Immunomodulatory drug development is trending toward increasingly complex modalities as science advances and more effective and safe immunotherapies are needed. Immunomodulatory drugs are at the forefront for the treatment of various types of cancer, infectious diseases, and numerous autoimmune diseases, including rheumatoid arthritis, type I diabetes, lupus, and multiple sclerosis. As the complexity of these therapeutics increases, so must the sophistication of the bioanalytical assays designed to either quantify them or measure their impact on the patient.

In this issue, we review common classes of immunomodulators, bioanalytical methods used to quantify them, and their associated biomarkers. We further present two scenarios that address the complexities of bioanalysis for immunomodulators and practical considerations to ensure quality bioanalysis to inform pharmacokinetic (PK), pharmacodynamic (PD), and safety data in clinical trials.

Issue 41 — Immunomodulation Assessments for Clinical Trials

Bioaccessla is paving the way for innovative medical device clinical trials in El Salvador. With a focus on advancing healthcare technology, these trials ensure devices are safe and effective for patients. El Salvador offers a unique environment for cutting-edge research, fostering global medical breakthroughs through rigorous testing and collaboration. For more info, visit our website: www.bioaccessla.com/services

Medical Device Clinical Trials in El Salvador

Current and future development of glucagon-like peptide-1 receptor agonists, more commonly referred to as GLP-1 RAs, or simply as GLP-1s, involves complexities not only in formulation but in all areas of early-phase drug development. Developing and refining preclinical models for early efficacy signals, developing and validating the bioanalytical assays necessary for quantitation, and designing the clinical studies that deliver the most robust data in this innovative therapeutic area are all key elements of a drug development program.

In this audiobook, we review the requirements for successful GLP-1 drug development, from the perspective of preclinical studies, clinical trials, manufacturing, and bioanalysis. Exclusive case studies are also presented.

Issue 42 — Managing the Complexities of Glucagon -like Peptide-1 Receptor Agonist Drug Development

Reducing hypertension risk isn’t just about cutting salt. This week on Beyond The Endpoint, Emily O’Brien, Manesh Patel, and Jenny Cook talk with Dr. Dhruv Kazi about the complex public health battle against hypertension. From interventions to strategies for patient and physician adherence, this episode covers scalable solutions to change the future of hypertension.

Bending the Curve on Hypertension

Smartwatches, fitness trackers, and health data—how are wearables reshaping clinical research? In this episode, Dr. Marat Fudim joins us for an insightful discussion on how wearable technology is shaping the way we monitor health and conduct research. Topics include:
 • Are wearables improving patient care or just tracking steps?
 • How do researchers use wearable data in clinical trials?
 •What are the biggest challenges in integrating this tech?
🎙️ Listen now and explore the possibilities of wearable health tech!

Wearables in Clinical Research: Data, Trends, and Challenges

This episode of VHHA's Patients Come First podcast features Hannah Khan, a nurse and clinical research coordinator with the VCU School of Nursing, who joins us to discuss how she overcame her fears to pursue a health care career, a research fellowship at VCU focused on dementia patients, and much more. Send questions, comments, feedback, or guest suggestions to pcfpodcast@vhha.com or contact on X (Twitter) (twitter.com/VirginiaHHA) or Instagram (www.instagram.com/virginiahha/) using the #PatientsComeFirst hashtag.

VHHA Patients Come First Podcast Hannah Khan

Ozempic curbing alcohol cravings, ADHD linked to shorter life expectancy, and an NBA rising star diagnosed with DVT—what does the science actually say? In this first episode of Beyond the Headlines, a new Beyond the Endpoint series, hosts Emily O’Brien and Manesh Patel break down the research behind these trending stories.

Beyond the Headlines: What’s trending in medical news?

This episode of VHHA's Patients Come First podcast features Jie Sun, PhD, a professor and researcher at the University of Virginia School of Medicine, whose work focuses on immunology and infectious diseases. Among other things, our conversation explores Dr. Sun’s career, recent research his team published on the long-term impacts of COVID-19, and what that could mean for patient care. Send questions, comments, feedback, or guest suggestions to pcfpodcast@vhha.com or contact on X (Twitter) (twitter.com/VirginiaHHA) or Instagram (www.instagram.com/virginiahha/) using the #PatientsComeFirst hashtag.

VHHA Patients Come First Podcast - Jie Sun

In this episode, cancer survivor Katie Ortman-Doble opens up about her journey through clinical research and why she chose to participate. Hosts Emily O’Brien and Manesh Patel, joined by Jenny Cook, talk about the life-saving potential of clinical trials and the real impact they have on patients and science.
 
Hear Katie’s inspiring story and the reasons behind her decision to join a trial.

Stepping Up: Why Participate in Clinical Research?

Why do people volunteer for clinical trials — and what should they know before doing so?
 
In this episode of Beyond The Endpoint, we explore common questions, reasons, and myths about clinical trial participation. Hosts Manesh Patel and Emily O’Brien talk with guest Krista Camuglia, a Research Practice Manager with the Duke Heart Center Clinical Research Unit, who brings unique insights thanks to her work on the frontlines of research coordination.

 
🎙️ Listen to "Part 1: Why Participate in Clinical Research?" https://dcri.org/blog/ep-7-stepping-why-participate-clinical-research

Stepping Up: From Curiosity to Confidence — What to Know Before You Join a Trial

At Bioaccess, we support in assisting startups with the execution of medical device clinical trials & offering exceptional support & guidance for your project.

As an end-to-end CRO/CDMO, we have expert knowledge in all early stages of drug development, and we’re sharing that knowledge with you in The Altascientist: The Audiobook. 

Each issue is a deep dive into a specific area of early-phase drug development, providing insider tips, considerations, and case studies. 


Altasciences is a drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

New tracks tagged #ClinicalResearch