INSIGHTS ON CELL & GENE CLINICAL TRIALS

• Saving Development Time And Economizing Distribution With A Single-Vendor Approach

  By minimizing the overall time, complexity, and effort of clients’ projects and reducing the risks, Thermo Fisher’s most complete integrated offering represents a strong single-vendor solution.

• Gene Therapy For Parkinson’s Disease: Strategies And Operational Requirements

  Gene therapy holds great promise as a potential treatment for Parkinson’s disease, a disorder for which currently available medications do not causally treat the underlying disease mechanisms. Download the available white paper to find out more.

• Rare Diseases: How To Leverage Social Media For Patient Analysis

  Due to insufficient sample sizes and a lack of granularity, traditional data analysis of rare diseases produces unreliable results. What can you do to learn more about patients with rare diseases? Leverage data from social media and other online sources! The internet offers a trove of public data waiting to be tapped into.

• Planning The Way Forward In Neurodegenerative Disease Studies

  The Food and Drug Administration (FDA) recently released specific draft guidance titled, Human Gene Therapy for Neurodegenerative Diseases (ND). This guidance provides recommendations for Sponsors who are developing human gene therapy (GT) products for neurodegenerative diseases, which affect adult and pediatric patients. It focuses on considerations for product development, preclinical testing, clinical trial design and marketing approval pathways. This article outlines several areas to consider when preparing for regulatory agency interactions.

• Is A Multitherapeutic Contract Research Partner The Best Fit For Your Clinical Trial?

  You wouldn’t hire a house painter to retouch fine artwork, so why would you contract a jack-of-all-trades research organization to pilot a clinical trial with critical end points that require specific, in-depth expertise?

• The Cumulative Risk Of Multiple CT Scans on Blood Cancer Patients Enrolled In Clinical Trials

  Bob Levis, Director of CLL Society, proposes alternatives to CT scans for the FDA's consideration.

• How Sites Can Win In The New Age of Genetically Engineered Treatments

  As gene therapies enter the pipeline at an exponentially-growing pace, how can private and hospital-based clinical trial sites prepare themselves to take advantage of the coming rush? In this blog, we will explore how proactive clinical research sites, from small private clinics to large integrated health systems, are preparing for the accelerated trend of gene therapy research.

• Identifying The Best People To Run A Clinical Study (And How To Hire Them)

  No matter how brilliant a clinical trial process or a technology may be, it is useless without skilled, motivated individuals at the helm.  

• Great Size ≠ Great Value: How Smaller Outsourcing Partners Benefit Small And Emerging Biotechs

  Large clinical research outsourcing partners tout extensive expertise or experience based on past success. But pulling back the curtain on this “corporate memory” often reveals inefficiencies caused by “that’s the way it’s always been done” thinking.

• 5 Key Takeaways: Drug And Device Development Secrets In The World Of Medical Aesthetics

  New treatment options for medical aesthetic indications are in record-high demand, fueled by growing awareness of the effects of physiological and environmental aging and the influence of lifestyle on skin health. Premier Research explored this evolving landscape in depth in our recent webinar Drug and Device Development Secrets in the World of Medical Aesthetics. In this blog, we discuss five of the most important takeaways for creating a competitive, differentiated aesthetic development program.