EDITORS' DESK

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

Riding With The Drug “Serializers” Of Pharma

A recent article with GSK mentioned the assistance Pharma is receiving from external serialization vendors and partners. Like in Wild West movies, the initial decision to bring in these benevolent gunslingers — I call them serializers — is difficult. Unlike the movies, though, there’s no moral equivalence: Few pharmaceutical companies — or packaging service providers — will achieve timely serialization compliance without this outside help.

Waldorf Departure Drama For DCAT?

I didn’t quite buy into the DCAT announcement regarding its departure from the Waldorf Astoria, the long-time central location for DCAT Week in New York City each spring. Call me cynical—a degree in public relations can do that – but I just couldn’t believe “checking out” of the Waldorf would be as easy as it sounded. I took this cynicism directly to Margaret Timony, Executive Director of the Drug, Chemical & Associated Technologies Association.

FLAG These Biopharma Outsourcing Beliefs

A few weeks away from Outsourced Pharma San Diego, we’re already into provocative discussion on outsourcing of drug development and manufacturing. Everything from the role of finance managers in CMOs; pharmacists in biopharma; Car-T and personalized medicine in development; the FDA in foreign lands; and project managers in situ. Frank Sorgi, Ph.D., President and CEO of FLAG Therapeutics, Inc., leads the charge.

More From Our Editors

GUEST CONTRIBUTORS

  • 10 Critical Components Of A Successful Global Drug Development Plan
    10 Critical Components Of A Successful Global Drug Development Plan

    We use plans every day to help us arrive at our desired destinations.  Pilots utilize flight plans prior to take off — although they have flown to their destination perhaps hundreds of times before, they nevertheless reviews and follows a flight plan. Likewise, ship’s captains also file plans and chart courses. Road maps provide guidance on how to drive from point A to point B, though today most people rely on electronic global positioning systems (GPS) to assist with navigation.

  • Best Practices For Measuring System Quality For Drug-Device Combination Products
    Best Practices For Measuring System Quality For Drug-Device Combination Products

    Combination product development is a complex matter governed by different areas of regulatory oversight. In my previous article, we discussed which current good manufacturing practice (cGMP) requirements apply when drugs, devices, and biological products are combined, and the typical pitfalls to avoid when doing so.

  • Opioid Crisis Pushing Changes To U.S. Chronic Pain Drug Market
    Opioid Crisis Pushing Changes To U.S. Chronic Pain Drug Market

    With the U.S opioid analgesic addiction and overdose crisis showing no signs of relenting, change is coming fast for manufacturers of chronic pain drugs.

More From Guest Contributors

PHARMA ONLINE WHITE PAPERS

  • Energy Efficient Automation Systems For Increased Revenues And Sustainability

    Sustainable energy efficiency in automation requires a sophisticated concept which covers a total of four areas: intelligent dimensioning, energy-efficient products and solutions, services,  and training and consulting. Each of these four areas contributes to an increase in energy efficiency – regardless of where the road begins. For optimum energy efficiency which meets the current standards or, looking forward, even surpasses them, it is recommended to use all four areas in combination.

  • Taming China’s Clinical Trial 'Dragon'

    There are many advantages to conducting clinical trials in China today. China boasts a huge market, a massive patient pool, rapid patient recruitment capabilities, low laboratory and technical costs, and a large number of highly-trained researchers and scientists. By World Courier

More Pharma Onine White Papers

INDUSTRY INSIGHTS

  • Increase In HPAPI Manufacturing Highlights Need For Containment And Isolation Systems
    Increase In HPAPI Manufacturing Highlights Need For Containment And Isolation Systems

    An estimated 25 percent of globally manufactured drugs contain highly potent active pharmaceutical ingredients (HPAPIs). HPAPI drugs, which include small-molecule and biologic compounds as well as antibodydrug conjugates (ADCs), are often used in the treatment of cancer. The fastest growing segment of the HPAPI market are ADCs, a new class of therapeutic agents that deliver cytotoxic drugs selectively to antigen-expressing tumor cells. Non-oncology HPAPI compounds include hormones, narcotics, and retinoids.

  • Digitally Transforming Laboratory Operations
    Digitally Transforming Laboratory Operations

    “Digital transformation” is a common buzzword across industries today, but is it more than just jargon?  Faced by shifting consumer demand, rapidly evolving technology and increasing competition, organizations — to a large extent from science-based industries — are realizing that business as usual (or only incremental change to traditional approaches) does not address today’s challenges in a sustainable, long-term way.

  • Spray Drying vs. Freeze Drying For Pharmaceutical Formulations
    Spray Drying vs. Freeze Drying For Pharmaceutical Formulations

    Freeze drying is the preferred choice for preserving a wide range of pharmaceutical formulations when stability in the liquid state is inadequate, storage requirements are too stringent, or a solid form of the product is desired.

  • What Does 'Room Temperature' Mean In Pharmaceutical Storage?
    What Does 'Room Temperature' Mean In Pharmaceutical Storage?

    For those products where ‘room temperature’ storage is a requirement, there is a continuous and ever-increasing demand from a wide variety of regulators for manufacturers to ensure the efficacy of products, previously thought not to need temperature control during transportation, storage and distribution. 

  • Importance Of Proper Cleaning And Maintenance Of A Laboratory Balance
    Importance Of Proper Cleaning And Maintenance Of A Laboratory Balance

    We so often run into balances in our customer’s laboratories that have been around for 10-20 years. If you read this sentence and wonder how those customers keep their balances in such great conditions for that long, then this article is meant for you.

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PHARMA INDUSTRY EVENTS

Market Access Mexico October 3 - 4, 2016
Mexico City
Asia-Pac Trial Master File Summit October 3 - 4, 2016
Tokyo
Biomarkers & Precision Medicine USA Congress October 3 - 4, 2016
Oxford, CA
More Industry Events

TRAINING COURSES

Pediatric Clinical Trials: Special Considerations and Requirements October 6, 2016
1pm-2:30pm EDT, Online Training
Biosimilars: Preparing For Opportunities And Challenges October 11, 2016
1pm-2:30pm EDT, Online Training
Medical Device Design Controls 101 – A Practical Crash Course October 12, 2016
1pm-2:30pm EDT, Online Training
The Top Method Validation Mistakes – And How to Avoid Them October 14, 2016
1pm-2:30pm EDT, Online Training
More Upcoming Courses