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Selecting the right CRO to partner with on your development program is a pivotal decision that can shape the trajectory of your product’s development. Our consultative approach ensures success by integrating research methodology, regulatory affairs strategy, and clinical operations. You have the oversight you need.
The Technical University of Denmark (DTU) has announced that an international scientific team has developed a CRISPR-based drug candidate that targets E coli directly and leaves the microbiome intact. The research team has designed four bacterial viruses which use CRISPR technology to kill the unwanted bacteria precisely.
Drug discovery and development is an incredibly expensive and time-consuming process, taking between 12 and 18 years, and costing on average between $2 billion and $3 billion. Robots can improve drug discovery and development. Lab-specific industrial co-bots can carry out both complex and repetitive tasks such as liquid handling.
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.
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinicalresearch? This new guidance will clearly impact the clinicalresearch field, but how? Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinicaldevelopment?
Hookipa Pharma and Roche have signed a strategic partnership and licence agreement for developing HB-700 and another undisclosed arenaviral immunotherapy. Under the deal, Hookipa will carry out research and initial clinicaldevelopment through Phase Ib for HB-700 to treat KRAS-mutated cancers.
Astellas Pharma and Sutro Biopharma have entered a global, strategic partnership and licencing agreement to discover and develop new immunostimulatory antibody-drug conjugates (iADCs). Astellas and Sutro will expedite the development of iADCs for three different biological targets. It can potentially enhance the anti-cancer effect.
German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). In 2016, the companies entered a strategic partnership to develop novel messenger RNA (mRNA) based PCVs.
Ablaze Pharmaceuticals is set to develop a new GPC3-targeted peptide drug candidate for the treatment of liver cancer in China. The agreement allows Ablaze to clinicallydevelop and commercialise the drug in Greater China. The company is licensing the first-in-class drug candidate under an existing deal with RayzeBio.
Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.
BioMed X has entered a research partnership with Sanofi to leverage artificial intelligence (AI) for drug development. Under the joint research project, a new research team will be set up at the BioMed X Institute in Heidelberg, Germany. The companies will select a varied group of skilled researchers for the project.
Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. What Differentiates Mid-Size CROs?
In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. And that has a lot of downstream consequences.” This trend, which Dr.
While there is no cure to this neurodegenerative condition, academics and companies are pushing through with research that could help patients and their families. Different approaches that are studied include antisense oligonucleotides (ASOs), and gene therapies, which are in early clinical trials.
Especially as we exited the blockbuster drug period of psychiatric development and trials were failing with huge placebo effects, I think we started realizing that the patients going into trials were not the real-world patients that were getting treated with drugs in the clinic.
Researchers at the Indian Institute of Science (IISc) have found that picolinic acid, a natural compound produced by mammalian cells, can block several disease-causing viruses such as SARS-CoV-2 and influenza A viruses. The Institute is now looking for partners in pharma companies to pursue further clinicaldevelopment of the findings.
VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinical trials, is aiming to enhance the efficiency and efficacy of clinicalresearch. This approach can speed up development and improve data quality, potentially leading to more effective and personalized therapies.
In this episode, Ayesha spoke with Mario Marcondes, MD, PhD, VP Head of ClinicalDevelopment at Nektar Therapeutics , a company focused on the discovery and development of novel therapies for autoimmune disorders and cancer. Dr. Marcondes is a licensed and trained physician, specializing in oncology and immune oncology.
This joint service offering, DRIVE™-Biologics, will leverage Abzena’s strength in design and developability, and cell line development through to commercial manufacturing.
For clinicalresearch professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Your CRO can also play a crucial role in helping you to understand existing precedents and how they apply to your study and overall development journey.
One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). A key provision of PDUFA VII is a budget and staffing increase for the Center for Biologics Evaluation and Research (CBER). Beefing Up CBER.
The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research and the Lupus Accelerating Breakthroughs Consortium (Lupus ABC) have launched the Lupus Research Alliance (LRA) in a bid to advance research for the condition. Asian, Hispanic, and Native American women are also at higher risk.
Parexel, one of the world’s largest clinicalresearch organizations (CROs) providing the full range of Phase I to IV clinicaldevelopment services, and the Japanese Foundation for Cancer Research (JFCR), the first and leading non-profit cancer research organization in Japan, has announced a strategic alliance to accelerate access to oncology clinical (..)
Accordingly, the development of non-opioid painkillers is experiencing a surge in activity and despite numerous novel targets receiving high levels of attention, cannabinoids have emerged as strong favourites to replace opioid-related medications. On 9 May, National Fentanyl Awareness Day was observed in recognition of the US opioid crisis.
Bayer has entered a strategic collaboration agreement with biotechnology company Bicycle Therapeutics to discover, develop, manufacture and commercialise Bicycle’s radioconjugates for a number of oncology targets. Bicycle will receive an upfront payment of $45m and up to $1.7bn as potential development and commercially based milestone fees.
Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinicalresearch, and how did you enter the field? We used drugs we developed in adults off-label in children.
Syneos said Panagos brings a wealth of leadership experience and industry knowledge, having previously held various executive roles within the healthcare and clinicaldevelopment sectors. Headquartered in North Carolina, Syneos offers contract research and commercial services to biopharmaceutical companies.
Angelini Pharma has entered an exclusive global development and commercialisation deal with JCR Pharmaceuticals to develop and commercialise new biologic therapies to treat epilepsy. The company will receive reimbursement of research expenses and an upfront payment, and will also be eligible for $505.5m
Poseida Therapeutics and Roche have signed a strategic partnership and licence agreement to develop allogeneic CAR-T cell therapies for hematologic malignancies. Roche and Poseida will also partner in a research programme for creating and developing next-generation features and enhancements for allogeneic CAR-T therapies.
ImmunoForge has expanded its licence agreement with Duke University in North Carolina, US, to jointly improve research and drug development opportunities. ImmunoForge chief technology officer Dr Jim Balance pioneered the clinicaldevelopment of peptide drugs genetically fused to ELPs.
Jayaprakash Kotha, MBBS, PhD, ASCP (SH), Vice President, Bioanalytical Laboratory Satish Kumar, MBB, Head of Process Improvement Continuous Innovation is a Cornerstone of Bioanalysis Approximately 80% of drugs that begin the research process fail to reach approval. What is one contributing factor that sets the 20% that do apart from the rest?
GSK has entered a strategic partnership with Wave Life Sciences to progress the discovery and development of oligonucleotide therapies for new genetic targets. The discovery alliance, with a preliminary research period of four years, will aid GSK in progressing up to eight programmes and Wave to develop up to three programmes.
Predictive Oncology and Cancer Research Horizons, a part of Cancer Research UK (CRUK), has collaborated to drive cancer drug development using the former’s PEDAL platform. This helps in more informed drug-tumour type combinations selection for clinicaldevelopment.
In this episode, Ayesha spoke with Arun Swaminathan, PhD, CEO of Coya Therapeutics , a company developing regulatory T cell (Treg) therapies targeting neurodegenerative, autoimmune and metabolic diseases. He began his career in clinicaldevelopment, taking on commercial roles of increasing responsibility at Bristol Myers Squibb and Covance.
Japan-based Astellas Pharma has entered a partnership with Cullgen to discover and develop multiple targeted protein degraders through the latter’s proprietary uSMITE targeted protein degradation platform, in a deal potentially worth $1.9bn. Astellas could pay Cullgen up to $85m upon using its license option regarding the deal.
Ono Pharmaceutical and Monash University have entered an option and research collaboration for the discovery and development of antibodies that target G protein-coupled receptors (GPCRs). The post Ono Pharmaceutical enters research deal with Monash University appeared first on Pharmaceutical Technology.
Gilead Sciences has entered an exclusive option and partnership agreement with MacroGenics for developing bispecific antibodies. Under the deal, the companies will leverage MacroGenics’ DART platform to develop MGD024 as well as two further bispecific research programmes.
A new CTTI publication , published in Clinical Pharmacology & Therapeutics , reviews current applications of disease progression modeling (DPM) and opportunities to advance the awareness and value of DPM in clinical trials.
Ongoing research will also explore rilzabrutinib’s potential in other immune-mediated diseases, underscoring its broader therapeutic possibilities. Rilzabrutinib stands apart by targeting upstream immune pathways through BTK inhibition, offering a distinct approach to managing ITP.
2seventy bio has announced a strategic collaboration with JW Therapeutics to expedite the research and development of T cell-based immunotherapies. This programme is currently being developed under a partnership with Regeneron. It is intended to develop T cell receptor (TCR) therapies for treating MAGE-A4 positive solid tumours.
UK psychedelic medicine specialist Beckley Psytech has raised an impressive £58 million (around $80 million) in an oversubscribed second-round financing that will help fund clinicaldevelopment of its psilocybin-based therapies. The post Beckley Psytech raises $80m for psychedelic meds development appeared first on.
Regeneron Pharmaceuticals has entered a collaboration and licensing agreement with CytomX Therapeutics for developing conditionally-activated bispecific cancer therapies. This collaboration will use Regeneron’s Veloci-Bi bispecific antibody development platform and CytomX's Probody therapeutic platform.
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