Strategies for Selecting the Right Immuno-Oncology Tumor Model

In our June 2017 blog post, we described advantages and challenges of using syngeneic, GEM, and humanized mouse models for preclinical immuno-oncology (I/O) drug development. In this blog, we expand on this idea and offer thoughts on choosing the most appropriate I/O tumor model for one’s study. While there are benefits and limitations of any model, one can use these considerations, as well as others, as a foundation for preclinical in vivo efficacy study design. Understanding tumor placement, immune composition, response to treatment, and molecular characterization for the model of interest can be invaluable when designing the most appropriate study for your research goals.

The pharma lens on real world evidence (RWE) for payer and patients

Real World Evidence (RWE) helps payers make reimbursement decisions and assists patients in budget management and estimating risk benefit of interventions. The integration of RWE in value assessment frameworks, used for ascertaining drug value, can help payers make informed evidence-based reimbursement decisions. RWE provides insight into real world impact of an intervention; facilitating “performance-based risk-sharing arrangements” between payers and manufacturers. United Health and Merck have collaborated to link payments to drug performance by utilizing RWE. Similarly, Amgen and Humana have partnered to target chronic diseases by generating RWE.

Exploring new opportunities for biomarkers in immuno-oncology

Pharmaceutical companies are increasingly relying on biomarkers to deliver precision medicine in immuno-oncology. Biomarkers can accelerate drug development and reduce the overall cost; they also allow sponsors to identify failed treatments sooner so that resources are not wasted on expensive, late-stage trials with unsafe or inactive compounds. Finally, these tests lead to better outcomes for patients, which help companies make a stronger case for reimbursement.

When to assess a drug’s potential for abuse: series introduction

Drug abuse and potential drug abuse are critical issues for today’s pharmaceutical industry and the health of patients. Understanding the latest FDA regulatory requirements, different study types, relevant timelines and logistics can be challenging. Conducted at a critical stage of drug development, the assessment for drug abuse potential is complex and must be acceptable to regulators.

Immuno-Metabolism impacts on T Cell populations

We are all familiar with cellular metabolism and how the production of ATP (cell energy) is critical for cell development, proliferation, and survival. Understanding the impact of immuno-metabolism and how this area can enhance the ever-evolving immuno-oncology research is a new and exciting field. Since the cells of the immune system are a fundamental component of the tumor microenvironment (TME), cancer immunotherapy continues to be a powerful therapeutic approach to use the immune system to produce an anti-tumor response. 

Case Study: developing a complex dosing drug schedule for a DART Pompe disease study

Amics Therapeutics, based in Cranbury, NJ (USA), focuses on finding treatments for a range of devastating and rare and orphan diseases. Its lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease enzyme replacement therapy that will be administered in combination with a pharmacological chaperone and tested in multiple human genetic diseases.

We’ve got preferences and so do you

Is it possible for a global CRO to improve – and even reshape – today’s drug development industry? We think so. We work with people like you to offer unique perspectives at every stage of development – from early phase development to clinical trials and commercialization.

Transforming pharmacovigilance with technology and automation

Pharmaceutical customers today are challenging pharmacovigilance service providers to deliver greater value for the funding they provide. Not surprisingly, service providers are addressing this need by investing in technology and automation tools that are poised to increase both the efficiency and quality of pharmacovigilance operations.

Designing a comprehensive self-administration drug abuse liability study | Part II

Regulatory agencies require that any drug (parent or major metabolite) that penetrates the brain and has CNS activity, regardless of its therapeutic indication, be assessed for that drug’s abuse potential. In this series on Assessing Potential Drug Abuse, we are sharing how the team designs and setup accurate and valid nonclinical GLP abuse liability assessment study types required by regulatory agencies: self-administration, drug discrimination and physical dependency studies. For the first in this series, we will explore how to design and develop a comprehensive self-administration study to test for a drug’s potential abusive or addictive nature. 

Emerging immuno-oncology therapies: life after checkpoint inhibitors

The clinical approval of biological therapeutics inhibiting CTLA-4 (ipilimumab), PD-1 (nivolumab, pembrolizumab) and PD-L1 (atezolizumab, avelumab, durvalumab) has ushered in a revolution in the field of cancer immunotherapy. Thus far, the approvals have occurred in a small number of cancer histotypes including melanoma, non-small cell lung cancer and urothelial cancers, but over 2000 active clinical trials of these drugs are ongoing. The common mechanism of action that links these agents together is that they target T cell checkpoint pathways. The role of T cell checkpoint receptors is to down-regulate T cell proliferation and effector function after these processes have been initiated by stimulation of T cells via the T cell receptor (TCR) and CD28, the primary T cell costimulatory receptor.