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elcome 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 clinical pharmacology by exchanging information, learning and progressing science.
 
Celerion Translates Science into Medicine
 

ACCOMPLISHMENTS

Awards
 
 

SCIENTIFIC EXCELLENCE

Liquid Handling Robot

A Liquid Handling Robot for Robust and Reproducible Preparation of Standard and Quality Control Samples in Bioanalysis

We describe a unique liquid handling platform, based on a Tecan EVO, specifically designed for the preparation of analytic calibrators and quality control samples according to the requirements of the Good Laboratory Practice (GLP). The platform utilizes a combination of off-the-shelf software (Tecan Gemini 4.2) and custom-programmed SPIKE 1.0. The system convinces with robust and reproducibly quality and a very easy, intuitive user interface. All security requirements as per FDA 21CFRpart 11 were considered, when programming the software bundle.


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Biometric Fingerprint Technology

Celerion Implements Biometric Fingerprint Technology and Marks Five-Year Anniversary with Verified Clinical Trials

Celerion has implemented Verified Clinical Trials (VCT) biometric fingerprint technology to prevent dual enrollment in clinical trials. Celerion was the first early-stage contract research organization (CRO) to partner with VCT to improve participant safety and clinical trial data. Over the last five years, Celerion performed nearly 50,000 verifications utilizing the VCT global clinical database registry to identify participants that are currently enrolled in other clinical studies.


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  • Celerion Appoints Dr. Marc Hoffman as Chief Medical Officer [Read Press Release]

  • Adding to the spectrum of insulin sensitive populations for mixed meal tolerance test glucose reliability assessment [Read Article]

  • Effectiveness of Community-Based HbA1c Screening as a Clinical Study Recruitment Tool [View ASCPT Poster]

  • Examining the Relationship Between Atherogenic Indices and the Non-Invasive Fibrosis Biomarker FIB4 [View ASCPT Poster]

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

Early drug development: assessment of proarrhythmic risk and cardiovascular safety

Early Drug Development: Assessment of Proarrhythmic Risk and Cardiovascular Safety

hERG assays and thorough ECG trials have been mandated since 2005 to evaluate the QT interval and potential proarrhythmic risk of new chemical entities. The high cost of these studies and the shortcomings inherent in these binary and limited approaches to drug evaluation have prompted regulators to search for more cost effective and mechanistic paradigms to assess drug liability as exemplified by the CiPA initiative and the exposure response ICH E14(R3) guidance document.


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Update and Trends on Pharmacokinetic Studies in Patients with Impaired Renal Function: Practical Insight into Application of the FDA and EMA Guidelines

Update and Trends on Pharmacokinetic Studies in Patients with Impaired Renal Function: Practical Insight into Application of the FDA and EMA Guidelines

The incidence of kidney dysfunction increases with age and is highly prevalent among patients with hypertension. Since many therapeutic compounds are primarily eliminated through the kidneys, impaired renal function can have negative consequences on drug disposition, efficacy and safety. Therefore, regulatory agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) have issued detailed guidelines for new drug applications to determine posology requirements for patients with renal impairment.


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OUR PEOPLE

Meet Marc Hoffman MD, Chief Medical Officer

As Chief Medical Officer, Dr. Hoffman leads the global medical staff and provides medical oversight and expertise to support early clinical research studies. Dr. Hoffman has over 28 years of knowledge and experience as a physician in the pharmaceutical, device, and CRO industries to this role. He has extensive experience in global drug development, medical affairs, pharmacovigilance and regulatory affairs, and has a proven track record in building, managing and globalizing medical teams.


Prior to this role, Dr. Hoffman served as Chief Medical Officer at Patient iP, providing clinical leadership around Patient iP’s innovative platform, customer programs and related medical affairs activities. Dr. Hoffman has also held the roles of Chief Medical Officer and Senior Vice President and General Manager over the Biopharmaceutical Business Unit at Theorem Clinical Research, leading the development of drugs and biologics. Previously in his career, he held positions of increasing responsibility in Medical and Scientific Affairs at Baxter, Hospira and Covance, providing senior-level strategic direction for Phase II-IV programs.


More About Celerion's Management Team

Marc Hoffman MD, Chief Medical Officer
Let's Talk
 
 
Celerion

+1.402.476.2811
info@celerion.com
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