"The right drug for the right patient at the right dose with the right effect."
Dr. Paul Stoffels
Chief Scientific Officer, Johnson & Johnson
Janssen Diagnostics Research & Development (R&D) combines world-class science and innovative thinking with rigorous quality standards and global breadth to improve people’s lives through new diagnostic tools and drug development services.
Janssen Diagnostics R&D is focused on the development of novel diagnostics tests for use within Janssen’s five therapeutic areas of focus:
We develop both companion diagnostics (diagnostic tests that are indicated in a drug’s prescribing information and required for its safe and effective use) and complementary diagnostics (diagnostic tests that may be in the drug’s prescribing information, but are used to assess disease state and aid in managing a person’s illness). We are dedicated to helping people live longer, healthier lives, and we operate Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories in the United States and Europe to support Janssen’s R&D efforts and to service the needs of other biopharmaceutical and research organizations in a number of therapeutic areas. Our assay development and manufacturing in Europe are working to meet the ISO13485 standard in addition to their CLIA certification.
Janssen Diagnostics R&D is determined to deliver novel companion and complementary diagnostics, support late-stage clinical biomarker validation, and expand our internal and external drug development capabilities. We challenge current thinking through incorporating diagnostics into end-to-end pharmaceutical development strategies, and we work globally to foster healthcare policies that will positively impact patient care through the appropriate use and reimbursement of diagnostic tools. Perhaps most importantly, we strive to foster a positive culture of trust, engagement and partnership with the ultimate goal of creating novel diagnostic business models.
We have a culture of collaboration and partnership, and actively seek out partners with the technologies needed to advance our existing diagnostic portfolio and develop new platforms.
Janssen Diagnostics operates its own CLIA-accredited labs in the U.S. and Europe, and has the ability to develop and perform sophisticated laboratory developed tests (LDTs) on behalf of Janssen and external companies. For external customers, we establish rigorous firewalls to ensure that their research remains confidential. Some of our key competencies include:
Complex Assay Development: Janssen Diagnostics has deep experience in the development of highly complex, custom assays. We work with customers to understand their needs and the desired output, and are relentless in ensuring that our work adheres to the highest standards of quality. We also perform proteomic and genomic analyses to further scrutinize samples.
CELLSEARCH® System: We can process samples on the CELLSEARCH® System to isolate a number of rare cells, including circulating tumor cells (CTCs), circulating epithelial cells (CECs) and circulating multiple myeloma cells (CMMCs). Additionally, we have the ability to provide sophisticated downstream analysis of isolated cells.
Molecular Biology: In addition to proteomics, we perform polymerase chain reaction (PCR) amplification and real-time PCR within our labs. We also conduct next-generation sequencing through our network of research partners. Janssen Diagnostics continues to explore additional technologies and tools for use on our internal research and projects undertaken on behalf of our customers.
Regulatory/Quality Expertise: Janssen Diagnostics has deep experience in working globally with regulatory authorities to receive premarket approval for our assays and applicable laboratory licenses. We work seamlessly with our Medical Affairs, Quality and Global Regulatory Affairs functions to implement and maintain the appropriate protocols from the start of a project through completion and final reporting. We have deployed a sophisticated laboratory information management system to further maintain our high quality standards.
Computational Analysis: We have demonstrated success in developing databases and complex algorithms to fully analyze large datasets, and predict mutations and drug resistance. An example of our expertise in this competency can be seen in the field of HIV research and treatment. Over the years Janssen Diagnostics (through its legacy Virco organization) assembled a very large, global database of HIV strains and patient outcomes. These databases were scrutinized and patterns of drug resistance explored. These data were essential to the development of new drugs that have been approved across the world to fight HIV.
For more information on our lab services, please contact [email protected].