FROM THE EDITOR

  • Pharma Asks: Who Manages What At Advancing Service Providers?
    Pharma Asks: Who Manages What At Advancing Service Providers?

    Antonio Magnelli has a new SVP role in Europe. Patheon and all stripes and sizes of pharma providers are on the move. Like sharks, stop swimming and they won’t survive. Sponsors need to pay attention to changing leadership positions as well as to who is managing their projects at their outsourcing partners. 

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OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION

  • Why We Took A Different Approach To Planning A Conference
    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.

More From Outsourced Pharma West...

OUTSOURCING INSIGHTS

  • A Five-Step Approach To Optimizing Cost And Performance In The Temperature-Controlled Transport Of High-Value Pharmaceutical Shipments
    A Five-Step Approach To Optimizing Cost And Performance In The Temperature-Controlled Transport Of High-Value Pharmaceutical Shipments

    Important things come in packages of all sizes, especially in the world of temperature-controlled, pharmaceutical transport, where it is not uncommon for even the smallest shipment to have a far-reaching impact on researchers, manufacturers, healthcare providers and patients.

  • The Role Of DCE-MRI In Drug Discovery Support
    The Role Of DCE-MRI In Drug Discovery Support

    Incorporation of Dynamic Contrast Enhanced (DCE)-MRI modality in clinical trials can contribute to discover more powerful imaging biomarkers, compared to conventional MRI, for assessment of early disease changes and for helping select patients most likely to benefit from drug response.

    • Vascular changes can be observed and quantified with DCE-MRI, which allows earlier assessment of drug efficacy and saves time and money in the drug development process.
    • The use of DCE-MRI in studies increases the study’s discriminative power and helps reduce the number of patients and study sites.
  • Bioavailability Enhancement: The Key To Unlocking The Potential Of Drug Development Pipelines
    Bioavailability Enhancement: The Key To Unlocking The Potential Of Drug Development Pipelines

    In this paper we look at the process CoreRx goes through when given an active ingredient with low bioavailability and four approaches that may be applied to increase the amount of the therapeutic that enters systemic circulation.

  • Simplifying The Analysis Of Genomic Data In Clinical Trials
    Simplifying The Analysis Of Genomic Data In Clinical Trials

    The completion of the Human Genome Project in 2003 launched a revolution in drug development and medical therapies in the pharmaceutical and biotechnology industries. The explosive growth of genomic-based drug research continues to drive improvements in clinical trials and significant opportunities in personalized medicine and orphan drug research. Genomic sequencing has rapidly become a major part of translational research, with a dramatic increase in the number of clinical trials using this technology to understand and improve human health. Currently, according to ClinicalTrials.gov, there are 59 clinical trials using genomics data.

  • The Challenge:  Making Adaptive Clinical Trials Operational
    The Challenge: Making Adaptive Clinical Trials Operational

    The Infectious Disease Division of a world-renowned nonprofit research organization in the Pacific Northwest is the world’s largest clinical trials network for the development and testing of an HIV vaccine. The group conducts all phases of clinical trials, from evaluating experimental vaccines for safety and their ability to stimulate immune responses to testing vaccine efficacy. Due to the nature of their work, researchers at the center frequently need to modify protocols during their clinical trials, either by changing the timing of scheduling windows or by inserting new steps into the protocol, such as adding vaccines or changing dosage, which may require collecting additional consent forms from research subjects.

  • The Role Of Strategic Partnerships In Meeting Today’s Drug Development Challenges
    The Role Of Strategic Partnerships In Meeting Today’s Drug Development Challenges

    As the biopharmaceutical industry becomes more global, the challenges facing companies become increasingly complex.  The constantly evolving drug-development environment creates intense pressure for them to find solutions that improve efficiency, optimize performance and deliver value.

    Rising operating costs and decreasing economic returns are forcing biopharmaceutical companies to rethink their approach to developing drug compounds. To gain a competitive edge, companies are focusing on generating greater productivity from their research and development (R&D) investment. As a result, decision-makers across the industry are relying more frequently on outsourcing services offered by clinical research organizations (CROs) and are subsequently transitioning from Project-by-Project outsourcing to Strategic Partnerships.

More Insights

OUTSOURCED PHARMA CONTRIBUTING EDITORS

  • UPS Worldport: A Transportation And Logistics Modern Marvel

    One of the joys of working in media is the amount of travel I get to do as part of the job. While boarding planes and sitting in airports can become exhausting and tedious at times, I do get to visit some pretty amazing places that I otherwise would not have the opportunity to access. Visits to major cities like Boston, Chicago, and NYC are always enjoyable, as are visits to landmark places such as the New York Stock Exchange. Since I have been involved in the life sciences space, I have also gotten to visit some pretty memorable manufacturing facilities such as CMC Biologics, Therapure Biopharma, and Gallus Biopharmaceuticals.

    Last week, I had the privilege of attending a tour of the enormous UPS Worldport facility in Louisville, KY. To say this hub is incredible would be an understatement. The place is more amazing than Disney World, and should probably be considered as a contender for the eighth wonder of the modern world.

  • Pain In The Chain Survey: Time To Capitalize On Untapped Opportunities

    UPS has released its 7th annual UPS Pain in the (Supply) Chain Survey of executives in the pharma, biopharma, and med device industries. While this latest version of the survey shows executives still have concerns over the economy, rising costs, and regulatory challenges, there are opportunities companies can capitalize on to help move the industry forward.

    On the positive side, the growth of the global population and the middle class, along with a rise in the median age has created a growing demand for healthcare services. The report notes in order to capitalize on these new opportunities, companies will need to move quickly to make strategic changes to their supply chains. Unfortunately, supply chain change seems to come slowly, and in the current risk-inherent environment, may be impeding growth in the industry.

    While some companies are reacting to emerging opportunities by transforming their supply chains, the report states the winners in tomorrow's healthcare marketplace will be those companies that make their supply chains more flexible and efficient, and begin making those changes as soon as possible. Those that don’t may be taking on the greatest risk of all.

  • ISPE Releases Drug Shortages Prevention Plan At Annual Meeting

    ISPE has released its Drug Shortages Prevention Plan at a media conference held during its annual meeting at Caesars Palace in Las Vegas. Present at the conference were new president and CEO John Bournas, strategic advisor John Berridge, and Drug Shortage Prevention Plan leaders Joe Famulare, Paul D'Eramo, Donna Gulbinski, and Sam Venugopal.

  • ISPE Set To Address Drug Shortages At Annual Meeting

    Drug shortages continue to plague the pharmaceutical industry. According to a GAO report on shortages, dated February 2014, the number of shortages continues to increase in the U.S., as well as around the world. In 2007 there were 154 shortages, 114 new shortages and 40 ongoing from a prior year. In 2012, there were 456 shortages, 195 news ones and 261 ongoing. As of June 30, 2013, there were already 73 new shortages and 288 ongoing.

    The public health importance of these shortages cannot be overemphasized. Shortage situations have included zinc for parenteral nutrition in neonates and premature infants, doxorubicin for ovarian and other cancers, and Propofol for anesthesia.

    Clearly something needs to be done. “ISPE believes efforts to address this complex and multi-faceted problem of drug shortages requires close collaboration and clear communication between the pharma industry and global health authorities,” says Francois Sallans, VP and chief quality officer for Johnson & Johnson, and presenter at the 2014 ISPE-FDA CGMP Conference. “We believe The Drug Shortages Prevention Plan being assembled by ISPE will provide guidance to pharma and global health authorities to manage drug shortages more effectively. But more importantly we are looking into ways for the two groups to manage these shortages more proactively as well. That is an important component that we need to have in place in order to make these shortages rare, but short-lived.”

  • What Can You Learn From The Educational Planning Process Of BIO?

    In my role as the 2015 co-chair of the BIO International’s educational planning committee, I am privy to what goes into creating one of our industry’s largest annual events. As many of you are involved in organizing your own customer educational programs (e.g., The Emerson Exchange) or have been asked to serve on an event planning committee, I thought a behind the scenes look into how BIO goes about the process would be helpful to your efforts. Here are some of the best business practices I have witnessed thus far.

More From Contributing Editors...

FEATURED SUPPLIERS

  • DPT Laboratories
    DPT Laboratories

    DPT is the contract development and manufacturing organization (CDMO) that specializes in semi-solid, liquid and sterile dosage forms. With unmatched technical expertise and fully integrated drug development and manufacturing services for sterile and non-sterile dosage forms, we can help you successfully develop and commercialize your next product.

  • 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...

  • That’s Nice LLC
    That’s Nice LLC

    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.

  • 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.

  • 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.

  • Patheon Inc.
    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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 UPCOMING TRAINING COURSES

Process Validation: Ensuring Compliance With Multiple Standards

November 4, 2014
1pm-2:30pm EST, Online Training

Building An Effective GMP Training System: A Risk-Based Approach

November 10, 2014
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How To Take Advantage Of The Companion Diagnostics Opportunity

November 13, 2014
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November 17, 2014
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OUTSOURCING EVENTS

Process Validation: Ensuring Compliance With Multiple Standards

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

Building An Effective GMP Training System: A Risk-Based Approach

November 10, 2014
1pm-2:30pm EST, Online Training
Price:  $299 - Introductory Rate

Outsourced Pharma West Conference & Exhibition

November 10 - 11, 2014
San Francisco, CA

Root Cause Analysis & CAPA Identification: A Step-by-Step Guide for Manufacturers

November 12, 2014
1pm-2:30pm EST, Online Training
Price:  $299 - Introductory Rate

How To Take Advantage Of The Companion Diagnostics Opportunity

November 13, 2014
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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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