This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
In the rapidly advancing field of cell therapies, Dr Jason Bock has emerged as a leader, known for his innovative approach to optimising the development process. With over 25 years of experience in therapeutics, Bock has played a pivotal role in shaping the future of cell therapies, particularly through his work at CTMC.
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.
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.
Dear Readers, I am thrilled to announce the launch of our new series, “Beyond the Lab,” which promises to deliver high-level insights commissioned exclusively by Drug Target Review magazine. Emerging Trends and Technologies The report highlights the latest emerging trends and technologies in cell and gene therapy.
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.
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.
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.
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.
Cambridge and Wetherby, UK, 18 January 2022: Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms announces that the next pre|CISION™ drug candidate, AVA3996, has been selected for pre-clinicaldevelopment (..)
But commitment to neuroscience drugdevelopment is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. Not failed drugs, but failed studies. As soon as drugdevelopers can begin to develop conviction, momentum increases.
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.
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.
This exclusive interview with Dr Sharon Benzeno, Chief Commercial Officer, Immune Medicine at Adaptive Biotechnologies, unveils some ground-breaking research on T- cell therapy for cancer , which has seen the first TCR-based therapeutic candidate progress to clinicaldevelopment, offering promising advancements in innovative cancer treatments.
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.
The field of cell and gene therapies (CGT) is constantly evolving, and there has been significant progress in this area of research. However, despite the promise of these therapies, the regulations governing them lag the science, which in turn hinders the clinical translation of these novel medicines.
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. What evidence is there that we can reverse aging with drugs? a commercial stage pharmaceutical company.
Even though AI-designed drugs arent yet a household term for FDA-approved, commercially available therapies, they are a reality in clinicaldevelopment pipelines.
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.
The PPD clinical research 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.
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).
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.
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.
These cytotoxic drugs include DNA base analogs, antimetabolic drugs, tubulin inhibitors, etc. However, most of these chemotherapeutic drugs show a low therapeutic index, and serious side effects are usually attributed to the exposure of non-specific drugs to off-target tissues.
Early detection of neurotoxicity induced by potential new therapies is a major challenge, and hiPSC-neuronal cells may provide a solution. Within the field of drug safety hiPSC-cardiomyocytes are now routinely used for early identification of cardiac liabilities in drug discovery.
Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994, 1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors. – If Approved, Investigational TAK-994 May Provide a Future Treatment Option Targeting the Orexin Deficiency Underlying NT1.
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.
How have advancements in antibody-drug conjugates (ADCs) expanded treatment options for different types of cancer? 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.
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.
The FDA’s January 2020 guidance, Chemistry, Manufacturing and Control (CMC) [1] Information for Human Gene Therapy Investigational New Drug Applications (INDs), outlines the analytical methods that define the quality, safety and efficacy of gene therapy therapeutics.
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.
Data is the cornerstone of any clinical trial, driving the decision-making process of drugdevelopment, and is a fundamental requirement for approval of new therapies by regulatory agencies like the FDA or EMA.
1,2 Many, however, do have dysfunctional proteins at their core, and for these diseases, a new option is being explored: autophagy-boosting therapies. One of our drug candidates at Samara activates Transient Receptor Potential Mucolipin 1 (TRPLM1), a protein that’s at the centre of the degradative machinery that’s so key to autophagy.
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.
. – Preclinical Data Underscore Treatment Potential for PBFT02 in Frontotemporal Dementia with Granulin (GRN) Mutations, a Devastating, Progressive Disorder Impacting Adults with No Approved Disease-Modifying Therapy Options. FTD is a debilitating form of early onset dementia that currently has no approved disease-modifying therapies. “We
“KSQ’s CRISPRomics discovery platform is a powerful technology to help us identify novel targets in line with our immuno-oncology strategy,” said Loïc Vincent, Head, Oncology Drug Discovery Unit and Immunology Unit at Takeda. Takeda will assume responsibility for funding all development and commercialization activities.
Orphan drug designation is a regulatory status granted to pharmaceuticals developed for the treatment of rare diseases. It provides incentives to encourage the research, development, and approval of therapies targeting small patient populations.
We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. For the last several years, the field has worked to unlock the potential of IO therapies for additional tumour types, and has explored options beyond checkpoint inhibitors.
Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) today announced a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR.
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.
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.
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.
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
69 
Let's personalize your content