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Monday, May 12, 2008 |
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Periapproval Services:
We were specifically designed to meet every goal you target.
With nearly 30 years of experience, Covance is your natural selection for all of your post-approval needs. In fact, Covance is the first and only specifically built periapproval services partner. We offer a wide range of professional, analytical, and technical resources. Our expert Project Managers and their interdisciplinary teams use state-of-the-art approaches and draw upon their vast knowledge and therapeutic expertise to anticipate and solve any periapproval challenge in creative, compliant ways. And, we consistently deliver the results and confidence you're looking for when you make your choice of a post-marketing CRO.
Please click here for more information. |
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Drug Approval Trends at the FDA and EMEA
Process improvements, heightened scrutiny and industry response
• Delayed approvals. Regulators are requesting more data to validate or refute conclusions about product risks. This is creating a rise in the size and number of clinical trials as well as overall research budgets.
• Rising R&D costs. Drug developers are continually increasing their R&D expenditures to generate approvable drug applications, despite rising financial pressures in the industry. Emerging technologies such as stem cells, genomics and proteomics are among the most prevalent initiatives being used to identify appropriate drug candidates.
• US generics focus. The FDA is allocating resources to generic drug approvals in an attempt to speed these products to market. However, although Europe has recently developed a clear regulatory path for generic versions of biologicals, this is yet be achieved in the US.
• Regulatory process improvements. Regulators are enhancing their drug review processes with new technologies such as electronic drug applications and technology-based standards for drug review.
Click Here for More Information |
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• Genetown (Watertown, Massachusetts) Hot Job of the Day:
Enanta Pharmaceuticals, Inc.rs
Associate Scientist - Biochemistry/Bioanalysis
The candidate will be responsible for enzymatic method development, in vitro/ex vivo drug metabolism studies, and biological sample analysis. He/She must be able to work independently with minimal supervision.
• BioTechxus (Fort Worth, Texas) Hot Job of the Day:
Alcon Laboratories
Clinical Team Leader
Implement clinical pharmacology studies and project-related activities to support the clinical evaluation of Alcon lead candidates. Provide strong leadership to subordinates and facilitate and support their roles within the CP Unit.
• Pharm Country (Montville, New Jersey) Hot Job of the Day:
Bayer HealthCare Pharmaceuticals
Clinical Safety Associate/Senior Clinical Safety Associate
The incumbent will be responsible for prioritizing all U.S. serious and non-serious adverse events received from physicians, investigators, pharmacists, nurses, consumers, patients, CROs (Clinical Research Organizations), and sales representatives.
• Biotech Bay (South San Francisco, California) Hot Job of the Day:
Breightworth Recruiters
Associate Director Clinical Operations
Manages resources, timelines and budgets for clinical programs run globally and within the United States to meet clinical and corporate goals and metrics.
• Biotech Beach (Irvine, California) Hot Job of the Day:
ClinAssure, Inc.
Senior Clinical Research Associate ( Senior CRA )
As a member of the clinical team under supervision, this position is responsible for performing clinical research activities related to all clinical research studies and projects according to Federal Regulations and ICH guidelines.
Get Noticed! Add your resume to the BioSpace Career Center!
See more than 5,000 job postings in the BioSpace Career Center! |
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New BioSpace White Paper!
Biotech Career Fairs For Job Seekers 101: Control Your Experience
By June Salvati, BioSpace Director of Events and Corporate Services
Read it Now!
We are pleased to present the BioSpace Career Fair in Pharm Country on Thursday, June 5, 2008 at the Hanover Marriott in Whippany, NJ.
BioSpace Career Fairs give job seekers the opportunity to meet face-to-face with the region's elite science industry employers while presenting the opportunity to interview for hundreds of specialized open positions.
CLICK Here to submit your resume for the Pharm Country Career Fair now!
Qualified candidates will receive their invitations and confirmation numbers via email 24 to 48 hours after their resumes have been submitted. Pre-screened and accepted candidates must bring a copy of their invitation with confirmation number to the event.
We look forward to seeing you at the Pharm Country Career Fair!
• Pharm Country Career Fair, June 5, 2008
• DDT - BioSpace 2008 Career Fair, August 6, 2008
• DeviceSpace Career Fair, September 8, 2008
• BioCapital Career Fair, September 30, 2008
• Biotech Bay Career Fair, October 14, 2008
More information about BioSpace's Career Fairs |
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Drug Development Clearly Explained
• Clear text explaining all aspects of global development, from laboratory to market hyperlinked to relevant guidelines
• Suitable for scientists, developers, business people wanting a clear but comprehensive summary.
• 21 Chapters, with key points and questions/answers to insure understanding
• E-book/pdf format/secure download only
250 pages plus 1800 page appendix. $295/EUR190; corporate licences for multiple users available.
www.alladex.com |
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Hot Company
GenVec Inc.
65 West Watkins Mill Road
Gaithersburg, Maryland 20878 U.S.A.
Phone: 240-632-0740 Fax: 240-632-0735
View Jobs
GenVec Inc. is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. Each of our product candidates uses patent-protected technology to deliver genes that produce beneficial proteins. Our lead product, TNFerade(TM), is currently in the pivotal Phase III PACT in locally advanced pancreatic cancer; Phase II studies are in progress in rectal cancer and melanoma, and Phase I/II studies are in progress in head and neck cancer. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV, malaria, seasonal and pandemic flu, HSV-2, and foot and mouth disease. |
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ClinicaSpace NewsBeat Team
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Editorial & Production Staff:
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Lana Ho
ClinicaSpace.com - The Most Trusted Source for Daily Clinical News |
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• Please distribute this e-cast freely.
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