EDITORS' DESK

  • Thomas Jefferson Hasn’t A Clue About Drug Development
    Thomas Jefferson Hasn’t A Clue About Drug Development

    Understanding what went before, and the steadfast resolve to get to the future, are invaluable for reaching success in our industry. An illustrative and teaching example of this – including the past and future of outsourcing – is embodied in the people at a “thirty-year-old biotech.” They have little in common with Thomas Jefferson.

Are CMOs Sufficiently Serving Biotechs?

Louis Demers of Xoma knows what he wants in contract development and manufacturing organizations. For example, they should be networked with other service providers, and in mission-critical alignment. Can he get what he wants? Can any outsourcing leader at a biotech today? CMO consolidation may make it more difficult.

Pharma Copycats In CMO Acquisition Strategy

It used to be Pharma swept up emerging companies and their new technologies. Now CMOs do so as well. With Pharma, the technologies might end up on the shelf; not so with CMOs. But what about those emerging companies themselves? "If there are two guys thinking about doing a startup, they should do it,” we’re told.

Pharma’s Potemkin Village On The River Of Outsourcing

Grigory Potemkin was governor of war-ravaged New Russia in 1787. He’s said to have deployed a shiny “mobile village” along the Dnieper River to impress Catherine II (and the world) as she inspected the region from her barge. Were we, too, in the year 2016, deploying polished porticoes to hide a dimmer reality, at our Outsourced Pharma conferences?

Pfizer Sets Example For CMOs In M&A Strategy

“Big CMOs” acquire smaller contract development and manufacturing organizations in the same way as Big Pharma has historically acquired biotechs and smaller drug developers. This allegory resurfaced with Pfizer’s recent asset acquisition of Bind Therapeutics. What better modern-day model for CMOs to emulate? And we’ve just seen the cases of Catalent’s gobbling up Pharmatek, and Piramal lassoing Ash Stevens …

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GUEST CONTRIBUTORS

  • Insights On FDA: What We Can Learn From Two New U.S. Inspector General Reports
    Insights On FDA: What We Can Learn From Two New U.S. Inspector General Reports

    The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) recently released two reports that contain nuggets of interest to those who are watching for trends in the pharmaceutical industry.

  • Rapid Microbiological Methods & Alternatives To Colony Forming Units: A Pathway To Implementation?
    Rapid Microbiological Methods & Alternatives To Colony Forming Units: A Pathway To Implementation?

    The challenges of comparing conventional colony forming units (CFUs) to newer technologies that are capable of counting individual cells or measuring different variables/factors (such as light, shape, or fluorescence) has limited the acceptance and implementation of new technologies in the pharmaceutical industry.

  • 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.

  • The Nonlinearity Conundrum In Pharmaceutical Facility Design

    In the pharmaceutical and biologics manufacturing community, we’ve been instilled with a unified and rigorous direction with respect to capital project execution. The emphasis is speed, and rightfully so. These projects are among the most complex and costly in facility construction; not to mention that, given the revenue at risk, the overarching focus on speed to market is undeniable. Understandably, the best methodologies of project management — with all its sophisticated tools of the most current thinking — are brought to bear. A strong focus on linear forward progress is always at the fore: initiate, achieve goal one, then goal two … finally finish.

  • Genentech’s Ocrevus: Pioneering The Progressive MS Therapy Landscape

    The last 12 months have brought about sought-after breakthroughs in the treatment of underserved progressive multiple sclerosis (MS) patients, and a landmark approval for one new therapy — Genentech’s Ocrevus (ocrelizumab) — may come in December. In Part 1 of this two-part article, we will explore the landscape that Ocrevus will enter and the factors that will influence its uptake in progressive MS.

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PHARMA ONLINE WHITE PAPERS

  • Determination Of Product Authenticity Using The IlluminatIR Infrared Microprobe In many instances, it is necessary to perform chemical analysis before a conclusion about product authenticity can be made. The IlluminatIR Infrared Microprobe is ideally suited to perform this chemical analysis, enabling a rapid, reliable, and non-destructive evaluation of the sample, i.e., within minutes an accurate conclusion as to a sample's authenticity can be made. Submitted by Smiths Detection
  • How Ready-To-Use PAT Solutions Allow Pharma To Achieve Efficiency And Reduce Costs

    Process Analytic Technology (PAT) can be summarized as a driver for change from “status quo” offline laboratory analytics for data collection and subsequent post process analysis to “dynamic,” online monitoring and real-time decision making with automated control. By Dan Kopec, Field Marketing Manager Process Analytics, Sartorius Stedim Biotech

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INDUSTRY INSIGHTS

  • What Your Future CDMO Wants You To Know About Writing RFPs
    What Your Future CDMO Wants You To Know About Writing RFPs

    For a CDMO to create a proposal that offers an accurate projection of the scope, costs, and timelines for a project, each RFP submitted by a sponsor must provide the same basic but important information. If a sponsor does not properly create an RFP, it can result in multiple emails, phone calls, and waiting periods, as well as potentially unwelcome surprises.

  • A Best Practice Approach To Handling Waste Powder From OSD Manufacturing
    A Best Practice Approach To Handling Waste Powder From OSD Manufacturing

    In pharmaceutical production, the need to contain and manage dust is particularly important, for a number of reasons. Dust produced when APIs are processed can be hazardous, especially some of the highly potent actives that are used to produce cancer drugs.

  • Extractables And Leachables – Assessing Risk In A Complex Landscape

    Within the medical device market, there is still confusion on the topics of extractable and leachable testing, as well as the process of making sense of and reporting the data to the regulatory authorities. This article offers an outlined process for extractable and leachable analysis which starts with the optimal component selection, assesses extractable information gaps and design fit, and defines the leachables testing plan.

  • TAP Certification Program
    TAP Certification Program

    Welcome to the industry’s first Temperature Assurance Packaging (TAP) Certification Program developed by Sonoco ThermoSafe’s ISC-Labs in partnership with The Packaging School, Dr. R. Andrew Hurley, Assistant Professor of Packaging Science at Clemson University, and an advisory panel of pharmaceutical manufacturers, wholesalers, logistics providers, and industry experts.

  • Cell Culture Media: Balancing Resources with Results
    Cell Culture Media: Balancing Resources with Results

    It all starts with media. Without an appropriate growth medium, no biopharmaceutical process would exist. The
    proper medium allows for cells to grow and generate product.

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PHARMA INDUSTRY EVENTS

Update to ICH GCP E6 (R2) – Final Changes and Implementation December 12, 2016
1pm-2:30pm EST, Online Training
Global Bioproduction Summit December 12 - 13, 2016
San Diego, CA
11th annual Cold Chain Distribution December 12 - 13, 2016
London
More Industry Events

TRAINING COURSES

Update to ICH GCP E6 (R2) – Final Changes and Implementation December 12, 2016
1pm-2:30pm EST, Online Training
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
Laboratory Data Integrity: Current Expectations for OOS Result Investigations December 14, 2016
10:30am-12pm EST, Online Training
More Upcoming Courses