Monday, April 23, 2012

FDA Pushes Back Bowel Drug Review: Ironwood, Forest - Apr. 23, 2012

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•  FDA Pushes Back Bowel Drug Review: Ironwood Pharmaceuticals, Forest Laboratories, Inc. (FRX) More...
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•  Amsterdam Molecular Therapeutics (AMT) (RHP.DE) Receives Further Opinion on Glybera® Marketing Authorization Application More...
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•  Achillion Pharmaceuticals, Inc. Announces 94 - 100% Complete EVR From Phase 2 Trial With ACH-1625 Based Regimen in Hepatitis C More...
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•  Celsion Corporation (CLN) Announces Data Monitoring Committee Unanimously Recommends Continuation of Phase III HEAT Study of ThermoDox® in Primary Liver Cancer More...
•  Keryx Biopharmaceuticals (KERX) Announces Positive Top-Line Results from Phase 3 Study of Ferric Citrate (Zerenex™) in Japan by Partner, Japan Tobacco, Inc. and Torii Pharmaceutical Co. More...
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Events

2012 Workshop on Protein Aggregation and Immunogenicity
July 9-12, 2012
Early Registration: $695 - $1,395

Aggregation of therapeutic proteins can occur during bioprocessing, shipping, storage and even delivery to the patient. Understanding of the roles of aggregates in immunogenicity of therapeutic protein products is critical. Such immune responses can have serious consequences for patients. Also, immunogenicity can be major stumbling blocks to product development and has even plagued licensed protein therapeutics. To increase understanding of the impact of protein aggregation on immunogenicity, the Workshop will focus on five central areas:

1) clinical aspects of immunogenicity to therapeutic proteins;
2) utility of animal models and in vitro cell assays for assessing immunogenicity of aggregates and particles;
3) causes and control of aggregates and particles in formulations;
4) causes and control of aggregates and particles during processing; and
5) insights and challenges with analytical methods.

Please note: The early registration fee expires May 1, 2012, and includes a buffet for breakfast and lunch each day, opening and closing receptions, and a workshop notebook.

To register and view the schedule of speakers by industry leader's visit our website.
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Rocky Bio (Phoenix, Arizona)

Roche Diagnostics
Clinical Specialist
Will support all aspects of clinically focused sales for Roche's ACCU-CHEK product line, which includes blood glucose meters, insulin delivery systems, diabetes information management solutions, diabetes programs and services, and co-promoted product solutions within an assigned territory.

Pharm Country (Kinnelon, New Jersey)

ClinAudits
Manager Clinical GCP Compliance Operations
Overseeing administrative and support functions such as continued communication with field auditors, employees, vendors and clients; scheduling and ensuring timely progress of workflow; managing databases; improving and enhancing workflow processes; and being a key part of the decision-making process.

Biotech Bay (Mountain View, California)

MedImmune, LLC
Associate Project Manager, Clinical Sample & Data Management
Represents CS&DM on Clinical Project Teams and applicable sub-teams for assigned ongoing and upcoming clinical studies of varying complexity across Therapeutic Areas. Plan and coordinate CS&DM activities in support of pre-clinical and clinical trials.

Biotech Beach (Irvine, California)

Allergan Inc.
Senior Manager, Clinical Quality
Design and oversee delivery of quality training programs to Global Development staff for controlled procedural and processes training. Design, lead and manage the development, maintenance, and delivery of Global Development training consistent with regional and global CFR / ICH GCP / ISO regulatory requirements.

Genetown (Billerica, Massachusetts)

PAREXEL International
Clinical Logistics Leader, Proposal Support
Ensures that clinical logistics projects are progressing and systems are set up and maintained according to quality standards, SOPs and applicable ICH-GxP* and other applicable industry guidelines.

• Get Noticed! Add your resume to the BioSpace Career Center!
• See more than 5,000 job postings in the BioSpace Career Center!


Pharm Country

BioCapital Career Fair

Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the Mid-Atlantic region.

Candidates with a 4-year degree in the life sciences and a minimum of 2-years of industry related experience are invited to attend. (Equivalent work experience may be considered in lieu of a four-year college degree. PhD and Postdoc candidates welcome.)

Exhibiting companies are recruiting for positions in areas such as: QA/QC, clinical research, engineering, manufacturing, biostatistics, clinical data management, chemistry, regulatory affairs, and research.

Job seekers may register here.

BioCapital Career Fair, Bethesda, MD April 25, 2012
Pharm Country Career Fair, King Of Prussia, PA May 1, 2012
BioNC Career Fair, Durham, NC May 2, 2012
Biotech Bay Career Fair, Burlingame, CA May 29, 2012

More information about BioSpace's Career Fairs

BioSpace White Paper
Biotech Career Fairs For Job Seekers 101: Control Your Experience
By June Salvati, BioSpace Director of Events and Corporate Services
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Hot Company

Astex Pharmaceuticals
4140 Dublin Boulevard, Suite 220
Dublin, California 94568 U.S.A.
Phone: 925-560-0100 Fax: 925-560-0101

Astex Pharmaceuticals is a leader in innovative drug discovery, development and commercialization, committed to the fight against cancer and other life-threatening diseases.

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