Preclinical feature articles

31. 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.

32. Why Every Biotech Needs Qualified Drug Hunters 11/29/2021

    Christopher Kirk, co-founder, president, and CSO of Kezar Life Sciences, believes every biotech needs a good drug hunter. “This is an industry that is rife with failure,” says Kirk. “Every failure will cost companies a lot of time and money. Every company needs their scientists focused on meaningful drug discovery research with the goal of reducing this failure rate.”

33. 6 Key Steps For Cell Therapy Clinical Development Success 9/14/2021

    While the simplest option for a small or emerging biotech is to outsource protocol and clinical development to a consultant or CRO, a disengaged or absent sponsor is unlikely to have its objectives realized. Prior to engaging with a consultant or CRO, you can take these six steps that are likely to leave both parties engaged in the clinical development process.

34. What Can Clinical Leaders Do To Tackle The Global Women's Health Gap? 9/9/2021

    Nearly 300,000 women die every year from preventable causes related to pregnancy and childbirth. Postpartum hemorrhage is the leading cause of maternal death globally — and in the US, it's on the rise. Uterine fibroids disproportionately impact Black women and are a leading cause of hysterectomies. We must drive a concerted, ecosystem-wide effort that scales up clinical research for women.

35. Biologics Clinical Research: The Year's Best 4/16/2021

    Harry Selker, M.D. sits down with BioProcess Online for a candid discussion on the Clinical Research Forum’s work, its awards program that recognizes the year's best advances in clinical and translational research, and why that’s such an important structural element in the bridge between academia and industry. 

36. Developing Triple-Combination Immunotherapies: Lessons Learned From HIV 7/30/2019

    Our body’s immune system appears to be the most effective therapy to fight cancer—more so than chemotherapy, radiotherapy, or any other anti-cancer therapy currently available. However, the immune system is only effective if it can detect cancer cells.

37. PreClinical Video Aims To Attract Patients 12/27/2018

    Every company moving into clinical trials on humans will face the challenge of attracting both investors and patients to their study. These challenges can be difficult, but Anthony Hayes, president, CEO, and director of Spherix, believes a 90-second video the company has in its possession will help them overcome both.  

38. What Would Convince You To Delay Your Trial For 12 Months? 6/19/2018

    If you were ready to begin clinical testing on a new molecule but discovered you already had an improved version of the drug in development, would you move forward with the program or delay the Phase 1 trial by more than 12 months? That is a decision Samantha Cobb, CEO of AdAlta, had to make. Her decision centered on the well-being of patients.

39. Tissue Modeling May Cut Clinical Trial Time 12/5/2017

    In the neuromuscular space, Fulcrum Therapeutics is using tissue donated from patients with facioscapulohumeral (FSH) muscular dystrophy, an incurable form of the disease, to find a treatment. The tissue is used to create research models that look and respond much like natural human tissues

40. France Tragedy Reminds Us Phase 1 Researchers Must Live With Tragic Results 3/29/2016

    The recent clinical research tragedy in France that resulted in the death of one patient and the hospitalization of four others shocked many who work in the clinical research space. The adverse effects experienced by the previously healthy patients, reportedly involving deep brain bleeds, were both rare and disturbing.