GUEST COLUMNISTS

• Is Being Competent And Qualified The Same Thing In The GCP World?

  When it comes to Good Clinical Practice principles, the mention of "competence" is underwhelming. Yet, there is plenty of talk about education, training, and experience. Is "competent" and "qualified" synonymous? Does one imply the other? And why does it matter? Kamila Novak of KAN Consulting explores and explains.

• RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3)

  Steve Young, member of Avoca Quality Consortium, PHUSE Working Group participant, and Tufts survey contributor, discusses the findings of the groups’ joint global research study with CluePoints and Price Waterhouse Cooper (PwC), the implications of the upcoming ICH E6(R3) guidelines, and the future of risk-based clinical trial conduct. 

• Pursuing Smaller, Faster Clinical Trials For Progressive Neurological Disorders

  Current progression measures of neurodegenerative disease are clinically focused, highly subjective, and can take years to reveal the effects of therapeutic intervention. Knowing that, the pursuit of smaller and faster clinical trials, particularly at the proof-of-concept stage, can be an innovative way to counteract some risks and sidestep the limitations of larger trials. 

• Vulnerable Populations Need Safer, More Effective COVID-19 Antivirals

  Although COVID-19 is no longer a public health emergency, elderly and immunocompromised individuals remain vulnerable to severe outcomes. Drug developers. therefore, must adapt to deliver next-gen oral antivirals through clinical trials that incorporate the lessons we have learned during the pandemic and address the needs of these high-risk patients.

• An Overview Of The 9 FDA Special Designations for Pipeline Drugs

  The FDA employs special designations to streamline and incentivize the advancement of drugs addressing medical gaps. While some designations can accelerate FDA timelines for NDAs and BLAs, others may abbreviate the duration of clinical trials. Let's look at each of the nine special designations and what scenarios or drugs/therapies are best suited for each.

• Patients Are Speaking, And We Must Listen

  Maimah Karmo knows all too well the importance of speaking up for oneself. Here, the president and CEO of Tigerlily Foundation shares what drove her to create the nonprofit and why she won't stop advocating for patients.

• What Do You MENA? The Arab World And Its Opportunities For Clinical Research

  Looking beyond the imperative of involving more Arab Americans in clinical trials, there’s more to be said about involving the Middle East and North Africa (MENA) region in clinical research. Arab Board of Clinical Research Chair and President Hadi Danawi, Ph.D. explores the challenges to and benefits of conducting clinical trials in this underserved region.

• Cautious Optimism For Biotechs And Their Outsourcing Partners

  Pre-revenue, including preclinical and clinical stage, biotechs have been the most impacted but also stand to gain the most after the economic downturn and subsequent recovery. This article will delve into how small to midsize pre-revenue biotechs have been specifically impacted and what this could mean for organizations that support them.