Today's Rundown Swiss bio Addex halts Parkinson's test as trial delays tick up on COVID-19 disruption Iveric bio the latest to be hit by COVID-19 as it delays a key trial J&J sets sights on November for COVID-19 vaccine trial [Sponsored] Biogazelle launches novel high-throughput RNA sequencing and data analysis services Ex-Shire cancer leader raises cash for solid tumor research Sage to run 3 new studies to save once-failed depression drug Verily's COVID-19 testing website quickly reaches capacity: NYT Fast-moving Regeneron eyes summer clinical trial for COVID-19 antibody cocktail therapy Get ready to vote: FiercePharma's #FierceMadness drug name tournament is back Featured Story | | | Wednesday, March 18, 2020 Addex Therapeutics has seen its shares down 15% on the news that it has had to delay a registrational study of its Parkinson’s disease candidate. |
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Top Stories Wednesday, March 18, 2020 Iveric Bio has been forced to hit the pause button for a pivotal test on its leading drug Zimura as COVID-19 continues to back up clinical trials. Wednesday, March 18, 2020 Johnson & Johnson expects to land on a COVID-19 vaccine candidate by the end of the month, en route to clinical trials in early November, Paul Stoffels, the company’s chief scientific officer, told CNBC on Tuesday. Along the way, J&J will set up processes for widespread production of the vaccine. Monday, March 16, 2020 Biogazelle NV, a CRO specializing in genomics and transcriptomics, announced the launch of HTPathwaySeq and HTTargetSeq, two cost-effective high-throughput RNA sequencing and data analysis services. Wednesday, March 18, 2020 The former head of oncology research at Shire has raised money to go after a solid tumor target once pursued by his former employer. Randolf Kerschbaumer, CEO of OncoOne, is working with other ex-Shire employees to target oxidized macrophage migration inhibitory factor using several different modalities. Wednesday, March 18, 2020 Sage Therapeutics has plotted out how it plans to bounce back from the phase 3 failure of SAGE-217 in major depressive disorder. The strategy centers on three short-term studies Sage thinks may enable it to bring the GABA receptor positive allosteric modulator to market in multiple indications. Tuesday, March 17, 2020 A new pilot project designed to guide people toward local coronavirus testing developed by Google’s health-focused sister company, Verily, hit its capacity for test appointments within a few hours of its unveiling, according to a report from The New York Times. Wednesday, March 18, 2020 During the 2018 outbreak of Ebola, Regeneron quickly developed a promising monoclonal antibody triplet therapy that’s now under review by the FDA. Now, amid the ongoing coronavirus pandemic, the biotech is at it again, planning to advance a antibody cocktail into the clinic by early summer. Wednesday, March 18, 2020 College basketball March Madness may be cancelled, but the #FierceMadness drug name tournament is back with lots of borderline absurd, work-from-home distracting fun, now is its 5th year. Enrollment Showcase | | | Presented by: Global EMBA for Healthcare & the Life Sciences, University of Toronto Prepare to step up in your career, build the expertise you need to reshape your organization, and explore opportunities worldwide. |
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Resources Sponsored by: eClinical Solutions Key findings from the 2019 Life Sciences Data & Analytics Survey conducted by the Tufts Center for the Study of Drug Development will be unveiled during this live webinar led by industry expert and study lead, Ken Getz, Director of Sponsored Programs and Associate Professor. 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. 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. 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Sponsored by: Baxter When different drug products are produced in shared facilities, potential for cross-contamination needs to be addressed. Outsourcing to a CMO with experience in multiproduct facilities can be an option. Sponsored by: WCG Metrics Champion Consortium Ineffective measurement could mean wasting both time and money. This whitepaper showcases a custom-built Metric Maturity Model that helps illustrate and define the process for measuring the right things the right way. Sponsored by: Eagle Productivity Solutions Mediocre adoption rates aren’t due to poorly designed software or lazy users. They’re the result of how skills are trained. Achieve high adoption rates by implementing the right methodology with a focus on behavior change. Sponsored by: The Kinetix Group Read about the innovative ways payers are making smart moves in the healthcare game. Sponsored by: Catalent This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. Sponsored by: Blue Matter Consulting White paper describing how a biopharma company can successfully differentiate an oncology product when the clinical profile alone is not enough to get the job done. Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. Sponsored by: Catalent Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric. Sponsored by: Altran This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future. Sponsored by: Catalent Pharma Solutions In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey. Bioprocessing Summit Europe – Practical Solutions for Today’s Bioprocess Challenges March 24-26 2020 | Barcelona, Spain BioBasics 101: The Biology of Biotech March 26-27, 2020 | Boston, MA Clinical Trial Innovation Summit – Technology, Data, Operations, Oversight April 6-8, 2020 | Cambridge, MA Medical Affairs Strategic Summit (MASS) East April 14-16, 2020 | New Brunswick, NJ BioBasics 101: The Biology of Biotech April 16-17, 2020 | Philadelphia, PA Drug Development Immersion April 23-24, 2020 | Boston, MA European Healthcare Compliance Certificate Program June 2-5, 2020 | Paris, France BIO International Convention June 8-11, 2020 | San Diego, CA U.S. Healthcare Compliance Certificate Program June 8-10, 2020 | Newark, NJ Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. | 