ALSO IN THIS MONTH'S ISSUE

  • Trump Surprises: 340B Reform And Pharmaceutical Exec For HHS
    Trump Surprises: 340B Reform And Pharmaceutical Exec For HHS

    Policymakers recently have focused on the 340B program as its size increased. Whole cottage industries have been created that instruct how hospitals and contract pharmacies can profit from the loose regulations, to the point that the drug industry can no longer overlook the market inefficiencies Yet despite several oversight hearings by the House Energy & Commerce Committee, Congress could not come to a consensus on how to reform it.

  • 2018: The Year Of Biosimilar Commercialization Wins Or Woes?
    2018: The Year Of Biosimilar Commercialization Wins Or Woes?

    We reached out to eight experts from biosimilar companies and consulting firms to see which topics they’ve been watching closely throughout 2017 and how they expect these trends will evolve and challenge the industry in 2018.

  • Virtual And Variable: Two Visions For Biopharma Outsourcing In 2018
    Virtual And Variable: Two Visions For Biopharma Outsourcing In 2018

    Deborah Dunsire, CEO of XTuit Pharmaceuticals; and Robert Discordia, executive director, global product development & supply procurement for Bristol-Myers Squibb discuss new approaches to external partnerships in pharma.

  • Why All The Talk About Real-World Evidence?
    Why All The Talk About Real-World Evidence?

    In 2017, real-world evidence (RWE) became the topic everyone wanted to discuss. Several executives I have spoken to recently believe it will continue to grow in importance as we move into 2018 and beyond. But why the sudden interest in RWE?

  • 7 Medical Device Leaders Talk About What’s Next For Their Industry
    7 Medical Device Leaders Talk About What’s Next For Their Industry

    Seven industry experts answer questions related to the med device funding climate, which device segment will be getting all of the attention in 2018, and upcoming M&A activity related to med devices.

More from this month's issue

BEYOND THE PRINTED PAGE

More beyond the printed page articles

WEB-EXCLUSIVE EDITORIAL

  • 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, whether conducted by an EU inspectorate or by the FDA, 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.

  • How The U.K. Became A Destination For Biosimilar Clinical Trials
    How The U.K. Became A Destination For Biosimilar Clinical Trials

    The biosimilars market is going to heat up considerably over the next three years, but is the NHS ready for the biosimilars boom?

  • 10 Ways to Speed Up in 2018
    10 Ways to Speed Up in 2018

    As a leader, your job is to make decisions that help your team navigate the endless demands on their time – and to protect energy and resources for the actions that matter most. Here are some suggestions on how to do that.

  • Blockchain & The Pharma Supply Chain — Beyond DSCSA Compliance
    Blockchain & The Pharma Supply Chain — Beyond DSCSA Compliance

    A holistic view of the value of blockchain to the pharmaceutical supply chain takes into account the magnitude of the global counterfeit drug problem; the financial, economic, and social costs of counterfeit drugs; and the positive financial and economic benefits of moving beyond compliance to tackling the issue of counterfeit drugs head-on.

  • 3 Keys To Scale-Up CAR T-Cell Therapy Manufacturing
    3 Keys To Scale-Up CAR T-Cell Therapy Manufacturing

    Kymriah and Yescarta have overcome the first hurdle to commercialization by receiving the FDA’s stamp of approval. Now, Gilead and Novartis must prove they can handle the supply chain complexities involved with manufacturing and distributing these personalized, time-sensitive therapies to wider patient populations.

  • What Value-Based Reimbursement Means For Drug Development
    What Value-Based Reimbursement Means For Drug Development

    Pharmaceutical reimbursement historically has largely been a process of first determining the efficacy and safety profile of a therapy and then deciding its ultimate coverage level based on its price. But now, payers are taking a cue from their European peers and beginning to do the sophisticated number-crunching and cost-effectiveness studies to take a more holistic approach to drug coverage.

More web-exclusive editorial

 EVENTS

Building An Effective GMP Training System: A Risk-Based Approach December 19, 2017
1pm-2:30pm EST, Online Training)
Price:  $299 - Includes Bonus Handouts!
Best Practices for Deviation Investigations: Cost-Effective Problem Correction January 8, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Renovating Pharmaceutical Manufacturing Facilities for Aseptic Fill/Finish: Critical Planning, Execution & Compliance Tips January 10, 2018
1pm-2:30pm EST, Online Training)
Price:  $299 - Introductory Rate
EU vs. US GMP: Understanding Major Differences Post FDA/EMA Mutual Recognition Agreement January 16, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum January 22, 2018
11am-12:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
More events....

DECEMBER 2017 DIGITAL EDITION

2017 CMO & CRO AWARDS EDITIONS

   

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