EDITORS' DESK

  • Debate On Project Management In Biopharma Gets Heated
    Debate On Project Management In Biopharma Gets Heated

    Forget presidential elections. We’ve got the debate we were looking for. The one on the professionalism of project management in the biopharma industry. It includes a reader’s comments that start with: “I call BS on this article.” The prosecuting paragraphs are copied below for careful dissecting. Vitriol can be valuable.

Biomanufacturing As Seen From A North Carolina Campus

Gary Gilleskie graduated with a Ph.D. in chemical engineering, went to work at a CMO, and became senior director for downstream manufacturing and process development. Now he’s back on campus to ensure part of his history isn't repeated: obtaining that first job in biomanufacturing without a solid background in the industry.

Still Spouting on Sovaldi? That’s A Misdiagnosis, Doc

In a recent LA Times Op-Ed, Dr. Daniel J. Stone, internal medicine and geriatric medicine specialist in Los Angeles, lashes out at the pharmaceutical industry, and the company that appears to have cured his patient of hepatitis. He raises some interesting points, and  give him credit for laying out his argument. Unfortunately, that argument includes a misdiagnosis of the ailment.

Silicon Valley, Meet BioPharma And Its CMOs (Please)

The information technology titans of Silicon Valley (and beyond) should meet up with the BioPharma industry and its subterranean contract development and manufacturing organizations (CMOs). We believe this could alter the topology of drug development and manufacturing. Here’s why, and an offer to assist in the primo incontro.

Will Teva’s Play Usher Generic, Biosimilar Makers Into “Innovator” Territory?

PhRMA is facing a controversial, potentially industry-altering decision. The generics king Teva has requested to become a member of the trade organization that traditionally represents “innovators”. Could this move redefine the industry's perception of "innovation"?

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GUEST CONTRIBUTORS

  • Are You Prepared For The EU’s Falsified Medicines Directive?
    Are You Prepared For The EU’s Falsified Medicines Directive?

    Given the complexities involved and time required for assessment and decision-making activities, it is imperative to start working toward meeting the EU’s Falsified Medicines Directive (FMD) standards immediately, leveraging previous efforts for compliance with other market regulations.

  • How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem
    How To Establish Sample Sizes For Process Validation Using The Success-Run Theorem

    This article demonstrates two methods using the success-run theorem, which uses the confidence level (how sure we are) and reliability value (valid, consistent results) to determine appropriate statistically valid sample sizes for process validation.

  • The 5 Basic Tenets Of Data Integrity — And How Failures Occur
    The 5 Basic Tenets Of Data Integrity — And How Failures Occur

    It amazes me that, with all the data integrity issues highlighted in regulatory agency inspections over the last several years, very few people I talk with today are familiar with the court case that set the legal precedent for data integrity standards.  To me, this is one of the reasons why we see so many data integrity issues — those who forget the past are condemned to repeat it.

  • Brexit’s Impact On The Global Pharmaceutical Industry: Market Authorization & Pricing

    The Brexit referendum has resulted in instability and uncertainty for many aspects of British society, including the pharmaceutical industry. As we discussed in Part 1 of this two-part article, life sciences funding and the common market are at risk, and with it billions of dollars in research funding and imports/exports. In this article, we will explore the UK’s future relationship with the EU after exit, which will affect many facets of the worldwide pharmaceutical industry, from marketing authorization to global pricing trends.

  • Brexit’s Impact On The Global Pharmaceutical Industry: Future Access To The EU Common Market

    On June 23, 2016, the voters of the United Kingdom voted to leave the European Union in an advisory referendum colloquially referred to as the “Brexit” (British exit) vote. The aftermath of the vote has been chaotic — from financial troubles that have seen the British economy and currency plummet, to political bedlam that has led to a number of political casualties, including the Prime Minister and his heir apparent. While analysts, journalists, and the public all discuss the impact of Brexit on the UK and the path forward, few realize the implications that the vote will have on healthcare, and the pharmaceutical industry in particular.

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PHARMA ONLINE WHITE PAPERS

  • Virus Retentive Filtration In Biopharmaceutical Manufacturing

    Virus removal using retentive filters designed to provide effective and consistent clearance of parvovirus (~20 nm) has now become an established standard in downstream purification processes for biologics produced using mammalian cells. Compared to other commonly used virus clearance methods, such as chromatography and low pH inactivation, retentive filtration is superior in its ability to clear almost all potential viral contaminants while also avoiding adverse effects on product quality. While commercially available retentive filters vary in chemical composition and structural configuration, all of these filters primarily clear viruses through the mechanism of size exclusion.

  • Saving Process Costs With Software Support Part 1: Practical Tips For Phases 1 – 3

    Product life cycles are becoming ever shorter. Less and less time is available, whether for development of an installation or its possible modernization. Companies and their employees therefore try to continuously optimize their processes as that is the only way they can remain competitive and deal with increasingly demanding challenges. This white paper offers guidance on the challenges in the individual value creation phases, support tools, how you can become even more productive with networked tools, and tips about which functions can be used and when.

More Pharma Onine White Papers

INDUSTRY INSIGHTS

  • Veterinary Medicine Is Becoming A Major Player In Regenerative Medicine
    Veterinary Medicine Is Becoming A Major Player In Regenerative Medicine

    As evidenced by the growing number of research publications, clinical trials, newly launched companies, and news stories, the Veterinary space is quickly becoming a major player in the application of regenerative medicine technologies.

  • Establishing Best Practice Qualification Metrics For Smart Shipping Containers
    Establishing Best Practice Qualification Metrics For Smart Shipping Containers

    Wernher von Braun, the father of modern rocketry famously stated, “one test is worth a thousand expert opinions.” The FDA has put their own regulatory spin on this axiom: “if you didn’t document it; it didn’t happen.” This extends beyond the drug therapies themselves to the packaging and logistics practices that are used to distribute them; what the FDA refers to as the “holding” of a drug.

  • Paving The Road To Compliance: Serialization Standardization Through Open-SCS
    Paving The Road To Compliance: Serialization Standardization Through Open-SCS

    As companies around the world implement the necessary changes to become compliant, it will add an increased level of cost, risk, and especially complexity to today’s operations. Specifically, part of these mandates requires that production floor and warehouse equipment are able to exchange information with a customers’ business system throughout the drug’s packaging lifecycle.

  • 4 Questions To Guide Your Laboratory Centrifuge Selection
    4 Questions To Guide Your Laboratory Centrifuge Selection

    A centrifuge is an integral component of a laboratory that is critical to the success of an analysis. They come in a variety of sizes, from mini-centrifuges that hold only a few small tubes and spin a few thousand RPM to high capacity centrifuges that hold up to 6 liters of samples to ultracentrifuges that spin upwards of 100,000 RPM. Multiple options in size as well as other areas can make choosing the right centrifuge for your application an overwhelming task.

  • It’s Time To Go Electronic In The Lab – Infographic
    It’s Time To Go Electronic In The Lab – Infographic

    The paper-based lab versus the digital lab. The largest barrier to innovation for any lab is performing tasks manually and recording experiment data in paper lab notebooks. Easy-to-use digital applications can increase productivity while reducing wasted time and inefficiencies associated with searching for relevant experiment data.

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PHARMA INDUSTRY EVENTS

Best Practices in CMC Dossier Preparation – Facing Tough Challenges July 28, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
Preparing for - and Surviving - a FDA Medical Device Inspection July 28, 2016
1pm-2:30pm EDT, Online Training
Preanca Pande July 28 - 29, 2016
Berlin, germany
kevin Parker July 28 - 29, 2016
Melbourne
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TRAINING COURSES

Best Practices in CMC Dossier Preparation – Facing Tough Challenges July 28, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
Preparing for - and Surviving - a FDA Medical Device Inspection July 28, 2016
1pm-2:30pm EDT, Online Training
Root Cause Analysis for GCP – A Risk Action Plan Guide August 2, 2016
1pm-3pm EDT, Online Training
Aseptic Processing: Preparing Staff and Programs For Compliance August 4, 2016
1pm-2:30pm EDT, Online Training
More Upcoming Courses