Improvement is needed in clarifying the therapeutic development process.
In this month’s main feature, we discuss the role of academic research and explore its relationship with pharma and clinical trials. In this article, our contributor interviews the NCATS’ (National Center for Advancing Translational Sciences) director of strategic alliances, who explains their work to ease passage across the so-called “Valley of Death.” Coincidentally, I was privileged to attend an in-person conference and learned much more about NCATS. Please visit their website to see all of the programs they offer...it’s truly astounding.
But buried in this website is a map. And this map is a gem...or the “board game from hell,” as one of its authors described. The two maps shown—one for small molecule development and one for biologics development—were designed to “provide a common framework for discussing the therapeutic development process and serve as an education tool for those who are new to it,” as well as offer a common language and collective knowledge base to enable systemwide improvements.
Let’s take a moment and just let this sink in. A group of highly intelligent, motivated and truly curious and passionate people, dug in deep into the clinical research enterprise and literally spent a lot of time to elucidate in the most usable and informed way to present this information, in the public domain, to further efficient research.
Then, think about all the blocks and colored boxes that represent a process or function, then imagine all the details that goes into any one of those functional areas on the daily. Regulatory. Operations. IRB. Enrollment. Data. Review. Mind you, this is after the basic science research, target identification, target pharmacology and lead identification.
Which is to say, this is an area ripe for “systemwide improvements that will benefit patients.” This related article, is a most eloquently detailed summation of any and all challenges in the current drug development system. In fact, in the future, if anyone sends me an article to review outlining the problems in clinical trials, I’m just going to copy and paste this link, and say “next.”
The author calls for increased support of the academic discipline of translational science, which must remain in academia, to vastly improve the current situation. As he noted: “The ultimate goal of translational science is not to traverse the Valley of Death. It is to eliminate the Valley of Death entirely.”
Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lhenderson@mjhlifesciences.com.
Phase III Trial Data Show Subcutaneous Pembrolizumab as Noninferior to IV Keytruda
March 31st 2025Subcutaneous administration of pembrolizumab with chemotherapy demonstrated a nearly 50% reduction in patient chair and treatment room time while maintaining efficacy and safety endpoints compared to intravenous Keytruda.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
FOCUS Trial Results Show Solriamfetol Significantly Reduces ADHD Symptoms, Severity in Adults
March 27th 2025Solriamfetol achieved the primary and key secondary endpoint of the Phase III FOCUS trial by significantly lowering attention-deficit hyperactivity disorder symptoms and disease severity in adults compared to placebo, with a favorable safety and tolerability profile.