ALSO IN THIS MONTH'S ISSUE

  • Congress Tackles The Opioid Crisis
    Congress Tackles The Opioid Crisis

    After passing a gargantuan appropriations bill that balloons the deficit by hundreds of billions and funds the government through October, the conventional wisdom in Washington is that Congress is done legislating for the rest of the year, save one major issue: addressing opioids.

  • 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

  • This is Your Captain Speaking: 5 Keys to Leadership in Tough Times
    This is Your Captain Speaking: 5 Keys to Leadership in Tough Times

    Sitting comfortably aboard a full commercial flight, ready to depart from Boston’s busy Logan Airport, I hear the captain’s calm and assured voice issued from the cockpit.

  • FY2017 FDA Drug Inspection Observations And Trends
    FY2017 FDA Drug Inspection Observations And Trends

    This article presents the most recent publication of GMP drug product inspection data from the FDA's Center for Drug Evaluation and Research (CDER), which addresses drug inspections conducted in FY2017. It looks at five years of data from the FDA, examines data from 2017, and evaluates five years’ worth of trends in GMP inspection enforcement.

  • How AI Tools Will Transform Quality Management In The Life Sciences
    How AI Tools Will Transform Quality Management In The Life Sciences

    FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.

  • 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?

More web-exclusive editorial

 EVENTS

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)
Duration:  90 Minutes
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)
Using Social Media for Patient Recruitment in Clinical Trials May 3 - 3, 2018
On-Demand)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
More events....

APRIL 2018 DIGITAL EDITION

2018 CMO & CRO AWARDS EDITIONS

   

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