EDITORS' DESK

  • Are CMOs Sufficiently Serving Biotechs?
    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 …

Pfizer’s Key Questions For CMO Innovation

As it turns out, Bernie Huyghe of Pfizer has a flair for interrogative statements. This has served him well as a leader in the biopharmaceuticals and vaccines outsourcing group at the company. It also helped lead a room full of bio/pharma and CMO professionals through the subject of innovation in the external development and supply chain.

More From Our Editors

GUEST CONTRIBUTORS

  • 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
    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
    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.

  • Do You Make These 8 Big Mistakes In Your Deviation Investigations?

    Deviation investigations are one of the most important quality activities in any GMP (good manufacturing practice) organization. They are also perennially near the top of the list of most frequently cited issues in observations, warning letters, and consent decrees from the U.S. Food and Drug Administration (FDA) and other regulatory authorities.

  • How To Establish Sample Sizes For Process Validation Using Variable Sampling Plans

    The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the relationship between risk and sample size. This article will demonstrate the use of variable sampling plans to establish sample sizes for process validation.

More From Guest Contributors

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

  • Avoiding Collaboration Failure In Bio Pharma: Is It Possible? With The Cloud It Is.
    Avoiding Collaboration Failure In Bio Pharma: Is It Possible? With The Cloud It Is.

    With the drug patent cliff continuing to cast a long shadow over biopharma, the industry is radically reinventing itself by embracing globalization and focusing on innovation and operational excellence. Most importantly, biopharma organizations are expanding externalized collaborative relationships beyond traditional boundaries and creating flexible networks of researchers — some in-house, others with industry and academic partners, research institutes and contract research organizations. These networks are increasing in size and complexity with many combining numerous partners with diverse project objectives. Externalized projects like this raise important data security and project management challenges.

  • Can You Spot A Fraudulent Calibration Certificate?
    Can You Spot A Fraudulent Calibration Certificate?

    It doesn't happen often. In over a decade Vaisala Canada's Quality Manager has seen it only once, but calibration certificates are sometimes counterfeited.

  • The CAPA Detective
    The CAPA Detective

    Every industry has its detectives.  Mechanics and journalists hunt for leaks.  Software testers and security experts look for bugs.  Meteorologists, defense strategists, and forensic accountants all look for trouble brewing off shore.  The level of intrigue may vary.

  • Drug Safety And The Importance Of ‘Last Mile Distribution’
    Drug Safety And The Importance Of ‘Last Mile Distribution’

    Inappropriate drug storage can reduce the quality of product, potentially affecting efficacy and safety, so manufacturers, patients and prescribers must be aware of these risks. World Courier looks at the importance of ‘last mile distribution’ to understand the effects it has on patient safety as well as cost for pharmaceutical companies.

  • 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.

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PHARMA INDUSTRY EVENTS

Clinical Trial Regulation Workshop December 6 - 7, 2016
Amba Hotel Marble Arch, Bryanston Street, London W1H 7EH
11th Annual IMVACS; Immunization & Vaccine Summit December 7 - 9, 2016
Boston, MA
More Industry Events

TRAINING COURSES

Update to ICH GCP E6 (R2) – 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