Clinical Researcher—April 2023 (Volume 37, Issue 2)
OVER THE TRANSOM
Edited by Gary W. Cramer (firstname.lastname@example.org), Managing Editor for ACRP
Although we do not typically spend much time dwelling on the dollars and cents of drug and device research and development (R&D) in the pages of Clinical Researcher, if anyone needed a reminder that ours is not an arena for contestants who are risk averse or cash strapped, they got one in a big way in March. When Silicon Valley Bank (SVB) collapsed, it at least badly rattled, if not entirely took down, the hopes and dreams of more than a few biotech borrowers who were counting on it to help them bring their products-in-development to life in an era when the financial outlook for many (especially smaller players) in the industry was already questionable.
Life goes own, however, and in this issue’s pages we offer up a variety of perspectives on ways to improve, broaden, and deepen the business aspects of the clinical research enterprise for the benefit of all its stakeholders. Included are welcome contributions from Ireland and the European Union on some big-picture topics, and focused columns that bring us valuable glimpses into such corners of our realm as patient recruitment and retention, data management, digital therapeutics, decentralized trials, dose optimization, and more.
Keeping in that vein, here are some excerpts from recent announcements of and opinions on other corporate movings and shakings in the rough and tumble research business world (no endorsements implied).
Partners to Leverage In Silico Modeling and Simulation for Rare Disease Therapies
Premier Research, whose mission is to help biotech and device companies take ideas from concept to commercialization, and Italy-based InSilicoTrials, which focuses on artificial intelligence (AI) and computational modeling and simulation (CM&S) to accelerate development of new therapies and medical devices, have partnered with the intention to create safer, faster, and more efficient pathways to regulatory approval for rare disease treatments.
They say that, with regulatory support for CM&S advances making possible the full or partial substitution of virtual patients for live ones in certain circumstances, in silico trials can enable simulated synthetic control or treatment arms, inform strategies for patient enrollment, and more efficiently predict the safety and efficacy of novel drugs and medical devices, particularly in rare disease research. The partnership aims to emphasize smarter in silico study design resulting in more effective preclinical review of trial design parameters and faster submission-ready studies.
“Modeling and simulation combined with AI is the most effective way to innovate the R&D process in drug development,” InSilicoTrials CEO Luca Emili said. “Computational models and AI are true game changers because they enable sponsors to dramatically accelerate the development of new medicinal treatments, improve the safety of medical products, and significantly cut R&D costs.”
Is the Medical Breakthroughs System Broken?
Medical research saves lives, yet it is too slow, causing much death and needless suffering, writes Dr. Simon N. Whitney, author of the new book, From Oversight to Overkill: Inside the Broken System that Blocks Medical Breakthroughs—And How We Can Fix It. Whitney says the problem is that the review system—created for good reason, to protect the safety of patients participating in research—is out of control, with institutional review boards (IRBs) imposing complex, draconian conditions that stifle and delay medical advances. In addition to being a physician, Whitney is a medical ethicist and a law school graduate.
Whitney sees regulation as an essential part of modern life, but maintains that regulations need to reflect real-world research if they are to serve their mission. The book’s argument—driven not by ideology, he says, but by the hope of relieving suffering and avoiding premature death—uses case studies of how vital breakthroughs for treating heart attacks, premature births, and kidney stones have been delayed, forcing (according to the author) doctors and patients to settle for less-effective treatments.
The regulatory system Whitney describes is largely beyond the public’s awareness, unlike the work of the U.S. Food and Drug Administration, whose approvals of medical treatments are often prominently reported by news outlets. In contrast, IRB rulings on the ethics of medical research at universities and research centers are overseen by the federal Office for Human Research Protections, which Whitney contends urges them to follow restrictive approval practices that delay and damage research without meaningfully protecting research subjects.
Driving Health Equity in Clinical Trials
Jumo Health, a provider of age-appropriate, culturally sensitive medical education, in March announced that, together with the I Choose Life Foundation (ICLF), it has expanded its health equity service line to include the recruitment and retention of people of color in clinical trials. To guide their pharmaceutical and biotech customers as they endeavor to develop culturally responsible medications, Jumo Health and ICLF have amassed a national network of more than 2,000 churches that primarily serve Black congregations. Those churches, which are located across the United States, have more than 500,000 members in total. This group offers rare access to a community that is historically underrepresented in clinical trials. While approximately 14% of the United States population is Black, the community only makes up approximately 5% of clinical trial participants.
“[We explain] difficult medical concepts in ways people can understand and act upon,” stated Kevin Aniskovich, President and CEO of Jumo Health. “With a keen understanding of health literacy, how various communities consume information, and the importance of storytelling, we ensure that people can ‘see themselves’ in the information provided; critically important when serving communities that have been historically overlooked by government and industry.”
“There’s no reason that my community accounts for 14% of the United States’ population yet we are only 5% or less of those participating in clinical trials,” shared Tony Wafford, President and CEO of ICLF. “Over 70 years ago, Dr. Martin Luther King Jr. said, ‘Of all the forms of inequality, injustice in healthcare is the most shocking and inhumane.’ The Black community can no longer be left behind when it comes to culturally competent education, recruitment, and Black retention in clinical trials and research. Through this partnership…we’re going to turn that narrative around! My goal is to make the Black community self-conscious agents of [its] own health and wellness.”
In Other News…
Germany-based PharmaLex group, a provider of specialized services for the pharmaceutical, biotechnology, and medical technology industries worldwide (and recent contributor of several articles to Clinical Researcher), has announced its intention to merge with Cpharm, a provider of pharmacovigilance and medical services in Australia and New Zealand. The merger expands PharmaLex’s footprint in the region through Cpharm’s capabilities in drug and device vigilance, while offering complementary services and expanding the service portfolio of both companies. For the past 20 years, Cpharm has provided a range of pharmacovigilance, safety and risk management, medical information, material review, and patient program services to support clients ranging from start-ups to top-10 multinational pharmaceutical companies.
Infectious diseases like COVID-19, HIV, and battlefield wound infections cause illness and disruptions that threaten health and military readiness across the nation. To help foster collaboration in the field and share best practices, the Uniformed Service University’s Infectious Disease Clinical Research Program (IDCRP) hosted its first annual Science Symposium in March. IDCRP is the top resource for the U.S. Department of Defense to readily identify and assess infectious disease risks, providing clinical research to help shape best practices and policies. It is also a global multicenter, collaborative clinical research network dedicated to reducing the impact of infectious disease threats in the Military Health System, improving care of the warfighter, and ensuring the military community is ready to respond whenever and wherever the next infectious disease outbreak occurs.
BSI Life Sciences, a specialist in software for life sciences, and Ledger Run, Inc., a technology company focused on optimizing clinical operations in the areas of site budgeting and payments, announced a new partnership in February. Through the partnership, the companies say that BSI Life Sciences’ Clinical Trial Management software BSI CTMS™ and Ledger Run’s ClinRun™ platform will streamline and enhance clinical operation budgeting and payment processes with an intelligent approach and seamless integration.