FROM THE EDITOR

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  Acquisition Expands Phase I Capabilities

  Clinical research firm PRA has announced it will be acquiring privately-held specialty research firm CRI Lifetree. CRI’s focus has been on early stage patient population studies with a focus in Human Abuse Liability (HAL), addiction, pain, psychiatry, neurology, pediatric and infectious disease services.

  With three Clinical Pharmacology Centers and over 200 beds, combined with over 20 years of clinical experience, CRI is one of the largest providers of patient population Phase I and confined Phase II-III services in the United States. 

• FDA Presents Regulatory Challenges For Finished Dosage Manufacturers

  As president of contract manufacturer Oso Biopharmaceutical Manufacturing, there are many concerns that might keep Milton Boyer awake at night. For example, he believes that, for most CMOs, every customer is always ready to leave. Therefore, manufacturers need to have a steady stream of new clients ready to fill the void. There are also cost pressures in the industry, concerns over hiring talented personnel, and internal problems that could arise and potentially derail any relationship. But when talking to Boyer, you get the feeling that no topic consumes more of his time than concern over the current regulatory environment.

• WIB Profile: Best Practices For Buying, Selling, And Maintaining Used Laboratory Equipment

  In this Women In Bio (WIB) profile article, Dawn Hocevar, director of national development for BioSurplus, discusses her job, trends in the market for used lab equipment, and best practices to keep in mind when shopping for used equipment. She also discusses what WIB can do for young women entering the pharma and biopharmaceutical industries.

OUTSOURCING INSIGHTS

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  Inflammation And The New Drug Development Paradigm

  Opportunities abound for new treatments for inflammatory diseases, which afflict millions of people. Upward spiraling development costs, however, impede progress and delay relief for patients suffering from such debilitating diseases. By Thomas Vihtelic, DVM, PhD, MPI Research

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  Enabling Technology Can be Critical To Timely CMO Delivery

  APIs that are advancing from discovery into the clinic are increasingly complex, and the chemistry and/or biology necessary to manufacture these compounds requires increasing sophistication. The selection of a CMO (Contract Manufacturing Organization) is the crucial decision in the life of any outsourced project. Therefore, it is imperative to select a CMO that can produce the desired compound, to the desired specifications, in the desired timeframe. One key consideration in the selection process is the technology available in the toolbox of the CMO. As the majority of new APIs under development are still small molecules, this article focuses on the required “classical” chemical capabilities for constructing such molecules. Some selected technologies include: chemocatalytic and biocatalytic transformations, transition metal couplings, high pressure chemistry, cryogenic technologies, hazardous reactions and chromatographic technologies like Simulated Moving Bed. Consideration should be given to the ability of the CMO to practice the required technologies at all scales - from laboratory to pilot plant to commercial production equipment.

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  Vaccine Potential And Preclinical Development Needs

  Few medical advances have made as large an impact on world health as vaccines. Globally, Vaccines prevent approximately 10.5 million cases of infectious illness each year. 2.5 million child deaths are prevented from diphtheria, tetanus, pertussis, and measles annually through immunization (BIO). Despite these facts, infectious diseases are still the second leading cause of death worldwide, and new infectious diseases continue to emerge. By Stephene Rose; Senior Study Director at MPI Research

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  How To Develop A Successful Supplier Management Program

  J&J’s answer to horizontal integration by standardizing their approach to suppliers and the development of business relationships with strategic suppliers.

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  Emerging Markets And Your Global Regulatory Strategy

  For pharmaceutical companies aligning the regulatory strategy across many countries saves time and money for drug developers, resulting in earlier access by patients.

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  What Can 2013 Outsourcing Trends Lead Us To Expect In 2014?

  With a 7 percent upturn in 2013, and according to Nice Insight’s research outsourcing expenditures are expected to rise modestly in 2014 chiefly for one reason.

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  FSP Or Full-Service Outsourcing For Clinical Trials?

  By outsourcing individual functional services, sponsor companies gain freedom they might not have in a traditional preferred provider relationship, however, many factors contribute to a successful FSP relationship and sponsors should look for certain qualities when evaluating CROs.

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  Style & Substance In The Pharma Supplier Space

  What is real, and what is illusory in the world of drug diagnostic, and device development?

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  Quality by Design: A CMO’s Perspective On Gaining Knowledge Faster And Better

  Although the phrase “QbD” has been thought of as a new or borrowed concept and discussed in terms of feasibility, many CMOs have been using these con-cepts, albeit perhaps not in a well-planned, cohesive manner.

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  Implementing A Single-use TFF System In A cGMP Biomanufacturing Facility

  This case study describes the process used to transition from a multi‐use system to a single‐use tangential flow filtration (TFF) for performing final buffer exchange steps.

NEWS HEADLINES

• Tyrosine Pharma Names Laslie President And CEO

  Tyrosine Pharma, Inc., has announced the appointment of Wayne Laslie as president and chief executive officer.

• Dyax Receives Orphan Drug Designation From The U.S. FDA For DX-2930 In Hereditary Angioedema
• NovaMedica Signs Distribution Agreement With Aptalis Pharma To Develop And Commercialize Gastrointestinal Pharmaceutical Products In Russia
• RBCC Appoints New CEO To Achieve Regenerative Medicine Goals
• European Medicines Agency Approves Once Every Two Weeks Dosing Option For Hizentra▼ (Human Normal Immunoglobulin, SCIg)

FEATURED SUPPLIERS

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  Norwich

  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.

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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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  World Courier Inc. World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.
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  Fujifilm Diosynth Biotechnologies

  Fujifilm Diosynth Biotechnologies is an industry leading Biologics Contract Development and Manufacturing Organization with locations in Research Triangle Park, North Carolina and Billingham, United Kingdom.  Fujifilm Diosynth Biotechnologies has extensive experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules expressed in a wide array of microbial, mammalian, and insect systems.  The company offers a comprehensive list of services from cell line development, including its proprietary pAVEway™ system to process development, analytical development, clinical and commercial manufacturing.  Both sites have been FDA-approved for the production of commercial products.

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  Pfizer CentreSource Pfizer CentreSource (PCS) is a leading pharmaceutical contract manufacturer that offers a range of GMP compliant sourcing and outsourcing services to meet your pharmaceutical production requirements.
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  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.

ARCHIVED NEWSLETTERS

• 12.04.13 -- Conducting Clinical Trials in Serbia And The Netherlands
• 11.27.13 -- Peptides And Proteins Make Significant Advances
• 11.20.13 -- Januvia and Tradjenta Battle For DPP-4 Supremacy
• 11.13.13 -- Global Trials Roundtable: Controlling Cost And Mitigating Risk