Pharmacy Market
PRNewswire | August 04, 2023
Ionis Pharmaceuticals, Inc. announced that it has entered a collaboration and license agreement with Novartis for the discovery, development and commercialization of a novel medicine for patients with lipoprotein(a), or Lp(a)-driven cardiovascular disease (CVD). This builds on the companies' existing collaboration focused on the development and commercialization of pelacarsen, which Novartis is currently evaluating in a Phase 3 cardiovascular outcome study. The next generation compound will be a potential follow-on to pelacarsen.
"We are pleased to expand our productive collaboration with Novartis aimed at delivering transformative therapies to patients with elevated Lp(a) who are at high risk of cardiovascular events," said Brett P. Monia, Ph.D., Ionis' chief executive officer. "This collaboration is designed to leverage Ionis' advancing RNA-targeting platform technologies to deliver a novel Lp(a)-targeting therapy that we expect will provide industry-leading efficacy and dosing frequency."
Ionis will receive a $60 million upfront payment from Novartis and is eligible to earn development, regulatory and commercial milestone payments and tiered royalties. Novartis will be solely responsible for the development, manufacturing and potential commercialization of the next generation Lp(a) therapy.
The agreement is subject to the satisfaction of requirements of the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
About Lp(a)
Lp(a) is a lipoprotein particle assembled in the liver that consists of a low-density lipoprotein cholesterol (LDL-C)-like particle and apolipoprotein(a). Lp(a) levels in the blood can vary greatly between individuals primarily due to genetic variations and do not correlate with LDL-C levels. Even patients with LDL-C lowered to target levels (<70 mg/dL) remain at high-risk of cardiovascular events if they have high levels of Lp(a). Elevated Lp(a) is a genetically determined condition that is not responsive to lifestyle changes, therefore patients are unable to adequately control their Lp(a) levels through improved diet or increased physical activity. Elevated Lp(a) is recognized as an independent, genetic cause of coronary artery disease, heart attack, stroke, peripheral arterial disease and aortic stenosis. Currently, there is no effective drug therapy to specifically and robustly lower elevated levels of Lp(a).
About Pelacarsen
Pelacarsen was discovered by Ionis and licensed to Novartis in 2019 for exclusive worldwide development, manufacturing and commercialization. It is an investigational antisense medicine designed to reduce apolipoprotein(a) production in the liver to offer a direct approach for reducing circulating Lp(a). It is estimated that more than eight million people worldwide have elevated Lp(a) and CVD.
Pelacarsen is currently being evaluated in Lp(a) HORIZON (NCT04023552), a global, multicenter, double-blind, placebo-controlled pivotal Phase 3 study conducted by Novartis. The study completed enrollment with 8,323 participants. Data are expected in 2025.
About Ionis Pharmaceuticals, Inc.
For more than 30 years, Ionis has been a leader in RNA-targeted therapy, pioneering new markets and changing standards of care. Ionis currently has four marketed medicines and a promising late-stage pipeline highlighted by cardiovascular and neurological franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision to become the leader in genetic medicine, utilizing a multi-platform approach to discover, develop and deliver life-transforming therapies.
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Pharmacy Market
PRNewswire | July 17, 2023
Cleveland Clinic Laboratories and LabConnect have announced a strategic alliance to accelerate clinical trials and connect patients to new medicines for improved patient care.
Through this alliance, LabConnect will utilize Cleveland Clinic Laboratories, the reference laboratory within Cleveland Clinic. LabConnect will leverage the health system's extensive array of testing and assay validation services to support laboratory testing for an increasing number of clinical trials.
"This new collaboration will enable our organizations to leverage our complementary strengths to deliver cutting edge testing to an expanded patient base, furthering the mission of Cleveland Clinic to touch more lives," said Brian Rubin, M.D., PhD., chairman of Pathology and Laboratory Medicine Institute at Cleveland Clinic.
The alliance will also significantly accelerate turnaround times for testing results and help researchers achieve clinical trial milestones sooner, resulting in more efficiently developing therapies for patients.
"With our shared mission to create healthier communities, we are excited about this alliance with Cleveland Clinic Laboratories to further accelerate the development of new medicines for patients around the world," said Dawn Sherman, LabConnect Chief Executive Officer.
LabConnect will also establish a new facility to process samples for testing in Cleveland, which is anticipated to result in potential new job opportunities for Northeast Ohio as part of the Cleveland Innovation District.
Partnering with pharmaceutical and biotechnology companies, contract research organizations (CROs), and foundations/non-governmental organizations (NGOs), LabConnect provides innovative central laboratory support services for clinical trials of all sizes and complexity across the globe. As the requirements for clinical trials and the drug development process have become more complex, LabConnect meets these requirements by offering researchers scientific and technical expertise for all laboratory-related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions tailored to each trial.
Cleveland Clinic performs more than 23 million tests each year in Ohio, providing access to high-quality, cost-effective, and convenient laboratory services. More than 100 board-certified anatomic and clinical pathologists, paired with hundreds of expertly trained medical technologists and laboratory technicians, provide essential services and test development to guide clinical decision making for more than 5,000 clients locally and globally.
LabConnect's Co-founder and Chief Development Officer, Jeff Mayhew stated, "With our combined team bringing an unparalleled breadth and depth of experience and expertise, our clients have access to the top clinicians and scientists in the world to help them develop their lab scientific strategy and optimize their protocol for accelerating the development of new medicines."
"By broadening access to expertise and quality care in pathology and laboratory medicine, we are able to continue evolving our services." said Ziad Peerwani, MD, Medical Director of Cleveland Clinic Laboratories. "Through this teamwork, we will support and elevate our work with local and global communities while creating the care for tomorrow."
About Cleveland Clinic
Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S. News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. Among Cleveland Clinic's 77,000 employees worldwide are more than 5,658 salaried physicians and researchers, and 19,000 registered nurses and advanced practice providers, representing 140 medical specialties and subspecialties. Cleveland Clinic is a 6,665-bed health system that includes a 173-acre main campus near downtown Cleveland, 22 hospitals, more than 275 outpatient facilities, including locations in northeast Ohio; southeast Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, UAE; and London, England. In 2022, there were 12.8 million outpatient encounters, 303,000 hospital admissions and observations, and 270,000 surgeries and procedures throughout Cleveland Clinic's health system. Patients came for treatment from every state and 185 countries.
About LabConnect
LabConnect improves lives by partnering with pharmaceutical and biotechnology companies, contract research organizations (CROs), and foundations/non-governmental organizations (NGOs), to accelerate the development of new medicines around the world. LabConnect delivers a unique combination of support services through Central Laboratory Services and Functional Service Provider Solutions that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex clinical trials.
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Pharma Tech
PRNewswire | July 10, 2023
Critical Path Institute (C-Path) and the Center for Health + Technology (CHeT) at University of Rochester today announced the release of two seminal publications about digital health technologies for Parkinson's. These technologies, such as smartphones and wearable sensors, offer an opportunity for objective, frequent and remote assessment of people with Parkinson's.
With 10 million people living with Parkinson's worldwide, collaboration and data sharing are crucial for driving innovation in drug development for the fastest-growing degenerative neurological condition.
Research leaders at CHeT have joined forces with organizations and regulators through C-Path's Critical Path for Parkinson's (CPP) Consortium, a precompetitive public-private partnership. CPP aims to accelerate the regulatory endorsement of digital tools in Parkinson's clinical trials through its Digital Drug Development Tools (3DT) initiative.
In June 2023, the Journal of Parkinson's Disease published two open access manuscripts, representing companion papers from this partnership that detail steps in conducting interviews of people with Parkinson's who participated in a clinical research study using smartphones. The manuscripts report on relevant symptoms in early Parkinson's and assess the relevance of digital measures from a smartphone application and smartwatch from the patient perspective.
The study was led by Jamie Adams, M.D., Associate Professor of Neurology and Associate Director of CheT at the University of Rochester and Jennifer Mammen, Ph.D., Assistant Professor at the University of Rhode Island, with support from CPP.
"This project pioneers a new path to efficiently advance tools aligned with the patient voice by engaging with regulatory agencies early and often," said Diane Stephenson, Ph.D., CPP Executive Director. "C-Path remains committed to learning what matters most to people living with Parkinson's."
"These manuscripts describe a novel methodology that will help inform the use of digital health technologies in clinical trials for Parkinson's disease and support more objective and patient-centered measures. The goal is to enable efficient, data-driven, and patient-centric utilization of digital health technologies to speed therapeutic development," said Adams. "Sharing the results with the study participants and witnessing how this information helped them in new ways has been most rewarding."
John Crawford, a CPP advisor, Parkinson's advocate, and manuscript coauthor states, "Digital health technologies have the potential to significantly impact Parkinson's management and have already revolutionized clinical trial conduct. Their advancement expedites trials, enhances intelligence, reduces costs, and ultimately accelerates the delivery of new therapies and technologies to patients."
The new publications coincide with CPP's participation in the World Parkinson's Congress taking place in Barcelona, Spain July 4-7, 2023. CPP will present two posters, Recommendations for Parkinson's Clinical Trials using Digital Health Technologies and Worldwide Collaborative Framework for Optimizing New Parkinson's Treatment Trials with Patient Centric Outcome Measures, at the conference coauthored by people living with Parkinson's highlighting the importance of worldwide collaborations.
About Critical Path Institute
Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path's mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona and C-Path Europe is headquartered in Amsterdam, Netherlands with additional staff in multiple other locations.
C-Path FDA Acknowledgement
The Center for Health + Technology (CHeT) is an academic research organization within the University of Rochester Medical Center. We are comprised of six units, with expertise in clinical trials coordination, clinical materials services, patient and caregiver-reported outcome measures, tech research and innovation, data modeling and predictive analysis, and health policy. Our skilled team of consultants are readily available to provide guidance to academic institutions, pharmaceutical companies, technology firms, not-for-profit foundations, advocacy groups, and the federal government.
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