ALSO IN THIS MONTH'S ISSUE

  • CMS Opens Path To Reform Of Part D
    CMS Opens Path To Reform Of Part D

    Pressure had been building for more than a year for something to be done about drug prices, and specifically inflated list prices to the patient at the pharmacy counter that do not reflect the substantial rebates manufacturers are providing. Where was all the money going? How could the list price and patient copays for drugs keep rising when the net prices — accounting for manufacturer rebates — stayed level?

  • Creating A Contingency Plan: Top 4 Pharma Concerns As Brexit Approaches
    Creating A Contingency Plan: Top 4 Pharma Concerns As Brexit Approaches

    March 30, 2019 — Brexit D-Day — isn’t as far in the distant future as some might hope. For U.S. pharma companies with headquarters or CROs in the U.K., much needs to be decided, planned, and executed before that time to ensure a smooth transition.

  • A Celgene Exec's Unexpected Trip To Washington, D.C.
    A Celgene Exec's Unexpected Trip To Washington, D.C.

    Recounting what an executive did while on sabbatical wouldn’t normally fit into our editorial model. That is, unless that executive is Richard Bagger, J.D., EVP of corporate affairs and market access for Celgene.

  • Breaking The Mold — A New Perspective On Alzheimer’s
    Breaking The Mold — A New Perspective On Alzheimer’s

    Casey Lynch has long had the gut feeling there was more to the cause of Alzheimer’s than beta amyloid and tau proteins. Turns out, she was right.

  • 5 Leadership Questions For Camilla Harder Hartvig
    5 Leadership Questions For Camilla Harder Hartvig

    Camilla Harder Hartvig is SVP of Canada and EMEA for Alexion Pharmaceuticals. Previously she was president, Europe and emerging markets, at Glenmark Pharmaceuticals and also worked for companies such as Allergan, AstraZeneca, and Novartis in various managerial positions.

More from this month's issue

BEYOND THE PRINTED PAGE

More beyond the printed page articles

WEB-EXCLUSIVE EDITORIAL

  • Communication For Leaders: How To Share The Good And The Bad
    Communication For Leaders: How To Share The Good And The Bad

    What do you do when the reality of a commercial launch is finally within reach? The fact is, there’s no one-size-fits-all approach.

  • Me-Too Drug Sales Return Via Competitive Pricing Or Marketing
    Me-Too Drug Sales Return Via Competitive Pricing Or Marketing

    Three non-oncology and three oncology examples since 2014 point to higher rates of successful me-too drugs versus a handful of drugs from 2005 to 2012.

  • Best Practices In FDA Orphan Drug Submissions
    Best Practices In FDA Orphan Drug Submissions

    Since 1983, pharmaceutical developers have been incentivized by the FDA via an Orphan Drug Designation (ODD) program to develop products to treat rare diseases and/or conditions. The program awards orphan status to drugs that show likelihood of benefitting an afflicted population that might not otherwise be the focus of targeted development efforts. To meet the FDA’s specific requirements, sponsors have found specificity matters. Though other steps in a drug’s life cycle require a wider scope, when it comes to defining the orphan population and making a case for the drug’s potential efficacy in that population, a razor-focused effort is key.

  • Do We Need Competency Standards For Clinical Researchers?
    Do We Need Competency Standards For Clinical Researchers?

    For clinical researchers, patient-centricity is not a buzzword. It reflects a commitment to patients. They should always be at the center of everything we do.

  • What’s the best approach for effective use of Real World Data – Functional Focus or Enterprise Strategy?
    What’s the best approach for effective use of Real World Data – Functional Focus or Enterprise Strategy?

    The 21st Century Cures Act encourages the use of Real-World Evidence (RWE). But what’s the best approach for this relatively new arena of Big Data and analytics?

  • Orphan Drugs And The Case For Standardization
    Orphan Drugs And The Case For Standardization

    Would a standardized approach to orphan drug development result in more and better therapies being made available to patients? We think so.

  • The FDA/EU Mutual Recognition Agreement — What You Need To Know
    The FDA/EU Mutual Recognition Agreement — What You Need To Know

    The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections to help determine whether statutory and regulatory requirements of the respective authorities have been met.

  • Bioprocessing Trends To Watch In 2018
    Bioprocessing Trends To Watch In 2018

    The current situation in biopharma is exciting, with new technologies, biosimilars, cellular and gene therapies, and opportunities in emerging markets.  And these innovative platforms are going to continue to need improved manufacturing technologies in the future.

More web-exclusive editorial

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CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum January 22, 2018
11am-12:30pm EST, Online Training)
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Sterility Failure Investigations – A Step-by-Step Process for Success January 24, 2018
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The New Medical Device Reporting (MDR) Guidance – An Easily Digestible Compliance Breakdown January 25, 2018
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Cell Therapy: Process Design Considerations To Support Commercialization February 1, 2018
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ICH E6 Addendum R2 Team Training and Action Planning February 5, 2018
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