Celerion Science Newsletter Q2 2018

Celerion Translates Science into Medicine

Welcome to the latest issue of the Celerion Science Newsletter, designed to provide to our readers information on the latest technologies, trends and stories specifically focused on early clinical development activities and professionals in clinical pharmacology and associated sciences. Celerion Translates Science into Medicine, using state of the art technologies and new, innovative approaches to early clinical research. We invite you to share our vision, techniques and experiences learned through our accomplishments in all aspects of early clinical development by exchanging information, learning and progressing science.

Accomplishments

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Scientific Excellence

Therapeutic Peptides for CNS Indications: Progress and Challenges

Attacking neurodegeneration and promoting neuroprotection have been the holy grail in neurology for almost 20 years and represent an area of high unmet medical need. However, indications like Alzheimer’s disease and stroke are areas in drug development fraught with failure. This review will highlight three CNS peptide programs which are tackling targets and indications in which traditional small molecule approaches have been difficult and challenging. The goal of these peptide programs is to produce selective therapeutics with a better safety profile.

Cystatin C is a More Reliable Biomarker for Determining eGFR to Support Drug Development Studies

Glomerular filtration rate (GFR) is routinely used as a surrogate endpoint for the development of investigational drugs in clinical trials. GFR and staging of chronic kidney disease are typically assessed by measuring the concentration of endogenous serum biomarkers such as albumin and creatinine. However,creatinine is subject to high biological variability,and levels of creatinine do not rise until nearly 50% of kidney function is damaged, leading to inaccurate chronic kidney disease staging and false negatives

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Conference Posters

American Thoracic Society: A Randomized, Double-Blind, Placebo Controlled, Multicenter Phase 2a Study to Assess Safety, Daily Respiratory Symptoms, Pharmacokinetics, and Biomarker Variations after Administration of either YPL-001, or Placebo in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease [View Poster]
World ADC Conference: Immunogenicity Assessment of Antibody Drug Conjugates in Cancer Studies [View Poster]
13^th Workshop on Recent Issues in Bioanalysis (WRIB) Conference: Total and Free VEGF Assays with High Drug Tolerance for the Anti-VEGF Inhibitors Avastin® Bevacizumab), Lucentis® (Ranibizumab), and Eylea® (Aflibercept) [View Poster]
World Vaccine Congress: A Multiplex qPCR Assay for Zika, Dengue, and Chikungunya Viruses (ZDC) to Support On-going Vaccine and Drug Efficacy Studies [View Poster]
American Society for Mass Spectrometry: Use of Alkaline Mobile Phase to Achieve Good Peak Shape in The Rapid Lc-MS/MS Analysis of Lisinopril in Human Plasma [View Poster]

Scientific innovations allow us to create new and better medicine for people who need it to survive.

Biomarker Qualification and Validation Challenges: The Insulin Case Study

Biomarkers follow varied paths into clinical trials for pharmaceutical development. Before implementation in clinical studies, candidate biomarkers are subjected to qualification and validation. Analytical validation ensures adequate assay performance in relation to the questions addressed in the clinical study (fit-for-purpose). Biomarker qualification entails collecting sufficient evidence of the relationship between a biomarker with the relevant biological processes and clinical end points. Biomarkers used in pharmaceutical research had not been under clear regulatory guidance until recently. The first FDA paper where biomarkers were mentioned was the PK guidance from 2013.

Evaluating Cardiac Risk: Exposure Response Analysis in Early Clinical Drug Development

The assessment of a drug’s cardiac liability has undergone considerable metamorphosis by regulators since International Council for Harmonization of Technical Requirement for Pharmaceuticals for Human Use E14 guideline was introduced in 2005. Drug developers now have a choice in how proarrhythmia risk can be evaluated; the options include a dedicated thorough QT (TQT) study or exposure response (ER) modeling of intensive electrocardiogram (ECG) captured in early clinical development. The alternative approach of ER modeling was incorporated into a guidance document in 2015 as a primary analysis tool which could be utilized in early phase dose escalation studies as an option to perform a dedicated TQT trial.

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Our People

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Meet J. Fred Pritchard PhD, Vice President, Global Drug Development

As Vice President of Global Drug Development, Dr. Pritchard leads a global team of drug development and regulatory affairs experts, project management professionals and alliance managers that work actively with clients to bring their drug products efficiently through early clinical testing.

Dr. Pritchard brings 30 years of drug development experience to his work, including pre-registration work on five currently marketed pharmaceuticals and several that are currently in clinical development. Leveraging his experience in leading international teams of scientists at large pharmaceutical companies, Dr. Pritchard founded and led a group of consultants and program directors within a full service CRO that collectively worked on nearly 40 integrated drug development programs, bringing several of these through IND into phase I and II clinical trials.

Dr. Pritchard has given numerous invited lectures at scientific meetings and academic institutions and is an author on over 120 scientific publications and abstracts. He is the 2000 Alumni Fellow of the Penn State College of Medicine, and named one of nine “Notable People in Pharmaceutical R&D” by R&D Directions magazine in 2009.

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