Today's Rundown Pfizer drops muscle-growth antibody after it misses phase 2 endpoint in DMD Sutro Biopharma eyes $75M IPO to push antibody-drug conjugates Sophiris eyes phase 3 after clearing patient death from its lead study FDA starts pilot to help sponsors use novel trial designs Vertex taps Genomics for target discovery help, makes investment RegenXBio adds another CNS program to gene therapy plans Sequoia leads $7M seed round for T-cell player RootPath Featured Story | | | Thursday, August 30, 2018 Pfizer halted two ongoing phase 2 trials of its Duchenne muscular dystrophy drug domagrozumab after the main efficacy study failed to meet its primary endpoint after one year of treatment. |
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Top Stories Thursday, August 30, 2018 On the heels of an $85 million private round, Sutro Biopharma has filed to raise up to $75 million in its IPO. The funding will support the clinical development of two antibody-drug conjugates being developed for blood cancers and solid tumors. Thursday, August 30, 2018 Sophiris Bio has completed its investigation into the death of a patient that halted additional dosing in a trial of its lead candidate topsalysin two months ago, finding its procedure for localized prostate cancer was unlikely to be the cause. Thursday, August 30, 2018 The FDA has initiated a pilot program to help drug developers use complex innovative trial designs. Sponsors accepted into the four-year pilot will meet twice with the FDA to discuss regulatory approaches to CID. Thursday, August 30, 2018 Vertex has joined with Genomics to use genetics and machine learning to improve target discovery. The partnership will leverage a platform that collates and analyzes genotype-phenotype studies to uncover insights into the underpinnings of disease. Thursday, August 30, 2018 Fresh from its latest $175 million fundraising, gene therapy specialist RegenXBio has added another program to its pipeline, its third in neurodegenerative diseases. Thursday, August 30, 2018 RootPath has raised $7 million in seed funding to develop a T-cell therapy platform for cancer treatment that addresses the shortcomings of current technology. | This week's sponsor is ExL Events. | | Let’s talk about success: Technology transfer with a CMO partner | ExL's 5th Technology Transfer for Biologics Conference
Gain expert insights on how to create successful partnerships with CMOs and the partnership management skills needed to maintain biologics quality at every step of process transfer.
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Resources Sponsored by: AWS and Tableau Inova is using the capabilities of Tableau on AWS to identify biomarkers for personalized treatment intended to improve health outcomes for children. Sponsored by: AWS and Reltio Reltio and IQVIA provide holistic data management solutions for traditional pharma, emerging biotech, and consumer health companies, on AWS. Presented by: AWS and Druva Life Sciences organizations are embracing cloud-based Master Data Management (MDM) to modernize the organization of critical data. Sponsored by: Health Strategies Group The window of market exclusivity continues to narrow dramatically in the global marketplace. Given this demanding environment, your global market access team faces increasing urgency to get the value proposition right at the time of launch. 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: 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 RESI HealthTech Week September 5-7, 2018 | Boston, MA 2018 Latin America Healthcare Compliance Certification Program September 24-27, 2018 | Sao Paulo, Brazil 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 | 