Premier Perspectives Blog

Insider Insights in Clinical Development

Nostalgia. Irritable heart. Shell shock. No, this isn’t a word-association game. These are among the many terms applied over the years to the highly amorphous condition we now call post-traumatic stress disorder. While people have experienced shocking, scary, and dangerous events since the dawn of mankind, the study of the cause and treatment of PTSDRead more

It’s already been three years since the FDA issued its “Guidance on Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” This guidance established a mandatory requirement for electronic submission of certain applications, amendments, supplements, and reports to the FDA’s Center for Biologics Evaluation and Research (CBER)Read more

There are currently more than 300 ongoing clinical research studies, mostly in the academic arena, occurring around the world into post-traumatic stress disorder (PTSD) in various populations. But those with PTSD may not be the only ones’ suffering. The members of the research teams trying to help those with trauma illnesses, like PTSD, need toRead more

Immuno-oncology continues to be an exciting frontier in the fight against cancer. Researchers continue to develop drugs that allow the body to weaponize its own immune system against the growth of new tumors. Most uses of immunotherapies have been limited to cancers, like those in the lungs or pancreas, that produce a strong immune response. In his articleRead more

The placebo response is a real psychological, physiological, and ultimately statistical phenomenon that can be a powerful therapeutic tool in the world of medicine, especially when it comes to chronic pain conditions. For a drug to be approved, its developers must be able to demonstrate that it is significantly more effective compared to a placebo.Read more

Immuno-gene therapeutics are transforming the therapeutic landscape of hematological malignancies. The recent approvals of two chimeric antigen receptor (CAR) T-cell therapies—tisagenlecleucel (marketed as Kymriah™) and axicabtagene ciloleucel (marketed as Yescarta™)—mark the beginning of the next revolution in cancer treatment. However, along with demonstrated efficacy in hematologic malignancies, CAR T-cells have the capacity to elicit seriousRead more

Over the past few years, there has been a dramatic increase in the use of genetically modified cells for cancer immunotherapy, including chimeric antigen receptor (CAR)-T cells, recombinant T-cell receptor T cells and genetically modified CD34+ cells for the treatment of hematological malignancies. Clinical trials of immuno-gene therapeutics are becoming increasingly common, and regulatory guidelinesRead more

Days before Christmas 2017, a nationwide call went out requesting nominations of patients and caregivers to join a new public/private-sponsored Patient Engagement Collaborative. Among the promised duties for this yet-to-be-filled body of 16 patient community representatives: Propose new collaboration models in which patients and patient advocates are partners in healthcare product development and U.S. FoodRead more

Experts describing recent advances in drug development often drift into hyperbole — but really, can you blame them? Gene therapies and drugs that weaponize the immune system against tumor cells are among recent breakthroughs that were unthinkable even a decade ago. But therapies for central nervous system disorders have been a stubborn exception. “We recognizeRead more

Forecasting the cost of clinical drug and medical device trials has never been easy, and as trials become more complex, estimating (and re-estimating) these costs becomes even more challenging. Lack of accurate forecasts has serious schedule and cost implications. By impeding effective cash management, inaccurate projections can lead to disruptions and delays that cost sponsorsRead more

After years in development, the final version of the Medical Device/In Vitro Diagnostic Medical Device Regulations was published in the Official Journal of the European Union on May 5, 2017. These regulations superseded the previous Directives for the European market and will be implemented over the next few years. In our last post, we went overRead more

The regulatory landscape for medical devices in Europe is undergoing some major changes. Published in May 2017, the new European Medical Device Regulation (MDR) (Regulation [EU] 2017/745) and In Vitro Diagnostics Regulation (IVDR) (Regulation [EU] 2017/746) is gradually replacing the Medical Devices Directive and the Implantable Medical Devices Directive in the European market. Although theRead more

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