Global Congress on Comparator Studies

This is a reminder that the Global Congress on Comparator Studies conference kicks off on Monday in Philadelphia. There is still time to register if you’re interested in integrating a comprehensive blueprint for your comparator studies. Get your comparator studies up to standards before the new administration mandates it.

A selection of confirmed attendees:
Allergan Inc * Almac Clinical Services * Bernstein CMC Regulatory Consulting * Celgene * Cerexa Inc * Eli Lilly & Co * Facet Biotech Corporation * Farma Mondo SA * GlaxoSmithKline * Hospira Inc * Human Genome Sciences Inc * Merck & Company Inc * Multipharma Inc * Mylan Pharmaceuticals Inc * Myoderm Medical * Pfizer * Schering Plough Corporation * Takeda Pharmaceuticals North America Inc * Wyeth Pharmaceuticals

Global Congress on Comparator Studies 2009 is offering a terrific three day conference to amalgamate with industry thought leaders, network with colleagues and develop relationships with industry professionals. Join us to hear insight into how industry leaders are minimizing operational, regulatory and financial risks.

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Making the Business Case for Improving your Comparator Studies

The globalization of clinical trials has arrived. As you know, the increasing use of comparator studies means that you’re playing by a new set of rules. At this critical junction, you can either evolve in 2009 to stay ahead of the curve or choose to play catch-up and try to deal with the challenges as they arise.

We hope you join us this July at the Global Congress on Comparator Studies in Philadelphia. Meet with visionaries from Merck, Wyeth, Schering Plough Corporation, Bernstein CMCRegulatory Consulting, GlaxoSmithKline and Allergan, among many other participating companies.


www.comparatorstudies.com.

Now available for download! Click here to view.
• Evolution of a Sourcing Strategy for a Midsize Specialty Pharmaco
Fredrick L. Naids, Ph.D., Senior Strategic Sourcing Director, Clinical R&D
• Supplier Identificationand SelectionCatie Cleary, Biogen Idec

Register by May 22 to save $400 off registration!

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Strategic Comparative Effectiveness Trials

Tony Dutta, senior vice president of operations at IDIS, recently wrote a great article in Applied Clinical Trials in which he describes the strategy pharma companies should put in place as the pressure mounts for them to conduct comparative effectiveness trials. Here's a brief recap of strategy he recommends.

Get strategic
To minimize delays that can evolve from financial implications, comparator sourcing strategies should include, "demand planning that can accommodate changes in the quantity of comparator drug needed in light of fluctuating patient enrollment or unexpected changes to a trial; changes in regulatory opinion, or temporary or permanent regulatory noncompliance by the source manufacturer; loss of the project's consulting global regulatory expertise; changes in global sourcing capabilities and logistics; and loss of connection to the comparator manufacturer via a sourcing specialist."

Timing is everything
A head start on planning is important as comparator drugs are like to be available from multiple places in multiple locations.


Single sourcing
Single Sourcing poses pros and cons, so sponsors should carefully evaluate risks before diving into this concept.

Read the full article

If you'd like to connect with other professionals in the field of Comparator Studies, join our Global Congress on Comparator Studies LinkedIn Group.

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