Featured Story | By Amirah Al Idrus Tyrosine kinase inhibitors, or TKIs, were a game changer for patients with chronic myeloid leukemia. But many patients still miss out on the benefits because their cancer develops resistance, or they can’t tolerate the side effects. Novartis is working on a new drug for these patients—and its latest data look good. read more |
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|  | Balancing Cost, Time and Quality When you support many clinical studies, one thing is certain—you gain experience. Explore critical factors in the packaging design process that can help to deliver the best possible outcome for your study. |
Top Stories By Nick Paul Taylor Amgen is set to file for FDA approval of its KRAS G12C inhibitor sotorasib by the end of the year. The plan positions Amgen to become the first company to win approval for a drug against the historically undruggable KRAS. read more By Angus Liu The FDA has released its internal review documents ahead of the closely watched COVID-19 vaccine advisory committee meeting scheduled for Thursday—and they bode well for Pfizer and partner BioNTech's prospects for securing a quick emergency use authorization. read more Sponsored By: NYCEDC The life sciences sector in New York City is on pace to raise $1B in venture funding in 2020, up from just $40 million ten years ago. In addition to NYC’s outstanding talent and funding, the city is rich with life science real estate offerings across the five boroughs. read more By Amirah Al Idrus People with hemophilia B lack a protein that helps their blood clot, so they rely on lifelong infusions of that protein to manage their disease. UniQure and CSL Behring’s hemophilia B gene therapy could transform chronic care into a one-time treatment—and its latest data suggest it could work for patients considered unsuitable for gene therapy. read more Sponsored By: RBC Capital Markets Biotech IPO markets are booming. But even in a boom, identifying the right time to go public and telling your post-IPO story for how capital deployment translates to value for investors is critical. read more By Nick Paul Taylor Forbion has raised a €460 million ($558 million) early-stage venture capital fund. The fund hit its hard cap weeks after opening, adding further evidence of the willingness of investors to back experienced European VC shops. read more By Leah Vann Drugs normally target problematic proteins, but Peter Smith believes his team at Remix Therapeutics can disrupt the process of a protein’s creation before it starts causing disease. Investors believe in him, too—the company launches with $81 million in funding to develop small molecules that reprogram RNA processing. read more By Amirah Al Idrus Alzheimer's disease may be the big target in neurodegeneration, but Vigil Neuroscience is taking aim at a smaller one, at least at first. The startup is betting on a new angle—one that focuses on the immune cells of the brain—and focusing on rare indications before expanding into larger ones. read more By Kyle Blankenship Given the enormous manufacturing challenges posed by COVID-19, big biopharma players have increasingly leaned on contract manufacturers to help out. In anticipation of what could be multiple successful COVID-19 vaccines in the near future, Fierce Pharma has assembled its list of the top 10 contract manufacturers in the fight against COVID-19. read more Resources Sponsored by: ZS Learn how Aerie fueled their product launches with advanced analytics. Sponsored By: Elligo Health Research® Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper Sponsored By: Thermo Fisher Scientific Lack of resources to move from lab concept to the manufacture/delivery of GMP clinical supplies to patients, key milestones can be missed. Sponsored by: Cytiva Human pluripotent stem cells (PSCs) have huge potential to produce cell therapies for many clinical areas. Here we describe a controlled, automated, and defined manufacturing process to fuel demand. 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. 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: 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: 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: 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. | 
