FROM THE EDITOR

  • An Antibody Drug Conjugate In Every Garage
    An Antibody Drug Conjugate In Every Garage

    The conference took on an old-time carnival atmosphere. At the end of one long day, I imagine a barker with megaphone among the booths: “Step right up. Get your very own look at an antibody drug conjugate platform. Don’t be the last in your neighborhood without an ADC in your garage.” Or maybe it was “in your pipeline.” It definitely was ADCs, though.

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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...

INDUSTRY NEWS

  • Patent Expirations Encourage Lilly To Streamline Manufacturing Activities

    Eli Lilly has decided to close its Guayama, Puerto Rico manufacturing site by the end of 2015 due to the impact of patent expirations. Paul Ahern, Ph.D., SVP of Global Active Pharmaceutical Ingredient and Dry Products Manufacturing at Lilly, stated the company evaluated its pipeline and concluded that, due to patent expirations, competition would grow for those medicines and reduce Lilly’s sales.

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OUTSOURCING INSIGHTS

  • 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 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.

  • Screening Prospective CROs: What Are Their Data Capabilities?
    Screening Prospective CROs: What Are Their Data Capabilities?

    Clinical development is the most costly aspect of getting a drug, medical device or diagnostic to market.  Previously priced at $1.3 billion, getting a product approved is now estimated to cost as much as $5 billion. If you entrust management of your clinical trial to a CRO, what criteria should you look for in a partner to ensure the most reliable results with the greatest efficiencies at the most affordable price?

    One major issue for sponsors partnering with CROs for analytic services is the ability to directly access and retrieve their raw data, which may only be accessible from the CRO's data warehouse, source systems, or down-stream analysis platforms.  Requesting and receiving both ad-hoc/custom and periodic standard reports from their CRO can potentially result in critical time lags and inefficiency for program, country, study and data managers, as well as for clinical research associates, investigators, clinicians and safety officers. 

  • A Global Forum For Outsourcing (With Simple Objectives)
    A Global Forum For Outsourcing (With Simple Objectives)

    Perhaps the best advice I’ve heard regarding industry conferences is twofold: first, make sure you attend, and second, keep your objectives for attending simple.

More Insights

OUTSOURCED PHARMA CONTRIBUTING EDITORS

  • 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.

  • Innovation In Clinical Trials: Is It Time To Change The Paradigm?

    “People hate change. This is true in the life sciences industry and everywhere in the world. I think it’s a major, major problem.”

    That statement, by Glen de Vries, president of Medidata, seems to sum up the challenge many have with trying to bring down the cost of clinical trials. To bring down costs we need to implement new, efficient, and available technologies. Unfortunately implementing new technologies involves change, which many people in this industry do not seem to want to embrace.

    Hopefully, that attitude may soon be changing. One of the trends de Vries has seen in the past year is a focus on innovation originating at the executive level. More managers, especially those in the C-suite, are saying we need to figure out how to do things differently.

  • Pfizer Issues A Challenge – Cook Pharmica Delivers

    When Pfizer approached Cook Pharmica about producing a monoclonal antibody, Cook saw it as an opportunity to demonstrate its ability to deliver a product to the specifications the sponsor desired. Cook was fairly new at the time, and had been working with clients for just over four years. The company looked good on paper, and was one of a few facilities that could produce ingredients as well as final drug products in the same facility. Still, Cook executives knew they needed to prove they could measure up to the six driving principles (quality, cost, adaptability, timeliness, and risk) that were crucial to Pfizer.

More From Contributing Editors...

FEATURED SUPPLIERS

  • BASi (Bioanalytical Systems Inc)
    BASi (Bioanalytical Systems Inc)

    BASi provides world-class research to the pharmaceutical industry worldwide. We offer an extensive array of contract laboratory services and manufacture more than 30 different scientific instruments.

  • 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.

  • 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.

  • Baxter BioPharma Solutions
    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.

  • CoreRX, Inc.
    CoreRX, Inc.

    CoreRx™ offers comprehensive drug product development services to the pharmaceutical and biotechnology industries. Supporting virtual, mid-size, and multinational companies, CoreRx offers customized formulation development & clinical material manufacturing solutions. Our solutions maximize client investments, shorten development time, and reduce overall costs. From First-in-Man drug development, to full CMC support, CoreRx combines 200+ years of pharmaceutical development experience and expertise to produce safe, effective, and innovative drug products, on time, and on budget.

  • 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...

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 UPCOMING TRAINING COURSES

Clinical Finance: Key Strategies to Stay in Control of Your Study Budget

October 28, 2014
1pm-2:30pm EDT, Online Training

The Top Method Validation Mistakes – And How to Avoid Them

October 29, 2014
1pm-2:30pm EDT, Online Training

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
1pm-2:30pm EDT, Online Training
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OUTSOURCING EVENTS

Clinical Finance: Key Strategies to Stay in Control of Your Study Budget

October 28, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

The Top Method Validation Mistakes – And How to Avoid Them

October 29, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

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 EDT, Online Training
Price:  $299 - Introductory Rate

Outsourced Pharma West Conference & Exhibition

November 10 - 11, 2014
San Francisco, CA
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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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