Friday, January 28, 2011

Biorepositories Asia Session Spotlight: Korean National Research Resource Center – The Exit For the Future Science

Leading up to Biorepositories Asia, we'll be highlighting a session from the upcoming conference. It will take place April 11-13, 2011, in San Francisco, California. For more information, download the brochure.

Featured Session: Korean National Research Resource Center – The Exit
For Future Science

Presented by: Professor Yeonhee Lee, Head, KOREAN NATIONAL RESEARCH
RESOURCE CENTERS (KNRRC)

About the Session:
The Korean National Research Resource Center (KNRRC) is a leading resource center in Korea with vast numbers of samples available for research. The organization has grown tremendously during the last 16 years and now consists of 42 different centers in Korea. In 2009 alone, the center provided over 20,000 samples to researchers in the industry. In addition, more than 800 research papers in the last 5 years have used samples from the center.

Hear directly from Professor Yeonhee Lee, Head of the KNRRC, as she shares insights from the center including:
• Strategies for producing center guidelines, running the total management system and database, and educating workforces
• Clarity on the center’s resources, which are prepared directly for research without the need for second processing
• Goals and future expectations for the KNRRC


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Wednesday, January 26, 2011

Large Pharma jumping head first in biosimilars

With a regulatory pathway on the way from the FDA, big Pharma is looking to dive into the new territory of biosimilars. They are looking at these drugs as a low risk platform that will provide a stable form of revenue.

Biogen Idec CEO George Scangos stated, "I think we are in a perfect position for this. The next decade will be about access and cost as much as it is about innovation."

Merck is looking to jump start their biosimilars business, and believes that they will have five potential products in the final steps of development by 2012. Read more at Reuters. How do you think large Pharma jumping into biosimilars production will change their game plan and the overall layout of large Pharma?

Research shows that the biosimilar industry is likely to expand into a multi-billion dollar industry over the next few years, so pharmaceutical companies need to obtain the latest tools and strategies to remain competitive on a global scale. At this year’s Business of Biosimilars event, taking place September 21-23 in Boston, MA; you will develop techniques to overcome some of the scientific, regulatory, legal, and manufacturing challenges to successfully commercialize your biosimilar drug.


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Friday, January 21, 2011

Biorepositories Asia Session Spotlight: Biobanks in China: Resources and Harmonization

Leading up to Biorepositories Asia, we'll be highlighting a session from the upcoming conference. It will take place April 11-13, 2011, in San Francisco, California. For more information, download the brochure.

Featured Session: Biobanks in China: Resources and Harmonization

Presented by:
Ti He, NATIONAL ENGINEERING CENTER FOR BIOCHIP, SHANGHAI

About the Session:
China has the largest population of patients, and the latest health reform encourages even more admissions to hospitals, however, potential resources for clinical research have been ignored for a long time. The boom of the pharmaceutical industry and the progress of biomedical studies in China necessitate the use of the clinical samples. In recent years, biobanks have emerged from various hospitals across China. While such biobanks provide access to clinical samples, there remain problems to solve down the road, especially the harmonization of procurement standards. Gain insights on increasing procurement opportunities, including how to:
• Establish key partnerships within the industry to facilitate clinical research
• Gain access to unique samples and cell lines
• Address procurement standardization challenges


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Monday, January 17, 2011

2011 Immunogenicity for Biotherapeutics Brochure Now Available!

At Immunogenicity for Biotherapeutics, coming up this April 4-6, 2011, in Washington, DC, get practical insights from more than 30 new case studies including how to assess the clinical impact of protein aggregates and pre-existing antibody for correlation with clinical safety and the highly anticipated white paper from UIPS on aggregates, breakage of tolerance and the role of CD4+ T cells.

12 Reasons to Attend the 12th Annual Immunogenicity Event
→ 10 Poster Sessions to Expand Scientific Discussions
→ 5 Perspectives Comparing FDA and EMEA Guidelines
→ 4 Panel Discussions Revealing Industry Tools to Reduce Immunogenicity
→ 7 Countries Represented for Global Regulatory and Pharmaceutical Perspectives
→ 4 New Technology Comparison Case Studies
→ 10 Round Table Subject Matter Expert Opportunities
→ 3 Hour workshop on Strategies for Immunogenicity Assessment of Biosimilars
→ 30 Biopharmaceutical Companies Represented
→ 3 Hours Dedicated to the Fundamentals of Immunogenicity Studies
→ 5 Approaches for Accurately Predicting Immunogenicity
→ 6 White Paper Authors Provide Clear Recommendations
→ 40 Industry Experts Share Best Practices for Immunogenicity Studies

Join speakers from Biogen Idec, Bristol-Myers Squibb, Covance , Pfizer, Genentech, Amgen, Ambrx, Astellas , Meenu Wadhwa, NIBSC, ProFibrix and more!

Download the brochure to find out more about the speakers and presenters at this year's event.
Register here to join us today.


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Friday, January 14, 2011

Biorepositories Asia Session Spotlight: Understand and Overcome Global Ethical Concerns to Obtain Approval from Ethics Committee

Leading up to Biorepositories Asia, we'll be highlighting a session from the upcoming conference. It will take place April 11-13, 2011, in San Francisco, California. For more information, download the brochure.

Featured Session: Understand and Overcome Global Ethical Concerns to Obtain Approval from Ethics Committee
Panelists: Rajeev Shrivastava, PhD, Senior Manager, Clinical Research, ELI LILLY AND COMPANY, INDIA

Amelia Wall Warner, PharmD, RPh, Head, Clinical Pharmacogenomics and Clinical Specimen Management Director, Experimental Medicine, MERCK RESEARCH LABORATORIES

Anita Nelsen, Manager, Genetics Sample Acquisition & R&D Human Sample BioRepository, GLAXOSMITHKLINE

Ethical issues and data privacy considerations can be a problematic barrier to global sample collection in Asia. Join this interactive discussion as industry leaders from multiple perspectives share open dialogue on some of the toughest issues surrounding sample management. Legal, regulatory, policy and ethical factors are addressed to help the industry manage patient privacy, while simultaneously pursuing the future potential of biospecimen research.

Discussion addresses how to:
• Manage variation with global ethics committees
• Understand protected health information and data confi dentiality laws and regulations
• Address concerns around collection for unspecific use
• Effectively communicate with global investigators and sites participating in clinical trials



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Wednesday, January 12, 2011

Overcome Regulatory and Ethical Concerns to Drive your Biobanking Business in Asia

According to a market research by Towers Watson, India and China were the top priority markets for drug makers because of the huge population. As pharmaceutical companies expand into these untapped regions, there is a need for sample management and biorepositories to deal with the increase in clinical trial data. But for many American companies, the vast opportunities seem out of reach with unknown regulations and cultural barriers. Attend the Biorepositories Asia event and hear directly from experts on how to overcome these challenges, expand your business, and benefit from Asia’s exponential growth.

Regulatory and Cultural Perspectives on Sample Collection for Future Research
One of the top concerns biopharma executives face as they expand into the APAC region is that of ethical concerns regarding data privacy and sample collection. Hear directly from Eli Lilly’s Dr. Shrivastava on these tough issues including
  • Regulatory insights into the ethics of sample collection for future research
  • How to overcome communication barriers with investigators on sensitive subjects such as ethical concerns of sample collection
  • Ethical and moral obligations to return results exploratory analysis to subjects
Biorepositories Asia will be taking place April 11-13, 2011 in San Francisco, California. Download the brochure to find out more about the speakers and presentation at this year’s event.


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Friday, January 7, 2011

Biorepositories Asia Session Spotlight: Regulatory and Cultural Perspectives on Sample Collection for Future Research

Leading up to Biorepositories Asia, we'll be highlighting a session from the upcoming conference. It will take place April 11-13, 2011, in San Francisco, California. For more information, download the brochure.

Featured Session: Regulatory and Cultural Perspectives on Sample Collection for Future Research
Presenters: Rajeev Shrivastava, PhD, Senior Manager, Clinical Research, ELI LILLY AND COMPANY, INDIA

About the session: One of the top concerns biopharma executives face as they expand into the APAC region is that of ethical concerns regarding data privacy and sample collection.

Hear directly from Eli Lilly’s Dr. Shrivastava on these tough issues including:
• Regulatory insights into the ethics of sample collection for future research
• How to overcome communication barriers with investigators on sensitive subjects such as ethical concerns of sample collection
• Ethical and moral obligations to return results exploratory analysis to subjects


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