FROM THE EDITOR

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  Puerto Rico Back On The Map Of Pharmaceutical Locations

  There were many options (and precious time) for a journalist at BIO 2014 in San Diego: pharmaceuticals, biotechs, academia, countries, regions, consortiums and the like. One place I just had to find: Puerto Rico. Where had the Commonwealth gone? Was it still on the map of pharmaceutical development, manufacturing and outsourcing?

• AAIPharma/Cambridge Major: A CDMO With Two Names And A New CEO
• Give Credit To The U.S. Pharma Industry For Leading Reincorporation
• Discovery Fast Track At GSK Assists Academia And Adds To The Pipeline
• Fibrotech Knows Translational Research Methodology, Shire and Pharma Industry Agree

OUTSOURCING INSIGHTS

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  Contract Development: Accessing External Innovation

  In the outsourcing business, many outsiders assume price is the primary motivation of all this outsourcing, but in an industry in which the  bestselling drugs bring in more than $1 billion a quarter, it makes little sense to risk delays by making decisions based solely on cost. The reality is the best service providers offer more than just financial flexibility. 

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  How Ultrasensitive Tests Support Endocrine And Metabolic Disease Drug Development

  Endocrine diseases are now a major public health concern, with diabetes alone affecting 382 million people worldwide. Biopharma companies are investing heavily to improve patient care, but the complexities that characterize the endocrine system make drug development a challenge. Ultrasensitive and specific testing methods are essential to address these issues. By Walt Chandler, PhD and Patrice Hugo, PhD, LabCorp Clinical Trials

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  Pharma & Biotech: Pricing Strategies In A Changing Market

  “So what do you think we can charge?” 

  A simple question posed every day by pharma/biotech executives and investors around the globe about products at the earliest stages of development.  The answer boils down millions upon millions of research dollars and thousands of man-hours to a single number. 

  This number will be controversial internally and potentially politically explosive externally.  How is a manufacturer able to assess pricing potential for an early stage asset and continue to build value in the asset throughout the development process in an evolving and increasingly complex healthcare payment system? 

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  Maximizing Your Data Quality: Our Relentless Journey

  It’s simple: You need to get the most from your clinical trial. So it’s no wonder that at Covance, we’re constantly asking: “How can we deliver higher quality data to you, faster?”

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  Following The Lead From Big Pharma Or Biotech May Not Identify The Right Supplier For Emerging/Niche Or Start-Up Companies

  A couple of years ago, Nice Insight explored how the essential qualities for outsourcing relationships varied between
  large and midsized companies, in addition to traditional pharma companies versus biotechs. As one would imagine,
  these essentials differ quite a bit from emerging or start-up companies, as their needs when it comes to outsourcing are different from larger companies’. 

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  Global Drug Discovery Outsourcing Market Gaining Momentum

  There is no doubt that global pharmaceutical companies have a desperate need to develop better drugs with high success rates. Consequently, more drug companies are utilizing external resources, while still constantly streamlining their internal R&D systems.

OUTSOURCED PHARMA CONTRIBUTING EDITORS

• Four Essential Steps To Selecting The Right CMO Partner

  If you are currently involved in outsourcing any of your pharmaceutical manufacturing, you know there are a lot of complexities around selecting the right CMO partner. It can be a daunting process to find a supplier that has the right level of quality, experience, is a good cultural fit, and has the right price.

• Women In Bio Profile - Lessons Learned From 10 Years Performing Tech Transfers

  Kelly Kral has worked in the pharmaceutical industry for more than 10 years. She started her career at Genzyme, working as a process engineer developing a fed batch process for the production of adenovirus in HEK293 suspension cells. Her responsibilities included media screening, cell growth characterization, and virus production in shake flasks, spinners, and bioreactors. She assisted in process transfer to a CMO and authored process documentation, skills she used extensively in her work as group leader for upstream process development at Percivia and in her current role of scientist I at bluebird bio.

• Pennsylvania Continues Aggressive Push For Life Sciences

  When you attend the BIO International Convention, you expect to see large pavilions from states heavily involved in the life sciences. This year’s show was no exception. Major time and financial investments were clearly made by California, Georgia, Massachusetts, Texas, New Jersey, and … Pennsylvania? Yes, Pennsylvania (PA).

• Covance Brings Together Pharma And Biotech To Speed Drug Development

  Having the right connections can be critical to any business. In life sciences, having the right connections can make or break a discovery company. For a small biotech firm, standing out in a crowded field of companies attempting to reach pharma partners can be a chore, especially during the early phases of development.  With that in mind, Covance has created Covance MarketPlace, a tool designed to help pharma and emerging biotech companies easily and securely forge new partnerships.

• How To Prepare A Facility For The Biopharmaceutical Revolution

  Drug discovery is an inherently inefficient process. It takes thousands of failed compounds before one can get approved as safe and efficacious, and this effort does not come at a low cost. Because of this, the industry is constantly looking for ways to bring safe, compliant, and profitable drugs to market faster and cheaper. Patheon facility in Brisbane, Australia, exemplifies the facility needed to survive the future of pharma. But how did they do it?

INDUSTRY NEWS

• Research Suggests Cystic Fibrosis Is Two Diseases, Not One

  A new study suggests that cystic fibrosis (CF) may not be one but in fact two separate diseases. One of these diseases affects several organs including the lungs, while the other does not affect the lungs or respiratory system at all.

• GSK Files EU MAA For World’s First Malaria Vaccine
• FDA Accepts Novartis Firm Sandoz’s BLA For Filgrastim
• Gilead Licenses Tenofovir Alafenamide For HIV To Medicines Patent Pool
• FDA Approves Two Novasep API Facilities In France

FEATURED SUPPLIERS

• 

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  That’s Nice is a full-service agency providing research-driven brand management and marketing that enable businesses to achieve their goals. Our integrated services reflect 18 years of knowledge in life science and materials science markets, a passion for strategic thinking, and a comprehensive approach that meets the needs of global companies.

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  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.

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  Baxter BioPharma Solutions

  BioPharma Solutions, a business unit of Baxter, partners with pharmaceutical companies to support their commercialization objectives by providing scientific expertise, sterile contract manufacturing solutions, parenteral delivery systems, and customized support services needed to meet the unique challenges that parenteral products face.

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  AMRI

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  UPM Pharmaceuticals

  At UPM Pharmaceuticals, scientific sophistication and experience come together with flexibility, responsiveness and innovation. UPM provides pharmaceutical drug development services including formulation development, GMP clinical and commercial manufacturing, analytical methods development and stability testing.

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  Norwich Pharma Services

  Norwich Clinical Services is a contract research organization that provides Bioanalytical Services, Pharmacovigilance and Clinical Research Programs to the pharmaceutical and biotech industries. We combine comprehensive services, exceptional customer focus, and the highly-respected resources and reputation of Norwich to offer a complete range of Clinical Services.

ARCHIVED NEWSLETTERS

• 07.23.14 -- Give Credit To The U.S. Pharma Industry For Leading Reincorporation
• 07.16.14 -- What Can Be Done To Change The Reputation Of Pharma?
• 07.09.14 -- DEA Imposes Extra Layer Of Regulations On Manufacturers Of FDA-Approved Prescription Drugs To Alleviate Pain
• 07.02.14 -- MedImmune's Blueprint For Building A Biologics R&D Engine