ARTICLES BY ED MISETA

  • Cell & Gene Therapies Require the Right Tracking Solution
    Cell & Gene Therapies Require the Right Tracking Solution

    In cell therapy trials, the ability to track a patient’s cells is essential. When you have over 100 patients, and the cells will require multiple shipments, using a spreadsheet is not possible. “For the safety of our patient, accurate tracking is a must,” says Gerald Garrett, VP of clinical operations for MarkerTherapeutics. “We need to know exactly where the product is at any step of the way.”

  • NeuBase Prepares To Face The Challenges Of A Rare Disease Trial
    NeuBase Prepares To Face The Challenges Of A Rare Disease Trial

    NeuBase is attempting to create a treatment for two rare diseases: Huntington’s disease and myotonic dystrophy. The company will face several challenges along the way, with the first being patient recruitment. Will young patients even want to know if they have the disease?

  • GenSight Uses Gene Therapies To Target Neurodegenerative Diseases
    GenSight Uses Gene Therapies To Target Neurodegenerative Diseases

    GenSight Biologics believes it is on the cutting edge of ophthalmology, gene therapy, and drug development. The company is focused on finding treatments for patients with neurodegenerative diseases and is developing products that are a combination of gene therapy, its mitochondrial targeting sequence technology, and optogenetics.

  • The Cell Therapy Discovery About To Disrupt Clinical Trials
    The Cell Therapy Discovery About To Disrupt Clinical Trials

    While pursuing hid PhD in chemical engineering at MIT, Armon Sharei developed an interest in novel cell therapies. That interest led him to a discovery that today is the foundation of SQZ Biotech, a cell-therapy company where he serves as CEO. Sharei discovered a new method of inserting materials into cells more effectively than anything that currently existed.

  • A Patient’s Journey: Human Interactions Matter In Immunotherapy Trials
    A Patient’s Journey: Human Interactions Matter In Immunotherapy Trials

    Mary Elizabeth Williams is a journalist and an author. She is also a patient who has with metastatic melanoma who participated in a Phase 1 immunotherapy clinical trial. There is much that pharma can learn from her in terms of how companies approach clinical trials and drug development.

  • Manufacturing Facility Will Meet Needs Of Cell & Gene Trials
    Manufacturing Facility Will Meet Needs Of Cell & Gene Trials

    Abeona Therapeutics is developing investigational gene and cell therapies for people living with serious and rare diseases. Last year, Abeona held a ribbon-cutting ceremony to celebrate the groundbreaking of a manufacturing facility that is one year later producing gene therapy material for their clinical and pre-clinical programs. As is the norm with gene therapy, Abeona uses a virus as vehicles to deliver functional copies of defective genes.

  • Novartis Turns To Digital Technologies For Clinical Trials
    Novartis Turns To Digital Technologies For Clinical Trials

    Jake LaPorte, head of digital development for Novartis, talks about how AI, IoT, and machine learning are all being leveraged for better clinical trials.

  • A Patient’s Journey To Join A CAR-T Cell Therapy Trial
    A Patient’s Journey To Join A CAR-T Cell Therapy Trial

    Nicole Gularte is currently battling cancer for the 8th time. The last time she had to do so, it seemed a CAR-T cell therapy trial might be the solution. This article is about her long battle with cancer, the struggle to get into a CAR-T cell trial, and the ups and downs she has faced along the way. Her story is an inspiration to others.

  • Science Driving Gene Therapy Development At bluebird bio
    Science Driving Gene Therapy Development At bluebird bio

    For patients with sickle cell anemia, just getting through the day can be a struggle. Symptoms of the disease include vision problems, swelling of the hands and feet, and periodic episodes of pain that can last from a few hours to a few weeks. In this article Nick Leschly, CEO at bluebird bio, discusses the progress being made with its investigational gene therapy for sickle cell disease.

  • Is Genetic Testing Creating a Moral Dilemma For Clinical Researchers?
    Is Genetic Testing Creating a Moral Dilemma For Clinical Researchers?

    Clinical trials are complex, but adding genomics to the equation has the potential to make them even more complicated. However, much of the genetic testing that is now being performed in the clinical space is done before a trial begins. That means companies need to do some thinking before adding a genetic test to the protocol.

  • Ensure A Smooth Start-Up In Gene Therapy Trials
    Ensure A Smooth Start-Up In Gene Therapy Trials

    Preparations for a large Phase 3 clinical trial will always present challenges. In the area of gene therapies, those challenges can be magnified. Gene therapy trials can add more time and cost to a trial, and will also require specific expertise not needed in small molecule and biologics trials.

  • Cell Therapy Trial Creates Skin Cells For Rare Disease Patients
    Cell Therapy Trial Creates Skin Cells For Rare Disease Patients

    Abeona Therapeutics recently conducted a Phase 1/2 clinical trial for individuals with Recessive Dystrophic Epidermolysis Bullosa (RDEB). RDEB is an often fatal connective tissue disorder marked by skin blistering and caused by a lack of a collagen protein responsible for anchoring the dermal and epidermal layers together.

  • Cell Therapy Trials Present Unique Challenges For Pharma
    Cell Therapy Trials Present Unique Challenges For Pharma

    Maria Fardis, CEO of Iovance Biotherapeutics, has spent 18 years working in the pharma industry. Although most of her experience has been in small molecules and proteins, she now works in the cell therapy space and notes these treatments are a new and exciting space with meaningful differences in how clinical trials are conducted.

  • CRS Files Lawsuit Against FDA
    CRS Files Lawsuit Against FDA

    The watchdog group Center for Responsible Science (CRS), along with clinical trial participants and the father of a deceased trial participant, has filed a lawsuit against the FDA for denial of CRS’ citizen petition, which was originally submitted in June 2014 and has since had several amendments.

  • Cell Therapy Trial Targets Type 1 Diabetes In Children
    Cell Therapy Trial Targets Type 1 Diabetes In Children

    Getting adult patients to take part in a clinical trial is difficult. When developing a treatment for a childhood disease, that recruitment challenge becomes even more difficult. The combination of patient age and the experimental nature of a treatment can cause concern amongst both parents and the FDA. Caladrius Biosciences is a company dealing with that challenge. The company is developing a cell therapy technology based on a patient’s own T-cells.

Ed Miseta

Ed Miseta



Ed Miseta is chief editor for the website Clinical Leader, executive editor for Life Science Leader magazine, conference chair for Clinical Leader Forum, and host of Clinical Leader Live. Ed studied Business Economics at The Pennsylvania State University and also holds a Master’s degree in Business Administration. Ed has been a writer for more than 12 years and has been covering clinical research since January 2013. Ed spent 10 years in banking and investments and also taught economics at Penn State for 8 years. In his current position, Ed interviews clinical executives from pharmaceutical and biotech companies and shares their insights with readers. His primary focus is on best practices, challenges faced and overcome, clinical trends, partnering, and implementing new technologies. He has also moderated numerous speaker panels at industry conferences and trade shows.