Featured Story | By Nick Paul Taylor The U.K. government has asked the national regulator to consider clearing AstraZeneca’s COVID-19 vaccine for temporary supply as soon as it receives safety, quality and efficacy data. Requesting use of the fast track positions the U.K. to be among the first countries to begin a COVID-19 vaccination campaign. read more |
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|  | The Challenge of Keeping Cool Pharmaceutical drugs must be maintained within strict temperature guidelines to protect the efficacy of the product. Learn about end-to-end temperature management for the clinical supply chain. |
Top Stories By Nick Paul Taylor Biogen is paying $1.5 billion upfront for a stake in Sage Therapeutics’ once-failed depression therapy zuranolone and an earlier-phase asset. The agreement gives Biogen rights to a drug that is closing in on data from three late-phase trials that will shape its future. read more By Ben Adams As Moderna continues to drip-feed the latest data from its late-stage COVID-19 vaccine effort, it has updated the shot’s efficacy figure. read more Sponsored By: RBC Capital Markets 2020 is on track to post the highest number of biotech IPOs in five years. But the pandemic and today’s shifting market have rewritten the rulebook. What are the new best practices for going public? read more By Amirah Al Idrus There is a host of treatments for people with asthma, from inhaled and oral corticosteroids to newer injected biologics. But these drugs don’t work for everyone, because different factors cause asthma in different people. Kinaset aims to close the treatment gap with a pan-JAK inhibitor designed to help patients regardless of what’s causing their disease. read more By Ben Adams U.K.-based alpha-synuclein biotech Wren will partner with Japanese pharma Eisai to seek out new ways of targeting neuro disorders. read more By Conor Hale The U.K. National Health Service is looking to get an early start on the international rollout of Grail’s multi-cancer blood test with a pilot program spanning 165,000 people. read more By Arlene Weintraub Researchers led by Emory re-engineered human adenovirus so it can’t be captured by the immune system and sent to the liver for destruction. It prolonged survival in mouse models of metastatic lung cancer and cleared tumors in about 35% of the animals, they reported. read more By Conor Hale Nominations are open for private startups and companies from across the globe, whether they’re currently working in COVID-19 or not. read more Resources Sponsored by: Covance Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: Veeva New industry-wide research reveals that the quality and breadth of HCP data is imperative as commercial teams adjust to remote engagement and execute a tailored approach. Read the full report to see all findings and benchmark your organization’s progress. 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Sponsored by: Rousselot This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments. Sponsored By: Lonza Liquid-filled hard capsule formulations offer unique options for the manufacture and dosing of highly potent actives. Sponsored By: Thermo Fisher Scientific One of the best ways to stay on-schedule is to start with a solid understanding of the most common API challenges. Awareness will help you choose a development partner with the ability to solve issues before they affect your timeline. Sponsored By: Clinical Ink This white paper covers a Phase III case study; BYOD advantages and misconceptions; and regulatory, copyright, and equivalency considerations. Sponsored By: Thermo Fisher Scientific Anticipate early development challenges to avoid rework and costs. Sponsored By: Cytiva Accelerating the production of viral-vector based therapy requires both understanding of strategies to address viral vector manufacturing and how to select the most cost-effective solution for your therapeutic. Read more in this article. Sponsored by: Aldevron Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience. Sponsored By: Outer Edge Technology A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success. Sponsored by: Catalent In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. Sponsored by: Outer Edge Technology Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now! Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. 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: 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: 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. | 
