ALSO IN THIS MONTH'S ISSUE

  • Vertical Mergers Of Rx Supply Chain Spark Antitrust Concerns
    Vertical Mergers Of Rx Supply Chain Spark Antitrust Concerns

    The recent announcement of two vertical mergers ­— the $52 billion acquisition of Express Scripts, the largest pharmacy benefit manager (PBM) in the country, by Cigna, and the $69 billion purchase of Aetna by CVS Health — raise significant antitrust concerns over how these megacompanies will impact patient access and pharmaceutical pricing.

  • Inside The Mind Of Life Science Innovator Mir Imran
    Inside The Mind Of Life Science Innovator Mir Imran

    After discovering that there have been up to 200 unsuccessful attempts at delivering biologic drugs orally, serial medical-device inventor and entrepreneur Mir Imran decided to tackle the problem.

  • Can A P3 Reduce Attrition Of Drug Candidates?
    Can A P3 Reduce Attrition Of Drug Candidates?

    A look at a unique UK-based public-private partnership (P3), called Open Targets that was created to help companies choose better drug targets and reduce attrition of candidate drugs.

  • Companies To Watch: CytoDyn
    Companies To Watch: CytoDyn

    CytoDyn’s expressed ambitions seem bold but reasonably free of hyperbole. It is only natural to hope for the best possible outcome here, considering the obvious need for new HIV and other immunological therapies.

  • Is Blockchain The Right Technology For The Pharma Supply Chain?
    Is Blockchain The Right Technology For The Pharma Supply Chain?

    The full implementation of global traceability standards is still a work in progress. Blockchain may prove to be the technology that will help save lives and secure the supply chain globally.

  • 3 Operating Principles For Successful Drug Development
    3 Operating Principles For Successful Drug Development

    Can a culture with supporting systems that are simple, efficient, and effective significantly shorten drug development times? Why not?

More from this month's issue

BEYOND THE PRINTED PAGE

More beyond the printed page articles

WEB-EXCLUSIVE EDITORIAL

  • How To Effectively Work Across Cultures In Global Clinical Trials
    How To Effectively Work Across Cultures In Global Clinical Trials

    Most of us have spoken to someone and struggled to understand an accent or word choice. Even within a country like the United States, different regions can have unique language, which can be confusing to an outsider. It can be as subtle as the difference between “soda” in the East and “pop” in the Midwest. But what happens when you try to coordinate complex projects across countries and regions? How do you work successfully, accounting for the differences in culture and honoring common objectives?

  • Too Little Or Too Late? Perspectives On FDA’s New Serialization Guidances
    Too Little Or Too Late? Perspectives On FDA’s New Serialization Guidances

    Looking forward, the U.S. pharmaceutical industry needs to be aware that the despite the FDA’s year-long delay in enforcement, the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.

  • Spark’s Luxturna Gene Therapy: What Can We Learn From Its Development & Commercialization?
    Spark’s Luxturna Gene Therapy: What Can We Learn From Its Development & Commercialization?

    Part 2 of this two-part article reviews lessons from Spark Therapeutics’ pivotal program for Luxturna, a gene therapy approved for the treatment of patients with retinal dystrophy associated with confirmed biallelic mutation in the RPE65 gene, and summarize key considerations for the clinical development and commercialization of gene therapies.

  • Don’t Take Candy From Strangers: 3 Warnings About Right To Try
    Don’t Take Candy From Strangers: 3 Warnings About Right To Try

    A busy practicing physician who might be asked by a friend or a patient for a first-impression opinion of the currently pending federal Right to Try legislation will find him/herself in a position roughly analogous to the hungry child being offered candy by a stranger: viscerally tempted, but intellectually very, very wary.

  • How To Structure Your Internal Audit Program
    How To Structure Your Internal Audit Program

    How have the first few months of 2018 treated your company?  Are you confident that you’ve got a good plan for the year, including internal auditing, or are you  still scrambling to catch up from issues identified late last year?

  • 15 Bold Predictions About Healthcare’s Future — And What Bio/Pharma Must Do To Prosper In It
    15 Bold Predictions About Healthcare’s Future — And What Bio/Pharma Must Do To Prosper In It

    Ever participated on one of those benchmarking exercises? You know what I mean: a (usually) fresh-faced consultant asks lots of questions and fills in a spreadsheet comparing what you do with your competitors. Well, beware.

  • As A Leader, Are You Invisible?
    As A Leader, Are You Invisible?

    Dr. Liz shares great advice on how leaders can be more visible within their organizations. Visibility allows for a more cohesive and productive organization.

  • The Gene Therapy Pipeline — And The Biggest Challenges Facing Developers
    The Gene Therapy Pipeline — And The Biggest Challenges Facing Developers

    With several first-in-class gene therapies now approved, distinct new challenges are now coming into focus. This article provides a high-level overview of the gene therapy pipeline for non-oncology rare diseases and discuss key issues impacting clinical development.

More web-exclusive editorial

 EVENTS

Instructional Design for GMP Training – Improve Effectiveness and Measurability April 24, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Measuring CAPA Effectiveness: Critical Tips in Getting the Right CAPA and Showing It Works April 25 - 25, 2018
2pm-3:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
The Top Method Validation Mistakes – And How to Avoid Them April 26 - 26, 2018
1pm-2:30pm EST, Online Training)
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Price:  $299 - Includes Bonus Handouts!
Executing Proper Event Investigations: Critical Steps In Ensuring Compliant Corrective Actions May 2 - 2, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $199 - Includes Bonus Handouts!
2018 HBA Woman Of The Year Event May 3, 2018
New York, NY)
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