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Explore the current environment of cell therapies in solid and hematologic cancer. Discover lessons learned from the front lines of cell therapy trial conduct. Decode the nuances and strategies of oncology cell therapy research and development. Equip yourself with the knowledge to amplify your program.
Precision for Medicine – Realize More. 
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Today's Big NewsMay 24, 2023 |
| By Annalee Armstrong The FDA needs a wee bit more time to consider the approval of Sarepta’s gene therapy for Duchenne muscular dystrophy, however the agency has indicated an accelerated approval is likely in a restricted age group. |
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By Eric Sagonowsky After the recent high-profile loss of exclusivity for AbbVie's megablockbuster immunology drug Humira, industry watchers' eyes moved to Johnson & Johnson's Stelara as one of the next major drugs expected to face biosimilar competition. Tuesday, the industry got more information about when exactly that clash might occur. |
By Andrea Park As Abbott shaves down its COVID-related revenue forecasts, so too is the company whittling down its COVID test-making workforce. |
By Annalee Armstrong After a five and a half month wait, Mirati Therapeutics finally has the answer it’s been waiting for on a lung cancer med called sitravatinib. The therapy didn't work. |
By Eric Sagonowsky Viatris Chairman Robert Coury has called the shots at Mylan and its successor Viatris for many years, but now he's getting ready to hang it up. |
By Max Bayer Friedemann Janus, Ph.D., may, as of now, only be leading Bayer’s business development team on an acting basis, but he'd like to lose the "interim" to his title. |
By Kevin Dunleavy Innoviva subsidiary Entasis has captured an FDA approval for Xacduro, a treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Xacduro targets bacteria known as Acinetobacter baumannii, a pathogen that can cause infections in the blood, urinary tract and lungs (pneumonia). |
By Max Bayer Annexon's geographic atrophy treatment failed to improve lesion growth in a phase 2 trial but did improve vision, which the CEO thinks will support a late-stage study. |
By Andrea Park As it transitions away from COVID-19 tests, shifting its focus back toward a range of other molecular diagnostics, Cepheid is also making some changes to its corporate makeup. |
By Zoey Becker Right after approving a new overdose reversal therapy, the FDA gave Braeburn's long-acting Brixadi an endorsement to treat opioid use disorder. |
By Gabrielle Masson Move over, ReNAgade. ElevateBio’s $401 million haul has already knocked the RNA company’s $300 million series A off the fundraising top spot after just one day. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we''ll discuss the recent biopharma layoff trends, plus Elizabeth Holmes, Sarepta Therapeutics, Abbott's FDA approval, and the rest of the week's headlines. |
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Friday, June 9, 2023 | 9am ET / 6am PT Plasmid DNA plays a very important role in cell and gene therapy, yet often manufacturing at large scale can present challenges for organizations looking to focus their efforts on therapeutic outcomes rather than bioprocessing roadblocks. Join this discussion to explore the latest opportunities, challenges, innovations, lessons learned and more. Register now. 
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Whitepaper ChatGPT shows promise in drug discovery for information extraction, scientific text authoring, hypothesis prediction, and chemical entity prediction. This whitepaper explores its potential to streamline research, delving into its technology, applications, and limitations. Sponsored by: Elucidata Corp., Cloud SAAS in Life Sciences R&D |
Whitepaper Learn how a GPCR-focused library with a cell-based biopanning strategy led to the discovery of 13 high-affinity and selective anti-GLP-1R antibodies with highly developable therapeutic properties. Sponsored by: Twist Bioscience |
eBook Discover a game-changing approach to clinical research with Hybrid and Decentralized Clinical Trials (DCTs). Learn about the benefits, challenges, and key elements for success. Sponsored by: EvidentIQ |
Research What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how. Sponsored by: CCC |
Whitepaper This paper focuses on stakeholder engagement and how Medical Affairs teams’ responsibilities, goals, tools, and techniques are changing. Sponsored by: Blue Matter, strategic consultants in the life sciences |
Research Strategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies Sponsored by: H1 |
Whitepaper Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment. Sponsored by: Catalent Clinical Supply |
Whitepaper Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific. Sponsored by: Catalent |
Whitepaper As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs. Sponsored by: Catalent |
Whitepaper For sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management. Sponsored by: Catalent |
Whitepaper Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region. Sponsored by: Catalent |
Whitepaper How can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis. Sponsored by: Catalent Clinical Supply |
Whitepaper Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial. Sponsored by: Catalent |
Whitepaper Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world. Sponsored by: Catalent |
| July 18-19, 2023 | Jersey City, NJ |
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