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

  • 5 Steps To Build A Quality Culture That Supports Data Integrity

    When it comes to building a culture of quality, many companies ask, "Where do we start?”

  • FDA vs. EMA? A Review Of Recent EU Enforcement Actions In The U.S.

    The FDA and the European Union (EU) have taken serious enforcement actions against several firms in the other’s geographic jurisdiction during the calendar year 2016. Perhaps this flurry of my-inspectors-are-more-rigorous-than-yours activity represents an unofficial test, of sorts, as these agencies move to rely more on each other’s inspections — though these recent actions may test the limits and validity of such mutual recognition.

More From Guest Contributors

PHARMA ONLINE WHITE PAPERS

  • Successfully Manage The Unique Demands Of Cell Therapy Supply Chains

    Cell therapy professionals joined a specialist webinar by industry experts from PCI Clinical Services and TrakCel, addressing the unique complexity of an autologous therapy supply chain. Hosted by European Pharmaceutical Manufacturer magazine, the webinar was delivered by Rachel Griffiths, Associate Director, Technical Services, PCI Clinincal Services, and Dr. Matthew Lakelin, Vice President, Scientific Affairs and Business Development, TrakCel . Here, we present the white paper from that webinar event.

  • Using A Risk-Based Approach To Plan Your Solid Oral Dosage Scale-Up

    Using a risk-based approach for planning the timeline and strategy for your drug’s development and scale-up can help you avoid very costly delays. Yet, in the race to bring a drug to market, assessing risk can often be overlooked. Each case is going to be different; however, by creating a comprehensive plan for risk management (applying ICH Q9 as a basis), you can lower the overall level of risk from beginning to end. This not only puts you in the best possible position to avoid questions from the FDA at the time of submission but it also results in a more efficient development process and a higher-quality product.  

More Pharma Onine White Papers

INDUSTRY INSIGHTS

  • Why Data Liquidity Is Your Company's New Business Objective
    Why Data Liquidity Is Your Company's New Business Objective

    How to merge ECM, BPM and archiving strategies so data and analytics power the content lifecycle.

  • 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.

  • How Big Data Is Transforming Pharmaceutical Manufacturing
    How Big Data Is Transforming Pharmaceutical Manufacturing

    Pharmaceutical manufacturers now have the ability to analyze massive amounts of quality, environmental, and IoT-generated factory data, which enables them to build end-to-end process controls — resulting in higher-quality products, more predictability, more efficient manufacturing, and faster time to market.

  • The Direct-To-Patient Model: Your Top 10 Q&A

    In clinical trials, a direct-to-patient model allows for drug therapies to be delivered and administered in the patient’s home and/or biological samples to be taken and uplifted from the patient’s home. Depending on the complexity of the trial protocols, patients may take medicines themselves, or rely on a homecare nurse or caregiver for clinical support. Because the direct-to-patient model allows the patient to participate in the clinical trial from home, it reduces the need for them to travel to the investigator site, increasing the likelihood they will agree to participate and decreasing the possibility that they will drop out of the study.

  • 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.

More Industry Insights

PHARMA INDUSTRY EVENTS

Signal Detection & Management Strategies September 29 - 30, 2016
Frankfurt
Is Site Payment Escrow a Thing of the Past? YES! September 29, 2016
Toronto, ON
Stanley Edward September 29 - 30, 2016
orlando, FL
International Conference on Kidney Transplantation September 29 - 30, 2016
orlando, FL
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