Successful Clinical [14C] Microtracer Investigations – Case Studies from Genentech and GSK


Held on 24th September 2015

 

Cornelis E.C.A. Hop, Genentech (Senior Director)

“Using Accelerator Mass Spectrometry to Explain the Pharmacokinetics of Vismodegib “

Download Marcel’s presentation

 

Teodora Pene Dumitrescu, GSK (Clinical Pharmacology Modeling and Simulation)

Harnessing the Power of [14C] Tracing by AMS to Characterize the Pharmacokinetics of Umeclidinium Following Dermal Administration

Download Dora’s presentation

 

 

Successful Clinical [14C] Microtracer Investigations – What can contemporary AMS do for you?


Held on 26th March 2015

 

Ken Cassidy, Eli Lilly and Company (Senior Research Advisor, Drug Disposition)

“Combining Accelerator Mass Spectrometry (AMS) with the Human ADME study”

Download Ken’s presentation – Xceleron Webinar 2015-03-26 Kenneth Cassidy

 

Graeme Young, GSK (Manager AMS, Biotransformation & Drug Disposition (BDD), RD Platform Technology & Science)

“GSK experience of application of AMS to clinical studies – the last 5 years & GBC (LC+AMS) Update”

Download Graeme’s presentation – Xceleron Webinar 2015-03-26 Graeme Young

 

Graham Lappin – G. Lappin Consulting & Visiting Professor, Lincoln University

“Intravenous Pharmacokinetics Enabled with Accelerator Mass Spectrometry”

Download Graham’s presentation – Xceleron Webinar 2015-03-26 Graham Lappin

 

A complete one-hour audio-visual recording is available at this link

 

Download the summary of Q&A from the Webinar – Xceleron Webinar 2015-03-26 Q&A

 


 

 

Celerion / Xceleron Webinar – Quality, Regulatory and Bioanalytical Considerations for IV Microtracer Studies


 

Summary:
Micro-radiotracer studies in humans that take advantage of the very high sensitivity of Accelerator Mass Spectrometry (AMS) provide new approaches to answering important questions in early clinical drug development.A key interest is the ability to give a small dose of 14C-labeled drug intravascularly (intravenously) while giving a therapeutic oral dose of non-radiolabeled drug extravascularly (e.g. oral, dermal, inhaled). The intravenous plasma concentrations of radiolabeled drug are tracked using AMS while the total drug concentration (labeled and unlabeled) is measured using conventional bioanalytical methods such as LC-MS/MS. From these measurements a good estimate of absolute bioavailability for the route of extravascular delivery can be obtained. However, this type of approach raises several questions from a regulatory point of view.
This webinar will review the requirements and practical considerations around preparation and parametric release of drug in a pharmacy clean room to be administered intravenously. In addition, the regulatory requirements around validation and quality control of AMS assays will be reviewed.
Presentation Date: July 8, 2011
Presentation Time: 10:30am EST
Presentation Type: Webinar
Recording Link: Click Here to Download Webinar Recording

Presenters / Speakers

Stuart Best, PhD
Senior Director of Operations, Xceleron
Method Validation of an AMS Supported IV-Tracer Study

Presenters / Speakers

Staci McDonald, PharmD
Vice President, Drug Development Services, Celerion
Considerations in Sterile Preparation for Human Use


Additional Information

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The Need for Speed: Enriching Early Clinical Studies for Better Data, Faster


Summary:
Leveraging Microtracer Technology to Obtain IV PK and Metabolism Data in First-in-Human Studies
Presentation Date: 7 Oct 2010
Presentation type: Webinar

Presenters / Speakers

J. Fred Pritchard, Ph.D.,Vice President, Drug Development Services, Celerion
Leveraging Innovation in Early Clinical Research

Jeremy Hague, BSc, Senior Director, Strategic Development, Xceleron Ltd.
Enriched Phase I Case Studies: Gaining Intrinsic Kinetic, Disposition and Metabolism Data as Part of a Fit-for-Purpose and Cost-Effective Translational Approach


Additional Information

In this webinar, Celerion partners with Xceleron to discuss how Accelerator Mass Spectrometry (AMS), through measurement of ultra low levels of drug-associated radioactivity, can enrich the information gathered from early clinical studies. Originally explored as a way to get early PK information in humans in Phase 0, this tool is now being used to gather knowledge of absolute bioavailability and metabolite profile prior to Clinical Proof-of-Concept (CPoC). We will explore with examples how leveraging AMS impacts the information available for key go/no go decisions in early clinical development.

This is the first in a three part series of webinars that will examine how we can generate critical data earlier to influence key development decisions. Can we shorten the time to get to a CPoC decision? What can we do to enrich study designs to acquire important data earlier? How can we enhance product value at CPoC?

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The Use of 14C and AMS for the Analysis of Biologics


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Summary:
Speakers from Xceleron, State University of New York at Buffalo, and GE Healthcare discuss how AMS can be used in protein analysis by tagging with 14C, current techniques of protein analysis, the requirement for isotopic tagging and methods of producing 14C protein by fermentation
Presentation Date: 12 Nov 2008
Presentation Time: 7:30 AM PT/10:30AM ET/3:30PM GMT/4:30PM CET
Presentation Type: Webinar
Recording Link: Click here to listen to the webinar

Presenters / Speakers

Dr. Graham Lappin : Head of R&D, Xceleron
Use of AMS in protein analysis by tagging with 14C

Professor Joseph Balthasar : Professor of Pharmaceutical Sciences, State University of New York at Buffalo
Methods of protein analysis, and the requirement for isotopic tagging

Mr. Mike Chappelle : Section Manager, Custom Synthesis, GE Healthcare
Methods of producing 14MC protein by fermentation


Additional Information

The use of radiolabelled compounds in the development of small drug molecules is commonplace. The use of radiolabelled therapeutic proteins however, is less common and the systemic fate of therapeutic proteins is typically studied using ELISA or sometimes LC-MS/MS. These techniques however may not always be applicable, for example: when the therapeutic protein cannot be distinguished from a naturally-occurring protein. ELISA and LC-MS/MS may be insensitive and may not work well when distribution and binding are important (i.e. the protein becomes “hidden” from the assay).

Under these circumstances it is often necessary to conduct a study with a radiolabelled therapeutic protein so that it can be specifically distinguished at low concentrations. Because of the high molecular weight of proteins, short half-life radioisotopes have been used, such as 125I. This isotope however, suffers from a number of disadvantages: 125I is a high energy β and γ-emitter and so there are safety issues with both handling and dosing to humans. High energy of 125I can cause instability of the protein. 125I has a t½ of 60 days which limits bench life of reagents, labelled proteins and samples. With the advent of AMS however, it is possible to use 14C to label proteins but still have adequate sensitivity. Advantages of 14C include: it is a low energy ?-emitter which is safer and less likely to damage the protein. It is possible to reduce the levels of 14C to a level that a human study would be deemed non-radioactive, but without compromising the sensitivity of the measurement.

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Microdosing – Current Status and Future Predictions


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Summary:
Over the last 10 years Xceleron has developed a database which compares PK data at microdose and therapeutics dose levels which shows that for 25 compounds studied microdose PK scales to pharmacological dose in over 80% of cases. This webinar gives an overview of the regulatory requirements needed to carry out a study, a review of the current published data and where it has greatest utility.
Presentation Date: 10 Jul 2008
Presentation Type: Webinar
Recording Link: Click here to listen to the webinar

Presenters / Speakers

Professor Colin Garner: President and CEO, Xceleron.
Regulatory, practical and financial aspects of Human Microdosing

Dr. Graham Lappin: Head of Research and Development, Xceleron
Microdosing: Where we are today

Professor Malcolm Rowland: Professor Emeritus, University of Manchester, and Chair of Xceleron’s Scientific Advisory Board and scientific advisor to the EUMAPP trial
New Microdose Data Produced by the Eumapp Project


Additional Information

Phase Zero (Human Microdosing) is a safe way of obtaining ADME information in humans for compounds just out of discovery with much reduced requirements in terms of CMC and toxicity testing when compared to conventional Phase I studies. Consistent with the FDA’s Critical Path Initiative, it is believed that human microdosing offers a faster, more accurate method of developing drugs — bridging the gap between the laboratory and the clinic. Xceleron has pioneered the concept of human microdosing as part of its ‘Power of Insight’ platform and has established a world-wide reputation in the field having performed microdose studies on over 50 compounds.

Over the last 10 years Xceleron has developed a database which compares PK data at microdose and therapeutics dose levels which shows that for 25 compounds studied microdose PK scales to pharmacological dose in over 80% of cases. This webinar gives an overview of the regulatory requirements needed to carry out a study, a review of the current published data and where it has greatest utility. There is an update on the most recent developments, including an overview the EC funded Euro 2M European Union Microdose AMS Partnership Programme (EUMAPP), which, lead by Xceleron, compared the PK of 7 compounds at both microdose and pharmacological dose levels.

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META-ID™ The Solution to the US FDA’s Guidance ‘Safety Testing of Drug Metabolites’


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Summary:
Webinar with speakers from Xceleron, Constella and GSK.
Presentation Date: 11 Apr 2008
Presentation Type: Webinar
Recording Link: Click here to listen to the webinar

Presenters / Speakers

Mr. Gilbert Carnathan: Principal Drug Development Consultant, Constella group
FDA and Drug Development

Presents the effect the US FDA Guidance document will have on the drug development process.

Mr. Graeme Young: Manager DMPK, GSK
GSK’s use of AMS for metabolism data

GSK’s use of AMS technology to obtain earlier human metabolism data.

Dr. Graham Lappin: Head of Research and Development, Xceleron,
Xceleron’s META-ID

Xceleron’s META-ID: The cost effective way to follow the FDA Guidance.


Additional Information

Xceleron’s META-ID™ allows drug development companies to obtain critical human metabolism information earlier in the drug development process.

The US FDA Guidance to Industry ‘Safety Testing of Drug Metabolites’ calls for drug developers to investigate human specific metabolism earlier in the development process and advises that any metabolite constituting 10% or more of parent AUC be tested for toxicity.

Xceleron is joined by speakers from Constella and GSK to clarify what this guidance means to drug developers and what measures can be taken to ensure that late stage surprises are avoided.

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