Advanced Modalities in Drug Development

• Only one first author per paper is allowed.
• First authors must be graduate students, postdoctoral fellows, or clinical residents (e.g., interns, residents, or fellows in medicine or pharmacy).
• All award money will be distributed to the first author only.
• Papers must be submitted by February 1, 2027.
• Authors must indicate in their cover letter that the paper is for the PhRMA Foundation Challenge Award competition and include the first author’s CV.
• Employees of pharmaceutical companies are allowed to compete but are not eligible to receive award money due to restrictions on provision of financial awards by the Foundation.

Advanced Modalities in Drug Development: Radiopharmaceuticals, ADCs, Delivery Systems and Biodistribution of Next-Generation Gene and Cell Therapies

The rapid expansion of advanced therapeutic modalities, including radiopharmaceuticals, antibody–drug conjugates (ADCs), next-generation gene and cell therapies, and innovative delivery technologies, is transforming the treatment landscape across oncology, genetic, metabolic, and immune-mediated diseases.

As these new modalities evolve, they present unique challenges and opportunities in the areas of drug disposition, pharmacokinetics/pharmacodynamics (PK/PD), biodistribution, target engagement, efficacy, and safety that extend beyond established approaches for traditional small molecules and biologics.

This Drug Metabolism and Disposition special collection will highlight the critical need to understand novel mechanisms of action, PK/PD relationships, and safety considerations associated with emerging therapeutic platforms and bridge the gaps between advanced molecular engineering in pharmaceutics and rigorous translational ADME (absorption, distribution, metabolism, and excretion) science.

By showcasing successful drug metabolism and pharmacokinetics paradigms for new modalities, this special section aims to provide a comprehensive forum for the latest advances shaping the pharmacology and disposition sciences of next-generation therapeutics. It will serve as an essential benchmark for: 1) moving the field beyond descriptive data toward cellular and molecular mechanisms governing complex disposition, 2) highlighting the critical bioanalytical workflows (e.g., hybrid LC-MS/MS, qPCR/ddPCR, and quantitative imaging) required to characterize multi-component entities, and 3) providing a foundational reference point for industry scientists and regulatory bodies to establish safety, exposure, and biodistribution criteria for candidate asset evaluation.

This special issue seeks original research articles and minireviews that advance our understanding of the ADME, biodistribution, and translational pharmacology of emerging therapeutics. Contributions addressing preclinical-to-clinical translation, innovative animal models, mechanistic disposition studies, and safety considerations are particularly encouraged.

Topics of interest include, but are not limited to:

• Radiopharmaceuticals and Dosimetry: Novel radiopharmaceutical design, chelation stability, radionuclide kinetics, and organ-level dosimetry.
• Next-Generation ADCs: Advanced linker-payload technologies, biotransformation pathways, bystander effects, and macro/microscopic tissue distribution.
• Targeted and Nonviral Delivery Systems: In vivo trafficking, mechanisms of cellular uptake, endosomal escape, and disposition kinetics of lipid nanoparticles, polymeric nanoparticles, and exosomes.
• Gene and Nucleic Acid-Based Medicines: Biodistribution, shedding profiles, tissue-specific tropism, and clearance mechanisms of gene-editing machinery, mRNA, AAVs, and oligonucleotides.
• Cell Therapies: In vivo trafficking, expansion kinetics, tissue persistence, and target engagement of next-generation cellular therapies (e.g., CAR-T, TCR-T).
• Translational Modeling and Bioanalytics: High-impact imaging methodologies, cutting-edge bioanalytical approaches for multi-component tracking, and the characterization of quantitative PK/PD and exposure–response relationships.

All submissions must follow DMD’s Guide for Authors and will undergo the journal’s peer-review process. Editorial decisions are final and remain entirely under the control of the journal editors. The PhRMA Foundation will have no role in editorial decisions.

All papers accepted for publication by DMD will be published, but only those selected as winners by the PhRMA Foundation will receive the $5,000 Challenge Award. Challenge Award winners will be determined by members of the Foundation’s Scientific Advisory Committee.

For those winners who do not choose a Gold Open access publishing license, their articles will be made freely available to read by Elsevier. 

Please direct any Challenge Award eligibility questions to info@phrmafoundation.org.