EDITOR'S DESK

  • New U.S And Canadian Facilities Boosting Biologics Capacity
    New U.S And Canadian Facilities Boosting Biologics Capacity

    Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.

Why Biosimilars Won’t Be “A Stake In The Heart Of Innovation”

There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"

2018 Outlook: Biosimilar Trends To Watch

Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.

Top 5 Biosimilar Developments Of 2017

These top five events reflect the steps the numerous industry stakeholders are taking to build what they hope will be a biosimilar friendly framework in the U.S. Though a number of these developments could bring positive implications for the biosimilar industry moving forward, several of these have raised a number of questions and concerns.

Biosimilar Evolutions To Watch For In The New Year

Experts from Adello Biologics, PA Consulting Group, Momenta Pharmaceuticals, and Avalere Health, share which trends and challenges they’re watching closely, along with how the industry could “break from tradition” in the next few years.

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GUEST CONTRIBUTORS

  • 5 Pitfalls To Achieving Proactive Risk Management In Life Sciences Companies — And How To Avoid Them
    5 Pitfalls To Achieving Proactive Risk Management In Life Sciences Companies — And How To Avoid Them

    Pharmaceuticals, large and midsize, have a long history of rewarding reactive firefighting as opposed to proactively identifying problems and preventing issues from occurring. As a result, proactive risk management and the cultural change that goes with it have been a hard sell.

  • An Analysis Of 2017 FDA Warning Letters On Data Integrity
    An Analysis Of 2017 FDA Warning Letters On Data Integrity

    Enforcement of failures in data integrity and data governance began almost 20 years ago and continues to increase in visibility and number of warning letter enforcement actions. While the FDA is not the only health authority that identifies these issues in inspections and enforcement actions, its transparency ensures the data is available.

  • MHRA Ramps Up Data Integrity, Global Supply Chain Security Efforts
    MHRA Ramps Up Data Integrity, Global Supply Chain Security Efforts

    Learn what U.K. Medicines and Healthcare products Regulatory Agency (MHRA) Senior GMDP (good manufacturing and distribution practices) Inspector Tracy Moore had to say about MHRA’s efforts in the areas of drug/device supply chain security and international efforts on harmonization of data integrity guidance.

  • What’s The Right Pricing Strategy For Cell And Gene Therapies?

    At the BIO-Europe Spring Conference in Amsterdam in March 2018, CRA hosted a special program where attendees from biotech, Big Pharma, healthcare provider/payer groups, and patient associations were asked to share their views on pricing strategies for innovative medicine, including cell and gene therapies. More than 60 attendees responded to a series of questions about drug pricing, with a focus on cell and gene therapies, and their responses were captured live through an instantaneous voting system during a panel session.

  • 4 Strategies To Thrive In The Competitive & Tech-Driven Biopharma Landscape

    The industry will see a mixture of new emerging trends and an evolution of historical trends heavily influenced by technology innovation and AI. The next year promises to be an exciting one that will strengthen the position of some existing leaders and elevate some new companies focused on building forward-looking platforms that will deliver future innovation and growth.

More From Guest Contributors

BIOPROCESSING WHITE PAPERS

  • Modular Does Not Always Mean Flexible For Pharmaceutical Facilities

    Flexible facility designs are often discussed in the same breath as modular designs. The two terms aren't interchangeable and are not even always that closely connected.

  • Best Practices For Chemical Inventory Management

    Companies that utilize chemicals in their labs and their manufacturing processes must manage those chemicals in a safe environment in accordance with government regulations. At a minimum, to ensure that this is accomplished, a system for managing information about the chemical safety and inventory data should be established and maintained. Best practices, on the other hand, take this minimum and leverage the management of the chemical inventory by taking full advantage of the people, processes, and technology involved. This white paper delves into the best practices involved in managing chemical inventory to achieve the most effective, holistic chemical inventory system.

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INDUSTRY INSIGHTS

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LIFE SCIENCE INDUSTRY EVENTS

Emerging Biotech Upstream Forum May 22, 2018
Rockville, MD
Emerging Biotech Upstream Forum May 24, 2018
Cambridge, MA
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TRAINING COURSES

Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner May 30 - 30, 2018
1pm-2:30pm EDT, Online Training
Pediatric Clinical Trials: Special Considerations and Requirements June 4 - 4, 2018
1pm-2:30pm EDT, Online Training
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