PRECLINICAL FEATURE ARTICLES
PRECLINICAL WHITE PAPERS & ARTICLES
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![GettyImages-1256602998-psychedelic-mindfulness]( "The Impact Of Expert PK/PD Modeling In Psychedelic Research")
Model-informed development that integrates preclinical and literature-based data is enabling smarter predictions of exposure and safety, transforming psychedelic research and advancing clinical innovation.
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![GettyImages-2158124620-scientist-laboratory-containers-testing-analysis]( "Accelerating IND-Enabling Studies With Automated Bioanalysis Workflows")
Reimagined as automation-first, bioanalysis shifts from being an Investigational New Drug (IND) bottleneck to a catalyst for innovation—helping companies move therapies forward with greater confidence.
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![exam, test, analysis, innovation, development-GettyImages-2149039471]( "Why Bioanalysis Needs To Break Free From Manual Bottlenecks")
Bioanalysis remains one of the most persistent bottlenecks in drug development, with CROs displaying inefficiencies that are no longer operational nuisances but strategic liabilities.
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![GettyImages-2189138619 lab]( "Strategic CMC Considerations For Pre-IND Meetings: Setting The Stage For A Successful TPP")
In biotechnology, the Pre-Investigational New Drug (Pre-IND) stage is a critical juncture. Explore the pivotal role of Chemistry, Manufacturing, and Controls (CMC) in navigating this phase.
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![GettyImages-2032712502-scientists-tablet-training-labratory]( "Enhancing The Biosimilar Review Process")
The biosimilar market is projected to reach over $100 billion in the next five years. Learn how to navigate the expanding landscape and overcome challenges in accessing key clinical information.
PRECLINICAL APPLICATIONS & STUDIES
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Developing And Validating Clinical Receptor Occupancy Pharmacodynamic Biomarker Assays9/25/2025
Receptor occupancy (RO) assays assess drug-target engagement and support PK/PD modeling. Accurate RO requires customized assays using stabilized blood to monitor CD6 modulation in autoimmune therapy.
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Advancing Immunotherapy In Head And Neck Cancer: The IT-MATTERS Study4/17/2025
This randomized controlled pivotal Phase 3 study evaluated efficacy and safety of neoadjuvant complex biologic administered for three consecutive weeks pre-surgery.
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LC-MS/MS Method Development Of Endogenous Small Molecule Biomarker1/17/2025
Biomarkers are essential to improve drug R&D efficiency. Explore some practical solutions for achieving a fit-for-purpose LC-MS/MS biomarker analysis method.
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Drug Development Program Management10/28/2024
Learn how a consultant helped a biotech company specializing in immuno-oncology to develop timeline reports for the product and portfolio and identify and address gaps in the filing plan.
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A Versatile Application For Rapid Mass Confirmation And Purity Assessment Of Biotherapeutics7/18/2022
We explore a streamlined integrated workflow for data acquisition, processing and reporting of deconvoluted mass data for biotherapeutics, deployable in regulated and non-regulated environments.
PRECLINICAL PRODUCTS & SERVICES
ClinicReady is the surrogate for outsourced drug development team for preclinical biotechs.
As a leading partner in ocular therapy, Altasciences is at the forefront of ophthalmic drug development. Our integrated CRO/CDMO solutions can support your program from lead candidate selection to market. You will benefit from working with a single partner as your product advances through each phase of drug development—from prototype formulation through preclinical testing, to early phase clinical trials, and manufacturing. This could mean up to 40% in time savings.
Within the global pharmaceutical and biotech industries, drug and medical device development are on the rise while stricter regulatory and sustainability requirements are being enforced to demonstrate product quality and safety.
Novotech initiated the first national, privately owned, commercial Institutional Biosafety Committee (IBC) in Australia, successfully accredited by the Australian Office of the Gene Technology Regulator (OGTR).
PRECLINICAL SOLUTIONS
PRECLINICAL SUPPLIERS
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![SAE / ADR / MDR Management]( "PRA Health Sciences")
PRA is a global Clinical Research Organization providing services through all phases of clinical development. PRA has supported over 3,100 clinical trials in more than 80 countries on 6 continents through our global offices. PRA's therapeutic expertise, global reach, and project experience with local knowledge enable our project teams to deliver consistent and on time performance for our clients.
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![MPI Research]( "MPI Research")
MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries.
PRECLINICAL & CLINICAL TRIAL NEWS
- Harlan Laboratories Continues Global Growth With Major Expansion Of North American Facilities
- La Jolla Pharmaceutical Company Announces Completion Of Phase 1 Portion Of GCS-100 Clinical Trial In Chronic Kidney Disease
- DSM And DecImmune Therapeutics Sign Agreement To Develop N2 Pathway Blocking Antibody
- Catabasis Initiates Phase 1 Trial Of CAT-2003 For Treatment Of Severe Hypertriglyceridemia
- Spanish Biotech PharmaMar Selects Medidata Clinical Cloud To Accelerate Trials For Marine-Based Oncology Drugs
- Cubist Announces Exclusive Option To Acquire Adynxx
- The Michael J. Fox Foundation Launches New Funding Opportunities For Parkinson's Research
- Ability Pharmaceuticals Awarded A 1.2 Million Euros Grant To Develop Its Lipid Analog ABTL0812 For Lung And Pancreatic Cancer
- Reaxys® Medicinal Chemistry Provided As Part Of Elsevier's Suite Of Life Science
- DiaMedica Successfully Completes DM-199 cGMP Manufacturing And Pre-Clinical Toxicology Safety Studies
- Savant HWP Announces NIDA Funding For Pre-Clinical Development Of 18-MC As Potential Treatment For Addiction, Obesity
- Bio-Matrix' Regen BioPharma Initiates Pre-Clinical Study In Support Of HemaXellerate™ Cell Therapy
- ClinicalRM Awarded Contract For Regulatory, Clinical And Technical Services To Support The U.S. Army Medical Materiel Development Activity (USAMMDA)
- Accelovance Strengthens Executive Team With Chief Medical Officer