FROM THE EDITOR

  • At Global Forum, Pharma Outsourcing Stakeholders Reveal Some Truths
    At Global Forum, Pharma Outsourcing Stakeholders Reveal Some Truths

    The stage was the Outsourced Pharma West conference in the Hyatt Regency in San Francisco. Some of the discussion swirled around big pharma’s full-scale incursion into China, perhaps for some unexpected reasons, and the contemplation of wringing “some risk” out of an India dependency. 

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OUTSOURCING INSIGHTS

  • Biomarkers In Preclinical Drug Development: Current And Future States
    Biomarkers In Preclinical Drug Development: Current And Future States

    Biomarkers are commonly used in clinical trials to identify organ injury before it becomes clinically evident. While they add value in early discovery work and in human trials to identify major safety issues, their potential has not yet been fully reached in preclinical development in animals. This paper explores the current state of biomarker use in preclinical development and examines possible steps for future use.

  • The Renaissance Of Sprinkle Formulations
    The Renaissance Of Sprinkle Formulations

    By Sven Stegemann, PhD, Capsugel

    About 25 years ago, multi-particulates were applied in pharmaceutical product development as so-called sprinkle formulations to overcome swallowing issues with larger oral dosage forms. After a growth in popularity in the 1990s, use of sprinkle formulations declined because of concerns about delivery and efficacy. These issues, which can easily be overcome, are addressed in this article.

  • Exposing Patients To The Bigger Mobile And Digital Health Picture – Did We Forget To Tell Them?
    Exposing Patients To The Bigger Mobile And Digital Health Picture – Did We Forget To Tell Them?

    To understand just how far mobile and digital technology can truly influence progress in global healthcare, we first need to form the foundation of the discussion with a few rudimentary facts.

    1. Clinical research (‘a branch of medical science in human beings’) is critical to healthcare.
    2. All patients are human beings.
    3. All stakeholders are current or potential patients.
    4. All stakeholders therefore have a vested interest in progression of healthcare.

    Our current healthcare model is evolving, slowly but surely. How this progression is defined, and how mobile and digital technology can help to speed this along will be explored in this article.

  • New Perspectives On Consumer Health In Pharmerging Markets
    New Perspectives On Consumer Health In Pharmerging Markets

    By Andy Tisman, Global Senior Principal, Consumer Health at IMS Health

    The global market for consumer medicines (over the counter medicines, OTC) is worth $111 billion in sales and continues to demonstrate strong growth potential, with growth over 5% in the latest year. Pharmerging countries are at the forefront of this robust growth, fuelled by higher out-of-pocket expenditure, favorable demographic trends and a growing and increasingly prosperous middle class. In these markets, distant from the corporate headquarters of multinational companies, OTC is growing faster than in mature markets, and consequently has a
    larger share of the total healthcare market.

  • 6 Crucial Steps For Establishing Humane Endpoints Before Your Preclinical Safety Study
    6 Crucial Steps For Establishing Humane Endpoints Before Your Preclinical Safety Study

    While development of humane endpoints for animals in preclinical safety studies is not an easy process, it is an absolute necessity.

  • Six Crucial Steps For Establishing Humane Endpoints Before You Start Your Preclinical Safety Study
    Six Crucial Steps For Establishing Humane Endpoints Before You Start Your Preclinical Safety Study

    While development of humane endpoints for animals in preclinical safety studies is not an easy process, it is an absolute necessity. And although humane endpoints must be established for obvious ethical reasons, it’s easy to overlook how much they can contribute to the success of a trial, ultimately helping to save valuable time and resources.

More Insights

OUTSOURCED PHARMA CONTRIBUTING EDITORS

  • FDA Outlines Upcoming Regulatory Changes And Urges Industry To Be Proactive And Transparent

    While reviewing upcoming changes heading industry’s way through regulatory legislations, such as the Food and Drug Administration Safety and Innovation Act (FDASIA) and the Drug Supply Chain Security Act (DSCSA), during her keynote session at Pack Expo 2014, Ricki Chase, director of investigations for the FDA’s Chicago office, urged the audience to not just focus on product integrity, but also personal and corporate integrity.

  • Implementing A Vendor Oversight Quality Management System: Insights From Biogen Idec Data Management

    As the volume and complexity of outsourcing increases, it becomes important to implement a risk-based approach to vendor oversight. Regulatory agencies expect that sponsor companies will ensure qualified personnel are working on their behalf, following GCP-compliant processes and have adequate controls in place to ensure patient safety and data integrity.

    Unfortunately, it is also common for silos to exist in many large organizations. Much of what the data management area might do is contained within that department. What the clinical operations department does might be confined to clinical operations. As a result, not all information generated on vendor interactions will be passed through all of the functional areas requiring access to the information.

    When those regulatory inspectors do show up at your door, it is not uncommon for them to ask “what have you done to oversee this vendor?” or “what evidence of vendor oversight can you produce?” As the sponsor is ultimately accountable for the quality of the data and the study conduct, it is important to ensure that oversight is applied throughout the lifecycle of the study. At the same time, it is important to not duplicate effort, micromanage the vendor, or fix issues that should be resolved by the vendor.  Oversight is essential, but spending time on unnecessary activities can have the effect of decreasing quality.

  • Merck Announces Positive Results From Phase 2b HIV Combo Therapy Study

    Merck has announced data from a 48-week Phase 2b clinical trial that evaluated the safety and efficacy of once daily oral doravirine plus tenofovir/emtricitabine (TDF/FTC). Doravirine is an investigational next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI). The study compared doravirine plus TDF/FTC to efavirenz plus TDF/FTC, in previously untreated patients with HIV-1 infection.  

    The treatment of HIV has changed considerably since the early days of the epidemic. Initially there were no therapies, which eventually gave way to single therapies. Today multiple classes of therapies are available which target different parts of the virus lifecycle are available. It has now become clear to researchers that combination therapies are key to battling the disease. With combination therapies, patients are able to live lives much closer to normal without the HIV complications that would often be fatal. 

  • Learning From Mistakes: Ulo Palm, SVP, Drug Development and Research Operations, Forest Laboratories

    I have always been taught you can learn as much from your mistakes as you can from your successes. Oftentimes the lessons learned are much more valuable than what you glean from those positive outcomes. While all learning experiences are valuable, unfortunately some can come at a fairly high price. If the lesson is learned at work, and the cost is sufficiently high, you may even have concerns about your career. That is a situation that Ulo Palm, SVP of Drug Development and Research Operations for Forest Laboratories (recently acquired by Actavis), once faced. Palm shared this personal story during the Dirty Laundry session at the 2014 Disruptive Innovations conference.

    “This lesson happened years ago during what I like to call the dark ages of patient recruitment,” says Palm. “Back then, we did not have the Internet, social media, and other sophisticated tools. You had to review investigator lists and call them to find out how many patients they could enroll in a study. Those who have done this can tell you it is not a very efficient way of managing recruitment.”  

  • MPI Research And Jasper Clinical: Getting Decisions To Sponsors Faster

    The Upjohn Company was founded in 1886 in Kalamazoo, MI to make friable pills, which were easily digested and could be “reduced to powder under the thumb.” In 1984, the company decided it needed an internal Phase 1 testing unit and felt Kalamazoo would be the best place to construct it. In 1995, Upjohn merged with Pharmacia. A subsequent merger in 2003 made Pharmacia a part of Pfizer. That same year, the Phase 1 testing unit became Jasper Clinic, an independent operation. In October 2014, that facility, now known as Jasper Clinical Research and Development with more than 80 staff members, became a part of the MPI Research family.

    That acquisition by MPI includes the Jasper Clinic, a 50-bed clinical trial unit providing early-stage study services, including pharmacokinetic and pharmacodynamics, drug interaction and methodology studies, and biomarkers. The 25,000 square-foot facility is located on the campus of Bronson Hospital and is physically connected to the hospital’s Level 1 Trauma Center.

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FEATURED SUPPLIERS

  • 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.

  • PPD
    PPD
  • Cook Pharmica
    Cook Pharmica

    Cook Pharmica is an integrated contract development and manufacturing organization that simplifies the supply chain needs of its customers. By offering a unique solution of providing support from drug substance through drug product and packaging all under one roof with one management team and one quality system, Cook Pharmica helps pharmaceutical companies mitigate their risk and avoid complicated technical transfers. Cook Pharmica also operates as a strategic partner with customers, freeing them up to focus on their core competencies, which typically include research and development of new products. By taking advantage of Cook Pharmica’s one source, one location model, pharmaceutical these companies can better leverage their budgets, simplify their supply chain needs, and achieve greater speed to market.

  • MPI Research
    MPI Research

    MPI Research, with global headquarters in Mattawan, Michigan, provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries.

  • CoreRX, Inc.
    CoreRX, Inc.

    CoreRx™ offers comprehensive drug product development services to the pharmaceutical and biotechnology industries. Supporting virtual, mid-size, and multinational companies, CoreRx offers customized formulation development & clinical material manufacturing solutions. Our solutions maximize client investments, shorten development time, and reduce overall costs. From First-in-Man drug development, to full CMC support, CoreRx combines 200+ years of pharmaceutical development experience and expertise to produce safe, effective, and innovative drug products, on time, and on budget.

  • That’s Nice LLC
    That’s Nice LLC

    That’s Nice is a full-service agency providing research-driven brand management and marketing that enable businesses to achieve their goals. Our integrated services reflect 18 years of knowledge in life science and materials science markets, a passion for strategic thinking, and a comprehensive approach that meets the needs of global companies.

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January 6, 2015
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