Articles By Ed Miseta

  1. “Your Journey, Our Mission”: PAREXEL Launches New Brand Platform To Strengthen Client Relationships 2/12/2014

    Attempting to simplify the journey of sponsors from the drug discovery process through to new treatments for patients, biopharmaceutical services provider PAREXEL is announcing the launch of a new initiative. The company’s promise to bio and pharma firms, “Your Journey, Our Mission”, was put in place to demonstrate its commitment to enhance client opportunities.

    PAREXEL has been working on this rebranding idea for more than two years. According to the company’s founder and CEO, Josef von Rickenbach, the process involved a lot of soul searching and examining of where the company and the industry were evolving, as well as the expectations of its clients. The goal was to understand how the strategies and visions of pharma could be best served by the companies it selected as partners.

  2. Cobra Biologics Extends GMP Certification 2/11/2014

    In December 2013, business growth necessitated CMO Cobra Biologics install a new Thermo Scientific 1000L HyClone Single-Use Bioreactor (SUB) at the company’s centre of excellence for mammalian antibody and recombinant protein production. In announcing the expansion, the company cited a ten-fold increase in antibody business over the prior two years, growth in contract manufacturing services, and its continued commitment to single-use disposable technologies.  

  3. Johnson & Johnson To Share Clinical Trial Data With Yale School Of Medicine 1/31/2014

    In a move that is sure to be seen as a major win for advancing science and medicine, Johnson & Johnson has announced that Janssen Research and Development, LLC, has reached an agreement with the Yale School of Medicine’s Open Data Access (YODA) Project to share data from its clinical trials. According to the terms of the agreement, YODA, as an independent body, will review requests from investigators and physicians seeking access to anonymized clinical trials data from Janssen, a subsidiary of J&J. In its role, YODA will also make final decisions on data sharing. According to the company’s press release, this will mark the first time any company has collaborated in this manner with an independent third party regarding requests for clinical data.

  4. Eli Lilly And Company Responds To Sanofi Lawsuit 1/31/2014

    This morning brought news that Eli Lilly and Co is being sued by Sanofi, a drug manufacturer based in France. The lawsuit alleges patent infringement on four of its patents relating to Lantus, the company’s popular treatment for diabetes. The lawsuit is expected to delay the launch of Lilly’s version of the treatment. Lilly applied to the FDA for permission to sell a biosimilar version of Lantus about a month ago.

  5. The Pfizer Approach To Clinical Outsourcing: Develop Capabilities And Align Objectives 1/29/2014

    Pam Garzone, executive director of biotechnology and clinical development at Pfizer WRD (worldwide research & development), is instrumental in implementing her company’s outsourcing strategy. As the clinical team lead, she is accountable for the clinical development strategy for programs originating at Rinat, a research unit within Pfizer. Her duties include working with different functional expert groups such as biologists, clinicians, both MDs and non-MDs, toxicologists, clinical pharmacologists, and statisticians. “I ensure that everyone on the asset team is in the same boat and rowing in the same direction,” she says.

  6. InformEx Celebrates 30 Years Of Success 1/29/2014

    Thirty years of taking care of customers is a very long time, especially in the trade show business. So it is no small accomplishment that InformEx recently celebrated its 30th year of bringing together clients and manufacturers in the specialty chemical industry. Industry leaders first came together in 1984 to address the demand for a show to foster better partnering opportunities between specialty chemical manufacturers and users. In Atlanta just one year later, the first InformEx show was held. The event, a small tabletop conference, hardly resembles the much larger show we know today with the education sessions, featured speakers, mobile app, and hundreds of chemical exhibitors from around the world.

  7. FDA: We Are Addressing IV Fluid Shortage 1/21/2014

    In a release from the FDA this morning, the agency is reporting that it is aware of the shortage situation existing for intravenous (IV) solutions, particularly 0.9% sodium chloride injection (i.e., saline). This solution is used to provide necessary fluids to patients with hydration and other conditions. FDA notes a range of factors may be responsible for the shortage, including increased hospital visits of patients experiencing symptions related to the current flu season.

  8. WIB Profile: Increased Challenges For Pharma Foster Closer Partner Relationships 12/20/2013

    Challenges in the pharma and biopharmaceutical industries, such as the end of the blockbuster model, the patent cliff, and rising costs, has companies relying more and more on outsourcing partners. In this Women In Bio (WIB) profile article, Laura Marquis, VP, Customer Solutions Management Group at Quintiles, discusses her job, the challenges her clients are facing, and how many of them are best dealing with those challenges. She also discusses what professional women can expect to get out of their affiliation with Women In Bio.

  9. Bring Down The Cost Of Clinical Trials With Improved Site Selection 12/19/2013

    With the cost of a single clinical trial costing upwards of $100 million, it’s not surprising the cost of developing a new drug has risen to more than $1 billion. The rising costs of drug development have personnel at every level of the process seeking ways to cut expenses. A recent collaboration between ViS Research and inVentiv Clinical Trial Recruitment Solutions (iCTRS) seeks to cut the cost of trials by speeding up the process of evaluating and selecting a clinical trial site.  

    “Pharma and CROs don’t have all of the information they need to properly select the right sites,” says Fabio Thiers, ViS founder and CEO. “As a result, pharma firms and CROs may well end up with centers that don’t recruit any patients, and trials that take twice as long as they should. This lack of available information on trial sites will therefore drive up the cost of trials.”

  10. WIB Profile: Cutting The Length, Cost, And Complexity Of Clinical Trials 12/19/2013

    Sophie McCallum has spent almost four years with clinical solutions firm ClinCapture, currently serving as its director of operations. In this position, McCallum oversees and manages the marketing, HR, finance, and inside sales departments. She also works with the governance team to plan and implement corporate vision and strategy, develops strategic plans and direction for products and services, develops tools and controls to track company profit margins and department budgets, and analyzes business and operation procedures to increase company efficiency and worker productivity. In this Women In Bio profile, McCallum discusses her role in helping build the company, and trends she sees occurring in the clinical research space.