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WEB-EXCLUSIVE EDITORIAL

  • Resisting Fragmentation In The Global Serialization Regulatory Landscape
    Resisting Fragmentation In The Global Serialization Regulatory Landscape

    In 2013, the United States enacted pharmaceutical serialization and traceability requirements under the Drug Supply Chain Security Act (DSCSA). In the years preceding and following passage of the DSCSA, many other countries considered similar regulation for their own markets. Argentina, China, India, South Korea, and Turkey currently require the serialization of pharmaceutical products and the reporting of some type of serialization data. Approximately 40 additional countries — including the U.S., the European Union, Brazil, Russia, and multiple Persian Gulf states — have enacted requirements with future implementation dates or are actively working on requirements.

  • 5 Steps To Help Keep Liability In Check During Clinical Trials
    5 Steps To Help Keep Liability In Check During Clinical Trials

    There is perhaps no riskier time in a product’s development cycle than during clinical trials. With the introduction of human research subjects, patient safety is paramount. Any failure to uphold rigorous standards not only leaves your company subject to the threat of costly litigation, it can cause irreparable damage to your reputation.

  • Managing Global Healthcare Professional Entertainment Limits
    Managing Global Healthcare Professional Entertainment Limits

    In the life sciences industry, a company’s anticorruption policy inevitably governs how employees engage with foreign healthcare professionals (HCPs) – who are considered foreign government officials (FGOs) under most global anticorruption laws.

  • Pipeline Analysis: Where Is Pharma Placing Its Bets?
    Pipeline Analysis: Where Is Pharma Placing Its Bets?

    Kaiser Associates’ second annual Hot Indications List is a global analysis of 13,000+ pharma R&D programs and investment trends. 

  • Payers And The Era Of Data-Driven Medicine Renews Interest In FDAMA 114
    Payers And The Era Of Data-Driven Medicine Renews Interest In FDAMA 114

    What should the industry understand regarding the rules and practices that govern the communication of drug information to payers and formulary committees in light of evolving FDA policies on scientific exchange, First Amendment case law, and proposed legislative changes to FDAMA 114?

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CUTTING ROOM FLOOR EDITORIAL

  • What Will The Global Biopharmaceutical Industry Look Like In 2027: Trendsetter Series Part 4 of 4

    The executive-level participation for Life Science Leader magazine's signature 2017 Outlook issue had an overwhelming. This year’s feature article involved 13 executive life science leaders! In part four of this series, which is a supplement to the feature magazine article, we pose the question, “Looking even further ahead, what is your vision for how the global biopharmaceutical industry might look in the year 2027?”

  • Shire CEO and Novartis CMO Weigh In On Trends For 2017: Trendsetter Series Part 3 of 4

    The December 2016 issue of Life Science Leader magazine raised the bar in our 2017 Outlook feature article with participation from 13 trendsetters, including pharma leaders, payors, and a representative from the NIH. We hope you enjoy reading their thoughts in this supplement to the magazine’s December 2016 cover feature.

  • How Biopharmas Are Addressing Key Trends For 2017: Trendsetter Series Part 2 of 4

    When Life Science Leader magazine asked for executive-level participation for the signature 2017 Outlook issue published in December 2016, we were overwhelmed with the response. This year’s feature article involved 13 executive thought leaders! In part two of this series, which is a supplement to the 2017 Outlook feature article, we pose the question, “What are you doing at your organization to address/capitalize on certain trends?” 

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LIFE SCIENCE TRAINING INSTITUTE COURSES

Reacting to “Human Error” – Moving Beyond “Retraining” As A Response December 13, 2016
10:30am-12pm EST, Online Training
The Top Method Validation Mistakes – And How to Avoid Them December 14, 2016
1pm-2:30pm EST, Online Training
More training courses

DECEMBER 2016 DIGITAL EDITION

BLOGS

  • Why “Partnering For Cures” Is A Highly Differentiated Experience
    Why “Partnering For Cures” Is A Highly Differentiated Experience

    Two weeks ago I went to the Partnering For Cures (Nov. 13 – 15) conference at the Grand Hyatt in New York. After the experience, it is almost painful to admit that this was my first time attending. Developed by Faster Cures and the Milken Institute, the conference (now in existence for over eight years) brings together nearly 1,000 leaders from across the research ecosystem. The event’s goal is to forge partnerships dedicated to reducing death and suffering. And while I have attended other conferences that preach partnering, this conference, for some reason, felt distinctly different.

  • Trump Wins: What Can Pharma Hope For In The Next 4 Years?
    Trump Wins: What Can Pharma Hope For In The Next 4 Years?

    On November 14, 2016, Carolyn Johnson posted “Trump just dropped a big hint to the pharmaceutical industry” in a wonkblog for The Washington Post. I shared the article on LinkedIn (receiving over 415 views) noting, “It is very early days, so let’s not get too excited or too concerned. But let’s be aware and strive to be part of the solution for helping patients.” This seemed like a natural fit to share considering a large percentage of my network have close ties to biopharma, and the industry seems to have always been pretty closely linked to politics. This fact was never more apparent than at the industry conference I recently attended.

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2016 CRO AWARDS SPECIAL EDITION

2016 CMO AWARDS SPECIAL EDITION

 UPCOMING EVENTS

5th Annual MEDTECH ACCESS Leaders Forum December 6 - 8, 2016
Berlin
The New Medical Device Single Audit Program (MDSAP) for Manufacturers – Analyzing Rewards and Challenges December 8, 2016
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Update to ICH GCP E6 (R2) – Changes and Implementation December 12, 2016
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response December 13, 2016
10:30am-12pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
More events