EDITOR'S DESK

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  Why New Jersey Should Be Your New Home For Pharma & Bio

  In 1998 New Jersey had 80 biotechnology firms. Today there are over 350. The state is also home to 23 large pharmaceutical firms including Sanofi, Bristol-Myers Squibb, Merck, Johnson & Johnson, and Novartis, as well as numerous medical device companies. If you look at the life science industry as a whole, the U.S. Department of Labor lists more than 1,000 firms located in the state. While many states would be happy with those numbers, many in New Jersey, from the governor’s office on down, will tell you they want more. At the 2013 Bio International Conference, New Jersey representatives made it clear they will continue to do their best to solidify the state’s role as the largest pharmaceutical hub in the nation and third in biotechnology.

• CRO Expansion In Wales: What It Means To You
• Australia Welcomes Custom Mammalian-Based Biopharmaceutical Manufacturing
• Benefits And Challenges Of EDC Adoption
• A cGMP Facility That’s Built For Quality

CLINICAL PERSPECTIVES

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  India’s CDSCO Calls For GDP Compliance To Safeguard Pharmaceutical Supply Chain

  The Central Drugs Standard Control Organization (CDSCO), the national regulatory body governing pharmaceuticals and medical devices in India, issued draft guidelines earlier this year designed to ensure the quality and identity of pharmaceutical products throughout the distribution process. By Mark Bishop, World Courier

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  The FDA’s Clock Is Ticking – Why Those 15 Days Are Critical

  When many companies respond to an FDA 483, they tend to address each specific violation in their response letter. Although they are addressing the individual complaints, they never actually get down to solving the underlying problems.
  
  Developing a response letter that addresses the inspectional observations as well as the underlying problems has gotten more challenging. The agency is now putting more pressure on drug manufacturers to answer within 15 workdays after an inspection closes out. The clock is ticking, and your time is running out!

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  A Powerful Method To Develop Highly Concentrated Protein Formulations

  Proteins perform an array of functions in living organisms, from structural scaffolds and signaling molecules to catalysts and cell-surface receptors. Structural perturbations and aberrant protein production are associated with many disease states, making these macromolecules potential candidates for pharmaceuticals. This strategy became a reality following the advent of recombinant DNA technologies, which allowed proteins to be produced on a large scale. Issues related to protein solubility can limit this approach, however, and drastically reduce the number of possible therapeutics that can be delivered to patients. “Solutions” to this problem are highly desirable.

FROM THE INDUSTRY EXPERTS

• Preparing For The Physician's Payment Sunshine Act Of 2009 Over the past several year interactions between Health Care Providers (HCPs), Health Care Institutions (HCIs) and Life Science organizations (pharmaceutical and medical device) companies have been under increased scrutiny.

CLINICAL WHITE PAPERS AND CASE STUDIES

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  Eight Best Practices Fir Compliant Essential Site Regulatory Documents

  In the push to initiate clinical trials, activating sites is understandably the primary focus—leaving essential site regulatory documents as a secondary priority and a bit of a “necessary evil.” Indeed, most sponsors and CROs approach essential site regulatory documents as a check-the-box exercise. By: Patrice Pompa, Director, Regulatory Document Management Services and Kevin T. Williams, MBA, MS, Vice President, Corporate Development and Marketing, CFS Clinical

• Regulatory Approval Of Clinical Studies In The Netherlands
• Human ADME & Studies With Radiolabeled Compounds
• Global Biosimilar Development
• End-To-End Management Of Clinical Trials Data

NEWS HEADLINES

• XenoPort Reports Top-Line Results Of Phase 3 Trial Of Arbaclofen Placarbil

  XenoPort, Inc. (Nasdaq: XNPT) announced today top-line results from its pivotal Phase 3 clinical trial of arbaclofen placarbil (AP) for the treatment of patients with spasticity due to multiple sclerosis (MS). The trial was unsuccessful in demonstrating that AP provided statistically significant improvement relative to placebo in the co-primary endpoints of the study.

• Takeda And Lundbeck Present Results From Pivotal Phase 3 Clinical Trials With Vortioxetine, An Investigational Compound For Major Depressive Disorder
• Thermo Fisher Scientific Releases New Small Benchtop Centrifuge
• Thermo Fisher Scientific Showcases Innovative Products At ASM 2013
• Frost & Sullivan's GIL 2013: Europe Set the Stage for a More Positive Economic Outlook

FEATURED SERVICES

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  BioREAD Independent Image Review

  BioREAD is a custom-designed system, developed by BioClinica which provides full image display capabilities for independent review of clinical trial imaging data.

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  CoSign Connector For SharePoint

  Organizations around the world and across industries have invested in Microsoft® SharePoint® for automating their business processes.

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  Global Clinical Trial Support

  For over 20 years, TransPerfect has been a trusted name in global support services for leading life sciences companies and CROs. That same level of commitment and expertise is endemic in Trial Interactive's global clinical trial support offerings.

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  Bio-STAR Technology Ensure that proper permits, site instructions and supplies are in place before the study begins.
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  Clinical Outcome Assessments/ePRO

  While certain aspects of your trial may be viewed as PRO, ClinRO or ObsRO, the most important output from your trial is data. As such, we offer you the ability to design and implement clinical programs that generate the highest quality data, be it from a patient, physician or caregiver.

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  IVRS/IWRS Services

  SynteractHCR offers full-featured global Interactive Voice and Web Response Systems for your clinical trial operations, through our validated 21 CRF Part 11 compliant proprietary system. Once implemented, the system is available 24/7 for use by sites, study participants and project team members. 

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  Ensuring Quality And Balancing Risks For Multiregional Clinical Trials Join industry and regulatory leaders to address multiregional clinical trial (MRCT) opportunities and risks from a global perspective.

ARCHIVE NEWSLETTER

• 05.15.13 -- Warning Letter Responses, Clinical Malpractice Risk, Sunshine Act
• 05.08.13 -- Managing Today's Clinical Environment, Outsourcing Opinions
• 05.01.13 -- Metabolic Footprint Of Diabetes, Outsourcing Insights From Biopharm President
• 04.24.13 -- FDA Warning Letters, The High Cost Of Clinical Trials, What Lies Ahead
• 04.17.13 -- The High Cost Of Clinical Research, Executive Insights From Purdue Pharma