PRELIMINARY SPEAKING FACULTY ANNOUNCED

NY – The International Institute for Business Information & Growth LLC (iiBIG) has announced the preliminary formation of the executive speaking faculty for its 3rd Annual BioPharma Outsourcing conference: “Rest-of-World CLINICAL TRIAL OUTSOURCING” – March 23-24, 2009 at the Princeton Hyatt in Princeton, NJ.

“This year’s conference is specifically designed for internationally-focused executives from leading trial sponsors in the pharmaceutical, biotechnology and medical device industries; who will be joined by executives from CROs, CMOs and other service providers,” said Don Buford, CEO, iiBIG.

“iiBIG is pleased to be joined by Michael Eckstein, President of Topaz Clinical, co-chair of this year’s event who is also helping to organize this year’s cross-border-focused event,” said Buford.

Executives interested in more information of how to join the speaking faculty and/or the business development opportunities associated with this conference are invited to contact:

• Michael Eckstein, President, Topaz Clinical – m.eckstein@topazclincial.com or 610-525-3634
• Kellie Swanstrom, VP Business Development, iiBIG – info@iiBIG.com or 973-571-0867

The following industry leaders have been invited to join the executive speaking faculty for this year’s conference:

Cory Gutterman, Associate Director, Outsourcing Global Pharma R&D, Abbott Laboratories Janet Edwards, Director, Global Clinical Outsourcing, Global Clincial Development, AstraZeneca Dr. Vinad Mattoo, Director Cardiovascular & Metabolics, Global Affairs & Pharmacovigilance, Bristol-Meyers Squibb Mohinder Bathala, Ph.D., Senior Director, Daiichi Sankyo, Ltd. Nicole Douglas, Contracts Associate, Genentech Dr. Kathleen Thompson Culkin, Director, Operations and Portfolio Management, GlaxoSmithKline Dr. Ali Nourbakhsh, Medical Director, Millennium Pharmaceuticals Anne Maria Ylissaari, Head of In and Outsourcing, Orion Pharma Lizabeth Khachadoorian, Senior Outsource Manager, Purdue Pharma Bernadette Donohue, Manager, Clnical Outsourcing, Schering-Plough Dr. Fred Naids, Senior Strategic Sourcing Director, Clinical R&D, Shire Pharmaceuticals

Jann Mouer, Contract Admin Manager, Sucampo Pharmaceuticals Dr. John Karlberg, MD, PhD, Director Clinical Trials Center, University of Hong Kong Diane Kikta, VP Global Clincial Strategic Resourcing, Wyeth Russ Pettit, VP Clinical Operations, ARIAD Pharmaceuticals Gail Adinamis, President, Clinical Resource Network, LLC Kathe Balinski, VP-Clinical Operations, MEDEREX Dr. Dmitry Shaikin, CEO, Outsourcing Clinical Trials C. Leith Kelly, Clinical Study Leader, Teva Global Respiratory Research Kathi Durdon, Clinical Operations Associate, Welch-Allyn Teresia L. Bost, Corporate Counsel Celgene Corporation Krishna Sarna, Esq., Founder and Managing Partner, Clinical Law Group (India)

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WHY YOU SHOULD ATTEND THIS CONFERENCE:

iiBIG’s Rest-of-World CLINICAL TRIAL OUTSOURCING – March 23-24, 2009, at the Hyatt Regency in Princeton, NJ – in the heart of the American pharmaceutical corridor – is the only event to cover ALL of the key business, legal, operational and financial aspects of clinical trial projects and partnerships that are increasingly taking place in the rest-of-the-world (ROW).

Key issues will be covered at one conference in two days. For both sponsors and clinical trial service companies alike, the business dynamics of operating overseas need to be known and understood. Sponsors are always looking for cheaper-better-faster site activation and patient recruitment metrics, and service providers will be challenged to show capabilities and resources in ROW markets. These ROW clinical trial projects present unique challenges versus the domestic US market:

• Protecting intellectual property rights in overseas jurisdictions
• Key elements required of CTA and MSA documents
• Currency impacts on payments to ROW investigators, institutions, labs and other vendors
• VAT and other related tax implications as applied to overseas payments
• Managing the CRO relationship over 10, 20 or more countries
• Special considerations for trials in emerging markets
• Liability and insurance issues in foreign markets
• Use and leverage local SMO organizations
• Translation, certification and notarization issues

Presentations will be case-study oriented, supplemented by roundtables and panel discussions with leading practitioners to provide timely ‘tools-you-can-use’ information to keep clinical trials goal-oriented, on-time and cost-effective. Take-aways will include specific documents and presentations with information that can readily be adapted to ROW clinical trial projects by both sponsors and service organizations.

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OVERVIEW/SYNOPSIS:

In 2007 American pharmaceutical and biotechnology companies spent in excess of $58 billion on drug discovery and development (Source: PhARMA). Where and how this money is spent is now at a tipping point. Between 2005 and 2007 – according to ClinicalTrials.gov – of the 5,167 trials and 126,980 study sites involved in industry sponsored phase II-IV trials:

• North America accounted for 50.6% of all industry-sponsored clinical trial sites globally.
• The rest-of-world (ROW): 49.4%

But the two-year trend line reflects increasing ROW activity and decreasing clinical trial site selection activity in North America. (Source: Clinical Trial Magnifier). By 2012, industry sources estimate that almost 60% of all industry sponsored clinical trials will have an ROW component.

If you are a clinical trial professional currently involved in partnerships with an ROW component – or if you are actively considering such partnerships, iiBIG’s Rest-of-World CLINICAL TRIAL OUTSOURCING – March 23-24, 2009, at the Hyatt Regency in Princeton, NJ – is the must attend conference and expo for you.

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WHO WILL ATTEND:
This conference is specifically designed for senior-level executives with titles and industry affiliations such as:

Titles:

CFO, VP Finance, Controller Corporate Counsel Director of Outsourcing Director of Clinical Operations

Director of Contract Management Director of International Clinical Operations Director of Risk Management Clinical Trial Project Directors

Industries:

Pharmaceutical Biotechnology Medical Device

Contract Research Organizations (CROs) Contract Manufacturing Organizations (CMOs) Site management Organizations (SMOs)

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PRICING/REGISTRATION INFORMATION – Register Early and Save!
Per-person Registration fees include all sessions, luncheon, and networking receptions.
(Conference attendees are responsible for making their own travel/lodging arrangements)

• Early Registration Discounts for Pharma and Biotech Clinical Trial Sponsors:

Before December 31, 2008	January 1 to 31, 2009	After February 1, 2009	Group of 3-or-More Discount
$1,395.00	$1,495.00	$1,595.00	$1,095 (per person) – No Deadline

• Early Registration Discounts for Suppliers, Vendors & Service Providers:

Before December 31, 2008	January 1 to 31, 2009	After February 1, 2009	Group of 3-or-More Discount
$1,695.00	$1,795.00	$1,895.00	$1,395 (per person) – No Deadline

Click HERE to register now!

CONTINUING EDUCATION CREDITS Continuing Education Credits (e.g. CLE, CPE, CME, etc.) may be available for iiBIG conferences. Upon request conference attendees will be provided with a “Certificate of Attendance” and a copy of the conference agenda, showing topics, length of sessions, and name(s) and professional affiliation(s) of presenter(s) for each session. Attendees wishing to apply for continuing education credits for attending this conference may submit this documentation to the relevant organization in his/her state when applying for such credits. The International Institute for Business Information and Growth (iiBIG) is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Suite 700, Nashville, TN, 37219-2417. Web site: www.nasbatools.com.