Insights on Clinical Trials

  1. Commercializing Disruptive Technologies In Advanced Therapies 1/11/2021

    From the back of the napkin to the bedside: Panelists from CUTISS, Humacyte and TreeFrog Therapeutics share their inspirational journeys commercializing disruptive technologies.

  2. Manufacturing Automation Solutions For Allogeneic Cell Therapy Production 1/11/2021

    Breakthrough manufacturing automation for cell expansion, formulation and working cell bank dispensing paves the way for the treatment of debilitating illness.

  3. Keys To Successful Risk Management In Clinical Trials 1/5/2021

    Effective risk management recognizes variables unique to each clinical trial while embracing consistent documentation practices, stakeholder responsibility, and best practices informed by experience.

  4. Conclusive & Positive Results Delivered Ahead Of Time – By Eight Months 12/22/2020

    Most patients with Binge Eating Disorder (BED) seek help from psychiatrists, nutritionists, or obesity specialists, but there was no approved, effective pharmacologic treatment. With unanticipated interest in pivotal Phase 3 studies, we needed to line up and train the right resources while collaborating effectively with the central laboratory, data manager, and other participants.

  5. Operational Challenges Of Neuroscience Clinical Trials, Part 1: Overview 12/22/2020

    With billions of neurons, the brain is the body's most complex organ, so it’s not surprising that neuroscience clinical trials face major challenges. In this new blog series, we’ll look at the challenges sponsors face when operationalizing clinical trials and share lessons from our experience in this therapeutic area.

  6. Evolution Of Treatment Of Atopic Dermatitis 11/19/2020

    The Atopic dermatitis (AD) treatment paradigm has significantly evolved in the last five years. Currently, AD is an area of intense focus for clinical developers. Globally, more than 100 pharmaceutical and biotechnology companies are investigating new therapeutic solutions for AD. This white paper will explore the pathophysiology of atopic dermatitis, as well as the rationale and mechanisms of action of existing and emerging therapies for AD.

  7. Beware of Underestimating The Value Of A Pre-NDA Meeting 11/19/2020

    Drug development is a resource-intensive endeavor. Seeking input from the U.S. Food and Drug Administration throughout the journey can help optimize those resources and maximize the likelihood of regulatory approval. When preparing to submit a new drug application (NDA), a pre-NDA meeting with the FDA can be a critical step in ensuring the submission of a well-organized NDA that fits the expectations of agency reviewers.

  8. Adaptive Design Methods Offer Rapid, Seamless Transition Between Studies 11/19/2020

    The evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy. Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials.

  9. Tumor-Agnostic Treatments: A Game Changer For Rare Oncology Trials 11/19/2020

    As our understanding of the molecular characteristics of tumors has improved, there has been a tremendous leap forward — not only in targeted therapies but also in the development of tumor-or tissue-agnostic treatments. Now, with precision or personalized medicine, treatments can be targeted to a subgroup of patients rather than relying on a one-drug-fits-all model. In this blog post, we explore the changing rare oncology landscape and novel approaches to rare cancer trials.

  10. Supporting Multiple Global Gene Therapy Studies For Rare Diseases 11/17/2020

    A long-term client called upon the Veristat team for help conducting two investigational Phase I/II studies. These global studies focused on proving the safety and efficacy of gene therapy for two rare genetic disorders. Working side-by-side with the client, our cell and gene therapy experts addressed many complicated challenges – including site start-up issues, stringent regulatory requirements, and the logistics of handling highly sensitive genetic material.