Xceleron

“Engaging Therapeutic Targets” : Xceleron Presents at Exploratory Clinical Development World Conference, London, 23-24th May 2012

Lucy — Wed, 02 May 2012 15:58:29 +0000

Date Posted:	2nd May, 2012
Summary:	Xceleron CSO, Professor Graham Lappin, is to present at Europe’s largest early clinical development congress, Exploratory Clinical Development World, in London on Thursday 24th May.

Graham’s presentation entitled “Engaging Therapeutic Targets” will be part of a session on Translational Medicine featuring guest speakers from GSK, Roche, Eli Lilly, Bayer and Novartis. In his talk, Graham will describe applications of Accelerator Mass Spectrometry (AMS) for the investigation of drug and metabolite concentrations in the systemic circulation as well as at the site of drug action, and ways in which this information can be used to improve the connection between PK and PD. Graham will also describe the use of AMS for the investigation of target turnover in the clinical setting.

As well as being asked to present at this conference, Xceleron will be a major sponsor of the congress and will have a stand in the exhibition hall. If you wish to learn more about Xceleron or to arrange a meeting while there, please do not hesitate to contact either Jeremy Hague (Jeremy.Hague@xceleron.com) or Ian Hallett (Ian.Hallett@xceleron.com).

Further details on the conference can be found on the Health Network website: Exploratory Clinical Development World
www.xceleron.com
Click to see more news

Analytical Technologies for Metabolite Identification and Quantitation

Lucy — Mon, 19 Mar 2012 09:09:18 +0000

Summary: Copy of presentation given by Xceleron’s CSO, Dr Graham Lappin, at the 2012 ASCPT meeting, held at the Gaylord National Hotel & Convention Center, National Harbor, Maryland from 12 – 17th March
Presentation Date:	17th March, 2012

Presenters / Speakers

This talk was given as part of a workshop called “Metabolites in Safety Testing: What Have Clinical Pharmacologists MIST” on the morning of Saturday 17th March and which included speakers from the FDA and Pfizer.
The presentation gives an overview on the methods available for the identification and quantitation of metabolites to satisfy the MIST guidance, as well as describing how Accelerator Mass Spectrometry can be used as part of an overall strategy in combination with other technologies to give quantifiable measurement of metabolites in all matrices. Case studies from industry are also given as examples.

[contact-form]

Click to see more presentations

Xceleron and Lundbeck Publish on the Use of AMS to Meet the MIST Guidelines

Lucy — Fri, 09 Mar 2012 13:45:17 +0000

Date Posted:	9th March, 2012
Summary:	Title: Meeting the MIST regulations: human metabolism in Phase I using AMS and a tiered bioanalytical approach Authors: Graham Lappin, Mark Seymour, Gerhard Gross, Martin Jørgensen, Morten Kall & Lisbet Kværnø Bioanalysis; February 2012, Vol. 4, No. 4, Pages 407-416 , DOI 10.4155/bio.11.334

The metabolites in safety testing and ICH-M3 guidance documents emphasize the importance of metabolites when considering safety aspects for new drugs. Both guidances state that relevant metabolites should have safety coverage in humans (although the guidelines have different definitions of relevant metabolites). Not having safety coverage for important metabolites in humans may cause significant delay in the overall pharmaceutical development program. This article discusses the regulatory background regarding safety and metabolites, as well as outlines an integrated strategy taken by one pharmaceutical company, Lundbeck A/S. Lundbeck uses metabolite exposure data from first-in-man studies, obtained using an accelerator MS approach followed by a two-tiered bioanalytical investigation. This enables early availability of key data on this aspect and, overall, represents a powerful risk mitigation strategy.

A full copy of this paper can be purchased for download here: Download
Click to see more news

Assessing the metabolic turnover of mAb targets in humans using Accelerator Mass Spectrometry

Lucy — Wed, 29 Feb 2012 10:49:14 +0000

Summary: This is a copy of a presentation given by Xceleron CSO, Professor Graham Lappin, at the 2nd Annual Biologics Symposium, Cambridge, UK
Presentation Date:	28th February 2012

Presenters / Speakers

Professor Graham Lappin.

In this presentation, Graham explains the importance of mAb-target engagement and rate of target turnover in assessing whether or not an antiboby target is druggable and to determine the most appropriate dosing regimen.
Graham then describes ways in which AMS can be used to measure target production in both the presence of a suitable antibody and prior to antibody development. The talk also outlines a pre-competitive consortium that Xceleron are setting up with colleagues in the pharmaceutical industry to carry out proof of concept studies for this approach in the clinic.

[contact-form]

Click to see more presentations

Xceleron CSO, Dr Graham Lappin, to Present at ASCPT Meeting in March 2012

Lucy — Tue, 21 Feb 2012 20:38:29 +0000

Date Posted:

21st February, 2012

Summary:

At this year’s ASCPT meeting, to be held at the Gaylord National Hotel & Convention Center, National Harbor, Maryland from 12 – 17th March, Xceleron’s CSO, Dr Graham Lappin, will be giving a presentation entitled:

“Analytical Technologies for Metabolite Identification and Quantitation”

The talk will be given as part of a workshop called “Metabolites in Safety Testing: What Have Clinical Pharmacologists MIST” to be given on the morning of Saturday 17th March and will include speakers from the FDA and Pfizer.

The presentation will give an overview on the methods available for the identification and quantitation of metabolites to satisfy the MIST guidance, as well as describing how Accelerator Mass Spectrometry can be used as part of an overall strategy in combination with other technologies to give quantifiable measurement of metabolites in all matrices. Case studies from industry will also be given as examples.

A copy of the presentation can be downloaded by following this link: Link

Click to see more news