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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 22, 2023 |
| By Fraiser Kansteiner,Zoey Becker,Angus Liu,Eric Sagonowsky,Kevin Dunleavy Many of the drugs on this list will be well known to industry watchers. Last year, bluebird, plus CSL Behring and uniQure, nabbed three gene therapy nods in quick succession. Elsewhere, Novartis’ established gene therapy Zolgensma continues to orbit the top of the price rankings. |
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| San Diego, CA |  |
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By Nick Paul Taylor Novartis is buying a gene therapy candidate from the cash-constrained Avrobio, striking an unusual deal that will see it pay $87.5 million without committing milestones or royalties to land the clinical-phase asset. The news comes months after Novartis was reported to be lining up a takeover of Avrobio. |
By Annalee Armstrong Fierce Biotech is once again seeking your nominations for the best, most exciting and innovative private biotechs. |
By Andrea Park According to the FDA, Beta Bionics’ system is not only an improvement over standard, non-algorithm-guided insulin pump therapy, but is also easier to set up than other currently available artificial pancreas systems. |
By Ben Adams Any publicity, even bad publicity, is good. So goes the old saying, but, for Novo Nordisk, too much publicity for its popular weight-loss drug Wegovy is becoming a bad thing, forcing the Danish drugmaker to turn off the marketing tap for the drug. |
By Annalee Armstrong Bristol Myers Squibb’s idiopathic pulmonary fibrosis therapy reduced the rate of lung function decline in a phase 2 study, providing the evidence needed to start thinking about a late-stage trial. |
By Andrea Park The buyout hands Freenome the reins of Oncimmune’s autoantibody platform and R&D pipeline, as well as its EarlyCDT Lung blood test, which is already CE marked for use in detecting lung cancer in its earliest stages. |
By James Waldron Having tasted blockbuster success with its IBS drug Linzess, Ironwood Pharmaceuticals is willing to pay $1 billion for the chance to make lightning strike twice. |
By Kevin Dunleavy Sanofi is touting the advantages of Dupixent in COPD, along with the prospects of its other pipeline treatments for respiratory disorders. These include SAR’765, which targets two pathways and has the potential to become the most effective biologic in asthma, the company said. |
By Zoey Becker The recommendation gives Bayer another boost in its quest to make its key growth driver Nubeqa a blockbuster. As for AstraZeneca, the company's Forxiga becomes the first NICE-recommended treatment in this specific heart failure indication. |
By Annalee Armstrong Storm clouds are brewing for Rain Oncology after its lead asset failed to improve progression-free survival versus chemotherapy in a phase 3 trial of patients with liposarcoma. |
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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