EDITORS' DESK

  • Emerging Biopharma – And Their CMOs – Crazy Like A Fox
    Emerging Biopharma – And Their CMOs – Crazy Like A Fox

    We’re learning of an emerging biopharma and CMO model. We’ll have to see if this evolution, of sorts, takes hold more largely throughout the industry. But then again, we’ve heard “crazy” things in the past that are proving tantalizingly accurate.

Value Creation Redefines BioPharma Outsourcing

Am I starting an article on biopharma outsourcing by noting Frederick Engels, co-author (with Karl Marx) of The Communist Manifesto? And asking Mary Kachinsky, VP Strategic Sourcing and Operations at FORMA Therapeutics, to participate? Well, yes, and it should be a “valuable" read.

Sanofi-Genzyme – And CMOs – Serious About Training Project Managers

Carol Sherako, Director Program Management at Sanofi-Genzyme, is a highly trained project manager. She humbly suggests other PMs in the biopharma industry should be, too. If biopharma is going to stick with the model of transitioning scientists from within its ranks to the status of PM, it ought to get serious about training them.

Required Skills For Project Management At Genzyme

“I’m not sure you want to hear my thoughts on project management in our industry.” That turns out to be the only statement Carol Sherako, Director Program Management at Sanofi-Genzyme, and I disagreed on in what became two articles of her views on the subject.

For M&A, Shire Stays Three Dimensional With CMOs

How do biopharmaceutical companies handle CMO and supplier relationships that stem from M&A activity? Who better to ask than Shire? The folks there know M&A and outsourcing as well as anyone in the global biopharma industry today. 

More From Chief Editor Louis Garguilo

GUEST CONTRIBUTORS

  • Risk-Based Approaches To Establishing Sample Sizes For Process Validation
    Risk-Based Approaches To Establishing Sample Sizes For Process Validation

    Using confidence, reliability, and acceptance quality limits (AQLs) to determine sample sizes for process validation are proven methods to ensure validation activities will yield valid results based upon an organization’s risk acceptance determination threshold, industry practice, guidance documents, and regulatory requirements.

  • Taking the Long Road to Continuous Manufacturing
    Taking the Long Road to Continuous Manufacturing

    New manufacturing methods that cut processing steps, speed production, improve efficiency and increase quality and safety all sound like great ideas.

  • Effective Risk Management: A Catalyst For Quality Performance
    Effective Risk Management: A Catalyst For Quality Performance

    When we think of risk in the context of drug development and manufacturing, it is human nature to associate any risk-based approach with adding risk to the decision or process. This guidance laid the foundation for two important concepts that influence how we develop and guarantee the quality of our drug products today.

  • Outsourcing Insights For Drug Delivery Devices
    Outsourcing Insights For Drug Delivery Devices

    Windgap Medical's wet/dry epinephrine delivery device is in its third generation of prototype development, and the company has fought through the gauntlet of outsourcing decisions. Here, CEO Chris Stepanian discusses outsourcing methodology, including which functions to outsource, vetting of potential partners, and more. 

More From Guest Contributors

PHARMA OUTSOURCING WHITE PAPERS

  • Using A Risk-Based Approach To Plan Your Solid Oral Dosage Scale-Up

    Using a risk-based approach for planning the timeline and strategy for your drug’s development and scale-up can help you avoid very costly delays. Yet, in the race to bring a drug to market, assessing risk can often be overlooked. Each case is going to be different; however, by creating a comprehensive plan for risk management (applying ICH Q9 as a basis), you can lower the overall level of risk from beginning to end. This not only puts you in the best possible position to avoid questions from the FDA at the time of submission but it also results in a more efficient development process and a higher-quality product.  

  • Optimizing Clinical Trial Enrollment: Same Day Turnaround Of Blood Chemistry For Eligibility

    Potential clinical trial participants and sponsors typically wait 2-3 days for lab results to determine eligibility. For the would-be participant every day that elapses could contribute to the loss of interest and increase the risk of losing a potential study subject for many reasons. By Paul S. Savuto, MS, MBA Blinded Diagnostics

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ABOUT US

Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.

Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.

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.

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.

Louis Garguilo Articles

INDUSTRY INSIGHTS

  • How Are Analytical Methods Exchanged In A Technology Transfer?
    How Are Analytical Methods Exchanged In A Technology Transfer?

    As the principal means of assuring chemical identity and purity, instrumental analysis is the lifeblood of pharmaceutical development and manufacturing. In addition to standard instrumental methods, molecules may undergo enzymatic or cell-based assays to demonstrate some critical quality. Products often become “married” to analytical methods, and transferring this panel of tests during a technology transfer requires care.

  • Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk
    Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk

    When planning for the development of a new product, a pharmaceutical manufacturer must determine very early in the process what a product’s anticipated demand will be at the time of launch. Not only is this very difficult to do, but also the consequences of incorrect forecasts can be very costly in a number of ways. Without the ability to predict capacity needs with 100% accuracy, pharma must come up with an effective way to eliminate demand risks.

  • US Clinical Labels 101: Steps To Ensure Accuracy
    US Clinical Labels 101: Steps To Ensure Accuracy

    Determining a drug candidate’s probability of commercial success is a most significant phase in the drug development process. There is no room for error. Therefore, every component of clinical studies must be performed with the highest level of accuracy, not only to ensure the validity of the study results but also to avoid costly delays. 

  • Implications Of Inaccurate Forecasting On Biologics Drug Substance Manufacturing
    Implications Of Inaccurate Forecasting On Biologics Drug Substance Manufacturing

    To better understand the issues that biopharmaceutical companies face when planning for clinical and commercial biologic drug substance manufacturing and supply needs, ORC International conducted interviews with biopharmaceutical executives in North America and Europe who consistently utilize forecasts for drug substance and commercial manufacturing planning for biologics. This research explored the causes, consequences, and potential solutions to forecasting challenges specifically related to biologic drug substance manufacturing.

  • Critical Factors of Fill Finish Manufacturing For Biologics
    Critical Factors of Fill Finish Manufacturing For Biologics

    With the explosion of the biologics market, which now accounts for an estimated 20% of all pharmaceutical sales, the industry has entered a new era of drug development. This growth — 10 percent to 15 percent each year — is being driven by monoclonal antibodies, which are anticipated to have worldwide sales of nearly $125 billion by 2021. However, this burgeoning market comes with some considerable challenges for drug manufacturers, due to the fragile nature and instability of these large, complex molecules.

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OUTSOURCING EVENTS

PHARMACEUTICAL GROSS TO NET ACCOUNTING SUMMIT June 27 - 29, 2016
PRINCETON, NJ
Effective Batch Record Review - Getting It Right The First Time June 28, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Effective Clinical Investigator GCP Training - Getting It Right The First Time June 29, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Medical Applications in 3-D Printing: Clinical Benefits, Regulatory Issues, and Manufacturing Challenges June 30, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
How to Write SOPs That are GCP Compliant and Implementable July 12, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
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