Friday, July 27, 2012

Globalization - Ethical & Business Considerations in Clinical Research

The ACRO publishes a white paper on Global Clinical Trials. 

This report analyzes the current state of global clinical research and the role that biopharmaceutical companies and their clinical research organization (CRO) partners play in ensuring that the dual goals of trial safety and quality are met.
With the changing landscape for CROs, the report has several key findings:
  • Global trials speed drug development - The report concludes that globalized trials can reduce development time by half while lowering costs and maintaining quality and safety.
  • Research quality standards must be met worldwide - The report found that trials in emerging countries, such as China and India, are subject to the same standards as those conducted in the U.S. and Western Europe.
  • Clinical research improves local economies - Clinical research offers huge advantages for host countries, including an influx of advanced equipment, trained personnel and high-paying jobs.
  • Emerging market equals growth market - CRO activity in Central European countries, South Korea and Taiwan is very robust, medical infrastructures are advanced and capabilities are just about on par with Western Europe.

For more details visit www.acrohealth.org

Tuesday, July 3, 2012

Keynotes & Leadership Announced for Global Clinical Trials 3rd Annual Event

New York - The Conference Forum has announced that the 3rd Annual Executing Global Clinical Trial’s event will take place on September 13-14 at the Fairmont Copley Square Hotel in Boston, MA.  “The trend to globalization creates opportunities and challenges for clinical trial management.  To be successful, we must focus on quality, ethics, fair market value, logistics and culture,” says Dr Barbara Skinn, Director of Collaborative Science Center of Excellence at Bristol-Myers Squibb.
Leadership
Led by Dr Skinn along with Dr Mitchell Katz, Executive Director Medical Research Operations at Purdue Pharma and Dr Aleksander Skuban, Director, Clinical R&D Emerging Markets at Merck, the conference addresses the most critical issues in globalizing complex studies to make significant progress to advance drug development for the benefit of patients globally.
Keynotes
Dr Debra S. Barker, Chief Scientific Officer, Emerging Markets, Novartis and Dr Christopher Gallen,CEO, SK Bio-Pharmaceuticals are delivering the keynote addresses. David R. Jones, Expert Scientific Assessor (Pharmacotoxicologist), Licensing Division, Medicines and Healthcare Products Regulatory Agency (MHRA), UK is a featured presenter speaking on How to Do Clinical Trials in Europe: Clarifying Confusion, Changes & Updates.

Regional Round Tables
As part of the conference, attendees will participate in region-specific round table discussions, including one-on-one question time with an industry expert in the following countries:
China ● EU ●  Latin America ●  India ●  Russia/Ukraine ●  Canada Brazil ●  Eastern Europe ●  Australia ●  Korea
Participating companies include: Novartis; BBK Worldwide; CSL Behring; Endo; Strategic Clinical Research Consulting, LLC; Baxter Healthcare Corporation; SK Bio- Pharmaceuticals; Millenium Pharmaceuticals; Momenta Pharmaceuticals; Medicines and Healthcare Products Regulatory Agency (MHRA), UK; Purdue Pharma LP; EnVivo Pharmaceuticals, Inc; Target Health; AMAG Pharmaceuticals; Merck Brazil; Merck Research Laboratories; Bristol-Myers Squibb; AAHRPP; Marken and Zalicus.
For more information on the complete speaking faculty and agenda details, click here.
Registration
Early Bird ends 7/20. Combine with 10% off with code BLOG for best price. Register today, click here. 

Monday, July 2, 2012

A Peak at GCT 2011




A Presentation on Corporate Social Responsibility, Applied Research Networks & Clinical Research Enterprise.



This Presentation was delivered by Linda Strause, PhD of Vical Inc. and Matt Whalen, PhD of Impact LLC. during the 2011 GCT program. 

For the 2012 program agenda, please visit here.