Featured Story | By Ben Adams Mikael Dolsten, M.D., Ph.D., Pfizer’s chief scientific officer and president for worldwide R&D and medical, is clear: The company's COVID-19 vaccine is here because of a decade of R&D work and taking major risks itself while not asking for government handouts. read more |
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Top Stories By Ben Adams It’s not been a great week for GlaxoSmithKline’s partnered R&D projects; after being forced to cull a major lung cancer trial with Merck KGaA, it’s now a case of déjà vu as it axes yet another experimental drug study. read more By Amirah Al Idrus Fighting the pandemic will remain a top priority in 2021, but just because we’re in a pandemic doesn’t mean all other diseases have stopped plaguing humanity. We asked executives which areas might see a resurgence this year, and neurology emerged as a popular horse to bet on. read more By Nick Paul Taylor The FDA has accepted Incyte’s PD-1 inhibitor retifanlimab for priority review in patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC). read more By Nick Paul Taylor The Biotechnology Innovation Organization has made “some staff reductions” as it faces up to the prospect of another year without the face-to-face events that were central to its pre-pandemic operation. read more By Conor Hale Shortly after Abbott completed its delivery of 150 million rapid antigen tests to the federal government, researchers at the CDC said the card-based diagnostic may fail to catch about two-thirds of asymptomatic cases. read more By Angus Liu Cancer metastasis is responsible for most disease-related deaths, but it’s hard to trace. Now, researchers led by MIT have developed a CRISPR-based method that helped them track the spreading patterns of tumor cells. What they learned could guide the development of new cancer drugs. read more By Angus Liu A fire broke out at a Serum Institute of India site and killed five. Previously treated stomach cancer has become the second U.S. indication for Daiichi Sankyo and AstraZeneca's Enhertu. Fujifilm plans to build an R&D-manufacturing facility in greater Boston. And more. read more By Fraiser Kansteiner Amir Reichman, global vaccines engineering core technology at GSK, is stepping down to pursue a CEO role at BiondVax. Covance's Maryland Franklin is stepping up to run Covance's cell and gene therapy business. Francesco Marincola joins as head of cell therapy research at Kite. read more Resources Sponsored by: Cytiva It’s an exciting time to pioneer what could be a life-changing medicine. Clear the path to the clinic with pro tips and expert insights from industry leaders. 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: Blue Matter Biopharma companies in rare diseases: How to maximize the odds of success by becoming a valued member of the unique “rare disease ecosystem.” Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: GenScript A significant number of new treatments have been approved so far, but some manufacturing and regulatory guidelines pose challenges for advanced therapies, leading to poor production yields. Sponsored by: Catalent Cell and gene therapies hold the promise to offer novel therapeutic avenues for individuals facing serious medical conditions, but bringing them through the clinical trial process introduces a level of supply chain risk and complexity. Sponsored by: AllianceRx Walgreens Prime Gene and cell therapy are shifting paradigms for manufacturers, patients, healthcare providers and pharmacies. We invite you to learn more by reading Gene and Cell Therapy: A New Age of Medicine. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Metabolon Learn six ways metabolomics provides greater confidence, higher success rates and complements the work of your in-house teams for your drug development pipeline. 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: 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: Premier Research Browse the latest learnings and insights from our clinical development professionals. 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: 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 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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