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October 7, 2010
The Need for Speed:
Enriching Early Clinical Studies for Better Data, Faster
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Speakers for this event:
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 |
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Leveraging Microtracer Technology to Obtain IV PK and Metabolism Data in First-in-Human Studies
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?
This webinar series is focused on how new technologies can enrich information available earlier in clinical development to enable strategic decision making. Innovative approaches are changing the way we measure, transmit, and reduce data to information and share that information.
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| THIS PROGRAM IS INTENDED FOR: |
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VP's, Directors, and Managers in the following areas:
- Clinical Pharmacology or PK/PD or DMPK
- Clinical Research or Clinical Development
- Clinical Operations
- Drug Development
- Research & Development
- Outsourcing
Plus Presidents, CEO's, Chief Medical Officers and Chief Scientific Officers for pharmaceutical and biotech companies worldwide
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J. Fred Pritchard, Ph.D.,Vice President, Drug Development Services, Celerion
As Vice President, Drug Development Services at Celerion, Dr. Pritchard leads a global team of drug development and regulatory affairs experts, program and project management professionals that work with clients to build value in their drug products.
Dr. Pritchard brings 30 years of drug development experience including pre-registration work on 5 currently marketed pharmaceuticals and several that are currently in clinical development. He is the author of over 100 scientific publications and abstracts, 2000 Alumni Fellow of the Penn State College of Medicine and named one of nine “Notable People in R&D” by R&D Directions magazine in 2009. The magazine describes Dr. Pritchard as “a veteran of the laboratory bench and a major contributor to several novel drugs now on the market.”
Dr. Pritchard was trained in pharmacology (Queen’s University, Canada), clinical pharmacology (Penn State Hershey) and worked for McNeil Pharmaceutical, Glaxo, GlaxoWellcome, GlaxoSmithKline and MDS Pharma Services before joining Celerion. |
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Jeremy Hague, BSc, Senior Director, Strategic Development, Xceleron Ltd.
Since joining Xceleron in 2003, Mr. Hague has been instrumental in developing fit-for-purpose applications of 14C tracer/AMS in clinical investigations. Mr. Hague combines a keen understanding of client need across a range of pharmaceutical stakeholder groups with a broad knowledge of how 14C tracer / AMS can be used to design novel and cost-effective clinical studies. Most recently, Mr. Hague has led or participated in the development of the following clinical solutions:
- IV-PK investigation of absolute bioavailability and other PK properties at pharmacological doses at incremental cost within existing Phase 1 investigations
- MIST – an innovative and cost-effective first view on human metabolism providing confidence in the representativeness of vitro and in vivo models
- Examining utility of 14C tracer/AMS for large molecule drug development particularly in target-mediated disposition and soluble target turnover
Mr. Hague is a Chemistry and Management Science graduate of Imperial College, London University. Prior to joining Xceleron, Mr. Hague held product development roles in Europe and Asia for Charles River, Mars / Masterfoods and Exxon Chemical . |
| ABOUT OUR SPONSORING PARTNERS |
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Celerion is one of the largest and most experienced CROs, formed through the acquisition of the early stage development and consultancy operations of MDS Pharma Services. With six locations and over 700 beds, Celerion is an industry leader in the conduct of early clinical research (including first-in-man to proof-of-concept clinical studies), clinical pharmacology sciences, discovery through late stage bioanalysis, early cardiac safety services, and drug development services The company offers a full range of resources to meet the needs of the pharmaceutical, biotechnology and generic industries.
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Xceleron is the industry-leader in the application of Accelerator Mass Spectrometry (AMS) in drug development. Pioneering the field for over 10 years, we have performed more than 200 AMS studies to support innovative study designs for pharmaceutical and biotech partners. Our portfolio of services, including IV microtracers, metabolism studies and microdosing, are aimed at reducing the risk of late-stage failure and providing substantially more information in early development than traditional approaches. |
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