FROM THE EDITOR

CROs In A Business Exchange With Silicon Valley?

As an applied economic theoretic, by driving out inefficiencies from the current model used by researchers to find and contract with CROs, the Science Exchange should improve the business model for drug discovery. But will all parties — Pharma/Bio, CROs and individual researchers — benefit equally? 

More From the Editor

OUTSOURCING INSIGHTS

  • Value Takes Center Stage Amid Excitement Over New Data At Annual Oncology Meeting In Chicago
    Value Takes Center Stage Amid Excitement Over New Data At Annual Oncology Meeting In Chicago

    The world’s leading cancer experts gather today in Chicago for the American Society of Clinical Oncology 51st meeting to explore topics in one of healthcare’s most complex and rapidly evolving therapeutic areas.

    It’s too early to say if there will be any big surprises this year, but looking over the weekend’s schedule, it is obvious that the conference discussion will largely center around pharmaceutical companies developing and launching novel immunotherapies that are changing the landscape in cancer care. This year’s conference also will highlight the companion topics of precision medicine and predictive diagnostics for finding the right patients for these advanced and costly treatments.    

  • How Do You Set Up A Quality Pharma Organization?
    How Do You Set Up A Quality Pharma Organization?

    In the pharmaceutical industry, the FDA good manufacturing practices are ever evolving, but the roots are established in 21 CFR Parts 210 & 211 (for drugs). FDA has recently began looking at quality metrics as well, and even established an Office of New Drug Quality Assessment (ONDQA) which assesses the critical quality attributes and manufacturing processes of new drugs.

  • Can Diamond Make Drug Authentication “Flawless?”
    Can Diamond Make Drug Authentication “Flawless?”

    Pharmaceutical industry insiders estimate that more than $350 billion worth of counterfeit drugs are now sold around the world each year.  In addition to diverting revenue from manufacturers and distributors, falsified medicines are also putting patients at risk. They are often not manufactured to even minimum quality standards, which can reduce their efficacy.  In addition, in many cases they contain dangerous impurities that pose significant safety hazards.

  • Prioritizing The BioPharma Portfolio – Get The Right Assets On The Bus (and The Wrong Ones Off)
    Prioritizing The BioPharma Portfolio – Get The Right Assets On The Bus (and The Wrong Ones Off)

    Everyone is looking for the silver bullet: the product that will change the face of biopharmaceuticals and draw blockbuster revenues. If you have one of these, you can stop reading. But if you are like most companies, your portfolio is a mix of some winners, some underachievers, and a lot of “in-betweeners.” The process of getting the right assets on the bus (and funded) in a cash-strapped environment is as much an art as a science. As consultants to the industry for many years, we’ve seen myriad processes – both good and bad. 

  • Assess Biodistribution And Pharmacokinetics Of Bone-Targeting With Anatomical Imaging Modalities
    Assess Biodistribution And Pharmacokinetics Of Bone-Targeting With Anatomical Imaging Modalities

    Next to blood transfusions, bone is the most commonly implanted material in the human body, with an estimated 600,000 grafts performed annually. New methods for replacing bone or stimulating bone formation in disease settings, such as arthritis and acute injury, can be challenging to evaluate in traditional preclinical models.

  • The Scarcity Mindset: How Capacity Shortages Are Hurting The Entire CMO Industry
    The Scarcity Mindset: How Capacity Shortages Are Hurting The Entire CMO Industry

    It takes ninety thousand trips to the flower fields to produce eight pounds of honey. Young worker bees eat that honey and excrete from it just one pound of precious wax. Then they congregate around their tiny clumps of wax in total darkness, without oversight, using body heat to warm and manipulate the wax into delicate honeycomb masterpieces. The result is nothing short of perfection: they build to a standard that is consistently within a two percent tolerance; far better than the ten percent tolerance the walls that surround you were built to.

More Insights

OUTSOURCED PHARMA CONTRIBUTING EDITORS

  • Prioritizing The BioPharma Portfolio – Get The Right Assets On The Bus (and The Wrong Ones Off)

    Everyone is looking for the silver bullet: the product that will change the face of biopharmaceuticals and draw blockbuster revenues. If you have one of these, you can stop reading. But if you are like most companies, your portfolio is a mix of some winners, some underachievers, and a lot of “in-betweeners.” The process of getting the right assets on the bus (and funded) in a cash-strapped environment is as much an art as a science. As consultants to the industry for many years, we’ve seen myriad processes – both good and bad. 

  • The Scarcity Mindset: How Capacity Shortages Are Hurting The Entire CMO Industry

    It takes ninety thousand trips to the flower fields to produce eight pounds of honey. Young worker bees eat that honey and excrete from it just one pound of precious wax. Then they congregate around their tiny clumps of wax in total darkness, without oversight, using body heat to warm and manipulate the wax into delicate honeycomb masterpieces. The result is nothing short of perfection: they build to a standard that is consistently within a two percent tolerance; far better than the ten percent tolerance the walls that surround you were built to.

  • Shifting Pharma’s Mindset: Viewing Quality As Value Creator, Not Cost

    After a decade of cost cutting in product development and manufacturing, many pharmaceutical companies have struggled to meet basic quality standards. In recent years, the U.S. Food and Drug Administration (FDA) has shuttered numerous manufacturing sites and banned a variety of products because of Good Manufacturing Practices (GMP) violations. As a result, many companies have experienced substantial hits to both their corporate reputation and profitability.

  • Remote SDV/SDR: Alternatives To Redact/Fax

    As part of their risk-based monitoring strategy, many sponsors and CROs are using remote techniques to conduct source data review and verification (SDR and SDV).The best implementations out there actually streamline activities at both ends, both for sponsors/CROs and for study sites.

  • Staying On Top Of Microbes: Smarter Testing Technology For Labs Of The Future

    Over the past decade, drug and medical device manufacturers have become leaner and more stream-lined. Given the current market pressures, companies are looking for more ways to improve their bottom-line.

More From Contributing Editors...

FEATURED SUPPLIERS

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  • WellSpring Pharma Services
    WellSpring Pharma Services

    WellSpring provides peace of mind to pharmaceutical companies for their contract manufacturing and packaging needs. When you work with WellSpring, you'll have a whole team of professionals backing your project. Our team will oversee the entire operation; while a project manager will help you plan all stages. You'll also have a dedicated technical team to manage all aspects of the project. All this at one convenient location, offering everything from clinical to commercial manufacturing, packaging and analytical testing services for virtually all non-sterile dosage form products including, tablets, capsules, creams, lotions, ointments, gels and oral liquids.

  • World Courier Management
    World Courier Management

    World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.

  • Pfanstiehl, Inc.
    Pfanstiehl, Inc.

    Pfanstiehl is the premier manufacturer of cGMP high purity, low endotoxin injectable grade excipients and biopharmaceutical components for upstream bioprocessing, downstream formulation, and specialty applications. In addition, Pfanstiehl is a leading contract development and manufacturing organization (CDMO) specializing in the isolation, purification, custom synthesis and scale-up development of small molecule Active Pharmaceutical Ingredients (API), in gram to multi-ton commercial quantities. While most ingredient manufacturers or resellers focus on other industries such as food, cosmetics, agriculture, and/or nutritional supplements, offering only a subset of “pharma grade” ingredients, Pfanstiehl is Pharma Grade through and through. It’s all we do. Pfanstiehl’s ICH Q7 compliant manufacturing facility is centrally located just north of Chicago, and only 35 minutes by car from O’Hare International Airport.

  • AMRI
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    With locations throughout the United States, Asia and Europe, AMRI has an unmatched ability to provide globally integrated solutions using flexible business models.

  • Ash Stevens
    Ash Stevens

    Ash Stevens Inc. is a full-service Contract Pharmaceutical Manufacturer offering comprehensive small-molecule drug substance development and cGMP manufacturing services. Founded in 1962 and headquartered in Riverview, Michigan, Ash Stevens has extensive experience developing and manufacturing Active Pharmaceutical Ingredients (APIs) for commercial clients in the Life Sciences industry developing innovator small-molecule drugs. Our business model is predicated on providing Sponsor clients with the safest and highest quality work product possible while meeting delivery obligations on time and on budget.

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Pediatric Clinical Trials: Special Considerations and Requirements

June 1, 2015
2pm-3:30pm EDT, Online Training
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FDA GMP Inspections – Proven Preparation & Survival Techniques

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Cost-Efficient/Cost-Effective Validation Protocols

June 3, 2015
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June 4, 2015
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