| | Working on an early phase oncology trial? Your trial design can make or break it. Targeted therapies are a cornerstone of precision medicine and how you design your trial is a critical factor. Download our guide to stay on the path to success. |
Novo Nordisk’s concizumab trials can resume after safety trial halt Passage Bio slapped with gene therapy clinical hold MicuRx gets $7.8M top-up to push new antibiotic into the clinic VBL’s ovarian cancer drug comes though interim phase 3 review Scholar Rock’s experimental SMA therapy nabs speedy review voucher Eleusis sheds light on psychedelics that relieve asthma in rats with no mental effects Featured Story | By Ben Adams Danish drugmaker Novo Nordisk is opening up its bleeding disorder trials five months after they were stopped. read more |
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| | CROs rely on data analytics to provide sponsors with continuous clinical insight of trends that could predict safety, and more importantly, efficacy for investigational products. Learn more about strategies for data analytics and evaluation from our free white paper. |
Top Stories By Nick Paul Taylor The FDA has placed a phase 1/2 trial of Passage Bio’s GM1 gangliosidosis gene therapy PBGM01 on clinical hold pending further assessment of the risks associated with its delivery device, delaying the start of the study until around the end of the year. read more By Amirah Al Idrus Just last week, MicuRx nabbed nearly $43 million in venture funding to expand its antibiotics pipeline and gear up for its first launch in China. Now, the Sino-American biotech is topping that up with $7.78 million from a nonprofit focused on antimicrobial resistance to push another asset into human trials. read more By Nick Paul Taylor The independent data safety monitoring committee has cleared VBL Therapeutics to continue a phase 3 trial of VB-111 in ovarian cancer patients. VBL got the green light after the committee looked at unblinded overall survival (OS) data for the second pre-planned interim analysis. read more By Ben Adams The FDA has handed Scholar Rock a rare pediatric disease designation voucher, which can allow the biotech a speedy review of its leading of spinal muscular atrophy (SMA) hopeful SRK-015. read more By Arlene Weintraub A team of researchers at Eleusis discovered that structural characteristics of the 2C-H class of psychedelics help to control inflammation in rat models of asthma without causing behavioral side effects. They plan to apply what they learned towards building a pipeline of drugs to treat asthma, retinal disease and other disorders. read more | | Experts in our field with 20+ yrs. experience in Viral Vector & Plasmid DNA (R&D, High Quality, GMP) manufacture for pre-clinical to commercial supply. Now part of the Cognate BioServices family, Cobra has rebranded – look around our updated website. |
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Resources Sponsored by: Thermo Fisher Scientific How to select the right dosage form for your Phase I clinical supply. Sponsored by: Thermo Fisher Scientific Quality by Design (QbD) reduces risk within drug development, while bringing therapies to market quicker. Sponsored by: Evotec Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Acorn AI by Medidata, a Dassault Systèmes company Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI. Sponsored by: Paysign Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all. Sponsored by: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: PRA Health Sciences Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research. Sponsored by: Lonza Pharma & Biotech A novel spray-dried dispersion platform has been developed to faciliate high drug load applications Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now! Pre-Boot Camp training ongoing now. | COVID19 provisions – training will be on-site as normal. | New – may be possible for some individuals to access the training virtually in real time. | 