DIA/FDA Tailored Therapeutics: Practical Issues and Methodologies for Selecting the Right Patients,

DIA/FDA Tailored Therapeutics: Practical Issues and Methodologies for Selecting the Right Patients

Oct 25 2011 8:00AM - Oct 26 2011 4:00PM
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852

Interest Area(s):
Clinical Safety/Pharmacovigilance,Clinical Research,Comparative Effectiveness/Health Technology Assess,Pharmacology,Nonclinical,Medical Communications,Quality Assurance/Quality Control,Regulatory Affairs,Statistics,Clinical Data Management/ eClinical

Overview:
This multi-disciplinary conference provides an opportunity to increase awareness,communicate shared experiences, and clarify terminology regarding tailored therapeutics across the stages of drug development, including:

• Topics of response guided therapy
• Biomarkers
• Diagnostic tests
• Clinical trial operational and regulatory issues
• Personalized medicine

CDER Forum for International Drug Regulatory Authorities

CDER Forum for International Drug Regulatory Authorities
October 17-21, 2011
College Park, Maryland

Over the years, the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has been privileged to host many of our international colleagues interested in learning about our drug review process. The CDER forum was established for the exchange of drug regulatory information between the U.S. FDA CDER and its counterpart agencies in other countries. The training is not open to the pharmaceutical industry or non-regulatory authorities. The training is not intended for U.S. government employees.

Science Shaping Our World (SHOW) – The Role of Academics in Drug Discovery: Filling the Gap

Thursday November 11, 6:00-9:30pm
Science Shaping our World - The Role of Academics in Drug Discovery: Filling the Gap
Event Organizer: Munevar and Associates
Location: Microsoft NERD, 1 Memorial Drive, Cambridge, MA 02142
Time: 6:00-9:30pm

For more information: http://shownovember2010.eventbrite.com

Science Shaping Our World (SHOW) is an ongoing seminar and networking series that highlights areas of life science research possessing significant application potential. Our mission is to bring together researchers, clinicians, entrepreneurs, investors, technology and business professionals, in a setting where they can gain exposure and insight into the life science advancements changing our world. Further, we seek to promote active inter and cross-disciplinary networking toward fostering the creation of opportunities in Life Science.

The end of axitinib

Pfizer was developing axitinib (a tyrosine kinase inhibitor or TKI) for the treatment of pancreatic cancer. Unfortunately, recent Phase III results were disappointing. As a result, Pfizer has terminated development on this agent. This is just another failure example of all the money, time, and energy spent on drug development research. It really is a shame because we need more effective therapies in oncology.

Drug Discovery & Development of Innovative Therapeutics

Drug Discovery & Development of Innovative Therapeutics is the ONE conference that continues, year after year, to bring together cutting edge scientists, leading academia, and the world's top drug discovery and development experts - all in one place, at one time.

August 4-7, 2008
World Trade Center Boston
& Seaport Hotel
Boston, MA

Highlights for 2008:

• Pre-Event Online Partnering System: A Community to Schedule Meetings Prior to the Conference
• New Expanded Areas of Content in 2008: Orphan Disease, Anti-Infectives, Imaging, Cardiovascular Disease
• FDA Keynote Panel on Biomarker Qualification
• Keynote Panel on Politics and Change in Pharma/Biotech

Register here: http://www.drugdisc.com/