OUTSOURCED PHARMA EDITORIAL

Federal Ruling Offers Some Regulatory Clarity For Biosimilars

On July 21, 2015, the Federal Circuit reached a momentous decision in the case of Amgen vs. Sandoz. The significance of this ruling goes well beyond the rights of these particular manufacturers, as the decision marks the first step toward clarifying the regulatory path for U.S. biosimilar manufacturers.

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OUTSOURCED PHARMA GUEST CONTRIBUTORS

  • Big Data Analytics: The Next Evolution In Drug Development
    Big Data Analytics: The Next Evolution In Drug Development

    The drug development process is complex and financially risky. A recent study by The Tufts Center for the Study of Drug Development estimates the cost of developing a new drug at $2.6 billion and suggests that costs of drug development are rising with a compound annual growth rate of 8.5 percent.

  • The Unsung Powers Of Moderation In Business
    The Unsung Powers Of Moderation In Business

    We live in a society that worships the new, the radical and the fast; yet we live on a planet that overwhelmingly favors a moderate pace to win the race. Can both be right?

  • The Crowd Will See You Now: How Do-It-Yourself Healthcare Will Make The World A Better Place…Someday
    The Crowd Will See You Now: How Do-It-Yourself Healthcare Will Make The World A Better Place…Someday

    We live in an era of convenience. We can, if we choose, grab dinner without leaving our cars, watch from the sofa as the the lawn service trims our hedges, wait for UPS to drop off our new clothes, and hang our dry cleaning outside the door for pick up. We live a life our grandparents only dreamed of. 

  • Rare Diseases And Intellectual Property: Creative IP Strategies
    Rare Diseases And Intellectual Property: Creative IP Strategies

    In recent years, medical research and drug development have transformed the outlook of countless people living with diseases that were formerly untreatable. Desire for tenable treatments and cures, however, is not sufficient to prompt the ongoing development of new therapies. Policymakers now face a challenge: to create and maintain a climate that fosters innovations in health while providing widespread access and meeting therapeutic needs.

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OUTSOURCED PHARMA INSIGHTS

  • Managing QbD From A CMO Perspective
    Managing QbD From A CMO Perspective

    The concepts and methods of Quality by Design (QbD), which the automobile, airline, and electronics industries have utilized to enhance the quality and reliability of their finished products, are gaining traction in pharmaceutical manufacturing. QbD enables pharmaceutical and biotechnology companies to identify, analyze, and control the sources of variation in manufacturing processes that can lessen the quality of drugs and other therapeutic products.

  • How Sustainability Efforts Change Your Supply Chain For The Better
    How Sustainability Efforts Change Your Supply Chain For The Better

    Going green is moving from a clichéd corporate phrase to simply the way business is run. Companies around the globe continue to make significant investments in sustainability that benefit not only the environment, but also the customers they serve. What does green mean for specialty logistics — and why does it matter for your supply chain? World Courier explores a few of the most critical questions shippers are asking when it comes to eco-friendly innovation.

  • Good Manufacturing Practice: The DNA of Pharmaceutical Quality
    Good Manufacturing Practice: The DNA of Pharmaceutical Quality

    Good Manufacturing Practices or GMP's are the pharma industry’s fundamental guidance set up by regulatory authorities to describe what is necessary to manufacture safe, effective drugs. 

  • CMO Selection: Going From "Could Fit" To "Good Fit"
    CMO Selection: Going From "Could Fit" To "Good Fit"

    Where does one start? For most drug owners seeking contract manufacturing support, it all depends on the type of product that they have. There’s always a set of established criteria, but there are a few other things for partner-seeking companies to look at, but it really depends on the mix and the philosophy of the organization, their cost sensitivity, price sensitivity, how aggressive they want to be, etc.

  • Finding A Contract Manufacturing Partner That Fits
    Finding A Contract Manufacturing Partner That Fits

    Any journey of discovery begins with the first step and so it goes when seeking manufacturing and contract services partners. The likely goal of course is to find partners that “fit,” but getting to whatever constitutes a “good” fit relative to your organization is a process that one should start with a bit of introspection; sort of like “you can’t have a good relationship with someone else until you know who you really are first.”

  • Seahorse Bioscience Keeps Product Development Information In Sync With Omnify Empower
    Seahorse Bioscience Keeps Product Development Information In Sync With Omnify Empower

    Seahorse Bioscience provides analytical instruments, biomanufacturing systems, and consumable labware products for biological research and drug discovery. Seahorse technology is used to advance understanding of the role of cell metabolism in neurodegeneration, aging, cancer, cardiovascular, cell physiology, toxicology and hepatobiology, immunology, infectious diseases, mitochondrial diseases, model organisms, obesity, diabetes, metabolic disorders, screening, and translational medicine.

  • What Is The Best Way To Keep Up With Changes In FDA Standards?
    What Is The Best Way To Keep Up With Changes In FDA Standards?

    This is an interesting concept, one that actually goes by the name of “Regulatory Intelligence.”  Regulatory Intelligence (RI) is something that's really important because the standards are always evolving. In the United States, for example, they start at the top with the Federal Food Drug & Cosmetic Act, and recently, the Drug Quality and Security Act of 2013. FDA takes these laws and promulgates regulations and guidance documents to interpret those regulations.

  • What Makes A Successful Due Diligence When In-Licensing A Pharmaceutical Product?
    What Makes A Successful Due Diligence When In-Licensing A Pharmaceutical Product?

    When a company is looking at acquiring or in-licensing a pharmaceutical product, there are a few technical factors that should be carefully considered before the deal is completed. 

  • Developing an Effective RFP (Request for Proposal) Process for Your Pharmaceutical Product
    Developing an Effective RFP (Request for Proposal) Process for Your Pharmaceutical Product

    More and more, pharmaceutical companies are outsourcing the manufacturing and packaging of their products.  With the increased use of Contract Manufacturing Organizations (CMO’s), the need for an effective and well-designed Request for Proposal to effectively communicate your organization’s needs and timelines is essential to ensure you and your CMO are on the same page when it comes to your project needs.

  • What Is Shelf Life Testing Of A Pharmaceutical Product?
    What Is Shelf Life Testing Of A Pharmaceutical Product?

    Shelf-life testing of a drug product is a means of assessing the functionality, effectiveness, and stability of a pharmaceutical product over a period of time to either establish a new expiry date for a new product, or to collect data in ongoing support of an already-existing expiry date for a commercial/marketed product.

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OUTSOURCED PHARMA FEATURED SUPPLIERS

  • Ash Stevens
    Ash Stevens

    Ash Stevens Inc. is a full-service Contract Pharmaceutical Manufacturer offering comprehensive small-molecule drug substance development and cGMP manufacturing services. Founded in 1962 and headquartered in Riverview, Michigan, Ash Stevens has extensive experience developing and manufacturing Active Pharmaceutical Ingredients (APIs) for commercial clients in the Life Sciences industry developing innovator small-molecule drugs. Our business model is predicated on providing Sponsor clients with the safest and highest quality work product possible while meeting delivery obligations on time and on budget.

  • 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.

  • 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.

  • 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.

  • 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.

  • Metabolon
    Metabolon

    Metabolon, Inc. has advanced the field of metabolomics by pioneering and patenting the industry’s leading biochemical biomarker discovery and profiling platform. It has developed the technology to quickly identify and measure all of the biochemicals in a biological sample through its proprietary global processing method.

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.

Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.

Outsourced Pharma is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

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Quality Assurance and Quality Control - Differences in FDA vs. EU Regulations

July 30, 2015
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New Pharma Compliant Google Ad Formats – Implementation Tips For Success

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Project Management: Best Practices for Validation & Regulatory Projects

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Medical Device Complaint Handling and MDR Reporting

August 11, 2015
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Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle

August 12, 2015
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