation in a clinical trial for an orphan rare disease provided a full-circle moment after years conducting preclinical animal research, highlighting the critical importance of volunteer participation for advancing medical discovery. Her experience underscores the need for greater data transparency in clinical trials and emphasizes individual responsibility in contributing health data to advance life-saving research.

This Supplier Spotlight® highlights Cresset Discovery, your scientific partner for molecule design that will assist you in discovering, designing...

This Supplier Spotlight® highlights BioChain, the world leader in high quality processed bio sample products and analysis services used in...

This Supplier Spotlight® highlights Eurofins Discovery, a global leader in drug discovery products and CRO services offering one of the industry’s...