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The pharmaceutical industry is currently experiencing a significant transformation. The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drug development. Ready to learn more about convergence of real-world data and technology for clinical trials?
Chief Executive Officer Steve Herne has spent more than 25 years in clinicalresearch, with senior roles at WCG, Bioclinica and Covance. Unlearn’s digital twins are now in use in both early and late-stage clinical trials, with adoption continuing to grow. Unlearn is one of the few companies applying this approach at scale.
According to Citeline’s Pharmaprojects tracking, some 21,000 molecules are in the drug development pipeline right now – and they are all being developed because they have the potential to change and save lives. Accelerate your drug development and clinical trial goals and benefit from our 360° CDMO and CRO solutions and expertise.
It’s important to recognize that for many large pharmaceutical and biotechnology companies, compounds that have the potential to treat a rare disease of significant unmet need might become lower strategic priority than those that have mass market potential.
For clinicalresearch professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. As we look towards future developments in oncology and beyond, the importance of strategic regulatory planning and execution cannot be overstated.
These survey results also highlight the importance of evaluating a variety of potential CRO partners of different sizes to choose the best match for your clinicaldevelopment goals and corporate culture.
The PPD clinicalresearch business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.
The highly dynamic biotech industry has a core need to remain as flexible and agile as possible across the spectrum of clinicaldevelopment activities. One primary way these companies create a nimble and adaptive environment is by outsourcing some portion of clinicaldevelopment functions.
QuartzBio’s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning and R&D productivity. Canada, Europe and Australia. For more information, visit PrecisionForMedicine.com.
Pritelivir (development codes AIC316 or BAY 57-1293 ) is a direct-acting antiviral drug in development for the treatment of herpes simplex virus infections (HSV). It is currently in Phase III clinicaldevelopment by the German biopharmaceutical company AiCuris Anti-infective Cures AG.
As the clinicalresearch landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs. Discover how Worldwide is positioned to meet your needs with agility, expertise, and a truly personalized approach.
for expanding activities in the US with its initial focus on facilitating clinicaldevelopment. Burr Boulevard, Teaneck, NJ 07666
(3) President: Yasushi Miyazawa
(4) Scope of business: Clinicalresearch and development
(5) Paid in capital: US$100,000.
(2) Location: 500 Frank W.
Rothenberg took over as Pfizer CMO in January 2019, but spent more than 12 years in total working for the pharmaceutical giant. From 2016 to 2018, he served as chief development officer for oncology at Pfizer, where he was responsible for leading clinicalresearch, development, and lifecycle management of all promising oncology products.
“Our commitment to supporting clinicalresearch sites with strategic flexible resources has been increasingly important over the past 12 months in particular. VERONA, Italy , Jan. ” About CROMSOURCE.
“Further, PDE4-inhibition is a well-documented pharmacological target for a number of other inflammatory indications, and we look forward to advancing our clinicalresearch to realize the full potential of orismilast for the benefit of the millions of patients living with inflammatory conditions globally,” adds Professor Sommer.
Clinicalresearch requires vast talent across a variety of roles and specialties, as well as across global locations. In this complex environment, functional service partnership (FSP) models have become a solution of choice for pharmaceutical and biotech companies navigating the challenges of clinicaldevelopment.
Clinicalresearch is a key component of developing. A critical component of our medicinal product development is clinicalresearch. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. We are committed to Good Clinical Practice.
Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. That is, how many clinical trials are actually managed by these organizations?
During her medical practice, Seredina worked in clinicalresearch as an investigator. The results of her research were published in a number of articles highlighting her knowledge of the critical challenges of clinical sites and of the importance of being patient-centric.
Hartfield previously served as CEO of Vitae Pharmaceuticals prior to its acquisition by Allergan. X4 Pharmaceuticals – Diego Cadavid was named chief medical officer of Boston-based X4 Pharmaceuticals. Cadavid will be responsible for the strategy, direction and execution of the company’s clinicaldevelopment programs.
With neuroscience experience in Alzheimer’s Disease (AD) and dementia, neurology , pain and addiction, rare and other diseases, and psychiatry, Worldwide has been involved in neuroscience research since the 1970s. Vial’s scientific advisory board has experience across all its therapeutic areas and immuno-oncology for the Oncology CRO.
When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. The post Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?
At the Bill & Melinda Gates Medical Research Institute, she previously held the role of chief of staff before being appointed special adviser. Previously, she was head of Business Development at Cubist Pharmaceuticals. Previously, Baffa was Therapeutic Area Head of Oncology, Global ClinicalDevelopment for Shire.
About Precision for Medicine Precision for Medicine is the first biomarker-driven clinicalresearch and development services organization supporting life sciences companies in the use of biomarkers essential to targeting patient treatments more precisely and effectively. Bethesda, Md.,
X4 Pharmaceuticals – Art Taveras was named CSO of Cambridge, Mass.-based Taveras will lead all research and non-clinicaldevelopment functions supporting the company’s pipeline of investigational therapies. Venugopal most recently served as executive director at Intercept Pharmaceuticals.
1-4 This approach saves time, money, and resources, and ultimately leads to safer medicines going forward to the clinic. CNS-related issues account for nearly a quarter of failures during clinicaldevelopment, a phase where consequences are high in terms of resources and patient impact. Regul Toxicol Pharmacol RTP. Rockley KL.
The Company anticipates using net proceeds from the offering to fund the continued development of ublituximab and umbralisib, the potential in-license, acquisition, development and commercialization of other pharmaceutical products, and for general corporate purposes. Morgan Securities LLC, Goldman Sachs & Co.
The Primitives of Biomedical Discovery and Development It’s noteworthy that the majority of approved medicines, around 60%, have their roots in academia, with the remaining 40% stemming from pharmaceuticalresearch and discovery.
The Company intends to use the net proceeds from this offering to support its planned New Drug Application submission for oral sulopenem for the treatment of uncomplicated urinary tract infections in patients with quinolone-resistant pathogens, the continued clinicaldevelopment of sulopenem, and for working capital and general corporate purposes.
The Costs of Working with a CRO Running clinical trials is an integral part of the pharmaceutical industry, crucial to the development and approval of new drugs and treatments. These services range from clinical study design and data management to statistical analysis and regulatory support.
We have seen how quickly vaccines and treatments can be developed when innovation is prioritised and stakeholders work together against the backdrop of imminent societal needs. Converting these challenges into opportunities, we must embrace new clinicaldevelopment strategies that promote agility, efficiency and effectiveness.
The consortium is funded by a public-private partnership called the Accelerating Medicines Partnership (AMP) , through which the Foundation for the NIH (FNIH) administers funds provided by industry, government, and nonprofits to scientists working on applicable basic or clinicalresearch to advance gene therapy development for rare diseases.
Harrison, MD, Director, Summit ClinicalResearch. A Japanese new drug application (J-NDA) is under review by the Pharmaceuticals and Medical Devices Agency (PMDA) to request approval for the manufacturing and marketing of Imeglimin for the treatment of type 2 diabetes.
Medical researchers and practitioners see in their own patients how these ailments interconnect and overlap, as do the pharmaceutical and biotech companies working to develop GLP-1 therapeutics. Were applying that expertise and commitment to every aspect of developing and running successful GLP-1 studies.
The new FIND-CKD study extends our clinicalresearch for finerenone to a non-diabetic population where the unmet need is high for brand spanking new treatments to delay disease progression.”.
The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. IQVIA has a vast collection of healthcare information, including over 1.2 increase on a reported basis and an 4.8%
AOP Orphan – AOP Orphan Pharmaceuticals took over the Viennese pharmaceutical company Amomed and the Luxembourgish health-tech company SciPharm. AOP anticipates new opportunities in Austria as a hub for research and business. Talking Medicine uses advanced AI to provide pharmaceutical companies with real-time data intelligence.
This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.
Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceuticaldevelopment expertise. Sairiyo is currently focused on advancing the clinicaldevelopment of Cepharanthine to treat rare cancer diseases.
Introduction Contract research organizations (CROs) are essential in pharmaceuticalresearch and development (R&D). This acquisition has allowed the company to position itself as a global leader in clinicalresearch services. launched a PV platform for clinicalresearch registries.
The appointments of Maarten and Teun come at an essential time for AM-Pharma as we finalize all preparations to move into the last stage of clinicaldevelopment for our lead program,” said Erik van den Berg , Chief Executive Officer at AM-Pharma. Dr. Kraan joins AM-Pharma from Pierre Fabre S.A.,
RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. About EXPLORER The EXPLORER clinicalresearch program is unmatched by any oral anticoagulant in the Factor Xa inhibitor class in its size, scope and ambition.
The Orphan Drug Act creates incentives for developing orphan drugs to treat such diseases. This will aid clinicaldevelopment and preparation for investigational new drug (IND) and biologics license application (BLA) submissions. Research sites without access to an IBC may consider relying on a commercial IBC.
How a CRO Accelerates ClinicalDevelopmentClinical trials are becoming increasingly complex as the industry evolves. Our recent survey on industry trends found that 51% of drug developers denote the increasing complexity of clinical trials as a top challenge, along with patient recruitment (55%) and regulatory hurdles (46%).
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