While growing up in the richest and most prosperous country in the world I never thought we would encounter shortages of any kind. I mean after all this is America, land of the free, home of the brave – the land of plenty!
Dr. Mehdi Yazdi
Why is it so important that assay and related substance methods for drug substance (DS) and drug products (DP) should be a stability-indicating method? The answer is two words, safety, and efficacy.
Christopher Reist
Telepsychiatry offers a tantalizing solution to the significant undertreatment of mental illness in the United States. According to the National Institutes of Health, an estimated 1 in 5 U.S. adults experience a mental illness, but despite this high prevalence, only 43% of those affected receive mental health services. The reasons for this are multifold and include stigma and access to care. A similar situation exists for mental health clinical trials; an estimated 90% of the population lacks access to traditional brick-and-mortar clinical trial sites. This impacts the diversity, recruitment, and retention of participants - all of which impedes treatment innovation.
Christopher Wittum
Expert detection of impurities can improve product safety and regulatory success.
Matthew Lyulkin
Novel drug delivery systems offer impactful solutions to improve upon existing pharmaceutical products. These delivery systems often lead to enhanced bioavailability as well as improved systemic and local safety profiles. In addition, assessing alternative delivery methods for existing drugs or biosimilars can benefit from efficient regulatory approval.
Justin Divan
Developing drugs and preparing them for commercial markets is a challenging task. But as pharmaceutical companies manage manufacturing footprints and capital budgets, securing experienced manufacturing partners has become a priority.
Sandy Munro, Nikki Willis, Dr. Geraldine Venthoye
There are many factors that need to be considered and evaluated when it comes to selecting the most appropriate delivery platform for an inhaled product. No two drug programs are likely to have exactly the same drivers, so these factors need to be evaluated afresh for each new product concept and development program. It is therefore important to approach defining the target delivery technology in a “device agnostic” manner, and to not necessarily be swayed by previous programs or a technology bias towards a single platform – be it a pressurized metered-dose inhaler (pMDI), dry powder inhaler (DPI), or nebulizer.
Serge Bodart
Just one in ten drug candidates are successful in clinical trials, and the number of products making it from development to approval is currently at an all-time low.
Chris Harvey
There’s no doubt the COVID-19 pandemic has heightened everyone’s concern about safety.
Brian Neman
Study-patient recruitment and retention continue to be significant challenges in medical research, and even more so, during the COVID-19 pandemic. The at-home isolation and social distancing orders for millions of Americans is a vital element to slow the COVID-19 pandemic, but the global pandemic has the potential to disrupt and delay vital research. In order to assist the research community in navigating these unprecedented times, The Food and Drug Administration (FDA) has issued new guidance in continuing medical research during the global pandemic to ensure the safety of trial participants and study personnel while maintaining research integrity.
Dr. LaRee Tracy
Hydroxychloroquine sulphate (Plaquenil) an analog of chloroquine has an established track record for treating malaria and has demonstrated in vitro activity against the SARS-CoV and is therefore being considered as a possible treatment for COVID-19. Recently, findings from a just-released manuscript by Gautret et al. (2020)1 summarizing findings from an ongoing study to evaluate hydroxychloroquine in patients with COVID-19 made news. The aim of this perspective is to summarize the study design, main results and to highlight limitations. Note that there is a wealth of information on the known toxicity associated with hydroxychloroquine and chloroquine, which are not covered in this perspective.
Aman Khera
With the emergence of the COVID-19 pandemic, the clinical research space has been hit by a "black swan” event. In the financial world, that term indicates a rare, unpredictable event with severe impact. The coronavirus health crisis meets all three criteria and has brought attention to global regulatory challenges impacting drug development.
Jessica Rayser
The goal and commitment of every pharmaceutical manufacturer is to produce a quality product that is safe and effective for patients. Environmental monitoring (EM) plays a significant role in achieving this goal as it provides critical information about the manufacturing environment in order to prevent the release of a potentially contaminated product.
Dr. Jennifer Bradford, PhD
Consumer-grade wearable devices offer the potential to continuously monitor many different physiological measures of health and fitness as individuals go about their daily routines. For a clinical trial, this could provide valuable insights between hospital visits, potentially enhancing the understanding of treatment response, delivering a rudimentary early warning system, providing objective measures of more subjective outcomes or even provide efficiencies in trial conduct.
Amélie Boulais
The response of the biomedical community and biopharmaceutical industry to the COVID-19 pandemic has been rapid and far-reaching.
Robert King, Hunter D. Everton, Philip Bartle
It has never been more important than it is today to be able to comprehensively but easily review the clinical data collected during a clinical trial. Clinical review demands now require data to be analyzed and interrogated immediately to provide actionable intelligence to a variety of audiences. These audiences are assessing many targets with the data, including medical monitoring to assess subject safety, reviewing trial progress, making protocol decisions (e.g., dose escalation), analyzing data anomalies, risk-based monitoring and/or reviewing overall trial governance within a rapidly evolving clinical trial space.
Patrick Hughes
ICH E6 (R2) was first introduced in 2017. It signified the greatest change in two decades to international clinical research. Intended to outline good risk management in the modern trial environment, it was formulated as a reaction to the rising complexity of studies and the industry’s increasing reliance in electronic data management and reporting systems. The guidelines outline that clinical programs ought to implement risk assessment at both trial and system level, and that metrics on clinical monitoring and data management are captured in preparation for Clinical Study Reports.
Steve Gens, Remco Munnik
Almost every organization - in life sciences as in other industries - is intrigued about the promise of artificial intelligence/machine learning as a means of delivering more value and better business outcomes.
David Gwyn
AMPLEXOR’s David Gwyn illuminates five areas in which richer, more holistic product information – compiled in response to regulatory requirements – could help to transform business outcomes. That is, once companies have established a unified, end-to-end data flow right around the global organization.
Linda B. Sullivan, MBA, Keith Dorricott, MBB
In response to the COVID-19 crisis, the life sciences industry is investing in new and innovative therapies, as well as eClinical solutions such as those that leverage artificial intelligence and machine learning to enable innovative study designs and virtual clinical trials.
This quarterly review of new drug applications contain data for applications approved for the first time during the fourth quarter of 2019 which includes New Molecular Entities (NMEs) and new biologics.