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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Innovative Clinical Trial Design and Management

The pharma industry is continually exploring new ways of improving drug developments and one area of focus is adaptive clinical trial designs. These innovative designs use accumulating data to guide potential modifications to the study as it progresses, without undermining the validity and integrity of the trial. The advantages of such designs include the reduced length and cost of clinical trials, lower patient numbers and the ability to stop a trial early where a drug has not shown efficacy.

'Innovative Clinical Trial Design and Management' published by Business Insights explores the major types of adaptive design and their role in dose-finding. The report investigates seamless Phase 2/3 trials and adaptive trials in pharmacogenomics, assesses the logistical implications of adaptive trial implementations and reviews the current regulatory standpoints of the FDA and EMEA. Detailed case studies of recent adaptive clinical trials are provided and the companies offering statistical expertise in this area are profiled. This report also includes a breakdown of potential cost and time savings offered by innovative designs throughout the clinical development process.

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. The Global Congress on Comparator Studies conference gives you the unique opportunity to get ahead of the industry and establish your strategy for sourcing comparators and overcoming regulatory challenges in just two days.

Send an email here to find out how you can order this report and receive a 15% discount.

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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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Join Us: Global Congress on Comparator Studies

Global Congress on Comparator Studies
July 20-22, 2009
The Ritz-Carlton Philadelphia

The Global Congress on Comparator Studies provides pharmaceutical and biotech executives the tool set required to establish a comprehensive strategy for sourcing comparators and overcoming regulatory challenges.

We’re looking to make GCCS an interactive experience to foster networking and knowledge sharing. The benefit is that attendees get to interact with peers in an informal setting and really get some of your challenges answered.

· Roundtable breakout sessions for regulatory and supply chain executives
· Interactive panel discussions with a cross section of industry leaders


To stay informed, please visit our event webpage and join our LinkedIn group

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Global Congress on Comparator Studies

Expedite Your Clinical Trials to Reduce Costs & Maximize Profit

Global Congress on Comparator Studies is one of the only industry events designed to provide you with proven, cost-saving tactics for sourcing comparator drugs in today’s global market. This conference provides pharmaceutical and biotech executives the tool set required to establish a comprehensive strategy for sourcing comparators and overcoming regulatory challenges.

Learn From Small, Mid-Sized, Big Pharma and Biotech Firms
The 2009 speaking faculty includes diverse perspectives from industry heavy weights like GlaxoSmithKline and Schering Plough in addition to smaller manufacturers including Facet Biotech and Allergan. This year’s program is specially designed to provide you with a vantage point for developing your own customized strategy based on the learning of industry leaders.

Featuring the Clinical Trial Supply Chain Summit!
In the current state of restricted travel and training budgets, we have moved the Clinical Trial Supply Chain Summit to take place immediately following the Global Congress on Wednesday, July 22. Any clinical trial executive looking to build a leaner supply chain should take a moment to save the date!

Think of Global Congress 2009 as your blueprint for optimizing the performance of your clinical trials for comparator studies. This is a golden opportunity to interact with your colleagues, get insight into what your competitors are doing and build your Rolodex. Register today to take advantage of early discounts and save your company $400 off the cost of registration! Rate expires on 5/22/09 – don’t miss out!

Looking forward to seeing you in Philadelphia!

Best regards,
Ian McRae
Conference Director

Registration Information

https://www.iirusa.com/comparatorstudies/register-now.xml?state=select_event

Mention your priority code: LYKBPLL

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