Clinical Research: Phase 1 - Phase 4

Clinical Research: Phase 1 - Phase 4

Applied Clinical Trials – Patient Engagement and Advocacy: Advancing the Cause of Clinical Drug Research

Duchenne muscular dystrophy (DMD) patients almost universally lose the ability to walk as the disease progresses. Patients generally understand that loss of ambulation is to be expected, and as was learned from a patient preference study, they tend to put greater priority on maintaining use of their hands. Yet for many years, DMD drug trials...

Clinical Research: Phase 1 - Phase 4

PharmaVoice – Small Pharma Driving Big Pharma Innovation

“Big pharma’s new role in this is to partner and fund the innovation that it so sorely needs to bulk up its dwindling pipelines. This is a cost-effective move for larger drug companies to leverage outside scientific talent to gain access to breakthrough discoveries. “‘This is a dominant trend in the industry,’ says Nach Davé,...

Clinical Research: Phase 1 - Phase 4

High Potential: Precision Cancer Drugs

Realizing immuno-oncology’s life-changing promises Immunotherapy is dominating advances in oncology drug development, paving the way for a new standard of cancer care. CAR T-cell therapies are some of the most powerful tools and are among the most widely studied investigative products, with more than 640 clinical trials now underway worldwide. Here’s a look at the...

Clinical Research: Phase 1 - Phase 4

Considerations for Operationalizing Pediatric Oncology Studies

Remarkable progress has been made in our understanding of the genomics of pediatric cancers, and these advancements have led to the recognition that products being studied for use in adult cancer indications may have health benefits for pediatric patients. By closing the orphan drug exemption loophole and enabling earlier discussions with the FDA, the Research...

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...