Featured Story | By Nick Paul Taylor Moderna’s phase 3 COVID-19 vaccine has hit its primary endpoint with efficacy of 94.5%. Ninety cases of COVID-19, including all 11 severe cases seen so far, happened in the placebo cohort, versus five cases among people who received mRNA-1273. read more |
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|  | Sterile Filling with Eurofins Eurofins BioPharma Product Testing can help eliminate human error and other associated risks when producing small batches of sterile GMP product for Phase 1 and 2 trials using our state-of-the-art vial filler. Learn More. |
Top Stories By Amirah Al Idrus More women are climbing to the top of the corporate ladder than ever before. This report recognizes 20 of them: women who lead the charge in life sciences, in everything from research to business development to regulatory to commercial, or have outright built and run their own companies. read more By Nick Paul Taylor Gossamer Bio has reappointed Faheem Hasnain as CEO one month after its lead drug failed in phase 2. Hasnain, the former CEO of Receptos, ran Gossamer Bio early in its history before handing off to Sheila Gujrathi in 2018. read more Sponsored By Cytiva The right automation design can meet your initial needs and be expanded for your future growth. Planning for success takes a little effort upfront but can pay huge dividends in the long run. read more By Ben Adams Johnson & Johnson is confident that it has a one-dose knockout vaccine that can protect against COVID-19, but it’s now starting a late-stage two-dose test just in case. read more By Amirah Al Idrus Luciano Rossetti is checking all the boxes. After nearly two decades in academic medicine and almost as long leading R&D teams at Merck KGaA and Merck & Co., he’s jumping over to the venture world as Flagship Pioneering’s first chief medical officer. read more By Amy Sokolow,Amirah Al Idrus Could a little-known organelle be the key to new treatments for diseases like Alzheimer’s and amyotrophic lateral sclerosis (ALS)? Apple Tree Partners is betting $50 million on it, creating Nereid Therapeutics with Princeton University biophysicist Clifford Brangwynne, Ph.D., to drug those organelles. read more By Conor Hale Genetic code has served as the basis of the human story for millennia. Now, a group of tech and medtech companies aims to spin digital data into DNA itself to archive information in the arrangement of its molecules. read more By Arlene Weintraub One of the most sought-after targets in immuno-oncology is “don’t eat me” signaling, a process by which cancer cells prevent immune cells from engulfing and killing them. OSE Immunotherapeutics showed in preclinical studies that blocking a checkpoint called CLEC-1 disrupts don't-eat-me signals and restores the T-cell attack on tumors. read more Resources Sponsored By: BBK Worldwide The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement. Sponsored By: WCG Need additional site resources for your current or upcoming clinical trial? Sponsored By: Veeva One sentence that will be displayed in the newsletter and should be written to grab the interest of your audience to want to read more. Sponsored By: BioAnalytix Download this eBook and Learn the Advantages of LC-MS based HCP Profiling for Development of Complex Biologics. Sponsored By: Polpharma Biologics Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards. Sponsored by: Premier Research Browse the latest learnings and insights from our clinical development professionals. Sponsored By: Medidata Responding to site challenges. Approaching virtualization. Leveraging real-time data. Medidata shares 8 parameters to implement your virtualization strategy during COVID-19 and beyond. Download Now. 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: LexisNexis Risk Solutions Get insights into healthcare decision-makers networks. 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: Formedix Learn how to save time and reduce costs and complexity by streamlining the clinical trial process. 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. | 
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