Utilization of Radiation in the Preclinical Oncology Setting

The American Cancer Society estimates that in 2017 over 1.6 million people will be diagnosed with non-skin cancers in the United States. It is known that more than 50% of all cancer patients will receive some sort of radiation therapy as part of their treatment plan. Why is it then that preclinical evaluation of drugs in combination with radiation is not mainstay in the industry? In fact, in early 2017 the Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, within the US Food and Drug Administration, wrote a commentary in the International Journal of Radiation Oncology to address this point.1 In the commentary Walker, et al., indicate that, despite the high frequency of clinical radiation use resulting in both curative and palliative outcomes, there is a paucity of drug development efforts to capitalize on the potential synergies between targeted therapies and radiation therapy.

5 Things to Know About the Evolving Requirements For SEND

As our industry approaches the one year anniversary of the implementation of SEND (Standard for the Exchange of Nonclinical Data) datasets as required by the FDA for regulatory submissions, attention is shifting to the next set of requirements. From recent notices to upcoming compliance dates, we’ve compiled five key highlights for your information that will also help you proactively prepare for the changes.

Accelerating FDA Submissions with the Trial Summary Domain

A Trial Summary (TS) domain represents an essential part of standardizing study data for electronic submissions. In July 2016, the U.S. FDA issued version 3.1 of the Study Data Technical Conformance Guide, which advised including a TS domain to identify the study start date in the submission. In clinical studies, the study start date is earliest date of informed consent from any subject enrolled in the study, whereas nonclinical studies use the study initiation (protocol finalization) date. This article reviews the importance of the study start date and makes recommendations to help ensure a successful submission for current and legacy studies.

Advancements and Challenges of Imaging in the Immuno-Oncology Space

Immunotherapy agents (IO) are increasingly being used to treat solid tumors due to their dramatic effects on tumor response. However, the assessment of tumor response is not always straightforward given their unique mechanisms of action which include enhancing immune cell infiltration and activation in tumors. Current standard imaging techniques such as fluorinated deoxy-glucose (18F-FDG) PET cannot differentiate between cancer and immune cells. These tumor immune responses can lead to radiographic pseudo-progression whereby there can be an initial “worsening” of radiographic lesions. While IO therapies can be incredibly successful, understanding when a given treatment is successful or if the regimen needs to be augmented, is paramount.1 This confounding, radiographic evidence can lead to patients continuing therapy when no benefit is present or removal of therapy prematurely due to a delay in response time.

Can We Expand Companion Diagnostics Beyond Oncology?

The majority of today’s approved companion (and complementary) diagnostics (CDx) support personalized medicine efforts in oncology, a testament to researchers’ growing knowledge regarding the genetic pathways impacted in various cancers. That understanding increases our ability to convert such knowledge of biology into treatments that specifically target disease based on a tumor’s genetic makeup. This has led to significantly improved outcomes for many patients.

ELISPOT Addresses the Complex Questions Arising From Vaccine and Novel Therapies

The accelerated arrival of novel vaccines and immunotherapies into the clinical space spurred the emergence of fields like personalized medicine, immuno-profiling and immuno-monitoring built around increasingly sophisticated testing platforms. Among them, immunoassays in the ELISpot (Enzyme-Linked ImmunoSpot) family are the most frequently used functional assays for single-cell analysis.1 

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.