Clinical Guest Contributors

1. Regulatory Requirements For A Clinical Investigation For Medical Devices According To MDR Annex XIV 1/24/2022

   On May 26, 2021, the Regulation EU 745/2017 (MDR) entered into force. A clinical investigation must be performed for novel implantable and Class III medical devices to demonstrate that the device is compliant with the general safety and performance requirements. This article also discusses related guidance from the Medical Device Coordination Group.

2. Explosive Investment In Virtual Trial Companies: The Latest Data 1/20/2022

   This article looks at the blossoming ecosystem and investment growth in the virtual trial space, specifically virtual trial companies that are foregoing the legacy clinical trial models and leveraging new technologies. Further, the article explores the power of the virtual trial platform and the key areas life sciences companies should consider when working with these virtual partners.

3. FDA Releases Draft Guidance On Use Of Real-World Evidence For Drug & Biological Products 1/19/2022

   The FDA has issued new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data (RWD) and real-world evidence (RWE) into clinical research, product approvals, and post-approval monitoring of drugs. You can submit public comments until March 3, 2022.

4. Sex Matters… In Preclinical Drug Development? 1/18/2022

   In safety pharmacology studies investigating short-term side effects on physiological functions, the scientist is obliged to “consider” sex in the study design of animal models. This article also shares the differences in anxiety and depression in human males and females.

5. Capital Raising For Cell & Gene Therapies: How To Craft Your Elevator Pitch 1/17/2022

   We often hear of the need for an “elevator pitch” in the context of raising capital – a brief 30-second persuasive speech to spark interest and engage with your audience. This article uses cytokine release syndrome (a disorder characterized by fever, tachypnea, and other symptoms) as an example to explain how to perfectly craft your elevator pitch within clinical drug development.

6. Designing Clinical Trials For Meaningful Patient Outcomes: 3 Lessons Learned 1/13/2022

   Balancing the needs of individual patients with providing benefit to the majority is just one part of the planning process when laying out a clinical trial design. Kezar Life Sciences often begins by understanding the patient mindset first. These are Kezar's three lessons learned.

7. Genome Sequencing Research For Rare Diseases & The Future Of The Field 1/11/2022

   Tomi Pastinen, M.D., Ph.D., is the director of the Genomic Medicine Center at Children’s Mercy Research Institute. In 2019, he and a team of CMRI researchers launched Genomic Answers for Kids, a first-of-its-kind pediatric data repository with the goal of collecting genomic data and health information from children and their families over the next seven years to create a database of 100,000 genomes. 

8. Can Anti-TNF Treat Post-operative Cognitive Decline? New Clinical Research Investigates 1/6/2022

   People who suffer from post-operative cognitive decline can develop difficulty remembering things and performing daily tasks, and may possibly end up in nursing homes. There are no existing therapies. However, 180 Life Sciences believes it has a novel understanding of how to treat it.

9. Harnessing The Human Virome For The Next Generation Of Gene Therapy Vectors 1/5/2022

   Advances in metagenomic sequencing have revealed insights into the human virome with boundless value for gene therapy researchers. This includes exploring the diversity of a family of small commensal viruses called anelloviruses that have never been associated with disease. Anelloviruses are a promising new tool in our effort to overcome today’s limitations in genetic medicine.

10. Collaborating With The FDA For Rare Disease Clinical Trial Success: Our Experiences 1/4/2022

    If you are familiar with rare diseases, you know there are unique challenges associated with conducting clinical trials to evaluate potential new treatments for small patient populations. When we set out to design our Phase 2b study for a treatment targeting congenital ichthyosis, we knew we would need a plan to tackle these challenges. Here's how we worked with the FDA throughout the process.