Today's Rundown Takeda, CSL-led alliance and NIH to test COVID-19 plasma treatment this summer Orchard Therapeutics cuts 25% of staffers, rethinks pipeline, closes California site Fortress joins KRAS race through Columbia University deal No respite for Solid Bio's troubled Duchenne program as FDA keeps it on hold After Alexion buyout, ex-Achillion nephrology lead jumps ship to Gemini Therapeutics Sorrento ventures into COVID-19 with Mount Sinai antibody pact Grail's 4th funding round nets $390M for its cancer-seeking blood test FiercePharmaAsia—Gilead's Japanese remdesivir nod, licensing talks; Lilly-Junshi COVID-19 antibody pact Chutes & Ladders—Johnson & Johnson elevates Khan to data science officer role Featured Story | | | Thursday, May 7, 2020 Takeda and its plasma-focused peers are wasting no time. One month after joining forces to create an unbranded plasma-based treatment for COVID-19, the partners, along with the NIH, are gearing up for a global clinical trial set to kick off this summer. The study will lay the groundwork for a regulatory submission for the medicine. |
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Top Stories Friday, May 8, 2020 Tough times at Orchard Therapeutics as it swings the ax across staffers and facilities, phases in new pipeline advances and reduces interest in others. Friday, May 8, 2020 Fortress Biotech has licensed a treatment for KRAS-driven cancers from Columbia University. Sticking to its blueprint, Fortress has set up a new biotech, Oncogenuity, to advance the preclinical asset and work to generate more oligonucleotides from the underlying platform. Friday, May 8, 2020 Solid Biosciences started 2020 by laying off one-third of its staff and “curtailing” most of its R&D to keep its Duchenne muscular dystrophy treatment afloat. Four months later, those efforts have yet to bear fruit. The FDA is keeping the program under a clinical hold despite Solid Bio’s efforts to appease the agency. Friday, May 8, 2020 Just a few months after Alexion snapped up complement inhibitor biotech Achillion, Gemini Therapeutics has nabbed one of its key R&D execs as its new chief medical officer. Friday, May 8, 2020 Sorrento Therapeutics is jumping into the race to develop therapies against COVID-19, teaming up with Mount Sinai to develop a cocktail of antibodies from the blood of 15,000 recovered patients. The company's scientists believe their multipronged therapy will sidestep risks such as treatment resistance. Thursday, May 7, 2020 Grail has secured its fourth nine-digit-plus financing round, bringing its total funding to nearly $2 billion as it looks to complete the clinical testing of its cancer-seeking blood test. Friday, May 8, 2020 Gilead Sciences' remdesivir, now called Veklury, has won a fast Japanese nod in SARS-CoV-2. The Big Biotech's scouting licensing partners to ramp up supply around the world. Eli Lilly has signed on China's Junshi Biosciences to develop neutralizing antibodies against the novel coronavirus. And more. Friday, May 8, 2020 Johnson & Johnson taps Khan for chief data role; Icon poaches AstraZeneca vet Buck as CMO; Intellia signs on Lebwohl as CMO. Enrollment Showcase | | | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
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Resources Sponsored by: Patheon, by Thermo Fisher Scientific Continuous Manufacturing vs. Batch for Oral Solid Dose Sponsored by: Cenduit, LLC Download this case study to read about how Cenduit navigated these challenges, and successfully supports the trial sponsor to execute the umbrella trial with agility. Sponsored by: Patheon, by Thermo Fisher Scientific Download this whitepaper to learn more about the importance of an integrated approach to formulation. Sponsored by: Acorn AI by Medidata, a Dassault Systèmes company Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI. Presented by: Optum The immediacy of EHR data availability can be significantly impactful, particularly as the health care system works to address COVID-19. Download this whitepaper to learn more. Sponsored by: Clarify Health Pharma launch teams spend significant resources on data and analytics with limited ROI. Read this case study to learn how a Life Sciences company identified two times more patients best suited for therapy, using Clarify’s deep and longitudinal patient and HCP insights. Sponsored by: Recro Gainesville Wurster processing is a versatile technique for developing and manufacturing multiparticulates for modified release dosage forms. Read this whitepaper to determine whether Wurster processing is the right option for your project. Sponsored by: AMRI In this webinar, the featured speaker will explore the key advances and critical hurdles for translating these emerging molecular biology technologies into real-world applications and commercial processes. Sponsored by: Quotient Sciences Tufts Center for the Study of Drug Development (CSDD) white paper sharing study results that indicate Quotient Sciences’ Translational Pharmaceutics® platform reduces development times by more than 12 months and lowers R&D costs by more than $100 million per approved new drug. Download the whitepaper. Sponsored by: Blue Latitude Health Report: Think you’re patient-centric? Think again. Find out how patients really feel about patient-centricity. Learn what they would like to experience along with tools and tips for maximising patient engagement across the product life cycle¬ – from clinical trials to service design and creative campaigns. Sponsored by: Lonza This whitepaper summarises approaches for modulating antibody effector functions and pharmacokinetics, and provides examples of antibodies in clinical studies. Sponsored by: Oracle Health Sciences The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need. Sponsored by: BBK Worldwide Leverage strategic solutions to respond to immediate challenges to patient and site engagement from COVID-19, and learn to maximize the FDA guidance on the conduct of clinical trials during a pandemic. Sponsored by: Copyright Clearance Center Despite advances in content aggregation and search, silos still limit the free flow of data and analytics. So, what can be done, and how can you get more value from the data you already have? Sponsored by: Outer Edge Technology To survive in these challenging conditions, companies need to promptly address business continuity issues - especially the remote delivery of data and voice solutions. See how Outer Edge can help. Sponsored by: Patheon, by Thermo Fisher Scientific Poorly soluble molecules hindering your workflow? 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. 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 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: 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. Medical Affairs Strategic Summit (MASS) East April 14-16, 2020 | New Brunswick, NJ 8-week Online Courses in Life Sciences Law and Compliance Virtual Course | May 31st, 2020 PEGS Virtual Interactive Summit Virtual Event | June 2-26, 2020 European Healthcare Compliance Certificate Program June 2-5, 2020 | Paris, France BIO 2020 Now Fully Virtual: Announcing BIO Digital June 8-11, 2020 | Virtual Event Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now! Pre-Boot Camp training is in session. | Take your new medicine development skills to the next level. | 