Clinical Research: Phase 1 - Phase 4

Clinical Research: Phase 1 - Phase 4

The Challenges in Fulfilling the Promise of Precision Oncology

Precision oncology promises a new model of cancer care where medical decisions are based on a holistic view of the patient, including their genes, environment, and lifestyle, and tailored to the molecular profile of their tumor. To date, great strides toward the paradigm of precision oncology have been made in the area of cancer immunotherapy,...

Clinical Research: Phase 1 - Phase 4

Understanding Recent Regulatory Changes for Pediatric Oncology Trials

Of the 1.7 million new cases of cancer in the U.S. in 2018, 10,590 involved children aged 14 or younger.[1] While children typically have a better cure rate for cancer, biopharma companies have traditionally shied away from pediatric oncology trials, resulting in fewer treatment options. However, the regulatory landscape is evolving, and the demand for...

Clinical Research: Phase 1 - Phase 4

Considerations In Conducting Pediatric Clinical Trials

There are many challenges inherent in pediatric clinical studies, where the traditional paradigms for evaluating pharmaceutical agents in adults often do not apply. These occur on ethical, physiological, pharmacometrics and economic grounds, among many others. It’s important to recognize that while these efforts are challenging, they are not impossible — and they may be better suited to creative solutions...

Clinical Research: Phase 1 - Phase 4

Neurodegenerative Disease Research: Steps to a Successful Clinical Trial

Neurodegenerative disorders present some of the biggest challenges in planning and conducting clinical drug trials. Diagnosis is challenging, given the often-delayed onset and diversity of symptoms. Operational challenges associated with clinical trial development complicate things even further. Identifying strategies to proactively address or mitigate these challenges can help to ensure a successful trial.

Clinical Research: Phase 1 - Phase 4

3 Critical Challenges: Fulfilling the Promise of Precision Oncology

Precision oncology promises a new model of cancer care where medical decisions are based on a holistic view of the patient, including their genes, environment, and lifestyle, and tailored to the molecular profile of their tumor. To date, great strides toward the paradigm of precision oncology have been made in the area of cancer immunotherapy,...

Clinical Research: Phase 1 - Phase 4

Premier Research And NUHS Centre For Innovation In Healthcare (CIH) Partner To Facilitate Adoption Of Health Innovations

SINGAPORE, AUGUST 20, 2019 — A strategic memorandum of understanding (MOU) has been signed between Premier Research and the Centre of Innovation in Healthcare (CIH), part of the leading academic institution National University Health System (NUHS) in Singapore. CIH is a one-stop hub that facilitates the clinical adoption of health innovations for maximum benefit to...

Clinical Research: Phase 1 - Phase 4

Premier Insight 251: It Helps to Know What’s Going to Happen Next

We were conducting a Phase 2b trial of a new treatment for nonalcoholic steatohepatitis, or NASH. And we knew three things: We knew that hepatologists would jump at the chance to enroll their patients, because the only existing treatment for NASH is the well-known lose weight – eat healthy – exercise more regime. This was...

Clinical Research: Phase 1 - Phase 4

A Brief Introduction to CAR T-cell Therapy

With the approvals of tisagenlecleucel (KYMRIAH™) and axicabtagene ciloleucel (YESCARTA™) last year, chimeric antigen receptor (CAR) T-cell therapies have changed the treatment paradigm for patients with certain hematologic malignancies. What is CAR T-cell therapy? CAR T-cell therapy involves re-engineering a patient’s own T-cells to recognize and eradicate cancer. These T-cells are genetically altered to express...

Clinical Research: Phase 1 - Phase 4

Principles Of CAR T Cell Therapy And The Pathway To Regulatory Approval

For many years, the primary forms of cancer treatment have been chemotherapy, radiation and surgery, but the toughest forms of cancer demand breakthrough therapies. Advances in immuno-oncology have led to the advent of Chimeric Antigen Receptor T (CAR T) cell therapy, which combines a patient’s own T cells with engineered T cell receptors known as...

Clinical Research: Phase 1 - Phase 4

Leadership Development and Becoming a More Effective Change-maker

They say that great leaders aren’t born, but grow into their positions through sweat and tears. No matter what stage in life, industry, or phase of your career you’re at, it is important to continuously strengthen your skills, and this ongoing development is one of the key values we look to foster in our team...