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This significance and focus are ever more apparent when the starting cellular material is imperative to drug product success. Within cell therapyclinical trials, apheresis collections contribute to the specific constituents of the given therapy.
The convergence of real-world data (RWD), technology and artificial intelligence (AI) is playing a vital role in accelerating drugdevelopment. In a recent panel discussion at DIA Global , our experts explored how these elements are reshaping clinical research and drug discovery.
It is hard to ignore some of the most pressing, long-term trends driving the push to accelerate innovation and progress in drugdevelopment. As a result, biopharma and biotech companies working to bring their drug pipelines to the market require deep expertise from trusted partners to help deliver critical therapies for their patients.
Cell and gene therapy (CGT) studies are rapidly gaining momentum in the Asia-Pacific region, fueled by growing patient demand and a thriving ecosystem of innovation. In China, the high incidence of solid tumors is driving an urgent need for advanced therapies, spurring the push for new treatment approaches.
Bayer and Broad Institute extend cancer therapy research collaboration By Corie Lok November 2, 2023 Breadcrumb Home Bayer and Broad Institute extend cancer therapy research collaboration Long-standing industry-academia collaboration has already resulted in three clinical oncology candidates.
But commitment to neuroscience drugdevelopment is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. Historically, what has limited investor interest in funding neurological and psychiatric therapies in development?
The Clinical Trials Grants Program provides funding for clinical trials that evaluate the safety and efficacy of potential treatments for rare diseases to help move promising treatments through clinicaldevelopment. The rest of this blog will focus on the Clinical Trials Grants Program.
Approaches to outsourcing clinical trials have changed significantly in recent years. Mixing of service models — a strategy that drugdevelopers are leveraging now more than ever — can bring life-changing therapies to market faster.
2 Unmet needs in lung cancer treatment Recent decades have seen significant advancements in lung cancer treatment, especially with the introduction of targeted therapies and immunotherapies, which have notably improved survival rates. 7 Recent clinical studies highlight promising developments in c-MET-targeting ADCs for NSCLC.
A clinicaldevelopment plan — a comprehensive strategy for developing an investigational product through regulatory submission — is a critical component of drugdevelopment and helps ensure that new therapies are safe, effective, and of high quality.
In the rapidly evolving landscape of oncology drugdevelopment, artificial intelligence (AI) has emerged as a revolutionary force, altering not just the pace but the very methodology of discovery and development.
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. We are acutely aware that turnover in key project team personnel can lengthen project timelines and inflate clinical trial costs.
Why is detecting cancers via liquid biopsy before they become visible on imaging important for drugdevelopment, not just diagnostics? We believe liquid biopsy is very helpful for oncology drugdevelopment because the reduction and clearance of circulating DNA occurs quickly before radiographic imaging is available.
A large majority of drugdevelopers utilize FSP or hybrid FSP/FSO models, half are “heavy users” Heavy users: Those that use FSP or hybrid FSP/FSO models for most of their clinicaldevelopment outsourcing. Heavy users leverage these models for nearly three-quarters of their outsourcing.
Five Promising Treatment Areas in Early-Phase DrugDevelopment in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drugdevelopment is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.
The drugdevelopment industry is constantly adapting and evolving to bring novel therapeutics to market to improve the lives of patients across the globe. While the drugdevelopment industry experienced setbacks during the COVID-19 pandemic, the field is again gaining momentum reminiscent of its pre-pandemic pace.
Through further research and work as a principal investigator on clinical studies for several central nervous system indications, I laid the groundwork for a career in gene therapydrugdevelopment. AskBio) I continue to work to bring innovative gene therapies to patients in need.
Contrary to popular belief, ageing is not caused by just random wear and tear of our bodies over time but is instead caused by a discrete set of biological mechanisms that we now better understand and can target with therapies. a clinical-stage private biopharma company developingtherapies for neurological and psychiatric diseases.
Rapid growth in gene therapy is expected to receive additional support as the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) prepares to launch Operation Warp Speed for Rare Diseases. Peter Marks, head of FDA’s CBER – the organization responsible for regulating gene therapies.
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As a result, drugdevelopers make better decisions more quickly (removing 50% of study timeline whitespace) to bring new therapies to market faster. Accelerate customer speed to market With a modern and integrated user experience, AI solutions put the right data and insights into the right hands in real time.
Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and controls (CMC).
Read the Guide FDA Launches Pilot Program to Help Further Accelerate Development of Rare Disease Therapies One frustrating aspect of traditional drugdevelopment, especially for rare disease communities, is the tempo of regulatory decisions on potential drugs.
Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.
In December, life sciences giant Bayer launched a cell and gene therapy platform within its pharmaceutical division in order to become a leading company within a rapidly emerging and evolving field that offers the potential of life-saving therapies. Photo courtesy of Bayer. We have set the bar high.
New multi-program collaboration to develop allogeneic TCR-T/CAR-T programs brings together Immatics’ allogeneic gamma delta T cell therapy platform ACTallo ® with Bristol Myers Squibb’s technologies and oncology drugdevelopment expertise. Executive Vice President, Research & Early Development, Bristol Myers Squibb.
Boehringer Ingelheim is pioneering a range of versatile therapeutic platforms in order to develop innovative medicines that target the tumor directly (tumor cell-directed therapies) or that enable the immune system to target the tumor (immune cell-targeted therapies). About Boehringer Ingelheim.
But immunotherapy was not yet widely used and had not been applied clinically to Merkel cell carcinoma, so she received traditional chemotherapy and radiation therapy, suffering life-threatening complications along the way. His mother had a presentation of the disease that suggested her immune system was already on the job.
There has been continuous growth in the variety and volume of available health care data, and newer applications for use of real-world data (RWD) and real-world evidence (RWE) to enhance the speed of patient access to new therapies. Tokenization can accelerate innovation in clinical trials and drugdevelopment.
Redig, SVP and Head of ClinicalDevelopment at HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC The American Cancer Society for Oncology (ASCO) annual meeting is among the highlights of the clinical oncology calendar. By Amanda J.
It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinicaldevelopment process.
As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drugdevelopment shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the DrugDevelopment Industry in 2024 1.
Small patient populations often result in difficulty in determining a significant effect of a therapy, given the low confidence power associated with the statistics. How do AI-enhanced approaches accelerate the drugdevelopment process for rare diseases?
These are incredible forecasts and CAGRs, which if we assume directionally correct, rely not only on steady growth for approved therapies but also a substantial success rate of, and continued investment in, the development pipeline.
The START pilot program was announced last September as a way to offer selected participants developing potentially life-saving and life-changing rare disease therapies enhanced communications with FDA review staff and a mechanism for addressing clinicaldevelopment issues, similar to the “Operation Warp Speed” communication model for vaccines in development (..)
As new higher‑throughput methods of discovery and biologic drugdevelopment come online, we can expect TCR-based therapeutics to play an important role in the treatment of cancer and other diseases in the coming years. Engineering soluble T-cell receptors for therapy. Cancer Therapy With TCR‑Engineered T Cells.
Often, however, a hybrid use case will fit into one of these general categories: 1) An existing FSO arrangement needs additional expertise or resources to support a specific study function, requiring the developer to scale or augment that FSO arrangement with FSP services.
Initial works from the lab concentrated on exploring the role of replicative stress in cancer and ageing, for which the group combined cell biology, mouse models and drugdevelopment projects. Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy.
The advent of monoclonal antibodies paired with improvements in each ADC design component has led to the approval of 11 ADCs with more than 180 ADCs currently in clinicaldevelopment. T-DM1, for example, is approved in patients with HER2-positive breast cancer and residual invasive cancer following neoadjuvant therapy.
BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”
In the past three years, Worldwide has collaborated on 105 oncology studies supported by a global team of oncology clinicaldevelopment experts. Other therapeutic areas include cell and gene therapy. Clinical trial designs are expected to become more complex, generating more data volume and diversity.
To support these functions, PPD™ Functional Service Partnership (FSP) Clinical Operations solutions harness the full range of innovative technologies, applying extensive skill and expertise to empower our customers to bring therapies to market quickly and within budget.
where he led global clinicaldevelopment programs including clinical strategy, clinicaldevelopment, and regulatory affairs. Prior to Taiho, he held the positions of senior vice president of Clinical Oncology and CMO at Geron Corporation. and CMO for Taiho Oncology, Inc.
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