• Pfizer Sets Example For CMOs In M&A Strategy
    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.

Pharma’s Super Heroes Of Innovation

The supply chain is Pharma’s new super hero of innovation. But like any super hero, drug development and manufacturing providers struggle with a dual identity. One is conservative, steadfast, an order-taker. The other – the one Pharma wants today – breaks out into innovation and ingenious solutions. Can CMOs serve Metropolis in both capacities? We’ll find some answers in this sneak preview.

Top (Secret) Quality Concerns For Selecting CMOs: How Important Are Records?

Five experts go undercover to prioritize a secret top-ten list of quality topics for Pharma and Bio sponsors selecting contract development and manufacturing organizations (CMOs). After weeks of discussion, they select a venue full of drug industry sponsors and service providers to unveil their work. They aren’t aware, though, that the audience will have its own stab at the list.

The Price At My CMO Isn’t Right … But How Do I Know?

“What we’re doing up here is never done – focusing on that one input in public. Instead of focusing on money, you talk openly about ‘value.' Well, what is that? Or it’s all about ‘relationships.’ The industry talks partnership in public, but behind closed doors, aren’t prices and costs closing or breaking outsourcing business deals?”

More From Our Editors


  • Single-Use Continuous Manufacturing: The New Paradigm In Biopharmaceutical Processing

    Two significant trends in biopharmaceutical production are coming together. For years, single-use systems have been gaining traction as a way to make processing of biotherapies more efficient. More recently, the industry has also been eyeing continuous manufacturing options to replace traditional “batch” processing methods — again, with the goal of obtaining greater efficiencies.

  • Quality Systems 101: Basic Concepts & Considerations

    Whether you are a life science startup with a brick-and-mortar office or working as a virtual company, at some point the question comes up: Do we need a quality system? Or perhaps your question is, What is a quality system?

More From Guest Contributors


  • 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

More Pharma Onine White Papers


  • 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.

More Industry Insights


Biosimilars 2016 October 27 - 28, 2016
Washington, DC, DC
CNS Summit 2016 October 27 - 30, 2016
Boca Raton, FL
Partnership Opportunities in Drug Delivery October 27 - 28, 2016
Boston, MA
More Industry Events


Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner November 9, 2016
1pm-2:30pm EST, Online Training
Preparing eCTD Submissions: A Step-By-Step Guide November 10, 2016
1pm-2:30pm EDT, Online Training
Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle November 15, 2016
1pm-2:30pm EST, Online Training
"Powering Up" Your GMP Training - Make Training Fun! November 16, 2016
1pm-2:30pm EST, Online Training
More Upcoming Courses