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.

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. 

The Creation Of Shire’s Outsourcing Model

Approaching $7 billion in annual sales, and fully reliant on outsourcing, no other biopharma today engenders more wonder at its business model than Shire. How does it all fit together? How is it managed? We learn firsthand here.

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GUEST CONTRIBUTORS

  • An Introduction To Biopharmaceutical Facility Design & Layout
    An Introduction To Biopharmaceutical Facility Design & Layout

    Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance.

  • A Review Of Recently Issued EMA Annexes & Their Impact On Manufacturers
    A Review Of Recently Issued EMA Annexes & Their Impact On Manufacturers

    The European Medicines Agency (EMA) is constantly adjusting its regulations, annexes, and guidances in responses to the needs of the industry, and the last 12 months have been no different. During this period they have issued a total of three revisions to established annexes and also issued a brand new guidance document in the GMP world. This article will focus on these four documents and describe what has changed and what it means to pharmaceutical companies.

  • 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

    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

    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.

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PHARMA ONLINE 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.  

  • Preventing Product Recalls For Manufacturers

    Technological advances in production equipment have made significant contributions to the efficiency of modern production processes. This has occurred in response to a growing demand for products, with manufacturers competing to get their product to market as quickly as possible without sacrificing quality. As production speeds increase, so too has the potential for defective products to reach retailer shelves. While it is certainly true that product inspection equipment contributes significantly to recall prevention, the manufacturing and safety processes involved are of equal importance. The combination of the two, proper equipment and proper processes, will greatly reduce product recalls.

More Pharma Onine White Papers

INDUSTRY INSIGHTS

  • Establishing Best Practice Qualification Metrics For Smart Shipping Containers
    Establishing Best Practice Qualification Metrics For Smart Shipping Containers

    Wernher von Braun, the father of modern rocketry famously stated, “one test is worth a thousand expert opinions.” The FDA has put their own regulatory spin on this axiom: “if you didn’t document it; it didn’t happen.” This extends beyond the drug therapies themselves to the packaging and logistics practices that are used to distribute them; what the FDA refers to as the “holding” of a drug.

  • Veterinary Medicine Is Becoming A Major Player In Regenerative Medicine
    Veterinary Medicine Is Becoming A Major Player In Regenerative Medicine

    As evidenced by the growing number of research publications, clinical trials, newly launched companies, and news stories, the Veterinary space is quickly becoming a major player in the application of regenerative medicine technologies.

  • Size Matters When It Comes To Labwashers - 8 Factors To Consider
    Size Matters When It Comes To Labwashers - 8 Factors To Consider

    To decide whether to buy two smaller undercounter washers or one large chamber glassware washer, you need to weigh the pros and cons and consider the tradeoffs. Here’s what you should take into account.

  • Reducing Analytical Method Steps For Accelerated Product
    Reducing Analytical Method Steps For Accelerated Product

    With an increasing number of products being considered for accelerated development, both the industry and regulators are looking for ways to safely hasten product development and approval times to ensure availability of innovative and low-cost drugs for patients.

  • 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.

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TRAINING COURSES

Effective Batch Record Review - Getting It Right The First Time June 28, 2016
1pm-2:30pm EDT, Online Training
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
How to Write SOPs That are GCP Compliant and Implementable July 12, 2016
1pm-2:30pm EDT, Online Training
More Upcoming Courses