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.

GSK’s Global Strategy For Serialization

The biopharma industry throws around the term “serialization” as if it were some global singularity to be tamed by an equally universal, technical silver bullet. Terry Crawford, Serialization Technical Manager at GSK, quickly shoots down that type of talk.

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.

More From Chief Editor Louis Garguilo

GUEST CONTRIBUTORS

  • The LAL Industry’s Invaluable Partner
    The LAL Industry’s Invaluable Partner

    Throughout history, bacteria has been mankind’s biggest predator. Plagues and epidemics have devastated cities and armies, sometimes in a matter of days.

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

  • Deciding Whether To Outsource A 3PL Provider: 4 Questions To Ask
    Deciding Whether To Outsource A 3PL Provider: 4 Questions To Ask

    A pharmaceutical manufacturer’s primary goal is to bring drugs to market that drive improved patient outcomes and lead patients on the road to wellness. However, the processes, resources and financial investment required to bring these drugs to market can be challenging roadblocks to overcome.

  • A cGDP Primer: New Distribution Models For Life Science Supply Chains
    A cGDP Primer: New Distribution Models For Life Science Supply Chains

    The life sciences industry has undergone many changes over the last decade, with consolidation, mergers, and acquisitions across both small and large pharmaceutical and biotech companies. One result of these changes is complex supply chain models, with a combination of in-house and outsourced research, product development, and commercial operations. The level of complexity has presented challenges for stakeholders and their supply chain partners: suppliers of materials, components, and packaging, as well as contract research (CRO), contract manufacturing (CMO), and logistics service providers.

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PHARMA OUTSOURCING WHITE PAPERS

  • 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.  

  • The 3 Cs You Should Expect From Your Pharma CDMO

    With the stakes higher than ever for drug sponsors, choosing a CDMO that is the best strategic fit is not just difficult, but imperative. These “Three Cs” can indicate whether a CDMO has the ability to provide a drug sponsor with not only the resources to fulfill a company’s long-term goals but also the confidence that every team member involved is committed to its success.

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ABOUT US

Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.

Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.

With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services  and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.

Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.

The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

Louis Garguilo Articles

INDUSTRY INSIGHTS

  • From Discovery To Development: GS Expression System For Next-Generation Biologics
    From Discovery To Development: GS Expression System For Next-Generation Biologics

    Compared to traditional antibody expression, where routine purification and analytical strategies have been established over the last few years, next-generation biologics have complex designs. If you are first in class or you have a very bespoke up- and downstream process, it also means you will have bigger hurdles to overcome when it comes to regulatory support and filing. At Lonza, these challenges are addressed with the GS™ expression platform.

  • Six Myths About Serialization
    Six Myths About Serialization

    The global countdown to serialization compliance is well underway. Early adopters, such as Turkey and Argentina, required serialization as early as 2010, and were followed by others such as India, China and Korea.  Over the next three years, many other major markets will require adherence to their own serialization requirements, including the United States and the European Union. Expect that by 2018, serialization mandates will govern most of world’s drug supply. Biopharmaceutical companies that don’t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.

  • Advancing Safety and Efficacy Studies with Novel Surgical Applications
    Advancing Safety and Efficacy Studies with Novel Surgical Applications

    Novel therapeutics such as gene and cell therapies, nanoparticles, and combination products requiring targeted delivery,  novel treatments for wound healing, cardiovascular disease, and bone regeneration,  and new medical device technologies call for innovative surgical procedures in preclinical trials to determine safety and efficacy.

  • How Are Analytical Methods Exchanged In A Technology Transfer?
    How Are Analytical Methods Exchanged In A Technology Transfer?

    As the principal means of assuring chemical identity and purity, instrumental analysis is the lifeblood of pharmaceutical development and manufacturing. In addition to standard instrumental methods, molecules may undergo enzymatic or cell-based assays to demonstrate some critical quality. Products often become “married” to analytical methods, and transferring this panel of tests during a technology transfer requires care.

  • 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.

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OUTSOURCING EVENTS

Reacting to “Human Error” – Moving Beyond “Retraining” As A Response September 27, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Introduction to Biostatistics: Collecting and Summarizing Data September 28, 2016
1pm-3pm EDT, Online Training
Price:  $349 - Introductory Rate
Pediatric Clinical Trials: Special Considerations and Requirements October 6, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Biosimilars: Preparing For Opportunities And Challenges October 11, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Medical Device Design Controls 101 – A Practical Crash Course October 12, 2016
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
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