ALSO IN THIS MONTH'S ISSUE

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BEYOND THE PRINTED PAGE

More beyond the printed page articles

WEB-EXCLUSIVE EDITORIAL

  • Is Hong Kong The New Wonder For U.S. Biotechs, Or Just Another Fad?
    Is Hong Kong The New Wonder For U.S. Biotechs, Or Just Another Fad?

    The latest country that seems to be courting the U.S. life science public offering market is China, specifically, the Hong Kong Exchange. In particular, U.S.-based life sciences companies with Chinese management teams or some other connections to China seem to be the primary target.

  • When Should Tax Functions Be Brought In-House?
    When Should Tax Functions Be Brought In-House?

    At what stage of a biopharma’s growth does it makes sense to bring on an internal tax function? The answer, of course, varies significantly, but here are some factors to consider when making this important business decision.

  • 3 Major Challenges With Global Clinical Trials — And How To Overcome Them
    3 Major Challenges With Global Clinical Trials — And How To Overcome Them

    The disconnect between increased investment/activity and output points to continuing significant challenges in the global clinical trials market. Here we examine three of the leading issues facing the biopharmaceutical industry today.

  • Scientist To Executive: Investing In Internal Talent For Future Leaders
    Scientist To Executive: Investing In Internal Talent For Future Leaders

    An employee already leading a department could someday be a candidate for the C-Suite. They just need the right educational tools to prepare them for the business and management-centered responsibilities future advancement will bring.

  • 10 Key Ingredients For Small Pharma GCP Quality Systems
    10 Key Ingredients For Small Pharma GCP Quality Systems

    Small to midsize pharmaceutical or biotech companies (small pharma) are enjoying the best of times. However, from a quality systems perspective, it could be the worst of times. Many have weak quality systems, are not following global regulatory authority regulations and/or guidance, or lack the level of documentation required to reconstruct every aspect of clinical trials.

  • Human Gene Therapy For Rare Disease — Examining FDA’s New Draft Guidance
    Human Gene Therapy For Rare Disease — Examining FDA’s New Draft Guidance

    The FDA recently issued for public comment six draft guidance documents intended to serve as part of a modern, comprehensive framework for how CBER will help advance the field of gene therapy. This is the fourth article in a six-part series summarizing each of the draft guidance documents. It will discuss the guidance Human Gene Therapy for Rare Disease.

  • FDA And Quality Metrics: Where Do Things (Currently) Stand?
    FDA And Quality Metrics: Where Do Things (Currently) Stand?

    Are you ready to give the FDA more?  “What?” you ask, as a manufacturer of API and finished goods. Are you ready to give them more data and information about your manufacturing process? You think, “Don’t they get all the necessary information from me during their inspections and from my filings?” Well, the answer is yes and no. 

  • Lessons In Patient-Centricity From Rare Disease Clinical Trials
    Lessons In Patient-Centricity From Rare Disease Clinical Trials

    Patient-centricity has been defined in various ways, but we like to think of it as simply “to identify and seize the opportunity to create value for patients — and to do so with patients whenever it’s feasible.” Pharmaceutical and biotechnology companies have begun to embrace the concept relatively recently. However, the idea — and practice — has been around for a long time in other industries.

More web-exclusive editorial

 EVENTS

A Holistic Approach to External GMP Surveillance, GMP Training, and Quality Knowledge Management August 14 - 14, 2018
1:00 PM - 2:30 PM EDT)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Reacting to “Human Error” – Moving Beyond “Retraining” As A Response August 22 - 22, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Measuring Medical Affairs Success – Identifying the Key Performance Indicators (KPIs) for Successful Teams August 24 - 24, 2018
1:00 PM - 2:00 PM EDT)
Duration:  60-Minutes
Price:  $199 - Includes Bonus Handouts!
Laboratory Data Integrity: Current Expectations for OOS Result Investigations August 29 - 29, 2018
1:00 PM - 2:30 PM EDT)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
LogiPharma 2018 September 5 - 6, 2018
Philadelphia, PA)
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AUGUST 2018 DIGITAL EDITION

BIOPHARMA MANUFACTURING EBOOK

2018 CMO & CRO AWARDS EDITIONS

   

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