| This week's sponsor is Premier Research. | |  | Placebo Response: Mitigating the Threat to Pain Trials
Fibromyalgia Awareness Day, May 12, is a timely reminder of how placebo response can skew analgesia clinical trials. Our placebo problem eBook can help you take the pain out of pain trials. Premier Research. It's what we do. Best. |
Today's Rundown Featured Story | | | Monday, May 7, 2018 A new type of drug for depression has been a long time coming, and Johnson & Johnson is looking increasingly likely to end the drought with esketamine—even though one of its late-stage trials missed the mark. |
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| This week's sponsor is Deloitte. | |  | |
Top Stories Monday, May 7, 2018 Atara Biotherapeutics has named Dietmar Berger, M.D., Ph.D., as its global head of R&D. Berger joins after seven years at Roche’s Genentech, during which time he had a hand in the approval of drugs including PD-L1 checkpoint inhibitor Tecentriq. Monday, May 7, 2018 Allogene Therapeutics is looking to sign on veteran biotech analyst Eric Schmidt as its new chief financial officer. The startup launched last month with an array of off-the-shelf CAR-T assets and $300 million in series A funding. Monday, May 7, 2018 Avoid delays in gene transfer trial start-up with tips from leading IRB and IBC experts. Monday, May 7, 2018 Promore Pharma has granted PharmaResearch Products the global license to commercialize PXL01 in the prevention of fibrosis after spinal surgery. The agreement sees PharmaResearch committing to fund development of the synthetic peptide in the indication and hand over milestones and royalties. Monday, May 7, 2018 The European Medicines Agency has validated Auris Medical’s design for a new phase 3 trial, mapping out an approval pathway for its acute hearing loss treatment, AM-111, and giving the company hopeful news after the drug failed in a clinical study late last year. Monday, May 7, 2018 Even though CRISPR offers the promise of cutting out disease-causing genes, it can also make unintentional edits to healthy DNA. A new gene-editing tool is designed to act more like the search-and-replace function in word processing, precisely cutting out genetic variants, then helping DNA repair itself to lessen off-target effects. Monday, May 7, 2018 Sarepta Therapeutics has partnered with genetic testing company Invitae to identify participants for its Duchenne muscular dystrophy (DMD) clinical trials. The initiative taps into the networks Invitae has built up to connect sponsors to patients and the clinicians responsible for their care. | This week's sponsor is LabConnect. | |  | SciOps Provides Solutions for Lost Samples, Missed Timelines and Scientific Personnel Needs
Managing outsourced studies can be challenging. Read how our team’s functional and strategic resourcing services allow you to focus on other core competencies. |
Resources Sponsored by: Seton Hall Law 4-day interactive educational program trusted by multi-national companies as part of their compliance training for employees. Explore legal, regulatory and ethical issues faced by pharmaceutical, biotech and medical device manufacturers operating globally. Visit event homepage for session topics. Sponsored by: USDM Life Sciences What are the biggest trends in life sciences this year? Presented by: Patheon There are many parenteral dosage forms from which the pharmaceutical scientist can choose to develop their drug product. In this article, the author discusses the choices available and strategies which can be employed at the different stages of development. Sponsored by: Veeva Systems Explore a new model for events management, and learn how to deliver more value. Sponsored by: Veeva Systems To deliver value to key opinion leaders, medical affairs needs to tailor their engagement with deeper analytics and insights. Sponsored by: Veeva Systems Learn how leading companies, from the world’s top pharma to emerging biotechs, are empowering their medical affairs teams. Sponsored by: Veeva Systems Learn how to reduce change management burden, keep systems current, and maintain compliance by applying a risk-based approach to change management of GxP systems. Sponsored by: Veeva Systems UCB took a more holistic approach to managing regulatory processes. Read how their efforts are paying off. Sponsored by: Veeva Systems Find out how to eliminate regulatory’s tracking spreadsheets for good. Sponsored by: Veeva Systems Learn how cloud-enabled solutions provide real-time insights and actionable analytics to improve clinical trial safety and performance in this short presentation. Sponsored by: Docusign Life science companies are experiencing a significant transformation in how they bring new products to market. Drug Approval, Manufacturing Quality & Regulation 2018 | Online Translational Biomarkers: Advancing Neuroscience Drug Discovery and Development May 14, 2018 | South San Francisco, CA
MIXiii-Biomed 2018 May 15-17, 2018 | Tel-Aviv, Israel Drug Development Immersion May 17-18, 2018 | Boston, MA BIO International Convention June 4-7, 2018 | Boston, MA
FierceBiotech Executive Breakfast at BIO 2018 – CAR-T 2.0: Innovation Never Stands Still June 6, 2018 | Boston, MA BioBasics: Biotech for the Non-Scientist June 13-14, 2018 | Toronto, Canada BioBasics: Biotech for the Non-Scientist June 13-14, 2018 | West Windsor, NJ Sensors Expo & Conference Conference & Expo: June 26-28, 2018 | Pre-Conference Symposia: June 25, 2018 | San Jose, CA 18th International Biotechnology Symposium and Exhibition August 12-17, 2018 | Montreal, Canada FierceBiotech 3rd Drug Development Forum October 1–3, 2018 | Hilton Boston Logan Airport Hotel | Boston, MA Drug Development Boot Camp® 2018 November 14-15, 2018 | Boston, MA | Register and start preparing Today! | 
