PK/PD Modeling and Simulation – A Brief Overview and Upcoming Blog Series

The year I graduated from college was the same year an old family friend was retiring. He had spent the majority of his career designing and deploying farm equipment across the United States. When I asked for advice as I entered the workforce he told me a story.

Medical writing for patients: An important niche

With evolving medical knowledge, there is an ever-increasing need to effectively facilitate knowledge transfer to key target audiences, especially patients and caregivers. Medical writing for patients must not only meet stringent good clinical practice standards and good publication practices but it must also communicate specific information in a clear, relevant and compelling manner. Patient-friendly writing is centered on generating content that engages, instructs and presents medical evidence, which is truly informative and is visually impactful—with use of graphs, figures and images.

Target-Mediated Drug Disposition

“Affinity” is defined as, “a spontaneous or natural liking or sympathy for someone or or something.” This concept applies also to the biologics (large molecules) we help to develop. Drugs like monoclonal antibodies (mAb) or bispecific antibodies are ideal drug candidates since they have very high affinity to bind to their target substance or site. Given the variability of the targets, safety profiles, and therapeutic windows, it is important to understand the characteristics of the affinity of the target and how to translate phenomena such as target mediated drug disposition (TMDD).

Establishing Control Over the Manufacturing Process and the Quality of your Biologic

When a patient reads the label on their medicine bottle, he or she naturally relies on the medicine to contain the correct drug, be safe, work as intended and list the correct dosage. The pharmaceutical companies that produce these medicines similarly must rely on their internal manufacturing processes and quality control testing to generate the medicine responsible for this patient trust.

Real world evidence (RWE) and market access in the US

Randomized control trials demonstrate drug safety and efficacy and hence are fundamental for regulatory approval. However, real world data (RWD) becomes a progressively more important source of evidence as we move across the development continuum of a drug. RWD can be potentially useful for obtaining regulatory approval as well. Communicating the value of a health technology is critical for supporting the market access of a drug. Favourable comparative clinical profiles and cost effectiveness can influence the position of a drug in the formulary of a payer.

Road map of real world evidence (RWE) in Europe

Several European countries have been utilizing big data together with randomized control trials to guide healthcare decision making and to address market access issues. The Region Europe RWE Advisory Board was formulated to explore potential areas of real world evidence (RWE) use in countries like UK, France, Portugal etc. The board engages stakeholders including payers, providers, and patient organizations with the intent of developing a platform and widening the community for RWE.

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.