Today's Rundown ASCO: Amgen's KRAS drug shows 'modest' efficacy beyond NSCLC BMJ, Nature warn against 'sabotaging' COVID-19 response with poor and 'chaotic' trials J&J-backed CAR-T biotech Legend guns for $100M IPO but sees CRS death in early trial [Sponsored] The COVID-19 crisis: Five ways pharmaceutical leaders can rise to the challenge ASCO: Johnson & Johnson's anti-BCMA CAR-T, improving with time, sweeps multiple myeloma aside ASCO: Roche's closely watched TIGIT combo shows 2 checkpoint inhibitors could be better than one ASCO: Off-the-shelf CAR-T pioneer Allogene shows early hints of efficacy in lymphoma ASCO: Arvinas unveils first-in-human data for novel protein degrader in prostate cancer Thermo Fisher, WuXi and Mayo Clinic to develop open-platform COVID-19 antibody test Featured Story | | | Thursday, May 14, 2020 Amgen’s KRAS inhibitor has shown limited efficacy in early testing in patients with cancers outside of the lung. The study linked the high dose of AMG-510 to a response rate of 12% in colorectal cancer patients and found similar efficacy in other solid tumor types. |
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Top Stories Thursday, May 14, 2020 The BMJ warns that a “deluge of poor quality research [in COVID-19] is sabotaging an effective evidence-based response,” while Nature argues that more patients are needed for better trial results. Thursday, May 14, 2020 Legend Biotech is hoping it can ride the biotech IPO wave and take in a cool $100 million for its cell therapy work. Monday, May 11, 2020 Amid the COVID-19 crisis, Takeda leaders share five ways to adjust to protect people’s families, colleagues and community, while maintaining a commitment to the people who need Takeda’s medicines. Wednesday, May 13, 2020 Johnson & Johnson’s BCMA-targeting CAR-T therapy banished tumors in 86% of patients with advanced multiple myeloma in a phase 1b study, improving on the 66% figure posted five months ago. The treatment could help patients who face a "dismal prognosis" and generally live for just a few months with standard of care. Wednesday, May 13, 2020 The more checkpoint inhibitors the merrier—at least that’s what Genentech is hoping to prove. Its PD-L1 blocker Tecentriq combined with its experimental anti-TIGIT antibody shrank tumors in 31% of patients with metastatic lung cancer—twice as many patients as Tecentriq alone. The findings could pave the way for an approach that makes checkpoint inhibitors work for more people. Wednesday, May 13, 2020 Allogene reported an overall response rate of 78% in a phase 1 trial of its off-the-shelf CAR-T ALLO-501 combined with the antibody ALLO-647. Although it's still early days, CEO David Chang believes the results provide solid proof-of-concept that administering CAR-T cells from unrelated donors can be a viable strategy for treating non-Hodgkin lymphoma. Wednesday, May 13, 2020 Many widely used oncology therapies work by inhibiting cancer-related proteins. Arvinas has instead set out destroy those proteins altogether. The company, which boasts partnerships with Pfizer, Roche and Bayer, reported that two heavily pretreated patients with metastatic castration-resistant prostate cancer responded to its lead drug candidate. Wednesday, May 13, 2020 Thermo Fisher Scientific is developing its own COVID-19 antibody test through an ongoing, three-way collaboration with WuXi Diagnostics and the Mayo Clinic, and plans to seek international authorizations for the test over the next few weeks. | | Experts in our field; with 20+ years’ experience in Viral Vector & plasmid DNA (R&D, High Quality and GMP) manufacture for pre-clinical, clinical & commercial supply. Take a virtual tour of our facilities & find out more about our expansion project. |
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 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: 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. 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: 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: 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. | 