NADDBio is dedicated to new approaches and thinking that make a lasting impact on the development of innovative treatments. We achieve this through distinctive clinical practice experience and extensive clinical development expertise with new chemical and biological entities.
We collaborate with partners utilizing cutting-edge technologies and insightful knowledge in core areas of disease biology to explore and develop medicines that drive transformational improvements in therapeutics.
Our oncology expertise spans the full spectrum of cancer drug development, from early-phase trials to pivotal studies. We bring deep understanding of tumor biology, biomarker-driven strategies, and innovative trial designs that accelerate the path to approval.
We support partners in developing targeted therapies, immunotherapies, and combination approaches across solid tumors and hematological malignancies.
We provide comprehensive support for cardiovascular and cardiometabolic drug development, including heart failure, atherosclerosis, diabetes, obesity, and chronic kidney disease programs.
Our team brings expertise in outcomes trials, innovative endpoints, and regulatory strategies that address the complex interplay between cardiovascular, renal, and metabolic conditions.
NADDBio supports the development of immunomodulatory therapies for autoimmune and inflammatory conditions, including rheumatoid arthritis, lupus, inflammatory bowel disease, and atopic dermatitis.
We understand the complexities of immune-mediated diseases and help partners design trials that demonstrate meaningful clinical benefit while managing immunosuppression risks.
Our neuroscience expertise covers CNS drug development for neurological and psychiatric conditions, including Alzheimer's disease, Parkinson's disease, multiple sclerosis, depression, and rare neurological disorders.
We navigate the unique challenges of CNS trials, from patient selection and biomarker strategies to innovative endpoint development and regulatory engagement.
NADDBio brings extensive experience in anti-infective drug development, including antibacterials, antivirals, and antifungals. We understand the regulatory pathways, trial designs, and endpoints specific to infectious disease programs.
Our expertise includes antimicrobial resistance strategies, emerging infections, and global health initiatives that address critical unmet medical needs.
We support vaccine development from preclinical through licensure, including prophylactic and therapeutic vaccines across infectious diseases and oncology indications.
Our team brings expertise in immunogenicity assessment, correlates of protection, adaptive trial designs, and the unique regulatory considerations for vaccine approval and post-marketing commitments.
NADDBio supports GI drug development across inflammatory bowel disease, NASH/MASH, functional GI disorders, and liver diseases. We understand the evolving landscape of GI therapeutics and the endpoint considerations for these indications.
Our expertise includes histological endpoints, patient-reported outcomes, and the regulatory strategies needed to demonstrate meaningful benefit in GI conditions.
We specialize in orphan drug development, navigating the unique regulatory pathways, trial designs, and patient engagement strategies essential for rare disease programs.
Our team understands the challenges of small patient populations, natural history studies, and the importance of meaningful endpoints that capture disease burden and treatment benefit in rare conditions.