| This week's sponsor is ReSolution Latin America. | |  | |
Today's Rundown Featured Story | | | Monday, August 13, 2018 Mustang Bio is licensing a treatment for X-linked severe combined immunodeficiency from St. Jude Children's Research Hospital. The rare disease gene therapy expands its pipeline beyond CAR-T treatment for cancer. |
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| This week's sponsor is Catalent. | |  | Article | The Importance of Clinical Returns Planning
Study sponsors often focus on upfront planning to ensure clinical sites are prepared to reach study milestones but ignore the logical challenges of managing their clinical returns. Learn how developing a forward-thinking plan to manage clinical returns can reduce study close out risk. |
Top Stories Monday, August 13, 2018 Orchard Therapeutics has raised $150 million (€132 million) to advance three gene therapies toward approval. The series C round continues a transformative year for Orchard defined by the acquisition of GlaxoSmithKline’s portfolio of approved and experimental rare disease gene therapies. Monday, August 13, 2018 MD Anderson Cancer Center and Accelerator Life Science Partners have co-founded a new company, Magnolia Neurosciences, to develop a new class of targeted neuroprotective drugs discovered by the cancer center’s researchers. Monday, August 13, 2018 With a novel therapy under FDA review, Insmed hopes to change the treatment paradigm for patients in the U.S. suffering from a rare and debilitating lung disease. Monday, August 13, 2018 U.K. startup Izana has begun recruiting patients into its phase 2a trial of its anti-GM-CSF antibody namilumab in ankylosing spondylitis, a severe form of arthritis affecting the spine. Monday, August 13, 2018 The FDA approved the first in a new class of self-administered hormonal contraceptives, formed as a reusable, flexible silicone ring that is placed in the vagina for three weeks at a time for a full year. Monday, August 13, 2018 “Game-changing” and “a tremendous achievement” are just a couple of the ways analysts and regulators described Friday’s approval of Alnylam RNAi drug Onpattro. But the biotech still has work to do if it wants to capitalize on the drug’s launch. | This week's sponsor is FierceBiotech. | |  | |
Resources Sponsored by: Patheon, part of Thermo Fisher Scientific “Faster and better” has become the mantra for biopharmaceutical companies as they face intense pressure to get therapies to market faster. Quickly proving efficacy in first-in-human (FIH) trials is a make-or-break milestone for these cash-strapped companies whose hopes hinge upon one or two molecules. Read how CDMOs are responding to this pressure. Sponsored by: PharmaCord When was the last time your patient support program perfectly aligned with the patient journey, solving all the critical gaps in positioning your brand for success? Follow the 3-D approach to your solution design, and you will achieve a better outcome for your patients. Sponsored by: WCG Selecting the right sites is the most crucial decision you’ll make in your next clinical trial, and the single most important factor to consider in selecting a site is whether or not it can meet its enrollment goals. Sponsored by: Veeva Industry Research: See new results from one of the industry's largest, global clinical operations surveys. Sponsored by: Medidata Accelerate Clinical Research as Study Complexity Grows Sponsored by: Veeva Ready to modernize your RIM environment? Secure buy-in with these tips. Sponsored by: Catalent Develop a basic understanding of principles and concepts of bioavailability of oral drugs. Drug Approval, Manufacturing Quality & Regulation 2018 | Online BIO Latin America 2018 September 4-5, 2018 | São Paulo, Brazil RESI HealthTech Week September 5-7, 2018 | Boston, MA 4th Annual Bio/Pharmaceutical Product Launch Summit September 25-26, 2018 | Cambridge, MA Drug Development Immersion September 26-27, 2018 | West Windsor, NJ FierceBiotech 3rd Drug Development Forum October 1–3, 2018 | Hilton Boston Logan Airport Hotel | Boston, MA Compliance Certification Program at Seton Hall Law October 8-11, 2018 | Newark, NJ BioImmersion: Biotech for the Non-Scientist October 16-18, 2018 | Chicago, IL 2018 BIO Investor Forum October 17-18, 2018 | Westin St. Francis, San Francisco, CA FierceBiotech Executive Summit: London October 30, 2018 | Royal Society of Medicine Drug Development Boot Camp® 2018 – Register Now! November 14-15, 2018 | Boston, MA | Register now and start your pre-Boot Camp preparation Field Service Amsterdam November 27-28, 2018 | NH Collection Amsterdam Grand Hotel Krasnapolsky | 
