FEATURED ARTICLES

• 

  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
• Regulatory Approval Of Clinical Studies In The Netherlands
• Human ADME & Studies With Radiolabeled Compounds
• Global Biosimilar Development

FROM THE EDITOR

• 

  How To Work A Trade Show – The BIO Way

  Prior to the 2013 BIO International Convention, I received many emails, sometimes more than a dozen per day. Most were from exhibitors, wanting to schedule time to meet with me at the show. But I also received several from BIO International requesting that I take a look at their partnering system. I have to admit, I ignored those. I was scheduling all of my appointments on my iPad and figured that was good enough. After having breakfast with a couple of contacts at the show, I may rethink that decision before attending future shows.

• Economic Freedom And Innovation – Why We Should All Be Worried

  Are you concerned about the ranking of the United States in regard to the Economic Freedom of the World Annual Report? If not, you should be – and here’s why. Economic freedom is not just about politics or tariffs or regulations. It is about people. It is about being able to work where you want, when you want, trade the way you want, and live in a society where you are protected from others. It is also about the level of your health and your life expectancy.

• Want To Learn Lessons From A Successful Entrepreneur?

  What would you ask a successful entrepreneur if you could have a conversation with him over dinner or a drink? I use these opportunities to ask questions, take notes, and learn what I can about businesses, the economy, or any other topic that comes up. I recently enjoyed having dinner with entrepreneur Gary Hoover, who shared with me some lessons learned on knowledge acquisition.

WHITE PAPERS

• Regulatory Approval Of Clinical Studies In The Netherlands

  The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands. 

• Human ADME & Studies With Radiolabeled Compounds
• Global Biosimilar Development
• Metric-Based Quality Improvement Program
• Beyond EDC: Resolving Data-Entry Challenges Faced By Electronic Data Capture Systems In Clinical Trials

NEWS HEADLINES

• BioDuro Opens State-Of-The-Art Discovery Lab In Shanghai

  BioDuro, A PPD Company, recently announced it has opened a new state-of-the-art laboratory in Shanghai, strengthening its ability to provide biopharmaceutical clients an extensive range of customized drug discovery services in Asia Pacific.

• Entelos And Institute For Systems Biology Partner To Deliver Breakthrough Insights Into Novel Drug Development
• Yusen Logistics Launches Temperature Assured Airfreight Solution To Australia For AstraZeneca
• Piramal Enterprises Limited Receives IND Approval From The US FDA For Its GPR40 Agonist P11187; An Anti-Diabetic Molecule
• Cobra Biologics And Vaccibody Sign Agreement To Manufacture DNA Vaccine

FEATURED SUPPLIERS

• 

  Covance, Inc.

  Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies, with annual revenues greater than $1.9 billion and more than 10,500 employees in more than 60 countries.

• 

  SynteractHCR

  SynteractHCR is a dedicated full-service CRO (contract research organization) with a successful track record of more than two decades supporting pharmaceutical, biotechnology and medical device companies in all phases of clinical development, across multiple therapeutic areas. 

• 

  Ropack, Inc. Since it was founded in 1976, Ropack has become much more than a remarkable and efficient packaging service provider. Every effort is constantly made to make Ropack an extension of your company, a strategic partner that provides turnkey production services and avant-garde solutions.
• 

  ShockWatch More than 35 years ago, ShockWatch turned a simple idea into a global resource. The company’s first proprietary indicators were used to detect mishandling of sensitive computer media in transit. We found this simple concept so effective that additional technology was developed for many other applications. Soon, ShockWatch introduced the marketplace to a whole new class of products: damage prevention.
• 

  Life Science Leader

  The vision of Life Science Leader is to be an essential business tool for life science executives. As such, our content is designed to not only inform readers of best practices, but motivate them to implement those best practices in their own businesses.

• 

  Patheon Inc.

  Patheon Inc. is a leading provider of contract development and manufacturing services to the global pharmaceutical industry. Patheon provides products and services to more than three hundred of the world’s leading pharmaceutical and biotechnical companies.

OUTSOURCING INSIGHTS

• 

  Regulatory Approval Of Clinical Studies In The Netherlands

  The EU Clinical Trials Directive (CTD) has been fully implemented in the Netherlands. 

• Human ADME & Studies With Radiolabeled Compounds

  During clinical drug development there can be several situations where the use of radiolabeled medication or other radiolabeled compounds is required or favorable to  accomplish the study objectives.

• Global Biosimilar Development

  Inconsistency in nomenclature used for biosimilars has led to confusion in referring to some products.

• Aerocore® Solution Assists Diagnostic Specialists In Spreading Innovation And Controlling Disease

  A novel screening test is changing the way tuberculosis is detected and controlled, thanks in part to a custom shipping solution from American Aerogel.

• Metric-Based Quality Improvement Program

  The objectives of the QIP were to provide a systematic process for measuring predefined quality goals, quantify the quality of GLP data and reports produced by our scientists, provide a mechanism for reporting meaningful results to management, and identify specific areas for potential process and individual performance improvements. 

ARCHIVED NEWSLETTERS

• 05.15.13 -- Clinical Malpractice Risk, Pharmageddon, 2013 Orphan Drug Report
• 05.08.13 -- The Sunshine Act, FDA Requirements, Serialization Strategies
• 05.01.13 -- FDA Challenges For Finished Dosage Manufacturers, Insights On Clinical Outsourcing
• 04.24.13 -- Outsourcing Insights, FDA Warning Letters, What Lies Ahead For Clinical