FROM THE EDITOR

  • Patheon Surfs Outsourcing Waves And Scoops Up Gallus Along The Way
    Patheon Surfs Outsourcing Waves And Scoops Up Gallus Along The Way

    Jim Mullen, CEO of Patheon parent company DPx Holdings B.V., is at it again.

    On the heels of my three-part series with Mullen on the details behind the springtime merger of his company and the pharmaceutical products division of Royal DSM, he has made his next move.

    This time it is a strategic entrée into the U.S.-based market for biologics services via an acquisition of privately held Gallus BioPharmaceuticals. With Gallus, Patheon adds new capabilities at well-established sites with name-brand clientele, in St. Louis, Mo. and Princeton, N.J., to its global locations in Groningen, the Netherlands and Brisbane, Australia.

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OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION

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OUTSOURCING INSIGHTS

  • Leak Rate Testing For Freeze Dryers: A Scientific Approach
    Leak Rate Testing For Freeze Dryers: A Scientific Approach

    Assurance of the vacuum integrity of freeze-dryers used for the manufacture of sterile pharmaceutical products is essential for GMP operations; however, there is currently no generally accepted scientific rationale for establishing acceptance criteria for such testing.

  • Pharmaceutical Development For ADCs: Not As Simple As ABC
    Pharmaceutical Development For ADCs: Not As Simple As ABC

    Formulation, process, and analytical development for antibody-drug conjugates, or ADCs, is complex. 

  • Lean Six Sigma From An Outsourcing Industry Raconteur
    Lean Six Sigma From An Outsourcing Industry Raconteur

    Bikash Chatterjee knows all about Lean Six Sigma. He’ll share that wisdom with us at Outsourced Pharma West in San Francisco, November 11-12. However, you might not notice when he’s doing it. 

     

  • Using Analytics To Improve Clinical Trial Compliance And Retention
    Using Analytics To Improve Clinical Trial Compliance And Retention

    The success of every clinical trial hinges on recruiting and enrolling a statistically significant set of patients who meet specific enrollment criteria. The goal is to keep these people engaged through the end of the study to produce the quality data necessary to gain approval to market the drug or medical device being studied. However, patient recruitment and retention is widely recognized as the single biggest bottleneck of the clinical trials process. By Ben McGraw, Clinical Analytics Evangelist, Comprehend Systems

  • Challenges In Global Development Of Genetically Modified Organisms Vector Immunotherapies
    Challenges In Global Development Of Genetically Modified Organisms Vector Immunotherapies

    Genetically modified viruses serve as vectors in a growing number of cancer immunotherapies, including vector-based and dendritic cell vaccines and therapies based on modified immune cells.

  • Strategic MedChem Reagents for a Judicial Design of Focused Compound Arrays
    Strategic MedChem Reagents for a Judicial Design of Focused Compound Arrays

    Even though modern compound libraries are more attractive and lead to better hit rates, they are less attractive from the economic point of view and even large pharmaceutical companies may have some difficulty in carrying out R&D in this direction. Moreover, on top of the initial investment, in the lucky event of a hit, its chemistry follow up will be again affected by the hit’s chemistry complexity, with additional expenses in the lead optimization program.

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OUTSOURCED PHARMA CONTRIBUTING EDITORS

  • GSK Discusses The Transformation Of Biopharmaceutical Manufacturing: Single Use Is Only Part Of The Strategy

    Historically, biopharmaceutical manufacturing has always been slow, expensive, and inflexible. However, the pressures in today’s biopharma space are driving trends in the opposite direction, which is causing experts to look for ways to drive costs down while improving flexibility and efficiency. GSK’s Randy Maddux, VP and Site Director of the company’s Global Manufacturing and Supply (GMS) site in Rockville, believes there are many factors involved in transforming biopharmaceutical manufacturing. And while single-use technology plays a key role, there are plenty of other aspects to consider.

  • The Supply Chain Of The Future: A Strategic View

    Evolutionary theory teaches us it is neither the strongest nor the most intelligent of the species that survives. It is the one that is the most adaptable to change. Peter Bigelow, president of xcell Strategic Consulting, likes to mention this quote, widely attributed to Charles Darwin, when opening presentations on the future of the pharmaceutical supply chain. Ingredient suppliers, manufacturers, quality standards and audits, and logistics are just a few areas where we can expect to see many changes going forward. Adapting to these changes will be critical to everyone involved in the process, and in ensuring medicines are delivered to patients safely and effectively.  

  • Why We Took A Different Approach To Planning A Conference

    Like you, I have attended a lot of educational events and conferences over the years. I’m sure we both could list some that were unique, valuable, and memorable while others could be simply categorized as “been there, done that.” And since time is my most precious resource, the last thing I want to do is spend this ever-diminishing asset on attending — or planning — a conference that’s just like all the rest.

  • Are You Properly Selecting Your CMO Partners?

    At the 2013 WTG Global Pharma Manufacturing Summit in Boston, Angie Green gave a presentation on the steps sponsors should follow when selecting CMO partners. The CMO selection steps Angie reviewed are echoed in many of the conference sessions for Outsourced Pharma West—topics chosen by Life Science Leader readers.

  • How To Maximize The Value Of Your Attendance At Outsourced Pharma West

    Outsourced Pharma West (OPW) will be here in just a few short months. Unlike conferences you have attended in the past, OPW will be a unique opportunity to learn and partner. The sessions were requested by you, our readers, via an extensive survey. In selecting speakers, we sought out the most qualified and experienced professionals in the pharma and biotech industries. Many top CMOs and manufacturing experts will be onsite for discussions and partnering opportunities. This is one show you won't want to miss.

More From Contributing Editors...

FEATURED SUPPLIERS

  • World Courier Management
    World Courier Management

    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.

  • Norwich Pharma Services
    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.

  • AMRI
    AMRI

    With locations throughout the United States, Asia and Europe, AMRI has an unmatched ability to provide globally integrated solutions using flexible business models.

  • MPI Research
    MPI Research

    MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries.

  • Charles River
    Charles River

    Charles River Laboratories is a world leading provider of critical research products and services that enable innovative and efficient drug discovery and development...

LEADERSHIP AWARDS

Life Science Leader developed the CMO and CRO Leadership Awards based on industry leading research conducted by Nice Insight. The awards help pharma and biopharm companies focus on potential partners who can handle their projects and are considered reputable in the industry. Click on the logos above to visit this year’s winners.

 

 UPCOMING TRAINING COURSES

Identifying and Closing the Training Gap in Clinical Research

September 4, 2014
1pm-2:30pm EDT, Online Training

Pediatric Clinical Trials: Special Considerations and Requirements

September 8, 2014
1pm-2:30pm EDT, Online Training

CRO Oversight: Risk Assessment & Action Planning

September 16, 2014
1pm-2:30pm EDT, Online Training

Vendor Qualification and Compliance: What Sponsors & CMOs Must Know

September 17, 2014
1pm-2:30pm EST, Online Training
More Upcoming Courses

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FIND A CRO IN SOUTHERN CALIFORNIA

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Find a CRO with BIOCOM’s drug development guide which provides a description of each phase along with a list of companies that can accommodate your needs in the drug development cycle.

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OUTSOURCING EVENTS

Identifying and Closing the Training Gap in Clinical Research

September 4, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

Pediatric Clinical Trials: Special Considerations and Requirements

September 8, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

CRO Oversight: Risk Assessment & Action Planning

September 16, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

Vendor Qualification and Compliance: What Sponsors & CMOs Must Know

September 17, 2014
1pm-2:30pm EST, Online Training

Medical Device Regulatory Affairs 101: Regulatory Affairs For Non-Regulatory Personnel

September 18, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate
More Events...

ABOUT US

Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services. With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services  and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.

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