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As biomarkers become increasingly relevant in indicating the workings and effects of novel therapies, their potential as valuable clinical and regulatory endpoints is also gaining recognition. Biomarkers can play a crucial role throughout clinicaldevelopment, especially in early phases.
Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S.
This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinicaldevelopment needs. Learn more The post How FSP Models Help Biotech Companies Augment Their ClinicalDevelopment Needs appeared first on PPD. FSP outsourcing is growing faster than FSO.
The journey of cell and gene therapies from preclinical discovery to clinical trials is complex and challenging, impacting every team member involved, from researchers in the lab to patients receiving treatment.
Chief Executive Officer Steve Herne has spent more than 25 years in clinicalresearch, with senior roles at WCG, Bioclinica and Covance. Today, we are focused on scaling AI-driven clinical solutions that help sponsors optimise their clinical programmes,” Herne says.
Generative artificial intelligence (AI) has captured global attention for its transformative potential across industries, and nowhere is the promise greater — or more fraught — than in health care and clinicalresearch. Accelerate your clinicalresearch with our drug development digital solutions from Thermo Fisher Scientific.
This dual role enables him to bridge research and clinical practice, ensuring scientific innovation is directly informed by patient care. “As Delpassand’s clinical experience plays a key role in shaping the research pipeline. This is where the SPICA Center comes in.
From academia to antibody architect JJ’s scientific path began in neurobiology with a PhD followed by a postdoctoral role at the Genome Research Center at Academia Sinica. That shift into translational research changed the direction of his career. He earned his Ph.D. in Molecular Medicine from National Taiwan University.
This partnership brings together Altasciences’ extensive expertise in preclinical research and early clinicaldevelopment with VoxCell’s groundbreaking tissue engineering technology, promising to deliver a more human-relevant, predictive, and efficient drug development paradigm.
Additionally, AI-driven predictive modelling can shorten the preclinical phase by simulating biological responses, leading to more targeted and efficient clinical trials. By using AI to simulate biological responses, researchers can anticipate how different patient cells will react to therapy, minimising trial-and-error approaches.
With the expiration of pirfenidone’s patent exclusivity in 2021, sponsors have renewed their focus on developing new therapies. The emergence of new drugs and treatment strategies has broadened treatment options that are in development and fueled research into urgently needed new therapeutic approaches for IPF.
His approach focused on integrating key components of the process: research, clinical, regulatory, and manufacturing into a cohesive, unified system. Ive been involved in therapeutics development for over 25 years, working with small, medium, and large biotech companies.
Pushkal Garg to Lead Unified Research and Development Organization, Signaling Strategic Expansion into Next Phase of RNAi Therapeutics Innovation Alnylam Pharmaceuticals , a global leader in RNA interference (RNAi) therapeutics, has announced the promotion of Pushkal Garg, M.D., He holds a B.A.
With over two decades of experience in biomedical research, he is leading efforts to translate breakthrough GPCR biology into differentiated therapeutic strategies that can overcome immune resistance and offer new hope to patients with limited treatment options. Preparing for the clinic Preclinical success is just the beginning.
Companies can benefit from solutions such as our Accelerator Drug Development, leveraging the combined strength of Thermo Fisher Scientific’s 360˚ Contract Development and Manufacturing Organization (CDMO) and Contract Research Organization (CRO) services , which provides CDMO, CRO and clinical trial supply chain capabilities that further streamline (..)
By integrating Regulus’ expertise in microRNA science with its own deep capabilities in clinicaldevelopment, regulatory affairs, and commercialization, Novartis is well-positioned to accelerate farabursen’s clinical path and potentially bring a first-in-class treatment to ADPKD patients.
This design was meant to enable clinician-researchers to gauge the ability of rilzabrutinib to control disease activity after the withdrawal of standard therapy. We look forward to further evaluating rilzabrutinib in subsequent phases of its clinicaldevelopment.” Fast Track and Orphan Drug Designations from FDA The U.S.
These elongated timelines are contributing to soaring costs, with the average cost of developing a new drug rising to approximately $2.6 For sponsors, the imperative to streamline development processes and improve clinicaldevelopment speed and efficiency has never been more critical. billion (versus $1-1.5
Director of Lymphoma Research at Sarah Cannon Research Institute and principal study investigator for the trial. Vice President of Early ClinicalDevelopment and Translational Research at Johnson & Johnson Innovative Medicine. “As formerly Cellular Biomedicine Group, Inc.).
Importantly, the agreement underscores the opportunity for Teva to leverage data generated by Fosun Pharma in its own ongoing and future clinical programs outside of the licensed territories — a synergy that promises to streamline and accelerate the eventual delivery of this therapy to patients in need across the globe.
a global oncology-focused biopharmaceutical company, delivered a comprehensive update to investors today during its highly anticipated Research and Development (R&D) Day. A Global R&D Footprint Backed by Clinical Execution BeOne’s engine of innovation is supported by a vast and diversified global clinicaldevelopment network.
About us The PPD clinicalresearch business of Thermo Fisher Scientific , the world leader in serving science, enables our customers to accelerate innovation and increase drug development productivity. Ready to learn more about how to leverage AI and machine learning to maximize your clinical trial efficiency?
While individual rare diseases affect populations that are small in numbers, collectively they impact millions globally, posing significant health and research challenges. Real-world data (RWD) and real-world evidence (RWE) have emerged as transformational tools in addressing these hurdles, advancing rare disease drug development.
Researchers must characterize the anti-drug-antibody (ADA) response in preclinical and clinical studies and report any ADA-positive samples as a risk-based approach. Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S.
Dr. Marjorie Green, Senior Vice President and Head of Oncology Global ClinicalDevelopment at Merck Research Laboratories, emphasized the significance of this new trial within the broader scope of the ADC’s development.
Multimodality however can detect and connect trends (and in future generate content) across different modalities and therefore allows for better interpretability, which builds trust between regulators, researchers and industry stakeholders. Using clinical genomics and AI in drug development to elevate success.
In contrast to a conventional pharma partnership, this large scale and flexible funding agreement enables Revolution Medicines to retain control of the clinicaldevelopment of daraxonrasib, as well as the ability to capture significant value creation that would result from the successful clinicaldevelopment and commercialization of its pipeline.”
This study explored the effects of beginning treatment with lower starting doses of MariTide to improve tolerability while maintaining clinical benefit. Both data sets now provide foundational insight into the design and direction of Amgen’s upcoming Phase 3 MARITIME clinicaldevelopment program.
As the biotech sector races to improve the tolerability of these revolutionary treatments, Poolbeg Pharma has a novel solution: an oral therapy, POLB 001, to block the development of CRS, by limiting inflammation without affecting the anti-cancer immune responses that are vital for effective immunotherapies.
This significant financial infusion is designed to fuel Revolution Medicines’ ambitious clinicaldevelopment and commercialization plans, with a particular focus on its groundbreaking RAS(ON) inhibitor programs for patients with RAS-addicted cancers.
These hubs support a geographically distributed remote workforce that provides greater stability and project continuity while offering the global expertise and capabilities needed to bolster clinicaldevelopment success.
Partnering with experienced contract development and manufacturing organisations (CDMOs) can help developers navigate these complexities, accelerate development timelines, and ensure readiness for scalable, cGMP-compliant manufacturing. 3 As these therapies evolve, so too must the tools and processes used to develop them.
While these regulations protect public health, they also introduce significant challenges for pharmaceutical researchers. Developing a new drug takes an average of 10–15 years and costs upwards of $2 billion, yet the majority of drug candidates fail before reaching regulatory approval.
ClinicalDevelopment Plans and Future Outlook Intellia’s ongoing Phase 3, randomized, double-blind, placebo-controlled HAELO trial is currently assessing the safety and efficacy of lonvo-z at the 50 mg dose in a larger patient population.
This unmet need has driven the development of alternative pharmacological options, including topical eye drops like MR-141, which aim to improve near vision through non-surgical means. Details of the VEGA-3 Phase 3 Trial The VEGA-3 study is part of Viatris’ broader clinicaldevelopment program to evaluate MR-141 for presbyopia.
Bayer and Tsinghua University Deepen Strategic Alliance to Advance Pharmaceutical Innovation in China Bayer and Tsinghua University (THU), two powerhouses in global pharmaceutical innovation and academic research, have announced a renewed commitment to their long-standing partnership.
Despite ongoing research and improvements in immunosuppressive therapy, there remains no FDA-approved treatment specifically for AMR , leaving clinicians with limited tools to prevent or manage the condition effectively. It arises when the recipient’s immune system produces antibodies that attack the transplanted organ.
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This foundational research effort provided valuable baseline insights into the disease burden and progression of CMS, thereby helping to inform the design and evaluation of ARGX-119’s clinicaldevelopment program. Peter Ulrichts, Ph.D.,
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In a research note on Wednesday, RBC Capital Markets analyst Leonid Timashev estimated peak yearly sales of the drug could reach nearly $640 million. Ibtrozi has also shown the ability to help people whose cancer has spread to the brain, a leading cause of disease progression, the company said.
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