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How Japan and South Korea are Shaping the Next Era of ClinicalDevelopment Discover why Japan and South Korea are emerging as clinical trial powerhouses, offering cutting-edge infrastructure, streamlined regulations, and unique commercial advantages. CMIC Group Resource Type Whitepaper CMIC_ListingLogo_250x190.png
To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinicaldevelopment.
A large majority of drug developers 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.
Please click download to access this FREE resource. This report offers an unparalleled opportunity to explore the forefront of drug discovery and gain valuable insights from industry leaders and experts.
jsabatino Tue, 10/10/2023 - 09:03 Download now to explore this challenge in detail, explaining the difficulties faced by regulatory affairs leaders and how regulatory intelligence solutions powered by artificial intelligence offer a path to enhancing efficiency and accelerating approvals.
UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinicaldevelopment qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,
To gain deeper insights into this pivotal shift and how it can benefit your clinicaldevelopment strategy, we invite you to download our full industry survey report. This industry shift represents not just a change in sponsor preference but rather a broader reevaluation of what attributes are most valued in a CRO partnership.
Our highly experienced teams in Singapore and the US span antibody discovery, pharmacology, production and clinicaldevelopment. Together we aim to accelerate the journey of new drugs from concept to clinical care. View original content to download multimedia: [link]. Mol Cancer Ther. 2020; 19: 490–501. [3] Cancer Res.
Making the best use of the modern tools at their disposal, allied to skills and expertise developed across multiple lead optimization programs in the past, will make success more likely. Download now! jsabatino Wed, 05/24/2023 - 12:56 In a lead optimization program, there is no substitute for experience.
executive vice president of Research and Development at Amgen, along with members of Amgen’s clinicaldevelopment team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C inhibitor sotorasib (AMG 510). Reese , M.D., On Monday, Sept. PDT , David M.
Key resources for ethnobridging in Phase I clinical trials: In this issue of The Altascientist , we demonstrate how ethnobridging can prevent the need for region-specific development programs, helping you safely achieve commercial milestones more efficiently. Download your copy today. In this complimentary webinar , Mel B.
Our PPD FSP solutions help biotech and biopharmaceutical companies meet their timelines by providing top-tier functional expertise that complements existing capabilities and helps companies tackle their unique clinicaldevelopment challenges.
For our clients, the ability to outsource these capabilities is a marked improvement compared to hiring, training and maintaining a large workforce to fulfill every aspect of clinical operations — a feat made even more complicated by workloads that can fluctuate widely depending on the number of products under development.
To rise above the competition, sponsors must understand the common pitfalls of vaccine development and have strategies in place to avoid them. It is imperative that the right vaccine development partner demonstrates expertise from early clinicaldevelopment to study design, execution, regulatory submission and commercialization.
Furthermore, there are two partnered assets: ALG.APV-527 in co-development with Aptevo Therapeutics Inc. and AC101 in clinicaldevelopment by Shanghai Henlius Biotech Inc. In addition, the company has developed a novel concept for more patient-specific immunotherapy: Neo-X-Prime. SOURCE Alligator Bioscience.
Her international experience in leading clinicaldevelopment and in building development organizations will significantly strengthen our clinical capacity. This is crucial in the phase we are in now, with two products on the way to Phase II and another product in clinical Phase I. SOURCE Alligator Bioscience.
This platform has enabled Apexigen and its collaboration partners to discover and develop high-quality therapeutic antibodies against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies. View original content to download multimedia: [link]. SOURCE Apexigen, Inc.
This grant will support Alume’s clinicaldevelopment of its novel nerve illumination technology in surgery. View original content to download multimedia: [link]. (Alume) announced today that it has been awarded a $2.5M Contact: Catherine Eng , catherine.eng@alumebiosciences.com. SOURCE Alume Biosciences. Source link.
He continues: “With the green light granted by the FDA to continue our clinical research, we are one step closer to offering psoriasis patients a novel, improved oral treatment option and thereby enhancing their quality of life. The following files are available for download: View original content: [link]. Sources 1: Li et al.
Most importantly, we are continuing to see patients benefit from the profound therapeutic effects of both approved products and those currently in clinicaldevelopment. Download the e-book here. We are committed to bringing these life-changing therapies to patients in need,” Lambert added.
15, 2020 /PRNewswire/ — Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing.
View original content to download multimedia: [link].
“The Covid-19 command center is customized to meet immediate needs related to research on the novel coronavirus, but can also be used more broadly for other infectious disease clinicaldevelopment efforts now and in the future.”.
APX005M is currently in Phase 2 clinicaldevelopment for the treatment of cancers such as pancreatic cancer, esophageal and gastroesophageal junction cancers, melanoma, non-small cell lung cancer, rectal cancer and sarcoma in various combinations with immunotherapy, chemotherapy, radiation therapy or a cancer vaccine. Source link.
SQI is accelerating the clinicaldevelopment of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test.
View original content to download multimedia: [link].
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Understanding the nuances of each pathway is crucial for small to midsize companies aiming to navigate the complexities of global clinicaldevelopment successfully. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.
The expansion of the eligible stocks of Hong Kong Stock Connect, will further optimize the interconnected, intercommunicated, and mutual development of the capital markets between Mainland China and Hong Kong. Any of these intentions may alter in light of future development. View original content to download multimedia: [link].
Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinicaldevelopment and commercialization. View original content to download multimedia: [link]. Michael Yu reviewed the history and achievements in the past nine years since the establishment of Innovent.
We are excited to expand our strategic site support services and look forward to providing even more sites and clients with the expert resources needed to deliver world class, innovative clinical research in keeping with the new normal in our industry.” View original content to download multimedia: [link]. Logo – [link].
Furthermore, there are two partnered assets: ALG.APV-527 in co-development with Aptevo Therapeutics Inc. and AC101 in clinicaldevelopment by Shanghai Henlius Biotech Inc.). In addition, the company has developed a novel concept for more patient-specific immunotherapy: Neo-X-Prime. SOURCE Alligator Bioscience.
Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinicaldevelopment as a monotherapy and in combinations. MRTX1133 is an investigational small molecule and selective KRAS G12D inhibitor in preclinical development. View original content to download multimedia: [link]. Source link.
“Filing an IND with the FDA is an important step in the clinicaldevelopment of Rabeximod. It is a quality stamp on our drug candidate and Covid-19 trial and would enable us to expand the clinicaldevelopment to the United States. The following files are available for download: View original content: [link].
Roquinimex (Linomide), a drug developed by Pfizer for the treatment of multiple sclerosis, is structurally related to laquinimod. Figure 3: Roquinimex (linomide) Clinicaldevelopment of both laquinimod and roquinimex was halted due to serious cardiovascular events. This was unexpected. The fun slides are at the end.
Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA’s preclinical and clinicaldevelopment programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Securities and Exchange Commission.
technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinicaldevelopment pipeline or for additional licensing and partnering. The following files are available for download: View original content: [link].
technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the company’s own clinicaldevelopment pipeline or for additional licensing and partnering. The following files are available for download: View original content: [link].
This Breakthrough Therapy designation will enable the accelerated development of Batoclimab for MG thereby bringing this life-changing innovative drugs to patients in China sooner.” View original content to download multimedia: [link]. ” he added. About Harbour BioMed. Harbour BioMed (HKEX: 02142.HK) Source link.
Oncopeptides plans to initiate clinicaldevelopment of OPD5 with an open-label phase 1, dose escalation study on safety and tolerability of OPD5 as a myeloablative regimen followed by Autologous Stem Cell Transplantation in patients with relapsed refractory multiple myeloma. More information is available on www.oncopeptides.com.
ET ) to discuss the results and next steps in clinicaldevelopment of BI-1206. technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinicaldevelopment pipeline or for additional licensing and partnering.
AR-301 is a fully human IgG1 mAb currently in Phase 3 clinicaldevelopment targeting gram-positive Staphylococcus aureus ( S. AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinicaldevelopment targeting Pseudomonas aeruginosa ( P. View original content to download multimedia: [link].
We empower sponsors by providing access to diverse populations, promoting technological innovation in clinicaldevelopment and co-creating partnership models optimized for success. Together, we will leverage these trends to accelerate your drug development initiatives into the new year and beyond.
Furthermore, there are two partnered assets: ALG.APV-527 in co-development with Aptevo Therapeutics Inc. and AC101 in clinicaldevelopment by Shanghai Henlius Biotech Inc.). In addition, the company has developed a novel concept for more patient-specific immunotherapy: Neo-X-Prime. SOURCE Alligator Bioscience.
” “Dynacure is a leader in rare disease drug development, as evidenced by its lead product candidate DYN101, which is in clinicaldevelopment for the treatment of Myotubular and Centronuclear Myopathies for which there are no FDA or EMA approved therapeutics,” said Ms. ” Ms. SOURCE Dynacure.
Members of the senior management team have a combined experience in the biopharmaceutical industry, spanning clinicaldevelopment, regulatory, financial and business management in both the USA and China. View original content to download multimedia: [link]. SOURCE Sirnaomics, Inc. Source link.
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