The Latest News in Clinical Trials

CONFERENCE COVERAGE

At the?Duke-Margolis Institute for Health Policy conference, industry and government leaders delved into the future of clinical trials and regulatory change, addressing critical issues and innovative approaches to modernizing the FDA’s regulatory infrastructure.?

The?Enhancing Adoption of Innovative Clinical Trial Approaches: FDA Convening conference?hosted by Duke Margolis Institute for Health Policy, presented an unparalleled opportunity to discuss the current state and future directions of clinical trial innovation.?Patrizia Cavazzoni, the Director of the Center for Drug Evaluation and Research (CDER) at the FDA, shared the stage with industry experts to explore transformative approaches within the regulatory landscape, emphasizing the FDA’s commitment to integrating innovation into drug evaluation and research processes.

Clinical research is a vast and dynamic field with numerous roles and opportunities. But like many sectors, it has areas where representation can be enhanced. One such area is the representation of black women. A recent meeting, anchored by?Danielle Mitchell, CEO of Black Women in Clinical Research and the White House Initiative on historically black colleges and universities, spotlighted black women’s significant impact and potential in clinical trials and research.

EXECUTIVE INTERVIEWS

In recent times, LinkedIn has transformed from a platform for professional networking to a sounding board for industry grievances. Clinical research sites, in particular, have been vocal about their challenges, leading to a mix of genuine concerns and performative complaints.

In today’s world, where data drives many decisions, the biopharmaceutical industry is no exception. Integrating data science into clinical trials promises to revolutionize how we approach research, from study planning to patient interactions. To delve deeper into this intersection of data science and healthcare, we sat down with Rohit Nambisan, the CEO and co-founder of Lokavant, a pioneering firm at the forefront of this transformation.?

Psychedelic therapy is a rapidly growing field with the potential to revolutionize the treatment of mental health disorders. In today’s interview, we have the privilege of speaking with two leading figures in the world of psychedelic therapy:?James Linden, the Founder and Chairperson of?Alvarius Pharma, and?Graeme McFarlane, CEO. They provide valuable insights into the future of psychedelics in healthcare, discussing everything from?clinical trials?and regulatory challenges to funding and societal perceptions.

CLINICAL TRIAL NEWS

EpiEndo Pharmaceuticals has successfully concluded its Phase 2A clinical trial evaluating EP395, a novel oral therapeutic for Chronic Obstructive Pulmonary Disease (COPD).

Recent research from AMRA Medical and collaborators has highlighted the impact of tirzepatide treatment on fat distribution in patients with type 2 diabetes (T2D). Using personalized fat z-scores derived from MRI scans, the study explored changes in fat storage patterns after 52 weeks of treatment.

Obsidian Therapeutics, a biotechnology company, unveiled promising updates on its Phase 1 study of OBX-115, a tumor-infiltrating lymphocyte (TIL) cell therapy, at the American Association for Cancer Research (AACR) Annual Meeting.

Synthekine Inc., a leader in engineered cytokine therapeutics, has announced promising initial findings from a Phase 1a/1b trial of their novel drug STK-012, an α/β biased IL-2 partial agonist. STK-012 is designed to stimulate specific T cells associated with tumor-fighting abilities, while avoiding the toxic effects often seen with IL-2 therapies.